The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 2
- 主要终点
- Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
研究概览
简要总结
The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to the HIV prevention plan for the Government of South Africa. Specifically, this project aims to: increase uptake, of sexual and reproductive health (SRH) services and readiness and uptake of PrEP among adolescent girls and young women (AGYW) aged 16 to 24 who engage in high-risk sexual behaviors; and reduce their barriers to accessing SRH services by addressing and reducing stigma and discrimination (S&D) in clinics.
详细描述
The researchers propose a cluster randomized trial with a factorial design to evaluate the efficacy of a multi-level intervention that addresses stigma in accessing healthcare, social support, and individual risk behaviors of adolescent girls and young women (AGYW) in South Africa. The researchers engaged stakeholders from the Department of Health, a Community Collaborative Board (CCB), and a Youth Advisory Board (YAB) to inform the adaptation of the evidence-based empowerment intervention, the Women's Health CoOp (WHC)-which addresses gender-based violence (GBV), substance use, and sexual risk-to address sexual and reproductive health (SRH) and pre-exposure prophylaxis (PrEP) readiness, uptake and adherence. Through engagement with stakeholders, the researchers also adapted a stigma and discrimination (S&D) reduction training curriculum for clinic staff.
The project plans to increase uptake of SRH services, and PrEP readiness, uptake and adherence among AGYW aged 16 to 24 who engage in high-risk sex. The investigators plan to conduct this through a multilevel HIV prevention strategy that addresses S&D in AGYW accessing healthcare, social support, and individual risk behaviors. This cluster randomized trial with a factorial design will be conducted across 12 clinics in Pretoria.
The aims of this study are (1) To engage stakeholders, the Community Collaborative Board (CCB), and the Youth Advisory Board (YAB) in adapting the Women's Health CoOp (WHC) and stigma and discrimination (S&D) reduction training, in the Pretoria area during a formative stage.
(2) To evaluate the impact of training on S&D among healthcare staff on the use of HIV and reproductive health services by adolescent girls and young women (AGYW), including pre-exposure prophylaxis (PrEP), and staff attitudes and behaviors toward AGYW at 4- and 8-month follow-up.
(3) To test the efficacy of a multilevel strategy that addresses structural (stigma and discrimination), interpersonal (social support), and individual (personal agency, substance use, and gender-based violence [GBV]) factors on PrEP readiness and uptake, and adherence (primary outcomes) and condom use, GBV, substance use, and HIV incidence (secondary) at 3-, 6-, and 9-month follow-up among vulnerable AGYW.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV negative
- •identify as female;
- •aged 16-24;
- •have had condomless sex in the past 3 months with a male partner;
- •not be currently pregnant and not want to get pregnant for the next year;
- •interested in taking PrEP;
- •not having previously participated in the formative phase of the study;
- •have not previously and not currently participating in any other PrEP-related demonstration project or research study;
- •not previously or not currently participating in any other HIV study in Tshwane;
- •lives in one of the target communities;
- •not on multidrug-resistant tuberculosis (MDR-TB) treatment;
- •intends to stay in the Tshwane district for the next 12 months;
- •agrees to provide contact information;
- •be willing to undergo rapid HIV testing;
- •be willing to undergo pregnancy testing.
排除标准
- 未提供
研究组 & 干预措施
No S&D Reduction Training; PrEP and SRH + YWHC
Arm 2 does not receive stigma and discrimination (S&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women).
干预措施: Young Women's Health CoOp (YWHC) (Behavioral)
S&D Reduction Training; PrEP and SRH only
Arm 3 receives stigma and discrimination (S&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women).
干预措施: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum (Behavioral)
S&D Reduction Training; PrEP, SRH + YWHC
Arm 4 receives stigma and discrimination (S&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women).
干预措施: Young Women's Health CoOp (YWHC) (Behavioral)
No S&D Reduction Training; PrEP and SRH only
Arm 1 does not receive stigma and discrimination (S&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women).
S&D Reduction Training; PrEP, SRH + YWHC
Arm 4 receives stigma and discrimination (S&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women).
干预措施: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum (Behavioral)
结局指标
主要结局
Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
时间窗: 8 months
Staff surveys that are modified from the Health Policy Project survey will be used to measure healthcare staffs' attitudes toward sexually active AGYW; the overall clinic environment; observed discrimination and stigmatizing behaviors toward AGYW. Greater values indicate higher levels of health clinic stigma and discrimination.
Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
时间窗: 8 months
A clinic audit, including a review of administrative data, will be conducted to assess the number of AGYW who uptake HIV and sexual and reproductive health services, including PrEP in each clinic.
AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
时间窗: 9 months
Self-report responses to a modified scale from the HIV Prevention Trials Network (HPTN) 082 trial and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess the extent to which AGYW are ready to initiate PrEP. Greater values indicate higher levels of PrEP readiness.
AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
时间窗: 9 months
Self-report responses to a modified scale from Microbicide Trials Network Studies (MTN) and single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated PrEP. Self-report responses on the AGYW questionnaire adapted from previous research will be used to assess PrEP adherence, including past 30-day use, and patterns of use, persistence and discontinuation.
AGYW Biological Outcome: Adherence to PrEP
时间窗: 9 months
Dried blood spot samples will be used to measure the amount of drug (Tenofovir-diphosphate) concentration in AGYW's blood to assess PrEP adherence.
AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
时间窗: 9 months
Self-report responses on the single item measures from the adapted Risk Behavior Assessment (RBA) questionnaires will be used to assess if AGYW initiated SRH services.
次要结局
- AGYW Participant Self-Report: Frequency of Drug Use(9 months)
- AGYW Participant Self-Report: Frequency of Alcohol Use(9 months)
- AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use(9 months)
- AGYW Participant Self-Report: Frequency of Condom Use(9 months)
- AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex(9 months)
- AGYW Participant Self-Report: Number of Other Sex Partners(9 months)
- AGYW Participant Self-Report: Engagement in Sex Trading(9 months)
- AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)(9 months)
- AGYW Participant Self-Report: Use of Contraception(9 months)
- Medical Record: Use of Contraception(Through study completion, an average of nine months)
- AGYW Participant Self-Report: Level of Perception of HIV Risk(6 months)
- AGYW Participant Self- Report; Level of Perception of HIV Risk(9 months)
- AGYW Participant Self-Report: The Frequency of Experienced Stigma(9 months)
- AGYW Participant Self-Report: The Level of Anticipated Stigma(9 months)
- AGYW Participant Self-Report: The Frequency of Observed Stigma(9 months)