HIV/AIDS
Conditions
Interventions
PrEP
Sponsors
Wits Health Consortium
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. AGYW (born female) at substantial risk for HIV infection who are confirmed age 16 - 24 years ( inclusive) 2. HIV seronegative 3. Interested in HIV prevention methods, including oral PrEP 4. Sexually active per participant report, defined as having vaginal intercourse at least once in the past 30 days 5. Willing and able to provide adequate locator information and 6. Willing and able to provide informed consent or assent ( if parental consent is required per local regulations) and 7. Regular access to mobile phone with SMS capability
Exclusion criteria
Exclusion criteria: Not planning to be in the study area during the follow-up period or has obligations that would require long absences (>8 weeks at a time) from the study area; •HIV seropositive; •Women identified at screening as being at immediate risk of harm (either from self or others); •Signs or symptoms of acute HIV infection; •Currently pregnant; •Renal dysfunction (creatinine clearance <60ml/min, Schwartz equation); •Receiving on-going therapy with agents with substantial nephrotoxic potential; or •Hepatitis B seropositive. •Currently enrolled or planning to enrol in another HIV prevention research study; •Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial; or •Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Key primary outcomes For part I, the main outcomes of interest are •The proportion of AGYW who accept HIV counselling and testing with clinical enquiry 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 clinical enquiry at 12 months; •Participant, provider and community stake-holder reported satisfaction with services (qualitative and quantitative data) For part II, we will assess •the proportion of AGYW who accept PrEP at enrolment, and overall; •time to PrEP initiation •attendance at adherence clubs •proportion of AGYW retained in care at scheduled follow-up visits, overall and by adherence intervention arm •the proportion of AGYW with detectable TFV levels at 3 and 6 months, overall and by adherence intervention •proportion of participants reporting GBV and/or stigma over 15 months of follow-up overall, by site and by adherence intervention •frequency of grade 2, 3, 4 clinical and laboratory events •empowerment scores among AGYW, overall and by adherence intervention •Participant, provider and community stake-holder reported satisfaction with services (qualitative and quantitative data) | — |
Secondary
| Measure | Time frame |
|---|---|
| Key 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; •Correlates of PrEP adherence and continuation; •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 and risk behaviours 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. | — |
Countries
South Africa, Tanzania
Contacts
Public ContactSinead Delany Moretlwe
Director Research
Outcome results
None listed