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

HIV Infections Clinical Trial

— Masibambane  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04833127
• Other study ID #: 7682
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 30, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
South Africa	South African Medical Research Council	Durban	KwaZulu-Natal

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Brown University, Medical Research Council, South Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (2)

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 Feb 26. doi: 10.1007/s10461-022-03632-6. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
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	Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up)
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.	Immediate post-intervention up to 3 months after the intervention
Secondary	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