- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
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
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, 남아프리카
- South African Medical Research Council
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 7682
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
HIV 감염에 대한 임상 시험
-
Hospital Clinic of Barcelona완전한
-
CDC FoundationGilead Sciences알려지지 않은
-
University of WashingtonNational Institute of Mental Health (NIMH)모병
-
University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation완전한파트너 HIV 테스트 | 부부 에이즈 상담 | 커플커뮤니케이션 | HIV 발병률카메룬, 도미니카 공화국, 그루지야, 인도
-
Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS), Ministério da... 그리고 다른 협력자들모집하지 않고 적극적으로HIV, 신생아 HIV 조기 진단(EID), 현장 진료 검사(PoC)모잠비크, 탄자니아
-
Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
Erasmus Medical Center모병
-
Erasmus Medical Center모집하지 않고 적극적으로
Gender-Enhanced -- Masibambane에 대한 임상 시험
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Boston아직 모집하지 않음자살 생각 | 자살 시도 | 자살
-
Duke UniversityUniversity of North Carolina, Chapel Hill; University of North Carolina, Greensboro; UConn...완전한
-
Second Affiliated Hospital, School of Medicine,...알려지지 않은
-
University of Colorado, Denver완전한