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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833127
Acronym
Masibambane
Enrollment
100
Registered
2021-04-06
Start date
2021-03-17
Completion date
2022-12-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Pre-Exposure Prophylaxis, oral, South African, Adolescent girls and young women, HIV prevention

Brief 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.

Detailed description

South African adolescent girls and young women (AGYW) remain at extraordinarily high risk of HIV infection. Oral pre-exposure prophylaxis (PrEP) has the potential to alter the epidemic in this vulnerable population, given that it is has been shown that if it is adhered to, oral PrEP can protect women from HIV infection. Yet, a critical question is whether AGYW will adopt and adhere to oral PrEP. The investigators propose that two innovations can reach young, at-risk AGYW, inform them about PrEP and motivate them to use it: (1) introducing PrEP through a gender lens in a group workshop; and (2) participant-driven recruitment-recruiting women to attend the workshop by those who have already attended it. To inform intervention development, the investigators conducted six focus groups with sexually-active AGYW (aged 18-25), 8 qualitative interviews with focus group participants, and 20 qualitative interviews with men (10 HIV-positive, 10 HIV-negative or of unknown status) partnered with women in this age range that explored knowledge of, beliefs about, motivators for, and concerns about using PrEP in the context of gendered relationship dynamics and PrEP-related stigma. Guided by gender theory and the Information Motivation Behavior (IMB) model, and in collaboration with a Working Group of AGYW, a virtual (online) group-based Gender-Enhanced (GE) Workshop (using the WhatsApp® platform) was developed. The intervention has components that are conducted by participants on their own time as well as a real-time live interactive session and aims to provide PrEP information and address AGYW's barriers to using it. The goal of the intervention is to promote consideration of and uptake of PrEP. In this phase 1 pilot study to assess feasibility and acceptability and potential for impact of the workshop, investigators compared AGYW (N=100) assigned to the virtual group-based (GE) workshop or 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. To evaluate participant-driven recruitment (PDR), AGYW assigned to either condition were invited to become Peer Health Advocates (PHAs), who are incentivized to talk to social network members and refer up to three to the workshop type the PHA attended. Acceptability and feasibility of PDR were evaluated by assessing whether the method can be self-sustaining (i.e., on average \>50% attendees become PHAs and \>2 recruits/PHAs attend a workshop); and whether it reaches high-risk women and women who would not be captured by other methods of recruitment (percent who score high on HIV risk; percent who never tested or attended family planning). If promising, these approaches will be further tested in a larger study.

Interventions

BEHAVIORALGender-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.

BEHAVIORALIndividually accessed

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

Sponsors

Medical Research Council, South Africa
CollaboratorOTHER
Brown University
CollaboratorOTHER
New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

1. self-reported HIV-negative or unknown status 2. heterosexual vaginal or anal intercourse reported in the past 6 months 3. Is not currently taking PrEP or planning to begin PrEP 4. presently residing in eThekweni-metropolitan Durban 5. has private smart-phone access 6. Conversant in isiZulu or English 7. Willing to recruit other women (if in first group of participants); 8. (If recruited subsequent to first group): Recruited by a peer health advocate (someone the participant knew knew prior to being recruited)

Exclusion criteria

1. Overt signs of cognitive impairment 2. Was a participant in the previously conducted focus groups 3. If assigned to the online group intervention, unwilling to be audio-recorded

Design outcomes

Primary

MeasureTime frameDescription
Percent of Participants Who Have an Individual Counseling Session About PrEP.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

Secondary

MeasureTime frameDescription
Percent of Participants Who Undergo HIV-testing and Counseling (HCT).Immediate post-intervention up to 3 months after the interventionPercent 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.
Percent Taking up PrEPImmediate post-intervention up to 3 months after the interventionIf participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report.

Countries

South Africa

Participant flow

Recruitment details

Met the goal

Participants by arm

ArmCount
Masibambane - Gender-Enhanced
A virtual (online) group-based interactive Gender-Enhanced (GE) Workshop (using the WhatsApp® platform). The intervention has components that are conducted by participants on their own time as well as a real-time live interactive session. 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.
50
Individually Accessed
In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. Individually accessed: The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
50
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up11

Baseline characteristics

CharacteristicIndividually AccessedTotalMasibambane - Gender-Enhanced
Age, Customized
Age
22 years
STANDARD_DEVIATION 2
22 years
STANDARD_DEVIATION 2
23 years
STANDARD_DEVIATION 2
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
South Africa
50 participants100 participants50 participants
Sex: Female, Male
Female
50 Participants100 Participants50 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 50
other
Total, other adverse events
0 / 500 / 50
serious
Total, serious adverse events
1 / 500 / 50

Outcome results

Primary

Percent of Participants Who Have an Individual Counseling Session About PrEP.

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

Time frame: Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up and nurse counselor log)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Masibambane - Gender-EnhancedPercent of Participants Who Have an Individual Counseling Session About PrEP.28 Participants
Individually AccessedPercent of Participants Who Have an Individual Counseling Session About PrEP.28 Participants
p-value: 195% CI: [0.56, 1.8]GLM (logit link) with GEE
p-value: 0.6995% CI: [0.62, 2.07]GLM (logit link) with GEE
Secondary

Percent of Participants Who Undergo HIV-testing and Counseling (HCT).

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.

Time frame: Immediate post-intervention up to 3 months after the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Masibambane - Gender-EnhancedPercent of Participants Who Undergo HIV-testing and Counseling (HCT).3 Participants
Individually AccessedPercent of Participants Who Undergo HIV-testing and Counseling (HCT).3 Participants
p-value: 195% CI: [0.35, 2.85]GLM with GEE
p-value: 0.92795% CI: [0.31, 2.9]GLM (logit link) with GEE
Secondary

Percent Taking up PrEP

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

Time frame: Immediate post-intervention up to 3 months after the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Masibambane - Gender-EnhancedPercent Taking up PrEP8 Participants
Individually AccessedPercent Taking up PrEP5 Participants
p-value: 0.21595% CI: [0.73, 4.04]GLM (logit link) with GEE
p-value: 0.29595% CI: [0.65, 4.13]GLM (logit link) with GEE

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026