[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Boston University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":660},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,35,0,25,[9,44,74,99,125,146,172,198,226,248,273,303,328,355,379,406,435,464,488,508,536,562,582,605,632],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100610827","impact-of-federal-and-state-medications-for-opioid-use-disorder-moud-policy-changes-during-the-pandemic-100610827",false,"NCT07232641","Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic","Comparing Treatment Use, Retention, and Patient Outcomes Pre- and Post-implementation of Federal Policy Changes Regulating Buprenorphine and Methadone Treatment for Opioid Use Disorder","IMPACT","Inclusion Criteria:\n\n* Substance use disorder (alcohol and\u002For opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)\n\nExclusion Criteria:\n\n* None","ALL","18 Years",{"count":21,"type":22},185810,"ESTIMATED","OBSERVATIONAL","\"Gold-standard\" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide \"whole-patient\" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent.\n\nThis study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.",[26,27,28],"Substance Use Disorders","Alcohol Use Disorder","Opioid Use Disorder",[30],"Medications for opioid use disorder (MOUD)","RECRUITING","2026-07-01",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2026-06-30",{"date":39,"type":22},"2029-09",{"name":41,"class":42},"Boston University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100599850","hiv-testing-in-community-health-center-dental-clinics-100599850","NCT07089849","HIV Testing in Community Health Center Dental Clinics","TEETH","Inclusion Criteria:\n\nCommunity health center:\n\n* Must be located in Suffolk County in Massachusetts.\n* Must provide dental care services.\n* Must possess the infrastructure necessary for laboratory-based HIV testing and counseling or have an affiliation with a laboratory that provides these service.\n\nProvider:\n\n* Dental care provider working at a participating community health center during the study period.\n\nPatient:\n\n* Be 18 years of age or older.\n* Receive dental care at a participating community health center during the study period.\n\nExclusion Criteria:\n\nPatient:\n\n* Self-report to be HIV positive at the time of the RHT\u002F referral.\n* Had an HIV test within 12 months (self-report or documented in EHR).",true,{"count":53,"type":22},6715,"INTERVENTIONAL",[56],"NA","This is a cluster randomized trial among dental clinics (n=4) to evaluate whether rapid HIV testing (RHT) during dental visits improves HIV testing rates compared to referral for laboratory HIV testing. Clinics will be randomized to either RHT or referral for HIV testing for a nine-month period - HIV testing will be offered to n\\~6700 patients by \\~ 15 dental providers (dentists and dental hygienists). Outcomes will be assessed using electronic health record reports (EHR), which will include the completion rates of HIV testing among dental patients (84 days after dental visit) and the frequency at which dental providers offer HIV testing (Upon completion of the 9-month testing period).\n\nThe objectives of this study are to:\n\n* Compare the effectiveness of on-site rapid HIV testing versus referral to a CHC lab in increasing HIV test completion within 84 days of a dental clinic visit, using EHR data.\n* Assess the sustainability of the HIV testing protocol by evaluating changes in dental clinic HIV testing rates over time.",[59],"HIV",[61,62,63,64],"Rapid HIV test","Referral for HIV test","Community Health Center Dental Clinics","Behavioral Model for Vulnerable Populations","NOT_YET_RECRUITING","2026-06-29",{"date":32,"type":35},{"date":69,"type":22},"2026-09",{"date":71,"type":22},"2028-03",{"name":41,"class":42},4,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":54,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100522873","texting-to-reduce-human-immunodeficiency-virus-hiv-risk-100522873","NCT06088277","Texting to Reduce Human Immunodeficiency Virus (HIV) Risk","Texting in Community Health Center Dental Clinics to Reduce HIV Risk","Inclusion Criteria:\n\n* Give informed consent and document consent via a signed and dated informed consent form in REDCap\n* Willing to comply with all study procedures and be available for the duration of the study\n* Be able to read either in English or Spanish\n* Be a dental clinic patient of record at one of our participating community health centers\n* Has at least one risk factor for HIV defined as self-report of at least one of the following: Men who have sex with men; multiple sex partners, or intravenous drug use\n\nExclusion Criteria:\n\n* Self-report of having HIV infection\n* Participating in another HIV study or another text message study\n* A woman who reports having sex exclusively with women\n* Does not have a mobile phone or other device which can receive text messages from Agile Health\n* Does not have unlimited texting on their mobile plan\n* Has not used any type of text messaging at least once in the past month\n* Single item literacy screening score of 2 or below.",{"count":82,"type":22},266,[56],"This is a 3-year study to test the efficacy of a text message-based intervention program. Dental patients at 4 community health centers (n= 266) will be randomized to receive either text messages (TMs) regarding HIV prevention or TMs regarding overall wellness. Prior to enrolling the 266 participants, the investigators will conduct a feasibility pilot (n=20) to test the TM delivery as well as all study procedures. For both the pilot and the randomized clinical trial (RCT), recruitment will be conducted at 4 Community Health Center dental clinics (Codman Square, East Boston (both East Boston and South End locations), Geiger Gibson, and Upham's Community Health Centers). Recruitment materials (flyers and permission to contact forms) may also be made available at other clinics within the health centers.\n\nThe study will enroll English and Spanish-speaking patients who have at least one risk factor for HIV but are HIV-negative. Patients enrolled in the pilot will complete self-report surveys at baseline, 1 and 2 months. Participants enrolled in the RCT will complete self-report surveys baseline, 3, 6, and 12 months after baseline; receive and respond to TM assessments during the 6-month intervention.",[86],"HIV Infections",[88,63,89,90,91],"Dental patients","Text messaging","HIV negative","HIV testing",{"date":32,"type":35},{"date":94,"type":35},"2024-08-16",{"date":96,"type":22},"2027-04-14",{"name":41,"class":42},2,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":54,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100608290","integrating-uu-into-hiv-counseling-in-south-africa-intuit-20-100608290","NCT07199634","Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)","Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0): a Cluster-Randomized Trial","Inclusion Criteria-\n\nClinic inclusion criteria:\n\n* Public sector facility\n* Primary care, outpatient clinic\n* Follows national guidelines for HIV counseling\n* Has dedicated HIV counselors\n* At least 10 patients receiving HIV counseling per week (based on pre-study data)\n* Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART)\n* Is interested in participating, as indicated by \"sign-off\" from the head nurse \u002F facility director\n\nIndividual participant inclusion criteria:\n\n* Adult (at least 18 years)\n* Received HIV post-test counselling or adherence counseling\n* Able to consent\n* Provides informed consent\n* Speaks one of the primary study languages: English, Zulu, Sotho, Tsonga\n* Receives care at the facility as evidence by having a clinical record there\n\nIndividual participant exclusion Criteria:\n\n* Require acute medical care that would be hindered by participation in the study\n* Determined by clinical staff not to be physically or emotionally able to initiate ART\n* Children (under 18 years).\n* Prisoners or other institutionalized persons.\n* Do not speak one of the primary study languages: English, Zulu, Sotho\n* Are not able to consent (e.g. intoxicated or of limited mental capacity)\n* Do not consent to participate in the study, including linkage to clinical records for follow-up",{"count":107,"type":22},880,[56],"Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally. Many PLHIV delay or avoid ART because they feel healthy and perceive little benefit, while also fearing stigma, disclosure, and social costs. U=U offers powerful motivation for ART uptake and adherence by reframing treatment as both a personal health and prevention tool, reducing internalised stigma, strengthening self-image, and supporting HIV prevention altruism. Yet, dissemination in Africa has lagged. To address this, the investigators developed an HIV treatment literacy App called \"Undetectable \\& You\", which delivers accurate U=U information alongside real-life video testimonials of PLHIV and their partners. This research will assess the impact of the \"Undetectable \\& You\" App in a cluster-randomized trial in South Africa. The study will establish whether disseminating U=U information via a video-based app at the time of HIV counselling improves retention in care and viral suppression among PLHIV in South Africa.