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临床试验/NCT05084716
NCT05084716已完成不适用

PrEP Provision for Ugandan Fisherfolk

RAND2 个研究点 分布在 1 个国家目标入组 885 人开始时间: 2021年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
885
试验地点
2
主要终点
Number of Participants Who Persisted On PrEP After Initiation

研究概览

简要总结

This study is a pilot test of enhancements to the standard of care for providing PrEP in Ugandan fishing communities. The specific aims are to conduct a mixed-methods study assessing enhancements to the standard of care for providing PrEP in fisherfolk communities in Lake Victoria, Uganda.

详细描述

The study will take place at two landing sites at which PrEP is provided to fisherfolk through the Ugandan national PrEP program. The comparison site will receive the standard of care for PrEP provision. At the intervention site, the investigators will implement a three-pronged intervention:

  1. During healthcare outreach events we will conduct PrEP workshops, in which people who want to know more about PrEP learn basic facts about PrEP and are taught skills about how to advocate for PrEP in their community.
  2. Check-in Calls: To support PrEP adherence, healthcare workers will call PrEP users two weeks after initiation, and the week before refill events, to check in about any questions and to remind them of the next date and place to pick up refills. Calls after PrEP initiation will ask about side effects.
  3. To support PrEP adherence, healthcare workers will encourage PrEP users to select an adherence supporter, who is a family member or friend to whom they disclose their PrEP use. The adherence supporter agrees to remind the PrEP user to adhere to PrEP and get refills. Healthcare workers will ask the PrEP user for the name and contact information for the adherence supporter, so that the adherence supporter can be contacted to remind them about refills, as well as if the PrEP user does not show up for a refill.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Not meeting the inclusion criteria

结局指标

主要结局

Number of Participants Who Persisted On PrEP After Initiation

时间窗: 6 months

Percentage of PrEP users who are still on PrEP at 6 months post-initiation

Number of Participants With PrEP Initiation

时间窗: Baseline. Individuals are asked if they wish to initiate PrEP after they have been tested and deemed eligible

Individuals who are eligible for PrEP (tested HIV-negative, aged 18 and older, in fisherfolk community) are asked by a healthcare provider whether they want to start taking PrEP

次要结局

  • Number of Participants Who Maintained PrEP Prescriptions Over 6 Months(6 months)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (2)

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