NCT04833127: Masibambane

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

Completed Phase 1 Results posted Last updated 23 September 2024

What this trial tests

Phase 1 trial testing Gender-Enhanced -- Masibambane in HIV Infections in 100 participants. Completed in 31 December 2022.

Timeline

17 March 2021

Primary endpoint
24 June 2022

31 December 2022

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	17 March 2021
Primary completion	24 June 2022
Estimated completion	31 December 2022
Sites	1 location across South Africa

Drugs / interventions tested

• Gender-Enhanced -- Masibambane
• Individually accessed

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 25, female only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Participants Who Have an Individual Counseling Session About PrEP. Primary · Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log)

Percent of all participants who request and undergo an individual counseling session with the study nurse about the possibility of taking up PrEP. This behavioral measure will be documented by the study nurse

Group	Value	95% CI
Masibambane - Gender-Enhanced	28
Individually Accessed	28

Percent of Participants Who Undergo HIV-testing and Counseling (HCT). Secondary · Immediate post-intervention up to 3 months after the intervention

Percent of all participants who undergo HIV testing and counseling, using self-administered OraQuick, either on her own or with study nurse support. This behavioral measure will be documented by the study nurse.

Group	Value	95% CI
Masibambane - Gender-Enhanced	3
Individually Accessed	3

Percent Taking up PrEP Secondary · Immediate post-intervention up to 3 months after the intervention

If participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report.

Group	Value	95% CI
Masibambane - Gender-Enhanced	8
Individually Accessed	5

Adverse events — posted to ClinicalTrials.gov

Time frame: up to the last assessment, at 3-months after the intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Masibambane - Gender-Enhanced

Serious: 1/50 (2%)

Deaths: 0/50

Individually Accessed

Serious: 0/50 (0%)

Deaths: 0/50

Serious adverse events (1 terms)

Reaction	System	Masibambane - Gender-Enhan…	Individually Accessed
violence from a partner	General disorders	—	—

Most-reported serious reactions: violence from a partner.

Data from ClinicalTrials.gov NCT04833127 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.