\n\nAim 1. Refine the \"Undetectable \\& You\" App to help PLHIV navigate U=U within relationships.\n\nAim 2. Establish the real-world impact of \"Undetectable \\& You\" on retention on ART and viral suppression in a cluster-randomized trial.",[59],[112,113,114,115,116],"HIV Counseling South Africa","Antiretroviral treatment (ART)","Person living with HIV (PLWH)","Undetectable=Untransmittable (U=U)","Viral load","2026-06-22",{"date":119,"type":35},"2026-06-25",{"date":121,"type":22},"2026-08",{"date":123,"type":22},"2029-01",{"name":41,"class":42},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":54,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":98},"100511043","mitigating-the-impact-of-stigma-and-shame-among-people-living-with-hiv-and-substance-use-disorders-100511043","NCT05934305","Mitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders","Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among People Living With HIV and Substance Use Disorders","MATTER","Inclusion Criteria:\n\n* HIV+\n* Meet criteria for an illicit (not solely including tobacco, cannabis, or alcohol) SUD\n* Endorse internalized stigma related to HIV, substance use, sexual orientation, or gender-identity\n* Either the participant reports a detectable viral load during past year OR if on oral ART, they report \\\u003C80% adherence in the past month OR if on oral ART, they report missing \\>=7 days of ART in any month in the past year OR for those on long acting injectable (LAI) ART, they report a period of \\>=14 days in the past year between LAI ART injections OR has a detectable HIV viral load (\\>20 copies\u002F mL) in the past year confirmed by medical records or viral load test from blood drawn obtained as part of the baseline visit\n* Provide informed consent in English\n* Verbally communicate and read in English or Spanish\n* Be ≥18 years old\n* Provide evidence or documentation of HIV+ status\n* Release HIV-related health records\n* Have access to a cell phone with text capacity (study will supplement phones and plans as needed consistent with our pilot work).\n\nExclusion Criteria:\n\n\\- HIV-",{"count":134,"type":22},256,[56],"People living with HIV and substance use disorders (SUDs) are less likely to be virally suppressed, which can lead to HIV transmission and negative health outcomes. This hybrid type 1 study will assess the efficacy, mechanisms, as well as facilitators and barriers to implementing the MATTER intervention, a virtually delivered 5-session text-enhanced psychobehavioral intervention designed to facilitate viral suppression by addressing internalized stigma and shame as barriers to engagement in HIV care among individuals living with HIV and SUDs in two locations with different levels of HIV resources (i.e., the Boston, Massachusetts and Miami, Florida metro areas). MATTER aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) developing behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of emotions and cognitions), and c) teaching and reinforcing compassionate self-restructuring (i.e., self- compassion), in addition to providing access to phone-based resource navigation. Scalable interventions such as MATTER are essential to our efforts to end the HIV epidemic in high priority regions.",[138,26],"Hiv",{"date":140,"type":35},"2026-06-23",{"date":142,"type":35},"2025-03-12",{"date":144,"type":22},"2028-06-30",{"name":41,"class":42},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":54,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":43},"100556526","evaluating-interventions-for-intimate-partner-violence-use-in-washington-state-100556526","NCT06526247","Evaluating Interventions for Intimate Partner Violence Use in Washington State","Inclusion Criteria:\n\nMen:\n\n1. Identify as a man\n2. Provide consent for the research team to contact his intimate partner(s) for data collection purposes;\n3. Court-referred for IPV intervention in Washington state\n\nWomen:\n\n1. Identify as a woman\n2. Were or currently are an intimate partner involved in an incident of IPV with a court-referred participant\n\nExclusion Criteria:\n\n1. demonstrates active psychosis that may interfere with their ability to participate in group\n2. expresses prominent suicidal or homicidal ideation that requires hospitalization\n3. does not possess proficiency in spoken English\n4. periods of incarceration after study enrollment",{"count":153,"type":22},800,[56],"Intimate partner violence (IPV), specifically physical and psychological aggression toward an intimate partner, represents a public health crisis that affects millions of Americans each year. There currently exists very little evidence from randomized controlled trials for the effectiveness of abuser intervention programs designed to prevent and end perpetration of IPV in the general population. This is troubling considering that approximately half a million men and women are court-mandated to these programs each year.\n\nThe investigators will conduct a randomized controlled non-inferiority trial evaluating the effectiveness of the Strength at Home (SAH) intervention in reducing intimate partner violence (IPV). The overarching aim of this study is to determine whether outcomes achieved through SAH are non-inferior to those achieved through standard IPV interventions offered in the state of Washington (treatment as usual; TAU) among court-involved men who have used IPV.\n\nThe specific aims are:\n\n1.1: Compare the frequency of physical and psychological IPV, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across Time 1 (baseline) and four 3-month follow ups (Times 2-5). It is expected that reductions in physical and psychological IPV perpetration observed in SAH will be non-inferior to those observed in TAU over the course of the year.\n\n1.2: Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants. It is expected that reductions in PTSD symptoms, alexithymia, and alcohol use problems observed in SAH will be non-inferior to those observed in TAU over the course of the year.\n\n1.3: Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5). It is expected that treatment satisfaction in SAH will be comparable to or greater than treatment satisfaction in TAU.",[157],"Intimate Partner Violence",[159,160,161,162,163,164],"Strength at Home (SAH)","Trauma-informed","Treatment as Usual (TAU)","Posttraumatic stress disorder (PTSD)","Alcohol use","Washington state","2026-06-18",{"date":140,"type":35},{"date":168,"type":35},"2024-11-18",{"date":170,"type":22},"2027-07",{"name":41,"class":42},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":54,"phases":181,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":43},"100506777","written-exposure-therapy-for-suicide-prevention-100506777","NCT05878795","Written Exposure Therapy for Suicide Prevention","Written Exposure Therapy for Suicide Prevention (WET-SP)","Inclusion Criteria:\n\n* Current active duty military service member, veteran, and beneficiaries\n* Admitted to Carl R. Darnall Army Medical Center (CRDAMC) for suicidal thoughts, a suicide plan, or a suicide attempt\n* Elevated levels of suicidal ideation severity in the past two weeks, as indicated by a score \\>= 3 on the Depressive Symptom Index-Suicidality Subscale (DSI-SS)\n* Ability to read, write, and speak English\n\nExclusion Criteria:\n\n* Active psychosis as the priority of care for hospitalization\n* Moderate or greater cognitive impairment (as determined by the inability to comprehend the baseline screening questionnaires)\n* Unable to provide informed consent",{"count":180,"type":22},160,[56],"Military service members admitted to inpatient psychiatry for self-injurious thoughts and behaviors (SITBs) represent an at-risk group for continued SITBs and rehospitalizations in the post-discharge period. However, there is an absence of evidence-based interventions designed to be delivered on inpatient psychiatric units to reduce the risk of post-discharge SITBs. To address this gap, the investigator's research group developed Written Exposure Therapy for Suicide Prevention (WET-SP), a brief, scalable, suicide-specific psychotherapy based on the written disclosure paradigm. Written disclosure, in which an individual writes about a personally stressful experience and the related thoughts and feelings, yields improvements across physical and psychiatric domains. Pilot data suggest that written exposure also yields reductions in SITBs. Yet, no study has adapted the written exposure paradigm specifically to target the amelioration of distress associated with suicidal crises and examined whether implementing WET-SP reduces the risk of subsequent SITBs and suicide-related hospitalizations.