为秘鲁利马的成年同性性行为少数群体男性夫妇评估基于夫妇的数字 HIV 血清学中立干预(Para Ti、Para Mí、Para Nosotros):为期 6 个月的试点随机对照试验方案》(Protocol for a 6-Month Pilot Randomized Controlled Trial)。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-10-10 DOI:10.2196/63106
Jason W Mitchell, Zoran Bursac, David Diaz, Edward Michael Reyes Diaz, Alfonso Silva-Santisteban, Kelika A Konda
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引用次数: 0

摘要

背景:在秘鲁利马,艾滋病毒对性少数男性(SMM,即男同性恋、双性恋和其他男男性行为者)的影响尤为严重;流行病学数据估计,32% 至 39% 的艾滋病毒新感染病例发生在主要伴侣关系(即男性伴侣)中的成年顺性别 SMM 身上。秘鲁利马的大多数艾滋病预防护理研究都集中在作为个体的 SMM 上,而不是夫妻。为了帮助解决预防保健中的这一关键缺口,我们开发了 "Para Ti, Para Mí, Para Nosotros"(P3):一种以夫妻为基础的、数字化 HIV 血清状态中立干预措施(DHI),针对秘鲁利马的成年同性 SMM 夫妻。P3 DHI 的设计目的是促进夫妻双方的技能建设、沟通、决策,并共同制定和遵守符合其明确性协议的详细预防护理计划。P3 DHI 具有理论依据、自我指导、定向、顺序和全自动等特点:这项试点随机对照试验(RCT)旨在研究 P3 对夫妻形成和坚持详细的预防保健计划的初步效果,该计划包含循证策略,并随着时间的推移与他们明确的性协议保持一致。此外,还将评估注册和保留的可行性以及夫妇对 P3 的接受程度:研究实施了一项为期 6 个月的前瞻性试点 RCT,其中有 3 个月的延迟对照条件。基线结束后,60 对注册的 SMM 夫妇将被随机分配到两种条件中的一种。随机进入非匹配延迟对照条件的夫妇将在 3 个月评估后的试验最后 3 个月中获得 P3 DHI。被随机选入即时干预条件的夫妇将立即获得 P3 DHI,使用期为 6 个月。研究评估将在基线、第 3 个月和第 6 个月进行。为实现具体目标,将使用广义线性混合效应模型、多层次模型和行为主体-伴侣相互依赖模型进行描述性分析、比较分析、定性分析和纵向分析:为期 6 个月的试点 RCT 正在进行中。招募、注册和数据收集工作于 2023 年 1 月开始,2024 年 4 月结束。共有 74 对成年顺性别 SMM 夫妇符合所有纳入标准,提供了同意书,并被纳入试点 RCT。第 6 个月的保留率为 92%(68/74)。目前正在对数据进行分析,以实现可行性、可接受性和初步疗效这三个具体目标:这项研究的结果将揭示夫妇们是否认为 P3 DHI 可以接受。研究结果还将突显 P3 DHI 通过调整预防保健计划和性协议,对夫妻双方长期控制艾滋病和其他性传播感染 (STI) 易感性的初步效果。试验结果将有助于确定 P3 DHI 的未来发展方向,同时解决当地夫妻预防和护理服务的现有差距:试验注册:ClinicalTrials.gov NCT05873855;https://clinicaltrials.gov/study/NCT05873855.International 注册报告标识符 (irrid):DERR1-10.2196/63106。
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Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial.

Background: HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated.

Objective: This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed.

Methods: The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims.

Results: The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy.

Conclusions: Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DHI while addressing the existing gap in prevention and care services for couples in the local context.

Trial registration: ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855.

International registered report identifier (irrid): DERR1-10.2196/63106.

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