跳至主要内容
临床试验/NCT05889533
NCT05889533终止不适用

Increasing PrEP Options for Women in Eswatini: A Prospective Mixed Methods Study on the Introduction of the PrEP Vaginal Ring

FHI 3608 个研究点 分布在 1 个国家目标入组 904 人开始时间: 2023年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
FHI 360
入组人数
904
试验地点
8
主要终点
Characterize implementation of the service delivery package for informed PrEP choice for women

研究概览

简要总结

The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.

详细描述

The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.

The two main study components include the following:

  1. Prospective, observational cohort of eligible individuals interested in initiating PrEP or continuing PrEP with screening for entry at time of HIV testing and followed throughout the study period (up to 18 months). Data collection will involve quantitative methods and for a subset of participants, data will also be collected using qualitative means, namely in-depth interviews, and focus group discussions.
  2. Mixed methods process evaluation that will document implementation of the enhanced service delivery package, assess ongoing perceptions of service delivery (i.e., acceptability and feasibility, barriers and facilitators) among providers and end users, and document other important implementation considerations including the integration of PrEP and family planning.

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

入选标准

  • HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.

排除标准

  • 未提供

结局指标

主要结局

Characterize implementation of the service delivery package for informed PrEP choice for women

时间窗: 18 months

Health system feasibility and delivery acceptance among users/providers

次要结局

  • Describe patterns of PrEP use in the context of informed PrEP choice(18 months)

研究者

发起方
FHI 360
申办方类型
Other
责任方
Sponsor

研究点 (8)

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