\n\nThe primary objective of this randomized controlled trial (RCT) is to evaluate the efficacy of WET-SP, in reducing the incidence and severity of SITBs in active duty military service members following a psychiatric hospitalization due to suicidal ideation, suicide plans, or a suicide attempt. Secondary objectives are to evaluate a potential mechanism of change (i.e., decreases in thwarted belongingness \\[cf. social disconnectedness\\]) and moderator of outcomes (i.e., arc of narrative \\[cf. linguistical parameters of the written narratives generated during treatment\\]). Participants randomized to WET-SP + TAU will receive five sessions of WET-SP delivered by the study team during their psychiatric hospitalization plus treatment-as-usual (TAU). Participants randomized to TAU will receive daily contact and patient-centered care delivered by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers). TAU includes psychiatric assessment, initial stabilization, nurse case management, medication management, treatment of medical comorbidities, group and individual therapy, and discharge planning. Outcome assessments will be administered at pretreatment, posttreatment, and 10-, 20-, and 30-week follow-ups.",[184,185],"Suicide, Attempted","Suicide Threat",[187,177,188,189],"Self-injurious thoughts and behaviors (SITBs)","Military service members","Treatment as usual (TAU)","2026-05-27",{"date":192,"type":35},"2026-05-29",{"date":194,"type":35},"2024-08-20",{"date":196,"type":22},"2027-09",{"name":41,"class":42},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":205,"minAge":19,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":54,"phases":208,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":225,"locationsCount":43},"100612167","self-help-cognitive-processing-therapy-cptwomen-veterans-network-woven-study-100612167","NCT07250061","Self-Help Cognitive Processing Therapy (CPT)\u002FWomen Veterans Network (WoVeN) Study","Augmenting Cognitive Processing Therapy With a Peer Led Support Intervention to Improve Well-Being: A Sustainable and Scalable Model for Enhancing PTSD Recovery in Vulnerable Populations","Inclusion Criteria:\n\n* Identifies as a woman\n* Has served in the United States military\n* A full or subthreshold (meets criteria for 2 out of 4 of the symptom clusters for PTSD) Post Traumatic Stress Disorder (PTSD) diagnosis\n* Able to read English well enough to complete study questionnaires\n\nExclusion Criteria:\n\n* Clinician judgment that the participant is not appropriate for self-help level of care for PTSD (i.e., recent psychiatric hospitalization, requires detox, volatile, active suicidality)\n* Current psychosis or unstable bipolar disorder (determined during baseline interview as described in screening and enrollment procedures)\n* Must not have participated in a WoVeN group within the last year\n* Must not be receiving an evidenced-based therapy for PTSD at the time of the screening","FEMALE",{"count":207,"type":22},100,[56],"Posttraumatic stress disorder (PTSD) can have significant impairment on aspects of mental well-being (MWB) including functioning, loneliness, physical health, and quality of life. There are several evidence-based treatments (EBPs) effective in treating PTSD such as Cognitive Processing Therapy (CPT) which is a specific type of cognitive behavioral therapy that has been proven effective in reducing symptoms of PTSD. However, there are several barriers (e.g., lack of providers, waitlists, costs, stigma, disabilities that complicate travel) that can prevent someone from engaging with these treatments. Recently, a self-help version of CPT was created to help address these barriers; but little research has been conducted to test its efficacy. Further, less is know about how a peer support program may augment improvements from participating in an EBP. The Women Veteran Network (WoVeN), a peer support program designed for women veterans, has a manualized 8-week program that directly targets MWB. It has been found to help foster belongingness and connectedness, particularly in those suffering from PTSD and depression.\n\nThe present study aims to establish the feasibility, acceptability and tolerability of a scalable, sustainable, and effective treatment option for trauma survivors with subthreshold or full PTSD. The overarching goal is to understand the effectiveness of a self-help version of an EBP (either alone or in combination with a peer support program) in reducing PTSD symptoms while also helping improve mental well-being, reduce barriers, and increase access to quality care within health disparity populations.",[211,212],"Posttraumatic Stress Disorder","Depression",[214,215,216,217,218,219],"Mental well being","Self help cognitive processing therapy","Peer support program","Quality of life","Loneliness","Women Veterans Network","2026-05-26",{"date":190,"type":35},{"date":223,"type":35},"2026-03-05",{"date":71,"type":22},{"name":41,"class":42},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":43},"100585599","advanced-hiv-disease-during-the-first-six-months-on-antiretroviral-therapy-in-zambia-100585599","NCT06904456","Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia","AHD-Zambia","Cohort 1\n\nInclusion\n\n* ≥18 years old\n* Presenting at a study site clinic for HIV diagnosis or care\n* Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening)\n* Screened for AHD by clinic, prior to or within 1 month of ART initiation\n* Written informed consent to participate\n\nExclusion\n\n* Pregnant and\u002For presenting for antenatal care\n* Too ill at the time of AHD screening and at the next clinic visit to participate in the study\n* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant\n\nCohort 2\n\nInclusion\n\n* ≥18 years old\n* Living with HIV and screened for AHD at a study site within 12 months of the start of study prospective data collection at that site\n* All inclusion criteria for the full cohort\n* Initiated\u002Fre-initiated ART within the past 6 months\n* Returns to the study site for a clinic visit during the study enrollment period\n* Written informed consent to participate\n\nExclusion\n\n* Pregnant and\u002For presenting for antenatal care as reported in records\n* All exclusion criteria for the full cohort\n* Too ill at the time of study enrollment visit to participate in the study\n* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant\n* Been on ART \\>6 months\n\nCohort 3\n\nInclusion\n\n* ≥18 years old\n* Living with HIV\n* Admitted for inpatient care related to AHD\n* Initiated or re-initiated ART within the last 6 months\n* Written informed consent to participate\n\nExclusion\n\n* Pregnant and\u002For presenting for antenatal care\n* Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff\n* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant\n* Confined to tuberculosis isolation ward; intensive care unit; or other ward specifically for clients with acute infectious disease.\n\nCohort 4\n\nInclusion\n\n* Employed by or at the study site for at least 6 months\n* Directly interact with clients presenting with AHD\n* Written informed consent to participate\n\nExclusion\n\n* None",{"count":234,"type":22},11800,"In Zambia, an estimated 20% of HIV-positive clients continue to present for first-time antiretroviral therapy (ART) initiation or re-initiation with advanced HIV disease (AHD). The Zambia Ministry of Health (MOH) and other key stakeholders lack information about the characteristics and behaviors of AHD clients, including how they are defined and diagnosed (e.g. low CD4 count v. clinical condition), their demographic and socioeconomic profiles, their HIV care histories, what services they receive, and their short-term outcomes (achieve viral suppression, remain AHD, disengage from care, die) and the timing of these outcomes.