- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04833127
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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KwaZulu-Natal
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Durban, KwaZulu-Natal, Sydafrika
- South African Medical Research Council
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
|
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.
|
Andet: 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.
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The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percent of participants who have an individual counseling session about PrEP.
Tidsramme: 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
|
Immediate post-intervention up to 3 months after the intervention (i.e., as reported on the 3-month follow-up)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percent of participants who undergo HIV-testing and counseling (HCT).
Tidsramme: 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.
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Immediate post-intervention up to 3 months after the intervention
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Percent taking up PrEP
Tidsramme: Immediate post-intervention up to 3 months after the intervention
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If participant is PrEP-eligible (HIV-negative) she initiates PrEP.
This outcome will be based on self-report.
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Immediate post-intervention up to 3 months after the intervention
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of correct reponses on PrEP information scale
Tidsramme: baseline to immediate post-intervention and 3 month follow-up
|
5-item scale developed for this study.
Count of correct responses
|
baseline to immediate post-intervention and 3 month follow-up
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Mean value on Perceived risk for HIV scale
Tidsramme: 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.
|
baseline to immediate post-intervention and 3 month follow-up
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Mean value on Perceived effectiveness of PrEP scale
Tidsramme: baseline to immediate post-intervention and 3 month follow-up
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10-item measure from Golub et al., Predictors of PrEP Uptake AIDS and Behavior 2019 23:1917-1924.
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baseline to immediate post-intervention and 3 month follow-up
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Mean value on Positive outcomes of taking PrEP scale
Tidsramme: baseline to immediate post-intervention and 3 month follow-up
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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.
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baseline to immediate post-intervention and 3 month follow-up
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Mean value on PrEP anticipated stigma, PrEP-user stereotypes subscale
Tidsramme: baseline to immediate post-intervention and 3 month follow-up
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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.
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baseline to immediate post-intervention and 3 month follow-up
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Mean value on PrEP Anticipated stigma, Disapproval by others subscale
Tidsramme: baseline to immediate post-intervention and 3 month follow-up
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The PrEP Anticipated Stigma Scale- Disapproval by others subscale.
from Calabrese et al.J Acquir Immune Defic Syndr 2018;79:46-53
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baseline to immediate post-intervention and 3 month follow-up
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Mean value on Medication beliefs
Tidsramme: 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.
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baseline to immediate post-intervention and 3 month follow-up
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Mean value on gendered partner disclosure beliefs
Tidsramme: baseline to immediate post-intervention and 3 month follow-up
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5-item measure developed by the team for this study
|
baseline to immediate post-intervention and 3 month follow-up
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Increase in value on Stage of change scale
Tidsramme: baseline to immediate post-intervention and 3 month follow-up
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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
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7682
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