Phase 1
N=100
A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04833127 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Sep 2024
Primary outcome: Primary: Percent of Participants Who Have an Individual Counseling Session About PrEP. — 28; 28 Participants — p=1.0
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gender-Enhanced -- Masibambane (Behavioral); Individually accessed (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Who Have an Individual Counseling Session About PrEP. |
28; 28 | 1.0 |
| SECONDARY Percent of Participants Who Undergo HIV-testing and Counseling (HCT). |
3; 3 | 1.00 |
| SECONDARY Percent Taking up PrEP |
8; 5 | 0.215 |
Summary
This is a phase 1 pilot study to assess feasibility and acceptability and potential for impact of a gender-enhanced virtual group workshop focused on oral Pre-Exposure Prophylaxis (PrEP) as an HIV prevention method for young South African women. It was developed in collaboration with South African adolescent girls and young women (AGYW) aged 18-25. The investigators compared AGYW (N=100) assigned to the virtual group-based (GE) workshop to those assigned to an Individually Accessed (IA) condition in which women were given access to a PrEP video and to websites that provide information on PrEP and on contraception options. Investigators also evaluated the acceptability and feasibility of participant-driven recruitment (PDR). AGYW assigned to either intervention condition were invited to become Peer Health Advocates (PHAs), who were incentivized to talk to social network members and refer up to three to the intervention type the PHA attended. The aim was to assess if PDR is self-sustaining and is effective at reaching women who might not be reached in clinics.
Eligibility Criteria
Inclusion Criteria
- self-reported HIV-negative or unknown status
- heterosexual vaginal or anal intercourse reported in the past 6 months
- Is not currently taking PrEP or planning to begin PrEP
- presently residing in eThekweni-metropolitan Durban
- has private smart-phone access
- Conversant in isiZulu or English
- Willing to recruit other women (if in first group of participants);
- (If recruited subsequent to first group): Recruited by a peer health advocate (someone the participant knew knew prior to being recruited)
Exclusion Criteria
- Overt signs of cognitive impairment
- Was a participant in the previously conducted focus groups
- If assigned to the online group intervention, unwilling to be audio-recorded
Data sourced from ClinicalTrials.gov (NCT04833127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.