\n\nThe Retain6 project aims to improve HIV treatment outcomes during clients' first six months on ART, when disengagement from care and mortality are highest. This protocol, called Advanced HIV disease during the first six months on antiretroviral therapy in Zambia (AHD Zambia), describes an observational study that will describe the experiences of clients who are diagnosed with AHD upon ART initiation (or re-initiation) in Zambia. Data collected will include clinical and socioeconomic characteristics, clinical and non-clinical needs, services delivered and received, and clients' and providers' concerns and preferences. The study's overall goal is to provide information to the Zambia MOH, treatment program partners, providers, and other stakeholders to better understand who is presenting with AHD in Zambia, how they are currently managed, and their treatment outcomes after starting ART. This information will be useful in determining interventions and guideline changes that might improve short- and long-term outcomes for AHD patients.\n\nThe study, which will be conducted in collaboration with the Zambia MOH, will include retrospective file reviews, prospective quantitative surveys with outpatient and inpatient clients, qualitative focus group discussions (FGDs) and interviews with clients, and provider surveys and interviews.",[237],"Advanced HIV Disease",[239,240,241],"Antiretroviral therapy (ART)","Zambia","Service delivery",{"date":190,"type":35},{"date":244,"type":35},"2025-04-22",{"date":246,"type":22},"2027-06",{"name":41,"class":42},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":255,"maxAge":19,"enrollmentInfo":256,"targetDuration":4,"studyType":54,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":272,"locationsCount":43},"100570687","a-pilot-project-to-facilitate-dental-care-and-reduce-barriers-for-youth-with-disabilities-100570687","NCT06710483","A Pilot Project to Facilitate Dental Care and Reduce Barriers For Youth With Disabilities","Do Telehealth Dental Interviews Facilitate in Person Clinical Visits for Patients With Complex Medical Needs?","Inclusion Criteria:\n\n* Have an appointment for a routine check up at the Pediatric Clinic or Pediatric Health Center at the Boston University Goldman School of Dental Medicine\n* Diagnosis of Intellectual or developmental disability (IDD)\n* Have a caregiver who is willing to participate in the study\n* Have a dental provider who is willing to participate in the study\n* English speaking\n\nExclusion Criteria:\n\n* None","12 Years",{"count":257,"type":22},50,[56],"This randomized clinical trial is an innovative pilot project to determine the acceptance and impact of telehealth visits on youth with intellectual and developmental disabilities (IDD), their caregivers, and dentists. The impact of the telehealth visit will be assessed by: 1) determining if the intervention group was more likely to achieve the set goals and 2) Likert scaled surveys of satisfaction of caregivers and dentists. Qualitative data will be collected to inform improvement on clinical interviews by the dentist.",[261],"Intellectual Disability, Variable",[263,264,265,266],"Intellectual and developmental disabilities","Telehealth interview","Pediatric dental care","Pre-Dental Care Telehealth Visit",{"date":268,"type":35},"2026-05-28",{"date":270,"type":35},"2025-08-20",{"date":69,"type":22},{"name":41,"class":42},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":18,"minAge":280,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":284,"conditions":285,"keywords":288,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":98},"100514023","covid-19-transmission-and-morbidity-in-malawi-100514023","NCT05973084","COVID-19 Transmission and Morbidity in Malawi","COVID-TMM","Inclusion Criteria Index Cases\n\n1. Presents with symptoms of COVID-19 and has infection confirmed through RT-PCR or a rapid antigen test;\n2. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers for the following 6 months;\n3. Confirmed SARS-CoV-2 infection and share a household with 1 or more individuals of eligible age;\n4. Has not received a SARS-CoV-2 vaccine in the previous 3 months\n5. Willingness to comply with study procedures and visits, and provides informed consent.\n\nHousehold Contacts of the Confirmed SARS-CoV-2 Case\n\n1. Aged 5 years to 75 years and plans to live in Blantyre, in the catchment area of the target research health centers in the following 6 months;\n2. Willingness to comply with study procedures and follow-up visits and provides informed consent.\n3. Has not received a SARS-CoV-2 vaccine in the previous 3 months\n\nVaccinees\n\n1\\) Aged 18 years to 75 years; 2) Willingness to receive the primary regimen of the AZ and\u002For JJ vaccines 2) Not in the other 2 cohorts; 4) Willingness to comply with study procedures and follow-up visits and provides informed consent.\n\n5\\) Has not received a prior dose of a SARS-CoV-2 vaccine\n\nExclusion Criteria Index Cases\n\n1. Conditions that precludes from adherence to the visit schedule;\n2. 50% or more of household members decline to participate.\n3. Pregnancy at the enrollment visit\n4. Long term use of cotrimoxazole prophylaxis\n\nHousehold Contacts of the Confirmed SARS-CoV-2 Case\n\n1. Conditions that preclude adherence to the visit schedule.\n2. Participants with 2 consecutive negative SARS-CoV-2 RT-PCRs will be excluded from visits after M1.\n3. Pregnancy at the enrollment visit\n4. Long term use of cotrimoxazole prophylaxis\n\nVaccinees\n\n1. Conditions that preclude adherence to the visit schedule.\n2. Pregnancy at the enrollment visit\n3. Long term use of cotrimoxazole prophylaxis","5 Years","75 Years",{"count":283,"type":22},1500,"SARS-CoV-2 transmission was expected to have a devastating impact in sub-Saharan African countries. Instead, morbidity and mortality rates in nearly the whole region are an order of magnitude lower than in Europe and the Americas. To identify what is different requires a better understanding of the underlying immunological substrate of the population, and how these factors affect susceptibility to infection, progression of symptoms, transmission, and responses to SARS-CoV-2 vaccination.\n\nStudy objectives\n\n1. Determine the risk and predictors of infection and disease among contacts of SARS-CoV-2 infection subjects in Malawi\n2. Determine whether innate immune responses lower the risk of SARS-CoV-2 infection and disease, and acquisition and duration of vaccine responses.\n3. Assess whether alterations in innate immune responses relevant to SARS-CoV-2 are associated with malaria or intestinal parasite infections.\n4. Assess the acquisition and longevity of antibodies (Ab) and cellular adaptive responses elicited by SARS-CoV-2 infection and vaccination.\n5. Assess whether malaria and intestinal parasite infections, chronic\u002Fmild undernutrition, and anemia mediate alterations in Ab and other adaptive cellular responses to SARS-CoV-2 through innate immune responses or a different unknown mechanism.",[286,287],"SARS CoV 2 Infection","SARS CoV 2 Vaccination",[289,290,291,292,293,294,295,296,297],"Natural infection","Immune phenotypes","Innate immunity","SARS CoV 2 adaptive immunity","SARS CoV 2 antibody response","Vacinees","Household contacts","Malawi","Sub Saharan Africa",{"date":268,"type":35},{"date":300,"type":35},"2023-01-17",{"date":71,"type":22},{"name":41,"class":42},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":54,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":43},"100477915","telehealth-for-pain-and-unhealthy-drinking-among-plwh-100477915","NCT05503173","Telehealth for Pain and Unhealthy Drinking Among PLWH","Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (PLWH)","Inclusion Criteria:\n\n* Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom.\n* Engaged in unhealthy drinking, defined as:\n* \\>7 drinks for women \u002F \\> 14 drinks for men per week.\n* OR ≥ 3 drinks for women \u002F ≥4 drinks for men on one occasion in the past month.\n* Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.\n* Own a smart phone.\n* Lives in the USA.\n* Has a US mailing address.\n\nExclusion Criteria:\n\n* History of bipolar, schizoaffective disorder or schizophrenia per self report.\n* Unstable dose of psychoactive medication for pain or alcohol\u002Fsubstance use \\[i.e., if on medication, participant has not been on same dose for least 2 months\\]\n* History of withdrawal-related seizures or delirium tremens\n* Current non-pharmacological treatment for alcohol use disorder or chronic pain\n* Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months.\n* Current cancer-related pain\n* Unable to provide one or more individuals for follow-up contact\n* Individual who is unwilling to provide their sex at birth\n* Limited or non-readers",{"count":311,"type":22},385,[56],"This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition.