EMPOWER: An evaluation of a combination HIV prevention intervention that includes oral PrEP for adolescent girls and young women in South Africa and Tanzania

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR202006754762723
• Lead Sponsor: Wits Health Consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified