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

Study Overview
=================
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 will compare AGYW (N=100) assigned to the virtual group-based (GE) workshop to those assigned to an Individually Accessed (IA) condition in which women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. Investigators also are evaluating the acceptability and feasibility of peer-driven recruitment (PDR). AGYW assigned to either intervention condition will be invited to become Peer Health Advocates (PHAs), who are incentivized to talk to social network members and refer up to three to the intervention type the PHA attended. The aim is 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) peer-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 at-risk 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 will compare AGYW (N=100) assigned to the virtual group-based (GE) workshop or to an Individually Accessed (IA) condition in which women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. To evaluate Peer-driven recruitment (PDR), AGYW randomized to either condition will be 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 will be evaluated by assessing whether the method can be self-sustaining (i.e., on average >50% attendees become PHAs and >2 recruitees/PHA 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.

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

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Gender-Enhanced -- Masibambane
* Behavioral: Individually accessed


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Masibambane - Gender-Enhanced<br>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. | Behavioral: Gender-Enhanced -- Masibambane<br>* 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.<br>|
| Other: Individually accessed<br>In this condition women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. | Behavioral: Individually accessed<br>* The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediate post-intervention up to 3 months after the intervention | 
| Percent taking up PrEP | If participant is PrEP-eligible (HIV-negative) she initiates PrEP. This outcome will be based on self-report. | Immediate post-intervention up to 3 months after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-Exposure Prophylaxis, oral, South African, Adolescent girls and young women, HIV prevention