\n\nTwo-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.",[59,315,316],"Chronic Pain","Unhealthy Alcohol Use",[318,319,320,321],"Pain management","Telehealth","Unhealthy drinking","Ecological momentary assessment",{"date":268,"type":35},{"date":324,"type":35},"2023-03-03",{"date":326,"type":22},"2026-12",{"name":41,"class":42},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":205,"minAge":19,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":54,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":43},"100476657","treatment-for-antepartum-posttraumatic-stress-disorderptsd-study-100476657","NCT05486793","Treatment for Antepartum Posttraumatic Stress Disorder\u002FPTSD Study","A Non-Inferiority Trial Testing Delivery of Written Exposure Therapy by Community Health Workers For Treatment of PTSD During Pregnancy","TAPS","Inclusion Criteria:\n\n* Pregnant woman receiving prenatal care at BMC Obstetrics and Gynecology (OB\u002FGYN) Department\n* Presenting for prenatal care prior to gestational age of 28 weeks\n* Meet diagnostic or subthreshold criteria (i.e., endorsement of 3 out of the 4 symptom clusters) for PTSD on the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)\n\nExclusion Criteria:\n\n* Clinician judgment that the patient is not appropriate for outpatient level care (i.e., patient needs detox, inpatient, or residential treatment)\n* Current psychosis or unstable bipolar disorder diagnosis (determined via clinician-administered interview)\n* Currently receiving exposure-based PTSD treatment (e.g., WET, prolonged exposure, cognitive processing therapy) elsewhere\n* Current incarceration. Incarcerated individuals are only seen at BMC for obstetrical care and are not allowed to receive mental health care outside of their correctional facility","50 Years",{"count":338,"type":22},240,[56],"The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.",[342],"PTSD",[344,345,346,347,348],"Written Exposure Therapy (WET)","Emotion Focused Supportive Therapy (EFST)","Community Health Worker (CHW)","Antepartum care","perinatal mental health",{"date":268,"type":35},{"date":351,"type":35},"2023-03-01",{"date":353,"type":22},"2027-07-31",{"name":41,"class":42},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":54,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":376,"leadSponsor":378,"locationsCount":4},"100638811","behavioral-optimization-for-overcoming-suboptimal-treatment-retention-bup-booster-100638811","NCT07607743","Behavioral Optimization for Overcoming Suboptimal Treatment Retention (BUP-BOOSTeR)","BUP-BOOSTeR: Behavioral Optimization for Overcoming Suboptimal Treatment Retention","BUP-BOOSTeR","Inclusion Criteria:\n\n* 18 years of age or older\n* Meet DSM V criteria for opioid use disorder during the past year\n* Be a patient in Office Based Addiction Treatment who has initiated buprenorphine in the last 30 days AND has had no use of prescribed buprenorphine in the 7 days before the current treatment episode AND has not received long-acting injectable buprenorphine in the 6 weeks before the current treatment episodes OR Be a person within the first 30 days of release from a carceral setting who is taking any formulation of buprenorphine for their OUD and who is within their first 30 days of intake at OBAT.\n* Be willing to provide informed consent, be randomized, and complete study materials\n* Be able to speak and read English sufficiently to complete study intervention and procedures\n* Be willing to provide the study access to their electronic medical records\n* Have no plans to change Office Based Addiction Treatment clinics during the study\n\nExclusion Criteria:\n\n-Be receiving hospice or other end of life medical care",{"count":338,"type":22},[56],"Buprenorphine, a medication for opioid use disorder (MOUD), is associated with decreased opioid overdose and all-cause mortality. Treatment outcomes improve if patients remain on MOUD for at least six months, a period recommended by expert guidelines, although most studies report retention on MOUD of 50-65% at 3-6 months. Psychosocial interventions have the potential to improve MOUD treatment retention particularly when applied in combination in efficient delivery systems.\n\nThe objective of this study is to develop an effective and efficient multicomponent intervention to increase buprenorphine retention at 6 months through an optimization trial.",[28],[368,369,370,371,372],"Behavioral activation","Attendance reinforcement","Peer motivational interviewing","Multiphase Optimization STrategy (MOST)","Buprenorphine","2026-05-24",{"date":268,"type":35},{"date":69,"type":22},{"date":377,"type":22},"2029-12",{"name":41,"class":42},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":51,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":54,"phases":388,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":405,"locationsCount":4},"100615479","glycemic-effects-of-meals---repeatability-trial-with-continuous-glucose-monitoring-100615479","NCT07293143","Glycemic Effects of Meals - Repeatability Trial With Continuous Glucose Monitoring","GEM-RT CGM","Inclusion Criteria:\n\n* Generally healthy\n* English speaking\n\nExclusion Criteria:\n\n* Prior diagnosis of diabetes or taking medications that influence glucose metabolism, such as insulin, glucocorticoids, or Glucagon-like peptide-1 (GLP-1) receptor agonists.\n* Taking hydroxyurea medication\n* Taking beyond the maximum dose of acetaminophen (4g\u002Fday)\n* Known food allergies or severe sensitivities to any study materials (dairy or soy)\n* Limited and non-readers\n* Cognitive impairment",{"count":387,"type":22},20,[56],"Almost half of adults in the United States have either diabetes mellitus (DM) or prediabetes (preDM), but many are undiagnosed and unaware of their condition. Current DM diagnosis and risk prediction are based on single \"snapshot\" measurements including: fasting blood glucose, postprandial glucose, and hemoglobin (Hb)A1c. Continuous glucose monitoring (CGM) offers a dynamic view of glucose levels throughout the day which enables characterizing individuals' dynamic glycemic profiles in response to physiological and environmental stimuli better than the conventional point-in-time glucose quantification approaches. By analyzing glycemic patterns from CGM tracings, it may be possible to identify individuals at increased risk of developing diabetes. However, an important prerequisite is to establish the reliability and consistency of glucose response patterns captured by CGM under controlled conditions.\n\nParticipants will be given six different meals to examine the glucose responses to these meals. Two of these meals (white rice and an Ensure drink) will be given twice for each participant to investigate whether individuals have the same glucose response to the same meal given on different days. Glucose will be measured using continuous glucose monitors, that have a thin wire sensor that measures glucose under the skin every five minutes for up to 10 days.",[391],"Glucose Response",[393,394,395,396,397,398],"Continuous glucose monitoring (CGM)","Post prandial glucose","Fasting blood glucose","Hemoglobin (Hb)A1c","CGM-based dietary challenges","Metabolic risk","2026-04-27",{"date":401,"type":35},"2026-04-28",{"date":403,"type":22},"2026-07",{"date":326,"type":22},{"name":41,"class":42},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":54,"phases":416,"briefSummary":417,"conditions":418,"keywords":423,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":432,"leadSponsor":434,"locationsCount":43},"100546254","online-intervention-for-transgendernonbinary-young-adults-experiences-with-alcohol-and-romantic-relationships-100546254","NCT06392542","Online Intervention for Transgender\u002FNonbinary Young Adults' Experiences With Alcohol and Romantic Relationships","Developing an Online Intervention Addressing Transgender\u002FNonbinary Young Adults' Experiences With Alcohol and Romantic Relationships","Inclusion Criteria:\n\n* Self-identify as transgender and\u002For nonbinary\n* Between 18 and 30 years of age, inclusive\n* Able to read and write in English\n* Residency in the United States\n* Currently in a romantic relationship that began at least six weeks prior to enrollment\n\nExclusion Criteria:\n\n* Prospective participants will be excluded as potentially inauthentic (i.e., not genuinely eligible for the study) based on scoring criteria developed through the investigators' prior online survey research with similar populations.","30 Years",{"count":415,"type":22},107,[56],"The objective of this study is to learn more about Whole Selves, an interactive online resource (\"intervention\") to help transgender and\u002For nonbinary young adults reflect on their experiences and goals related to both alcohol use and romantic relationships. Existing