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

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04833127
Collaborator
Medical Research Council, South Africa (Other), Brown University (Other)
100
Enrollment
1
Location
2
Arms
21.1
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gender-Enhanced -- Masibambane
  • Behavioral: Individually accessed
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Developing a Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women
Actual Study Start Date :
Mar 30, 2021
Actual Primary Completion Date :
Jun 24, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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)]

    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 Outcome Measures

  1. Percent of participants who undergo HIV-testing and counseling (HCT). [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.

  2. Percent taking up PrEP [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.

Other Outcome Measures

  1. Number of correct reponses on PrEP information scale [baseline to immediate post-intervention and 3 month follow-up]

    5-item scale developed for this study. Count of correct responses

  2. Mean value on Perceived risk for HIV scale [baseline to immediate post-intervention and 3 month follow-up]

    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.

  3. Mean value on Perceived effectiveness of PrEP scale [baseline to immediate post-intervention and 3 month follow-up]

    10-item measure from Golub et al., Predictors of PrEP Uptake AIDS and Behavior 2019 23:1917-1924.

  4. Mean value on Positive outcomes of taking PrEP scale [baseline to immediate post-intervention and 3 month follow-up]

    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.

  5. Mean value on PrEP anticipated stigma, PrEP-user stereotypes subscale [baseline to immediate post-intervention and 3 month follow-up]

    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.

  6. Mean value on PrEP Anticipated stigma, Disapproval by others subscale [baseline to immediate post-intervention and 3 month follow-up]

    The PrEP Anticipated Stigma Scale- Disapproval by others subscale. from Calabrese et al.J Acquir Immune Defic Syndr 2018;79:46-53

  7. Mean value on Medication beliefs [baseline to immediate post-intervention and 3 month follow-up]

    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.

  8. Mean value on gendered partner disclosure beliefs [baseline to immediate post-intervention and 3 month follow-up]

    5-item measure developed by the team for this study

  9. Increase in value on Stage of change scale [baseline to immediate post-intervention and 3 month follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 South African Medical Research Council Durban KwaZulu-Natal South Africa

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Susie Hoffman, Associate Professor of Clinical Epidemiology (in Psychiatry), New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT04833127
Other Study ID Numbers:
  • 7682
First Posted:
Apr 6, 2021
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Susie Hoffman, Associate Professor of Clinical Epidemiology (in Psychiatry), New York State Psychiatric Institute
Pre-Exposure Prophylaxis, oral
South African
Adolescent girls and young women
HIV prevention
Additional relevant MeSH terms:
HIV Infections

Study Results

No Results Posted as of Jul 1, 2022