CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 100 enrolled
Drug / intervention
Gender-Enhanced -- Masibambane +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04833127
NCT04833127Phase 1Completed

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

New York State Psychiatric Institute·interventional·Posted Apr 6, 2021·Updated Sep 23, 2024

In Brief

A Phase 1 clinical trial evaluating Gender-Enhanced -- Masibambane and Individually accessed for HIV Infections. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSouth Africa

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedApr 6, 2021
Enrollment StartMar 17, 2021
Primary CompletionJun 24, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.2 years ago

Interventions

Gender-Enhanced -- Masibambanebehavioral

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.

Individually accessedbehavioral

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