online interventions focused on alcohol use often aren't a good fit for trans\u002Fnonbinary people, and existing relationship education programs don't account for how being trans\u002Fnonbinary might influence someone's relationships. For these reasons, the investigator is working with trans\u002Fnonbinary young adults and other community stakeholders to create a new intervention specifically for trans\u002Fnonbinary young adults. The goals of this clinical trial are to:\n\n1. Find out what transgender\u002Fnonbinary young adults think of the Whole Selves intervention in order to improve it\n2. See whether the Whole Selves intervention seems to work as expected\n3. Help the investigator make plans for a bigger clinical trial of the Whole Selves intervention, which could tell us how well it works\n\nIn this study, participants will use the Whole Selves intervention; complete online surveys about themselves, their romantic relationship experiences, their mental health, their alcohol use; and provide feedback on the Whole Selves intervention.",[419,420,421,422],"Alcohol Use, Unspecified","Relationship, Social","Depression, Anxiety","Transgenderism",[424,425,426,427,428,429],"Transgender young adults","Nonbinary young adults","Interactive online alcohol education","Interactive online relationship education","Whole Selves intervention","Supportive romantic relationships",{"date":401,"type":35},{"date":403,"type":22},{"date":433,"type":22},"2027-04",{"name":41,"class":42},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":18,"minAge":442,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":54,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":43},"100571661","oral-surgery-virtual-reality-glasses-study-100571661","NCT06723158","Oral Surgery Virtual Reality Glasses Study","Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery","Inclusion Criteria:\n\n* Patients requiring IV sedation for oral surgery procedure\n* Patients able to understand the use of virtual reality glasses and provide informed consent\u002Fassent\n* Patients classified as American Society of Anesthesiologists (ASA) I or II\n* No reported substance use within the previous 24 hours\n* No reported excessive alcohol consumption\n* Willingness to wear eye protection\n* Willingness to use certified interpreters if required\n* A legal guardian must accompany minors\n\nExclusion Criteria:\n\n* Patient with hearing aids or severe hearing impairment\n* Patient with blindness or significant visual impairment that is not corrected by contact lenses\n* Patients with cognitive impairments determined and assessed by the researchers\n* Pregnant women or women who could be pregnant based on self reporting\n* Patients unable to tolerate virtual reality glasses due to motion sickness or other issues\n* Patients with history of seizures or epilepsy per self report\n* Patients who cannot tolerate VR glasses due to discomfort or a medical emergency that arises during the procedure","16 Years","65 Years",{"count":445,"type":22},80,[56],"The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses.\n\nThis study has two primary objectives.\n\n1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.\n2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.\n\n80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).",[449,450],"Procedural Anxiety","Procedural Pain",[452,453,454,455,456],"Virtual reality glasses","Non emergent oral surgery","IV sedation","Patient Health Questionnaire (PHQ)","Generalized Anxiety Disorder (GAD)","2026-04-01",{"date":459,"type":35},"2026-04-07",{"date":461,"type":35},"2025-11-18",{"date":403,"type":22},{"name":41,"class":42},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":43},"100626697","behavioral-risk-identification-and-decision-guidance-for-hiv-engagement-100626697","NCT07439003","Behavioral Risk Identification and Decision Guidance for HIV Engagement","Behavioral Risk Identification and Decision Guidance for Engagement","BRIDGE","Inclusion Criteria:\n\nGroup 1:\n\n* ≥18 years old at treatment initiation or re-initiation\n* Initiating ART (newly or re-engaging after a period of interruption) or currently receiving ART at one of the participating study sites.\n\nGroup 2:\n\n* Seeking care at an intervention site during their early treatment period\n* Reachable at telephone (mobile) number provided\n* Consented to participate in qualitative data collection\n\nGroup 3:\n\n* Employed by DOH or an implementing partner at a study site\n* Trained and participated in delivering the intervention\n* Consented to participate in qualitative data collection\n\nExclusion Criteria:\n\nNo exclusion criteria for any group.",{"count":473,"type":22},15270,"Despite much progress towards reaching UNAIDS goals for HIV treatment, disengagement from care remains one of the biggest obstacles to HIV elimination. In many African countries, including South Africa, the early treatment period (first six months after starting or re-starting antiretroviral therapy (ART)) is the interval with the highest risk of treatment interruption and disengagement, but until recently, this period had received relatively little attention from researchers and policy makers. The Retain6 project was launched in 2021 to generate data about the early treatment period, propose potential improvements to guidelines and models of care, and conduct preliminary tests of some potential interventions. Since then, Retain6 has collected detailed data about, among other topics:\n\n* Patient-level preferences, barriers, and facilitators of care during the first six months to help predict interruption risks and develop relevant interventions (PREFER survey, protocol M220440 (Wits HREC), H-42726 (BU IRB)\n* Predictors of risks of treatment interruption during the early treatment period and characteristics of patients most likely to experience interruptions, with an improved risk assessment approach for use at primary clinic level (PREDICT model, protocol M210472)\n* Interventions currently available at primary healthcare clinics to improve engagement in care, to match interventions to risks\n* Current facility compliance with South Africa's 2023 HIV treatment guidelines (FIRST-HIV, protocol 250409)\n* Provider views of retention in care and potential ways to improve it, to understand facility barriers to implementing guidelines (FIRST-HIV, protocol 250409)\n* Effectiveness of tracing interventions following an interruption, to optimize tracing procedures once disengagement occurs (GREAT-South Africa, protocol M2409113).\n\nUnder the proposed BRIDGE (Behavioral Risk Identification and Decision Guidance for Engagement) protocol, the investigators aim to synthesize the data listed above to create and test a client retention toolkit comprising a package of targeted, light-touch interventions that aim to improve outcomes during the early treatment period. The retention toolkit is expected to include:\n\n* An updated adherence risk\u002Fvulnerability assessment tool for use by clients and providers during consultations to identify clients vulnerable to disengagement from care\n* A \"menu\" of available interventions that can be matched to identified vulnerability factors for disengagement and allow patients to choose what they believe will be most effective for them\n* A \"treatment roadmap\" to help new and re-starting ART patients understand and adhere to treatment schedules\n* A WhatsApp based tool, AI Coach, developed by external colleagues to provide confidential and empathetic support and information after treatment initiation.\n* An improved process for identifying patients eligible for tracing and monitoring tracing results.\n* A co-designed, user-friendly checklist\u002Fjob aid to support providers in adhering to the 2023 ART guidelines during early treatment.