[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659772":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":23,"interventions":34,"overallOfficials":16,"centralContacts":42,"locations":16,"responsibleParty":52,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":16,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":16,"enrollmentInfo":68,"targetDuration":16,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":16,"overallStatus":82,"whyStopped":16,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":16},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Implementation outcomes will include feasibility, acceptability, and appropriateness of the intervention","Feasibility, acceptability, and appropriateness data tool, this is one tool that assesses the intervention using a Likert scale: 1) completely disagree, 2) disagree, 3) neutral, 4) Agree, 5) completely agree.","1 year",{"measure":14,"description":15,"timeFrame":12},"3-month PrEP persistence","PrEP initiation",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE",[24,29],{"label":25,"type":26,"description":16,"interventionNames":27},"Intervention Arm","ACTIVE_COMPARATOR",[28],"Behavioral: POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.",{"label":30,"type":26,"description":31,"interventionNames":32},"Control Arm","Standard of Care",[33],"Other: Standard of Care",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":16},"BEHAVIORAL","POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.","2\\. Study Aim and Objectives\n\n2.1. Overall Aim\n\nTo evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-component intervention integrating POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.\n\n2.2. Primary Objective\n\nTo evaluate the effect of the multi-component intervention on 3-month PrEP persistence among\n\npregnant and postpartum women. PrEP persistence will be defined as current PrEP use at the 3-month follow-up visit (measured from enrolment), with participants who do not initiate or who discontinue PrEP classified as not persistent.\n\n2.3. Secondary Objectives\n\n* To determine the prevalence of STIs among pregnant and postpartum women\n* To determine the feasibility and acceptability of aetiological STI testing within the antenatal\n\nand postnatal clinical workflows by HCPs\n\n● To determine the acceptability and uptake of HIV\u002FSTI services by partners of pregnant and postpartum women",[25],{"type":6,"name":31,"description":31,"armGroupLabels":41,"otherNames":16},[30],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":16,"email":47},"Nicole A Montañez, MSW","CONTACT","3108255047","nmontanez@ucla.edu",{"name":49,"role":45,"phone":50,"phoneExt":16,"email":51},"Dvora Joseph Davey, PhD","3107942555","dvoradavey@g.ucla.edu",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","Nicole Montanez","Principle Investigator",[57],{"name":58,"class":6},"University of Cape Town","100659772","the-act-prep-study-100659772",false,"NCT07867990","The ACT-PrEP Study","ACT-PrEP Study: Aetiological STI Testing (Point-of-care), Cognitive Behavioral Counselling, and Targeted Partner Engagement to Support PrEP Enrolment and Persistence in Pregnant and Postpartum Women in South Africa","Inclusion Criteria:\n\n* age ≥18 years;\n* HIV-negative,\n* minimum gestational age of 18 weeks for pregnant women, and\n* eligible for PrEP as per South African guidelines.\n\nExclusion Criteria:\n\n* inability to provide informed consent,\n* medical contraindications to PrEP.","ALL","18 Years",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"NA","AIM: To evaluate the integration of point-of-care etiological STI testing, cognitive behavioral counselling (CBC), and sexual partner engagement strategies to improve STI management, PrEP uptake and 3-month PrEP persistence among pregnant and postpartum women PRIMARY OBJECTIVE: To evaluate the effect of the intervention on 3-month PrEP persistence among pregnant and postpartum women (PPW) SECONDARY OBJECTIVE: Determine the proportion of PPW initiating PrEP Determine the prevalence of STIs among pregnant and postpartum women Determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs Determine the acceptability and uptake of HIV\u002FSTI services by partners of pregnant and postpartum women STUDY DESIGN AND POPULATION: One-site, two-arm, individually randomized controlled type-1 hybrid implementation pilot This pilot study will follow a type-1 hybrid implementation-effectiveness design to be implemented at a public sector primary healthcare centre with a high HIV\u002FSTI burden (Gugulethu Community Health Centre).\n\nEnrollment: 120 pregnant women attending a routine care visit. Follow-up visits may fall in the post-partum period depending on age of gestation upon enrollment. Inclusion criteria include: 1) age ≥18 years; 2) HIV-negative, 3) minimum gestational age of 18 weeks for pregnant women, and 4) eligible for PrEP as per South African guidelines. Exclusion criteria include: 1) inability to provide informed consent, 2) medical contraindications to PrEP. Sexual partners of PPW will be engaged through the distribution of HIV\u002Fsyphilis self-test kits, and 10 healthcare providers will participate in cognitive behavioral counselling (CBC) training and competency assessments.",[76,77,78,79,80,81],"HIV","PrEP","Acceptability","Appropriateness","Feasibility","Implementation Science","NOT_YET_RECRUITING","2026-10-06",{"date":85,"type":86},"2026-10-09","ACTUAL",{"date":88,"type":70},"2026-10-02",{"date":90,"type":70},"2027-06-30",{"name":5,"class":6}]