[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590067":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":63,"collaborators":67,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":26,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":57,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MM+ Intervention","EXPERIMENTAL","MM+ will involve mentor mother delivery of brief MI sessions individually over a series of clinic- based visits over a 6m period during pregnancy and postpartum. Intervention content, duration, and full menu of HIV prevention services offered will be finalized prior to launch. We anticipate no fewer than five to six 15-20 minute MI sessions focused on the benefits of reducing alcohol use during pregnancy, managing HIV risk among women without HIV and importance of ART use and viral suppression for reducing the risk of vertical transmission. Participants in MM+ arm will receive enhanced HIV prevention counseling integrated into routine antenatal care visits, including PrEP and ART biofeedback adherence counseling, provided by a trained study nurse. Participants in the intervention arm will also receive EtG testing (alcohol use) and corresponding biofeedback counseling.",[13],"Behavioral: MM+",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced HIV attention control (eSOC)","ACTIVE_COMPARATOR","Similar to placebo pills, attention control is often used in randomized trials for behavioral interventions to control for the nonspecific effects of the intervention. Given that existing MM models focus on prevention of vertical transmission and HIV treatment and our primary interest is understanding how inclusion of alcohol reduces alcohol use improves adoption of ART\u002FPrEP use, we will use an enhanced HIV attention control with the same time frame for the intervention (e.g. 2-3 sessions during antenatal\u002Fand 2-3 sessions during postpartum periods). Sessions will consist of educational counseling on HIV risk, partner testing modalities as well as PrEP\u002FART urine assay testing followed by real-time in-clinic adherence counseling delivered privately by lay counselors (different from MM+ arm to avoid contamination), all coinciding with routine ANC visits when possible.",[19],"Behavioral: Enhanced HIV attention control (eSOC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","MM+","Participants in both study arms will receive clinic-based HIV counseling, including urine tenofovir testing and biofeedback counseling on recent PrEP or ART use. Activities unique to women enrolled in the intervention arm include: Brief motivational interviewing sessions with a mentor mother focusing on 1) EtG testing and biofeedback on recent alcohol use, 2) counseling and mentorship on ways to reduce alcohol use.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Participants in the enhanced HIV attention control arm (comparison group) will attend a similar number of study visits within the same time frame as intervention participants (5-6 sessions during 6-month timeframe including both pregnancy and postpartum). Control arm sessions will consist of one-on-one educational counseling on HIV risk, partner HIV testing modalities, as well as conducting PrEP\u002FART urine assay testing followed by real-time in-clinic adherence counseling delivered privately (different from study nurses delivering PrEP\u002FART biofeedback in MM+ intervention arm to avoid contamination), all coinciding with routine ANC visits.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Dvora L Joseph Davey, PhD","CONTACT","310-701-1526","dvoradavey@ucla.edu",[37,55],{"facility":38,"status":39,"city":40,"state":41,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Saldanha Bay Municipality Clinic","NOT_YET_RECRUITING","Cape Town","Western Cape","South Africa","ZA",{"type":45,"coordinates":46},"Point",[47,48],18.42322,-33.92584,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":26,"email":54},"Zaynab Essack, PhD","0333245022","zessack@hsrc.ac.za",{"facility":56,"status":57,"city":58,"state":41,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":26,"geoPoint":26,"contacts":59},"Saldanha Bay Clinics","RECRUITING","Saldanha Bay",[60],{"name":61,"role":33,"phone":62,"phoneExt":26,"email":54},"Zaynab Essack Principal Investigator, PhD","+27 78 099 1509",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dvora Joseph Davey, PhD, MPH","Principal Investigator",[68,70,72],{"name":69,"class":6},"University of Cape Town",{"name":71,"class":6},"San Diego State University",{"name":73,"class":74},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100590067","mentor-moms-study-100590067",false,"NCT06962592","Mentor Moms+ Study","A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)","(MM+)","Inclusion Criteria:\n\n* • ≥ 16 years;\n\n  * Pregnancy confirmed;\n  * reported alcohol use during pregnancy (in last 2 months);\n  * lives within 20 kilometers of the study facility;\n  * able and willing to consent to study participation.\n\nExclusion Criteria:\n\n* Individuals not meeting the above criteria will be excluded.",true,"FEMALE","16 Years",{"count":87,"type":88},100,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (PLP) who use alcohol. Through the pilot RCT, we aim to understand if tailored intervention, Mentor Mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (PrEP or ART) adherence (secondary outcomes) among pregnant and breastfeeding women living with and without HIV in a community heavily burdened by this syndemic.\n\nThe investigators will conduct an pilot randomized control trial in 100 pregnant women, recruited during antenatal care (ANC) visits within the Saldanha Bay Municipality clinic in Cape Town, South Africa. The RCT will involve the delivery of brief, individual motivational interviewing sessions provided by trained mentor mothers from the community who are on either PrEP (living without HIV) or ART (living with HIV) and who stopped or reduced alcohol use during pregnancy. The enrolled participants will be followed for a 6-month period spanning both pregnancy and postpartum stages.",[94,95],"HIV","Alcohol Consumption",[97,98,99,100,101,102],"pregnant","postpartum","HIV prevention","HIV treatment","Alcohol use","breastfeeding","2026-07-01",{"date":105,"type":106},"2026-07-02","ACTUAL",{"date":108,"type":106},"2025-09-01",{"date":110,"type":88},"2027-08-31",{"name":5,"class":6},2]