[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hiv-care-loss-to-followup\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hiv-care-loss-to-followup":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100626740","choice-based-support-for-adults-starting-or-restarting-antiretroviral-therapy-in-cape-town-south-africa-100626740",false,"NCT07439562","Choice-Based Support for Adults Starting or Restarting Antiretroviral Therapy in Cape Town, South Africa","Zikhethele - Choose For You Aim 3 Exploring the Feasibility, Acceptability and Preliminary Impact of Choice-based Antiretroviral Therapy (ART) Support Interventions for Adults Starting and Restarting ART in Cape Town, South Africa: A Pilot Randomised Controlled Trial","Zikhethele","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Living with HIV\n* Starting ART for the first time or restarting ART after an interruption of at least three months\n* Eligible to start or restart ART based on local guidelines\n* Clinically stable (no acute illness or evidence of TB\u002Fmeningitis)\n* English or isiXhosa speaking\n* Willing and able to provide informed consent to participate.\n\nExclusion Criteria:\n\n\\- Pregnancy at the time of enrolment","ALL","18 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"NA","Disengagement from HIV care is very common in the first year after starting or restarting antiretroviral therapy (ART). There is increasing recognition of people cycling in and out of HIV care over time people newly starting and restarting treatment after an interruption are at high risk of subsequent disengagement from care. While guidelines advocate for patient-centered models of care, patient preferences are often not considered fully in the design of interventions. Building on existing support intervention modalities, formative qualitative research and a stated preference survey, the investigators have designed a choice-based ART support intervention. The intervention offers a choice of a) in-person group support, b) low-touch WhatsApp support group, and c) individual digital support through the AI Coach chatbot.\n\nThis study will explore the feasibility, acceptability and preliminary impact of choice-based ART support for adults starting and restarting ART in Cape Town, South Africa, through a randomized pilot feasibility trial.\n\nThe objectives of this study are:\n\n1. To determine the feasibility, acceptability, appropriateness and fidelity of the Zikhethele intervention components, including offering patients a choice of ART support intervention.\n2. To describe the distribution of actual choices in the choice arm.\n3. To describe outcomes in each pilot trial arm and explore the preliminary impact of offering a choice, compared allocation to a support intervention or standard of care, on patient empowerment and treatment outcomes.\n4. To explore the hypothesised mechanisms of action and contextual moderators through in-depth interviews with participants and providers including consideration of patient empowerment, stigma and social support, and trust in provider, peers and digital tools.\n\nA total of 140 adults starting or restarting ART will be consecutively recruited and randomised to a) standard of care (n=35), b) in-person support (n=35) and c) a choice (n=70) of in-person support, WhatsApp group support, AI coach, or no additional support (standard of care).\n\nThe intervention components will run for the first four months after start or restart, through to the first viral load and eligibility assessment for routine differentiated models of care. Briefly, the in-person group support will consist of monthly informal and discussion-based sessions framed around chronic medication adherence (including HIV, diabetes, and hypertension), designed to create a safe and supportive space where participants can share experiences, problem-solve, and build motivation to remain in care. The WhatsApp group support will be a virtual adaptation of the in-person model, designed to provide an accessible, low-barrier option for participants who prefer remote or flexible engagement. The AI Coach is a pilot AI chatbot (developed by Audere, PSI, HSRC, and Matchboxology, and being piloted in Gauteng and KwaZulu Natal by HE2RO at the Wits Health Consortium) inspired by the in-person Coach Mpilo model-a peer navigator case management approach in South Africa that employs men living with HIV as \"coaches\" to support linkage, retention, and re-engagement in care. The AI coach is available anytime via WhatsApp, and offers trusted information (through a curated large-language model), and empathetic counselling and behavioural nudges to encourage healthy habits.\n\nIndividuals (aged 18 and older, living with HIV and currently attending the clinic to start ART for the first time or to restart after an interruption of 3 or more months) will be approached during their routine clinic visit by a trained research fieldworker. Eligible individuals will undergo informed consent and be enrolled. Participants will complete an interviewer administered questionnaire at enrolment and at four months. Outcome data will also be abstracted from paper and electronic medical records, as well study and intervention logs, intervention debriefings and chatbot logs. A subset of 20 participants, purposefully selected to include each intervention component, will be invited to complete an in-depth interview at 4 months. Providers (n=6), while not involved directly in this pilot implementation, will also be invited to participate in an in-depth interview to explore the potential of this intervention.\n\nThis exploratory pilot study serves as a proof-of-concept for offering people living with HIV different modalities of support for engagement in care in the first four months. The study is not powered for efficacy but will provide valuable insights into feasibility (of both the trial design and intervention components) and acceptability, as well as real-world preferences and trade-offs. The investigators hypothesize that those able to choose a support intervention most appealing or most fitting to their life circumstances may have improved health empowerment which may in turn improve health outcomes.",[27],"HIV Care Loss to Followup",[29,30,31,32,33],"HIV","antiretroviral therapy","engagement in care","patient choice","adherence support","NOT_YET_RECRUITING","2026-02-24",{"date":37,"type":38},"2026-02-27","ACTUAL",{"date":40,"type":21},"2026-02",{"date":42,"type":21},"2026-08",{"name":44,"class":45},"University of Cape Town","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100597197","a-trauma-informed-intervention-for-the-newly-hiv-diagnosed-100597197","NCT07055360","A Trauma-Informed Intervention for the Newly HIV-Diagnosed","A Trauma-Informed Intervention for Sexual Minority Men Recently Diagnosed With HIV","RISE","Inclusion Criteria:\n\n* Diagnosed with HIV within the past 3 months\n* Self-identification as Black or African American\n* Aged 18-39 years\n* Elevated traumatic stress as indicated by scores above clinical cutoffs on either of the following subscales of the Impact of Event Scale--Revised: Intrusion (score of 5 or greater) and Avoidance (score of 7 or greater)\n* Owning a phone with short-message service or messaging\n* Access to a device with a screen, a web browser, and adequate internet speed for videoconferencing (e.g., smartphone, computer).\n\nExclusion Criteria:\n\n* Demonstrating cognitive impairment or acute psychosis\n* Reporting unvailability to participate in the Baseline Assessment, the RISE intervention, and 3-, 6, and 9-Month Follow-Up Assessments","MALE",{"count":57,"type":21},80,[24],"The current approach to HIV prevention emphasizes: (1) achieving viral suppression among HIV+ people in order to reduce HIV transmissibility, particularly for disproportionately affected groups such as Black sexual minority men (BSMM), by increasing retention in HIV care, and (2) addressing comorbidities and complications, which include mental health concerns such as trauma symptomology and severe acute stress reactivity. Despite the disproportionate impact of both HIV and traumatic stress on BSMM and the adverse effects of stress on engagement in HIV care, BSMM remain grossly underserved with respect to mental health. To address these gaps, the proposed study will develop an intervention that will: (1) provide a brief, resilience-oriented, trauma-informed intervention that combines online sessions and highly tailored text-messaging to reduce participant burden and motivate clients between sessions, (2) provide preliminary treatment for HIV+ BSMM's unaddressed mental health needs, and (3) be embedded early in the HIV continuum of care immediately after diagnosis to facilitate linkage to and retention in HIV care.",[61,27,62],"Stress","HIV Treatment Cascade",[64,65,66,67,29,68,69,70,71,72],"resilience","trauma","intervention","mental health","HIV care","newly-diagnosed","mHealth","eHealth","stress","2025-06-27",{"date":75,"type":38},"2025-07-08",{"date":77,"type":21},"2026-01-05",{"date":79,"type":21},"2026-09-12",{"name":81,"class":45},"Temple University"]