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临床试验/NCT06190613
NCT06190613招募中不适用

Adapting and Testing a Combination Peer Navigation and mHealth Intervention to Enhance Treatment Engagement and Viral Suppression Among Sexual and Gender Minority Youth in Nigeria

Northwestern University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
HIV viral load suppression

研究概览

简要总结

The study will adapt and test a combination peer navigation and mHealth approach, Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria), to improve HIV treatment engagement, medication adherence and viral suppression among YMSM and YTW, ages 15-29.

详细描述

The study will adapt and test a combination peer navigation and mHealth approach, Intensive Combination Approach to Rollback the Epidemic in Nigeria (iCARE Nigeria), to improve HIV treatment engagement, medication adherence and viral suppression among young men who have sex with men (YMSM) and young transgender women (YTW), ages 15-29. The 24-week pilot study will randomize participants at a ratio of 1:1 to the intervention or control. The goals of the pilot study are to assess: a) whether the intervention worked as intended (initial efficacy); and b) the feasibility, satisfaction, and acceptability among the target population of YMSM and YTW receiving HIV care in the community setting.

Specific aims are to:

  1. Adapt the iCARE Nigeria HIV clinic-based intervention to a community-based outreach approach for YMSM and YTW ages 15-29 in Ibadan, Nigeria. This process will be structured using best practices for adaptation of evidence-based intervention, including distillation of adaptable components and incorporation of feedback from stakeholders, following user-centered principles of iterative design.
  2. In a randomized controlled trial, test the adapted iCARE intervention for initial efficacy, feasibility, satisfaction, and acceptability among YMSM and YTW in the key population (KP)-focused community settings. The primary outcome will be viral load suppression (viral load<200 copies/mL). Secondary outcomes include antiretroviral drug adherence, and treatment retention via abstraction of medical records.
  3. Evaluate implementation indicators based on RE-AIM (reach, adoption, implementation, maintenance) to improve external validity and to inform sustainability and scalability of the adapted iCARE Nigeria intervention. A mixed methods approach will be used to collect data for implementation outcomes from interventionists, intervention participants, and representatives of KP-friendly community centers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 29 Years(Child, Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •HIV seropositive
  • •registered as a patient at one of the collaborating key population (KP)-focused community centers
  • •male sex at birth
  • •identify as YMSM or YTW (or report a history of sex with men)
  • •understand and read basic English, Yoruba, or Pidgin English
  • •intention to remain a patient at a collaborating clinic during the 24-week follow-up period
  • •has a cellphone

排除标准

  • •Unable to obtain parental permission if 15 years of age and not emancipated

研究组 & 干预措施

Combination peer navigation and mHealth Intervention

Other

Peer navigation and SMS text message medication reminders

干预措施: Combination Peer navigation and mHealth intervention (Behavioral)

Control

No Intervention

standard of care

结局指标

主要结局

HIV viral load suppression

时间窗: Baseline, 24 weeks

Viral load suppression (\<200 copies/mL) at baseline and 24 weeks

次要结局

  • Retention in HIV care(Baseline, 24 weeks)
  • Medication adherence(Baseline, 24 weeks)
  • Feasibility of intervention(24 weeks)
  • Acceptability of intervention(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Kuhns

Professor

Northwestern University

研究点 (1)

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