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

NCT04833127 | Completed Phase 1 Results DMC

• 1 other identifier: 7682
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Immediate post-intervention up to 3 months after the intervention

• Percent Taking up PrEP

  Immediate post-intervention up to 3 months after the intervention

Study Arms (2)

Masibambane - Gender-Enhanced

ACTIVE COMPARATOR

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

Individually accessed

OTHER

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

Interventions

Gender-Enhanced -- Masibambane BEHAVIORAL

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.

Masibambane - Gender-Enhanced

Individually accessed BEHAVIORAL

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

Individually accessed

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Medical Research Council, South Africa: collaborator
• Brown University: collaborator

Study Sites (1)

South African Medical Research Council

Durban, KwaZulu-Natal, South Africa

Location

Related Publications (4)

• 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.

  PMID: 35306944 BACKGROUND

• 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.

  PMID: 35218452 BACKGROUND

• 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.

  PMID: 38416275 BACKGROUND

• 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.

  PMID: 36735226 BACKGROUND

Related Links

• Publically-available website about the study

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Pilot trial with sample size of 100 participants, designed to assess feasibility and acceptability rather than efficacy.

Results Point of Contact

• Title: Dr. Susie Hoffman
• Organization: NYS Psychiatric Institute and Columbia University

sh51@cumc.columbia.edu

718 744 7686

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Epidemiology (in Psychiatry)

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: April 6, 2021
• Study Start: March 17, 2021
• Primary Completion: June 24, 2022
• Study Completion: December 31, 2022
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)