Mixed-methods Protocol for the WiSSPr Study: Women in Sex Work, Stigma and Psychosocial Barriers to Pre-exposure Prophylaxis in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- PrEP initiation (#/% ever taken PrEP)
研究概览
简要总结
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH).
详细描述
WiSSPr is a prospective observational cohort study grounded in community-based participatory research principles with a community advisory board (CAB) of key population (KP) civil society organi sations (KP-CSOs) and the Ministry of Health (MoH). The study will administer a one-time psychosocial survey vetted by the CAB and follow 300 WESW in the electronic medical record for three months to measure PrEP initiation (#/% ever taking PrEP) and persistence (immediate discontinuation and a medication possession ratio). The study will conduct in-depth interviews with a purposive sample of 18 women, including 12 WESW and 6 peer navigators who support routine HIV screening and PrEP delivery, in two community hubs serving KPs since October 2021. The study seeks to value KP communities as equal contributors to the knowledge production process by actively engaging KP-CSOs throughout the research process. Expected outcomes include quantitative measures of PrEP initiation and persistence among WESW, and qualitative insights into the enablers and barriers to PrEP use informed by participants' lived experiences. https://doi.org/10.1136/bmjopen-2023-080218
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all of the following criteria:
- •Identify as a cisgender or transgender woman.
- •Be 18 years of age or older.
- •Earn a significant amount of income from exchanging sex for money or goods within the last 3 months.
- •Be HIV-negative and eligible for PrEP according to national guidelines.
- •Not be planning to transfer care to another site within the next 30 days.
- •Speak English, ChiNyanja, or IchiBemba.
- •Be willing and able to provide written informed consent.
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Do not identify as a woman.
- •Are under 18 years of age.
- •Have not earned a significant amount of income from exchanging sex for money or goods, or have done so for less than 3 months.
- •Are HIV-positive, have an unknown HIV status, or are ineligible for PrEP.
- •Are planning to transfer care to another site within the next 30 days.
- •Are unable to speak English, ChiNyanja, or IchiBemba.
- •Are unwilling or unable to provide written informed consent.
研究组 & 干预措施
PrEP initiators
women who initiate on PrEP
干预措施: PrEP (Drug)
PrEP refusers
women who refuse PrEP
结局指标
主要结局
PrEP initiation (#/% ever taken PrEP)
时间窗: 3 months
PrEP initiation (Number or percentage of Women Engaging in Sex Work (WESW) initiating on PrEP)
PrEP Persistence (#/ % eligible refills obtained until first discontinuation)
时间窗: 3 months
PrEP persistence. Number or percentage of women engaging in sex work with high levels of stigma who will persist on PrEP
次要结局
未报告次要终点