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A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women

NCT04833127 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-23

Study results available
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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.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Gender-Enhanced -- Masibambane

The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a "real-time" "live" interactive session with trained facilitators.

BEHAVIORAL

Individually accessed

The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options

Sponsors & Collaborators

  • Medical Research Council, South Africa

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • New York State Psychiatric Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-17
Primary Completion
2022-06-24
Completion
2022-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04833127 on ClinicalTrials.gov