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

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

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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Gender-Enhanced -- Masibambane; Behavioral: Individually accessed

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa
      • South African Medical Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Other: 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.	Behavioral: Individually accessed; The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options

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 and nurse counselor log)

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correct reponses on PrEP information scale	5-item scale developed for this study. Count of correct responses	baseline to immediate post-intervention and 3 month follow-up
Mean value on Perceived risk for HIV scale	8-item measure from Napper LE, Fisher DG, Reynolds GL. Development of the perceived risk of HIV scale. AIDS and Behavior. 2012;16(4):1075-83.	baseline to immediate post-intervention and 3 month follow-up
Mean value on Perceived effectiveness of PrEP scale	10-item measure from Golub et al., Predictors of PrEP Uptake AIDS and Behavior 2019 23:1917-1924.	baseline to immediate post-intervention and 3 month follow-up
Mean value on Positive outcomes of taking PrEP scale	5-item measure from Teitelman et al., 2020 Beliefs associated with intention to use PrEP among cis-gender US women at risk: Archives of Sexual Behavior (2020) 49:2213-2221.	baseline to immediate post-intervention and 3 month follow-up
Mean value on PrEP anticipated stigma, PrEP-user stereotypes subscale	The PrEP Anticipated Stigma Scale- PrEP-User Stereotypes subscale. from Calabrese et al. HIV Pre-Exposure Prophylaxis Stigma as a Multidimensional Barrier to Uptake Among Women Who Attend Planned Parenthood J Acquir Immune Defic Syndr 2018;79:46-53.	baseline to immediate post-intervention and 3 month follow-up
Mean value on PrEP Anticipated stigma, Disapproval by others subscale	The PrEP Anticipated Stigma Scale- Disapproval by others subscale. from Calabrese et al.J Acquir Immune Defic Syndr 2018;79:46-53	baseline to immediate post-intervention and 3 month follow-up
Mean value on Medication beliefs	4-item scale adapted from adapted from Kalichman et al. Medication Beliefs and Structural barriers to Treatment Adherence Among People Living with HIV Infection. Psychol Health. 2016 April ; 31(4): 383-395.	baseline to immediate post-intervention and 3 month follow-up
Mean value on gendered partner disclosure beliefs	5-item measure developed by the team for this study	baseline to immediate post-intervention and 3 month follow-up
Increase in value on Stage of change scale	Stages of Change based on Prochaska, J. O., & Norcross, J. C. (2002). Stages of Change. In J. C. Norcross (Ed.), Psychotherapy relationships that work: Therapist contributions and responsiveness to patients (p. 303-313). Oxford University Press.	baseline to immediate post-intervention and 3 month follow-up

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: Brown University; Medical Research Council, South Africa

Publications and helpful links

General Publications

• Harrison A, Bhengu N, Miller L, Exner T, Tesfay N, Magutshwa S, Khumalo S, Bergam S, Hoffman S, Hanass-Hancock J. "You tell him that 'baby, I am protecting myself'": Women's agency and constraint around willingness to use pre-exposure prophylaxis in the Masibambane Study. Womens Health (Lond). 2022 Jan-Dec;18:17455057221087117. doi: 10.1177/17455057221087117.
• Bergam S, Harrison AD, Benghu N, Khumalo S, Tesfay N, Exner T, Miller L, Dolezal C, Hanass-Hancock J, Hoffman S. Women's Perceptions of HIV- and Sexuality-Related Stigma in Relation to PrEP: Qualitative Findings from the Masibambane Study, Durban, South Africa. AIDS Behav. 2022 Sep;26(9):2881-2890. doi: 10.1007/s10461-022-03632-6. Epub 2022 Feb 26.
• Fordjuoh J, Dolezal C, Bhengu N, Harrison AD, Exner TM, Hanass-Hancock J, Hoffman S. Peer-to-Peer Chain Recruitment for Enrolling Young South African Women into an HIV Pre-exposure Prophylaxis (PrEP) Intervention Study: How Did It Perform? AIDS Behav. 2024 May;28(5):1782-1794. doi: 10.1007/s10461-023-04256-0. Epub 2024 Feb 28.
• Hanass-Hancock J, Bhengu N, Exner T, Magusthwa S, Harrison A, Dolezal C, Miller L, Bauman L, Hoffman S. Masibambane-Ladies Chat: Developing an Online Gender-Enhanced PrEP Information-Motivation Workshop for Young South African Women. AIDS Educ Prev. 2023 Feb;35(1):14-35. doi: 10.1521/aeap.2023.35.1.14.

Helpful Links

• Publically-available website about the study

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 21, 2021
• First Submitted That Met QC Criteria: April 3, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: May 26, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: HIV prevention; Pre-Exposure Prophylaxis, oral; South African; Adolescent girls and young women
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 7682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No