Personalized Prevention for Couples

Florida International University2 个研究点分布在 1 个国家目标入组 778 人开始时间: 2023年1月11日最近更新: 2025年9月17日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Florida International University
入组人数: 778
试验地点: 2
主要终点: Change in HIV incidence by comparing results from test kits received at baseline to 16-months.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This couples-based, digital health intervention project is serostatus neutral and seeks to determine efficacy for: a) use and adherence to evidence-based HIV/STI prevention-care strategies; b) creation and adherence to a tailored prevention-care plan; c) creation and adherence to a tailored sexual agreement; and d) improvements in other relationship dynamics among male couples who are in a relationship (defined as greater than 3 months or more).

详细描述

The project draws on our strong findings from the preliminary work we conducted in the US (R34 pilot randomized control trial & mixed method acceptability project). The 5-year project will revise and update an existing digital health couples-based HIV/STI prevention toolkit intervention that showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples Interdependence Theory for health behavior change. The project is a 16-month randomized control trial with 375 at-risk male couples using a delayed, educational control condition of 8 months. Our Specific Aims are to: 1) examine efficacy of the intervention on couples' a) formation and adherence to a risk-reduction plan and agreement, b) relationship functioning, c) self-reported and biomarker-confirmed indicators of risk (sexual behavior and STI), and engagement in HIV prevention (PrEP adherence) and care (ART adherence); 2) evaluate use of the intervention over time by using three different data sources; 3) explore moderating and mediating effects on couples' outcomes a-c. The project has high Public Health significance given the HIV disparities and the importance of attending to couples' unique relationship and prevention needs.

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: Single (Participant)

盲法说明

Participants and relationship partner will not know in advance which arm they are assigned and randomized to in the trial.

入排标准

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

入选标准

•assigned male at birth and currently identify as male (cis-gender) or gender queer;
•has had condomless anal sex (CAS) within the prior 3 months;
•both partners endorse being in a relationship with one another, defined as "someone you feel emotionally or romantically committed to above all others, and may be referred to as partner, husband, boyfriend etc.";
•be in a relationship with current partner for at least 3 months;
•be at least 18 years of age;
•not have any history of intimate partner violence since relationship began;
•self-report not feeling coerced by partner to take part in the study activities,
•has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
•lives in the U.S. and plans to live in the U.S. for the next 16 months;
•willing to complete the activities required to obtain and mail back their biomedical data (i.e., self-administer a rapid HIV test (if applicable), willing to use swabs to self-collect their own specimens for STI testing, willing to provide dried blood spot for ART adherence (if applicable), willing to provide dried blood spot for PrEP adherence (if applicable).

排除标准

•Does not meet one or more of the inclusion criteria

结局指标

主要结局

Change in HIV incidence by comparing results from test kits received at baseline to 16-months.

时间窗: Baseline to 16-months

Participants will be asked to provide sample to test for HIV at baseline and 16-months, using at-home self-collection test kits. Count: New HIV and STI diagnosis via biomedical testing at follow-up occurring 16 months after baseline randomization.

Changes in relationship commitment by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.