Study Title:
An evaluation of a combination HIV prevention intervention that includes oral PrEP for adolescent girl and young women in south africa and tanzania
Sponsor Name: Wits Health Consortum (Pty) Ltd, South Africa
Application Number: TFDA0016/CTR/0012, Date Received: 20/10/2016
Principal Investigator: Dr Said Kapiga Mwanza Intervention Trials Unit, National Institute for Medical Research, P.O. Box 11936, Mwanza
Intervention Medicinal Product Status of IMP
Truvada? (Emtricitabine/Tenofovir disoproxil fumarate) Registered
Primary Disease: HIV Infection
Trial Site: Mwanza Intervention Trials Unit, National Institute for Medical Research, P.O. Box 11936, Mwanza
Start / Approval Date: 03/08/2017, Status / Approval Remark: Approved
Primary Purpose: To evaluate the feasibility, acceptability and safety of ? integrating screening and linkage-to-care for GBV and stigma within HIV counselling and testing for AGYW, and ? ? supporting PrEP acceptance, effective use (adherence) and retention in care through adherence clubs that include a four-session empowerment curriculum, compared to counselling and SMS support alone, in HIV negative AGYW
Study Phase: IV
Study Type: Interventional
Expected Completion Date: 03/07/2020
Target Sample Size: 500
Recruitment Status: Completed, Follow up completed
Outcome: Primary outcome: For primary objective 1: The proportion of AGYW who accept HIV counselling and testing with screening for GBV/stigma out of the total number offered at (1) programme entry, and (2) over 12-15 months of follow-up; ? The proportion of AGYW who report experience of GBV/stigma at (1) programme entry, and (2) over 12-15 months of follow-up; ? The proportion of those who report GBV/stigma who accept referral to other services, including HIV treatment; ? Proportion of providers who continue to offer HCT with integrated GBV/stigma screening at 12 months; ? Participant, provider and community stake-holder reported satisfaction with services (qualitative and quantitative data) Secondary Outcomes; Correlates of GBV and stigma, and factors associated with linkage-to-care for GBV; ? Correlates of PrEP acceptance and time to first acceptance; ? Patterns and correlates of PrEP adherence and continuation/discontinuation; ? Correlated of AGYW self-efficacy, empowerment, and influence on relationship dynamics (including partnership harmony, perceptions of couple communication and fidelity; reported intimacy and partner testing; ? Change in HIV prevention, risk behaviours and STIs among PrEP users and non-users over time; ? Frequency of antiretroviral drug resistance among women who acquire HIV infection; ? Costs and cost-effectiveness of the combination package and each of its elements; ? Correlates of contraceptive use and pregnancy incidence; ? To explore through qualitative and quantitative assessments whether this combination package leads to improvements in quality of care for GBV and HIV.