Department of Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, United States.
Department of Biostatistics, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, United States.
JMIR Res Protoc. 2024 Oct 10;13:e63106. doi: 10.2196/63106.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63106.
在秘鲁利马，艾滋病毒在性少数男性（SMM；例如，男同性恋、双性恋和其他与男性发生性关系的男性）中不成比例地流行；流行病学数据估计，在成年顺性别 SMM 的主要伴侣关系（即男性伴侣）中，有 32%至 39%的新艾滋病毒感染发生。秘鲁利马的大多数艾滋病毒预防护理研究都集中在 SMM 作为个体，而不是夫妇。为了帮助解决预防护理方面的这一关键差距，我们开发了 Para Ti，Para Mí，Para Nosotros（P3）：一种基于伴侣的、数字艾滋病毒血清学中性干预（DHI），用于秘鲁利马的成年顺性别 SMM 伴侣。P3 DHI 的设计旨在帮助伴侣建立技能、沟通、决策和共同努力，制定和坚持详细的预防护理计划，该计划与他们明确的性协议一致。P3 DHI 具有理论依据、自我指导、定向、顺序和完全自动化。
这项初步随机对照试验（RCT）旨在研究 P3 对伴侣形成和遵守包含循证策略的详细预防护理计划的初步影响，这些策略也随着时间的推移与他们明确的性协议保持一致。此外，还将评估招募和保留的可行性以及伴侣对 P3 的接受程度。
该研究采用前瞻性、6 个月的初步 RCT 和 3 个月的延迟对照条件进行。基线后，将 60 对入组的 SMM 夫妇随机分为 2 个条件之一。随机分配到不匹配、延迟对照条件的夫妇将在试验的最后 3 个月（即 3 个月评估后）获得使用 P3 DHI 的机会。随机分配到即时干预条件的夫妇将立即获得 6 个月的 P3 DHI 访问权限。研究评估将在基线以及第 3 个月和第 6 个月进行。使用广义线性混合效应、多层和参与者相互依存模型进行描述性、比较性、定性和纵向分析，以解决具体目标。
6 个月的初步 RCT 正在进行中。招募、入组和数据收集于 2023 年 1 月开始，2024 年 4 月结束。共有 74 对符合所有纳入标准、同意并入组初步 RCT 的成年顺性别 SMM 夫妇。6 个月时的保留率为 92%（68/74）。目前正在分析数据，以解决关于可行性、可接受性和初步疗效的 3 个具体目标。
该研究的结果将揭示伴侣是否认为 P3 DHI 是可以接受的。研究结果还将强调 P3 DHI 对伴侣随着时间的推移通过调整其预防护理计划和性协议来管理其艾滋病毒和其他性传播感染（STI）易感性的初步疗效。研究结果将有助于塑造 P3 DHI 的未来方向，同时解决当地背景下伴侣预防和护理服务方面的现有差距。
ClinicalTrials.gov NCT05873855；https://clinicaltrials.gov/study/NCT05873855。
国际注册报告标识符（IRRID）：DERR1-10.2196/63106。
