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

This is a multi-site prospective implementation science study to assess the feasibility, acceptability and safety of offering oral PrEP (Pre-exposure prophylaxis) as part of a combination prevention package that addresses gender-based violence (GBV), stigma and HIV in adolescent girls and young women (AGYW) at substantial risk for HIV infection aged 16-24 years in two demonstration sites (South Africa and Tanzania).

Primary objectives are:

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 standard adherence care

Participants who consent for screening will be counselled and tested for HIV and asked about experiences of gender-based violence (GBV) and stigma. Those that test positive for HIV will be linked to care. Those that report current experiences of violence or stigma and that are at immediate risk of danger will be linked to care.

HIV negative participants will be invited to consent to enrol in a prospective cohort and followed up for a maximum of 15 months. Participants will be provided with information regarding their HIV risk and prevention options, including oral PrEP. Those that are interested in using PrEP will be assessed for eligibility. Up to 500 PrEP acceptors will be enrolled in the study.counselling and SMS support alone, in HIV negative AGYW.

Participants who accept oral PrEP will be randomised in a 1:1 ratio to receive standard adherence support (counselling and SMS support) compared to enhanced adherence support which includes allocation to adherence support clubs that will offer a four-session empowerment intervention in addition to the standard adherence support. Randomization will be stratified by site to ensure balance.

All participants will be followed up quarterly for a maximum of 15 months. Three community dialogues will be implemented during the follow-up period to promote social support for positive social norms around gender and HIV prevention.


  • Principal Investigator(s): Sindead Delaney-Moretlwe (Wits Reproductive Health Institute, South Africa) and Saidi Kapiga (Mwanza Intervention Trials Unit, Tanzania)
  • Other LSHTM research staff involved: Sheila Harvey, Shelley Lee.


For more information on this project please contact Manuela Colombini.

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