TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use Among Sexually Active Female University Students in Zambia: Study Protocol of a Hybrid Effectiveness-implementation Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- PrEP uptake
研究概览
简要总结
The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia. The main question it aims to answer is:
• Can a mhealth peer navigator intervention effectively promote HIV pre-exposure prophylaxis PrEP use among high-risk female students in Zambia?
Researchers will compare the mhealth peer navigator intervention to treatment as usual to see if there are effects on female student's use and continuation of PrEP for HIV prevention.
Participants in the intervention will be paired with a trained peer navigator who will offer education, social support, and help navigating the health systems to access PrEP and other sexual and reproductive health services.
All participants in both arms will complete surveys at baseline, 6 months, and 12 months to evaluate health behaviors.
详细描述
We are conducting a 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial to determine the effectiveness the TwySHE intervention in Lusaka, Zambia. We will follow all participants for 12 months with regular data collection. All intervention activities will end at 6 months (primary endpoint window), but we will continue to follow and survey participants in both study arms at 12 months to determine long-term post-intervention effectiveness. PrEP and contraception uptake and persistence will be objectively verified using a study medical visit card filled out and signed by health providers. We will also collect and assess behavioral mechanisms hypothesized to be on the casual pathway, including participant knowledge regarding HIV and unintended pregnancy prevention, health beliefs (perceived risk of HIV or unintended pregnancy), perceived social support to access and adhere to HIV/unintended pregnancy prevention methods, stigma, behavioral intention to use PrEP and contraception, and self-efficacy to use PrEP and contraception. Lastly, we will conduct exit interviews with peer-navigators and a sub-sample of participants to explore the implementation outcomes of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 24 years
- •Current university student
- •Not diagnosed with HIV
- •Self-report of 3 more HIV risk factors
排除标准
- •Less than 18 years of age
- •Greater than 24 years of age
- •Diagnosed with HIV
- •Less than 3 self-reported HIV risk behaviors
- •Not a university student
研究组 & 干预措施
TwySHE mhealth peer navigator intervention
Trained peer navigators will promote PrEP and contraception uptake/persistence among participants by communicating with them in-person or over mobile devices twice per month for 6 months. The first visit (in-person) is focused on building rapport and a trusting relationship with the participant. During the second visit (in-person) and subsequent sessions (in-person or mobile communication), the peer navigators will focus on encouraging, supporting, and helping build the skills of their participants to address their HIV/SRH needs, provide referrals and linkage to available services, and follow up to ensure participants access those services. Subsequent visits will be conducted as needed, depending on the participant.
干预措施: TwySHE (Behavioral)
Control
Participants will receive a referral list for local HIV/SRH services and informed of the longitudinal data collection process through 12 months.
结局指标
主要结局
PrEP uptake
时间窗: 6 months
Self-reported use of PrEP products verified through health clinic documentation
次要结局
- Contraception uptake(6 months)