\n\nThis package is currently being co-designed with key stakeholders, including the National Department of Health, and is intended to be implemented within the existing systems and require minimal additional resources. On completion of the co-design process, the investigators will conduct a pilot assessment of the retention toolkit to describe acceptability, feasibility, uptake, and preliminary impact on near-term outcomes (attendance at next scheduled visit) at a selected set of primary healthcare clinics in South Africa. The study procedures will combine secondary analysis of de-identified medical record data and qualitative data collection among patients and providers. Data collection will take place during the first half of 2026, with a waiver of consent requested for medical record data and written informed consent for qualitative data collection. The maximum total sample size for the medical record data will be 30,000 patients and for the qualitative data collection will be 180 patients and 90 providers.",[59],[59,477,478,479],"retention","guidelines","South Africa","2026-03-30",{"date":482,"type":35},"2026-04-02",{"date":484,"type":35},"2026-03-27",{"date":486,"type":22},"2027-12",{"name":41,"class":42},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":43},"100625895","tracking-and-continuity-of-care-in-advanced-hiv-disease-100625895","NCT07428577","Tracking and Continuity of Care in Advanced HIV Disease","TRACK-AHD","Inclusion Criteria:\n\n* Known HIV positive status\n* Admitted to inpatient care for an AHD-related illness\n* Aged 18 years and above\n* Able to provide written consent or consent using a thumbprint\n* Consent to be contacted after discharge and can provide contact information\n\nExclusion Criteria:\n\n* Confined to tuberculosis isolation ward or other wards for patients with acute infectious disease that requires isolation procedures\n* Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff\n* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant",{"count":496,"type":22},150,"Despite the scale-up of HIV testing and the implementation of the universal test-and-treat policy, a substantial proportion of people living with HIV (PLHIV) continue to present with advanced HIV disease (AHD), defined by a CD4 count below 200 cells\u002FµL and\u002For WHO clinical staging of stage 3 or 4. Global and regional analyses estimate that nearly half of hospitalized PLHIV meet criteria for AHD, with similar findings reported in South Africa. Patients with AHD face high risks of opportunistic infections, hospitalization, and mortality, and frequently disengage from care after discharge. This study aims to examine inpatient and post-discharge care pathways for individuals with AHD in South Africa, identify gaps in continuity of care between hospitals and primary healthcare (PHC) facilities, and generate evidence to inform strategies that strengthen linkage, retention, and long-term outcomes.\n\nA prospective cohort study with a nested process evaluation will be conducted at Helen Joseph Hospital, a large public tertiary facility in Johannesburg. Adult patients (≥18 years) admitted with HIV-related conditions and meeting AHD criteria will be consecutively enrolled once deemed clinically stable. Data will be collected through structured inpatient interviews, medical-record reviews, and follow-up telephone interviews at four- and eight-weeks post-discharge to assess linkage to PHC services, ART continuation, and readmissions. Quantitative data will be analyzed descriptively using standard statistical methods.\n\nThis study will generate a detailed understanding of how patients with AHD transition from inpatient to outpatient HIV care, highlighting critical points where continuity of care fails. Findings will identify system- and patient-level barriers to effective linkage and retention and inform interventions to improve post-discharge outcomes. The study poses minimal risk to participants, involving only structured interviews and review of existing medical records, with no invasive procedures.",[237],[500,479,501],"Advanced HIV disease","Inpatient care",{"date":503,"type":35},"2026-03-31",{"date":505,"type":35},"2026-02-24",{"date":486,"type":22},{"name":41,"class":42},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":515,"maxAge":516,"enrollmentInfo":517,"targetDuration":4,"studyType":54,"phases":519,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":43},"100574268","phase-4-management-of-postoperative-discomfort-in-young-children-following-dental-rehabilitation-under-general-anesthesia-100574268","NCT06757075","Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia","A Comparison of Standard Dose of Ibuprofen Alone, Alternating, or Combined With Acetaminophen for the Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) I-II\n* Requiring Oral Rehabilitation under General Anesthesia\n* Possess legal guardians proficient in English\n* Not have a history of any adverse\u002Fallergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen\n\nExclusion Criteria:\n\n* ASA III or IV\n* Asthma diagnosis\n* Contraindication to acetaminophen or ibuprofen","4 Years","6 Years",{"count":518,"type":22},75,[520],"PHASE4","The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures.\n\nThe analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.",[523],"Pain, Postoperative",[525,526,527,528,529],"Dental rehabilitation under general anesthesia (DRGA)","Dental surgery patients 4-6 years","Acetominophen","Ibuprofen","Pacing analgesics",{"date":482,"type":35},{"date":532,"type":35},"2025-04-16",{"date":534,"type":22},"2027-03",{"name":41,"class":42},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":54,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":43},"100522875","enhancing-ptsd-treatment-outcomes-by-improving-patient-provider-communication-100522875","NCT06088303","Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication","AWARE","Inclusion Criteria:\n\n* Diagnosis of PTSD\n* Stable on psychiatric medications for at least 4 weeks\n\nExclusion Criteria:\n\n* Current unstable bipolar disorder\n* Current psychosis\n* Current active suicidal or homicidal ideation with intent or plan\n* Current severe substance use that warrants immediate medical attention\n* Current trauma-focused treatment\n* Significant cognitive impairment that would prevent engagement in assessments and therapy (e.g., advanced dementia, severe traumatic brain injury).",{"count":544,"type":22},54,[56],"The purpose of this clinical trial is to learn whether existing treatments for posttraumatic stress disorder (PTSD) can be improved. Two treatments for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) will be studied. CPT and PE are effective treatments that are widely available, but interventions are needed to improve patient outcomes in these treatments. The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health communication strategies to enhance CPT and PE by improving communication between patients and therapists about patients' experiences in treatment. This research will investigate whether adding AWARE to CPT and PE will lead to better treatment outcomes compared to CPT and PE provided as usual without AWARE. AWARE includes a brief writing task asking patients about their experiences in treatment, as well as guided therapist responses to improve patient-therapist communication about patients' experiences in treatment. In the first phase of the study (case series phase), CPT or PE with AWARE will be provided to four adults with PTSD to pilot test adding AWARE to CPT and PE, seek patient and provider feedback, and refine AWARE. The first four participants who enroll will be part of the case series and will receive CPT or PE with AWARE. Then, in the second phase of the study, the randomized controlled trial (RCT) phase, the investigators will enroll 50 more adults with PTSD who will be randomly assigned (like flipping a coin) to receive CPT\u002FPE as usual or CPT\u002FPE with AWARE. It is expected that 25 participants will be randomized to CPT\u002FPE with AWARE and 25 participants will be randomized to receive CPT\u002FPE provided as usual. The goals of the RCT phase are to study whether AWARE is acceptable to patients, whether it is feasible to add AWARE to CPT and PE, and whether adding AWARE to CPT and PE improves patient-therapist communication and treatment outcomes compared to CPT\u002FPE as usual.",[548],"Stress Disorders, Post-Traumatic",[550,551,552,553,554,555],"Posttraumatic stress disorder","Cognitive processing therapy","Prolonged exposure","Adjunctive writing for amplifying response and engagement","Health communication","Patient-provider communication",{"date":457,"type":35},{"date":558,"type":35},"2025-01-15",{"date":560,"type":22},"2028-12",{"name":41,"class":42},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":54,"phases":570,"briefSummary":571,"conditions":572,"keywords":573,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":581,"locationsCount":43},"100463085","cognitive-processing-therapy-cpt-memory-support-ms-study-100463085","NCT05310097","Cognitive Processing Therapy (CPT) Memory Support (MS) Study","Enhancing Memory and Learning in Cognitive Processing Therapy for Post Traumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Current diagnosis of PTSD as determined by the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\n* For potential participants on psychiatric medication, dose must be stable for the past four weeks.