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临床试验/NCT05708261
NCT05708261招募中不适用

Tailoring Healthy Relationships to Improve HIV Outcomes for MSM in Eastern Cape, South Africa

Arizona State University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Feasibility Survey

研究概览

简要总结

This study will adapt the evidence-based intervention, Healthy Relationships, and then assess its feasibility using a pilot randomized controlled trial with HIV-positive MSM living with HIV in Eastern Cape, South Africa

详细描述

This project will adapt the intervention, Healthy Relationships (HR), and then conduct a pilot test of the intervention in Eastern Cape, South Africa, with HIV positive men who have sex with men (MSM). HR is a group based intervention designed to develop participant skills in assessing HIV stress and communication skills for disclosure and safe sex. This original intervention was developed with MSM and subsequently adapted for video conference (VC) delivery with women in the U.S. The adaptation will include updated HIV education and focus on MSM in relationship because limited HIV disclosure and prevention risk assessment and communication skills are associated with lowered ART adherence, and the intervention will be named MPowered in Relationships (MR). Similar to the VC version of HR for women, investigators will deliver MR via Zoom followed by three group check ins via Zoom as well. The check ins will review MR skills learned and applied including assessing individual action plans in these areas. Also, through this project, investigators will develop a community advisory board that will guide intervention adaptation. The outcomes of the pilot-test are to assess feasibility, acceptability, willingness and safety of the MR, as well as assess the potential impact of the intervention on behavioral measures, ART adherence and viral load. Our hypothesis is that HIV disclosure and prevention skill will be feasible and demonstrate a preliminary impact on behavioral and biomedical measures that will support a clinical trial of the intervention.

After adaptation of the intervention, Healthy Relationships (HR), with enhanced components for MSM (Aim 1) and then a pilot test of the intervention to determine if it is feasible in Eastern Cape, South Africa (Aim 2). The name of this intervention will be MR. The proposed project is based on preliminary research conducted by the principal investigators, and the study is benefitting from collaborations with the Foundation for Professional Development in Eastern Cape, South Africa.

Intervention adaptation (Aim 1) will use mixed methods to include interviews with MSM and health experts to integrate updated HIV prevention and treatment education (PrEP, U=U) and contextual components to ensure skill-building for HIV communication and disclosure risk assessment. This aim will include a usability test to ensure conceptual understanding of the intervention content by MSM to finalize adaptation. This feasibility study (Aim 2) will be a pilot-test using a randomized controlled trial design.

In Specific Aim 2, investigators will pilot test the adapted intervention, MR, with HIV positive MSM in Eastern Cape, South Africa. The outcomes for this pilot are to understand feasibility (feasibility, acceptability, willingness, and safety) and preliminary impact on behavioral and biomedical outcomes of the intervention for this group. The findings from this pilot study will be used to inform a larger clinical trial to determine the effectiveness of MR in reducing HIV disclosure, prevention and treatment outcomes for MSM in this setting. The pilot study will be a randomized controlled trail with participant recruited from MSM specific HIV activities in Eastern Cape, and then investigators will be randomly assigned to either the intervention or control groups. The study design will include an attention matched control in order to reduce the effect of other mHealth tools that MSM may be experiencing during the study. The intervention will complete MR, and the attention matched control arm will complete Be Well.

MR: One MR session will be delivered per week for five weeks over Zoom, and then three group check ins will be conducted eight, twelve and sixteen weeks. Each of the original five HR sessions will be divided into two one hour sessions and delivered via Zoom where participants will access using their personal smartphone. During the intervention, participants will complete viral load tests at baseline and post intervention. Also, participants will complete behavioral assessments at baseline, mid study, post intervention, and follow up at 16 months. For baseline and post intervention, the behavioral assessment will measure areas like HIV treatment knowledge, internalized HIV stigma, HIV care self efficacy, alcohol use, HIV disclosure, safe sex practices, relationship factors, and ART adherence behaviors. In addition, each participant will complete MR feasibility interview during study visit with a feasibility survey that will be completed at post intervention.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility Survey

时间窗: Month 6

A study specific survey to assess feasibility, willingness, safety, acceptability

Feasibility Interview

时间窗: Month 6

Indepth interview to assess feasibility, willingness, safety, acceptability

次要结局

  • HIV treatment adherence(Month 9)
  • HIV viral load(Month 9)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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