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

2022년 6월 28일 업데이트: Susie Hoffman, New York State Psychiatric Institute

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 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.

연구 개요

상태

모집하지 않고 적극적으로

정황

상세 설명

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.

연구 유형

중재적

등록 (실제)

100

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
다른: 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.
The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percent of participants who have an individual counseling session about PrEP.
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Percent of participants who undergo HIV-testing and counseling (HCT).
기간: 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.
Immediate post-intervention up to 3 months after the intervention
Percent taking up PrEP
기간: 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.
Immediate post-intervention up to 3 months after the intervention

기타 결과 측정

결과 측정
측정값 설명
기간
Number of correct reponses on PrEP information scale
기간: 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
Mean value on Perceived risk for HIV scale
기간: 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
Mean value on Perceived effectiveness of PrEP scale
기간: 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.
baseline to immediate post-intervention and 3 month follow-up
Mean value on Positive outcomes of taking PrEP scale
기간: 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.
baseline to immediate post-intervention and 3 month follow-up
Mean value on PrEP anticipated stigma, PrEP-user stereotypes subscale
기간: 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.
baseline to immediate post-intervention and 3 month follow-up
Mean value on PrEP Anticipated stigma, Disapproval by others subscale
기간: 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
baseline to immediate post-intervention and 3 month follow-up
Mean value on Medication beliefs
기간: 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.
baseline to immediate post-intervention and 3 month follow-up
Mean value on gendered partner disclosure beliefs
기간: baseline to immediate post-intervention and 3 month follow-up
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
기간: 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.
baseline to immediate post-intervention and 3 month follow-up

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 3월 30일

기본 완료 (실제)

2022년 6월 24일

연구 완료 (예상)

2022년 12월 31일

연구 등록 날짜

최초 제출

2021년 3월 21일

QC 기준을 충족하는 최초 제출

2021년 4월 3일

처음 게시됨 (실제)

2021년 4월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 6월 28일

마지막으로 확인됨

2022년 6월 1일

추가 정보

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HIV 감염에 대한 임상 시험

Gender-Enhanced -- Masibambane에 대한 임상 시험

3
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