\n* Veteran status\n\nExclusion Criteria:\n\n* Current DSM-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder\n* Active suicidal or homicidal ideation with plan or intent\n* Current moderate or severe substance use disorder, as defined by DSM-5 \\[i.e., at least 4 diagnostic symptoms of Substance use disorder (SUD) present\\]\n* Prior receipt of CPT or concurrent therapy for PTSD\n* Significant cognitive impairment as indicated by a score \\\u003C10th percentile on the Montreal Cognitive Assessment\n* History of moderate or severe traumatic brain injury (TBI) based on the Ohio State University TBI Identification Method and Veterans Administration\u002F Department of Defense (VA\u002FDOD) guidelines\n* High verbal memory ability, as indicated by a score \\>1 standard deviation (SD) above the population mean on the California Verbal Learning Test® Third Edition (CVLT-3) immediate recall task",{"count":207,"type":22},[56],"The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD.\n\nThe primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.",[342],[574,575,576],"Cognitive Processing Therapy (CPT)","Memory Support (MS)","CPT + MS",{"date":457,"type":35},{"date":579,"type":35},"2023-01-04",{"date":433,"type":22},{"name":41,"class":42},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":205,"minAge":19,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":54,"phases":592,"briefSummary":593,"conditions":594,"keywords":596,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":602,"leadSponsor":604,"locationsCount":43},"100623580","prepwise-pilot-among-black-women-in-eastern-virginia-100623580","NCT07398482","PrEPwise Pilot Among Black Women in Eastern Virginia","Feasibility and Preliminary Effectiveness of PrEPwise Intervention on PrEP Initiation Among Black Women in Eastern Virginia","PrEPwise","Inclusion Criteria:\n\n* Black women seeking HIV testing services at the community HIV testing clinic\n* Eligible for PrEP according to CDC guidelines\n* Willing to be followed for 3 months\n* Able to provide contact information\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Participated in the development of the intervention (provided input in the adaptation of PrEP decision aid)\n* Unable to provide informed consent\n* Unable to provide contact information\n* Currently using PrEP",{"count":591,"type":22},108,[56],"HIV is a virus that affects many people, but Black women in the U.S. are a population at a much higher risk of getting it compared to white women-about 18 times higher. Pre-exposure prophylaxis (PrEP), a medicine if taken as recommended by a clinician can prevent HIV almost completely (99% effective). The problem is that many Black women, especially those living in the Southern U.S., don't know about this medicine called PrEP or find it hard to access it. To address this, healthcare providers sometimes use \"decision aids\" which are tools, like brochures or videos, designed to help people understand their medical options and make informed choices based on what's important to them. While these tools have worked well for other health issues, they haven't been widely used for preventing HIV. The challenges are doctors do not have enough time to explain PrEP fully to patients during clinic visits and also some Black women do not trust the healthcare system because of a long history of unfair treatment toward Black communities.\n\nCommunity health workers (CHWs) are trained health workers from the same communities as their patients and can facilitate their ability to provide culturally appropriate health education and information consistent with patients' values and needs. Because of this, patients are often more comfortable talking to them. This project aims to test the acceptability and effectiveness of a decision tool to be integrated into HIV testing services to help Black women decide if PrEP is right for them. The investigators are calling this intervention PrEPwise. A tool originally designed for women dealing with opioid addiction will be adapted to fit the needs of Black women living in the South. The long-term goal of this project is to make it easier for Black women to learn about PrEP and decide whether to use it, ultimately helping lower the number of new HIV cases in Black women.",[86,595],"Sexually Transmitted Infection",[597,346],"Pre-Exposure Prophylaxis (PrEP)","2026-02-09",{"date":600,"type":35},"2026-02-11",{"date":433,"type":22},{"date":603,"type":22},"2028-07",{"name":41,"class":42},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":54,"phases":615,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":43},"100568045","the-optimal-injection-site-for-a-3d-guided-inferior-alveolar-nerve-block-device-ianbd-100568045","NCT06676098","The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD)","The Optimal Injection Site for a 3D Guided Inferior Alveolar Nerve Block Device (IANBD): A Randomized Control Trial","IANBD","Inclusion Criteria:\n\n* Patient of Henry M. Goldman School of Dentistry (GSDM)\n* Medical History indicating American Society of Anesthesiology (ASA)1\n* Need Non-surgical Endodontic Therapy on Mandibular Molar or Premolar\n* Asymptomatic pulpal diagnosis (normal, necrotic, asymptomatic irreversible pulpitis, retreatment with no symptoms)\n* The quadrant to be treated must have at least 3 vital teeth.\n* Going to receive a CBCT required for clinical purposes\n* Must be willing to receive guided IANB\n\nExclusion Criteria:\n\n* Allergy to lidocaine or articaine\n* Resin allergy\n* Normal teeth unresponsive to thermal testing (ie calcified chamber)\n* Prior jaw surgery\n* Currently pregnant",{"count":614,"type":22},10,[56],"Given the thicker cortical bone in the mandible compared to the maxilla, mandibular teeth cannot be effectively anesthetized via local infiltration anesthesia. Instead, clinicians typically perform regional anesthesia and most commonly, Inferior Alveolar Nerve block (IANB). However, the inferior alveolar nerve is deeply submerged by surrounding structures of bone, muscles, ligaments and vessels. Traditional IANB is a technique by using anatomical landmarks not directly related to Inferior Alveolar Nerve (IAN) to approximate the location of mandibular foramen, where IAN enters mandible. IANB is considered a blind technique and known for the lack of accuracy and precision. The failure rate can be as high as 30-45%. In contrast, the investigator's cone beam computed tomography (CBCT) guided IANB device (IANBD) effectively directs the needle to the mandibular foramen which improves the success rate of the IANB on the first attempt, minimizes injection tissue damage, and reduces patient discomfort.\n\nIn this proof of concept trial, a 3D printed CBCT guided IANBD will be used to administer anesthesia at three injection sites instead of the traditional IANB technique. Participants will be consented patients at the postdoctoral endodontic treatment center, Department of Endodontics, Boston University (BU) Henry M. Goldman School of Dentistry.\n\nThe goal of this research is to to evaluate the acceptability, safety, and effectiveness of guided anesthesia using the IANBD by enrolling 10 subjects who require non-surgical endodontic therapy with a simple, affordable and reliable prototype to be used by clinicians in the dental care setting.",[618],"Inferior Alveolar Nerve Block",[620,621,622,623],"Inferior alveolar nerve block (IANB)","Inferior alveolar nerve block device (IANBD)","3D guided IANBD","Cone beam computed tomography (CBCT)","2026-01-26",{"date":626,"type":35},"2026-01-27",{"date":628,"type":35},"2025-12-17",{"date":630,"type":22},"2027-11",{"name":41,"class":42},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":638,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":54,"phases":641,"briefSummary":644,"conditions":645,"keywords":647,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":659,"locationsCount":43},"100545697","phase-1-the-role-of-vitamin-k-on-knee-osteoarthritis-outcomes-100545697","NCT06385275","The Role of Vitamin K on Knee Osteoarthritis Outcomes","Inclusion Criteria:\n\n* ≥60 years old\n* Clinical diagnosis of knee OA by the treating rheumatologist\n* English fluency\n\nExclusion Criteria:\n\n* Anticoagulation use (including warfarin, dabigatran, rivaroxaban, apixaban)","60 Years",{"count":640,"type":22},55,[642,643],"PHASE1","PHASE2","The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 300µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,\n\nThe overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures.",[646],"Osteo Arthritis Knee",[648,649,650,651,652],"Vitamin K-1","Vitamin K-2","Menaquinone-7 (MK-7)","Uncarboxylated matrix Gla protein (ucMGP)","Phylloquinone","2026-01-21",{"date":655,"type":35},"2026-01-23",{"date":657,"type":35},"2025-06-03",{"date":326,"type":22},{"name":41,"class":42},""]