“携手更强大”项目：一项在美国三个城市对血清学不一致男性伴侣进行二元干预以提高其参与艾滋病护理程度的测试方案。

Project Stronger Together: Protocol to Test a Dyadic Intervention to Improve Engagement in HIV Care Among Sero-Discordant Male Couples in Three US Cities.

作者信息

Stephenson Rob, Suarez Nicolas A, Garofalo Robert, Hidalgo Marco A, Hoehnle Samuel, Thai Jennie, Mimiaga Matthew J, Brown Emily, Bratcher Anna, Wimbly Taylor, Sullivan Patrick

机构信息

Center for Sexual and Health Disparities, University of Michigan, Ann Arbor, MI, United States.

Department of Health Behaviors and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.

出版信息

JMIR Res Protoc. 2017 Aug 31;6(8):e170. doi: 10.2196/resprot.7884.

DOI:10.2196/resprot.7884

PMID:28860107

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5599729/

Abstract

BACKGROUND

An estimated one- to-two-thirds of new human immunodeficiency virus (HIV) infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this fact, there remains a lack of prevention interventions that focus on male sero-discordant dyads. Interventions that provide male couples with skills to manage HIV risk, and to support each other towards active engagement in HIV prevention and care, are urgently needed.

OBJECTIVE

The objective of this paper is to describe the protocol for an innovative dyadic intervention (Stronger Together) that combines couples' HIV testing and dyadic adherence counseling to improve treatment adherence and engagement in care among HIV sero-discordant male couples in the United States.

METHODS

The research activities involve a prospective randomized controlled trial (RCT) of approximately 165 venue- and clinic-recruited sero-discordant male couples (330 individuals: 165 HIV sero-negative and 165 HIV sero-positive). Couples randomized into the intervention arm receive couples' HIV counseling and testing plus dyadic adherence counseling, while those randomized to the control arm receive individual HIV counseling and testing. The study takes place in three cities: Atlanta, GA (study site Emory University); Boston, MA (study site The Fenway Institute); and Chicago, IL (study site Ann & Robert H. Lurie Children's Hospital of Chicago). Cohort recruitment began in 2015. Couples are followed prospectively for 24 months, with study assessments at baseline, 6, 12, 18, and 24 months.

RESULTS

Stronger Together was launched in August 2014. To date, 160 couples (97% of the target enrollment) have been enrolled and randomized. The average retention rate across the three sites is 95%. Relationship dissolution has been relatively low, with only 13 couples breaking up during the RCT. Of the 13 couples who have broken up, 10 of the 13 HIV-positive partners have been retained in the cohort; none of these HIV-positive partners have enrolled new partners into the RCT.

CONCLUSIONS

The intervention offers a unique opportunity for sero-discordant couples to support each other towards common HIV management goals by facilitating their development of tailored prevention plans via couples-based HIV testing and counseling, as well as problem-solving skills in Partner Strategies to Enhance Problem-solving Skills (STEPS).

TRIAL REGISTRATION

ClinicalTrials.gov NCT01772992; https://clinicaltrials.gov/ct2/show/NCT01772992 (Archived by WebCite at http://www.webcitation.org/6szFBVk1R).

摘要

背景

据估计，在美国男男性行为者（MSM）中，新感染人类免疫缺陷病毒（HIV）的病例中有三分之一到三分之二发生在主要伴侣关系中。尽管如此，仍然缺乏针对血清学不一致的男性伴侣的预防干预措施。迫切需要为男性伴侣提供管理HIV风险的技能，并支持彼此积极参与HIV预防和护理的干预措施。

目的

本文的目的是描述一种创新的二元干预措施（携手更强大）的方案，该措施结合了伴侣HIV检测和二元依从性咨询，以提高美国血清学不一致的男性HIV伴侣的治疗依从性和护理参与度。

方法

研究活动包括一项前瞻性随机对照试验（RCT），该试验招募了约165对通过场所和诊所招募的血清学不一致的男性伴侣（330人：165名HIV血清学阴性和165名HIV血清学阳性）。随机分配到干预组的伴侣接受伴侣HIV咨询和检测以及二元依从性咨询，而随机分配到对照组的伴侣接受个体HIV咨询和检测。该研究在三个城市进行：佐治亚州亚特兰大（研究地点：埃默里大学）；马萨诸塞州波士顿（研究地点：芬威研究所）；伊利诺伊州芝加哥（研究地点：芝加哥安&罗伯特·H·卢里儿童医院）。队列招募于2015年开始。对伴侣进行前瞻性随访24个月，在基线、6个月、12个月、18个月和24个月进行研究评估。

结果

“携手更强大”于2014年8月启动。迄今为止，已招募并随机分配了160对伴侣（占目标入组人数的97%）。三个地点的平均保留率为95%。关系破裂的情况相对较少，在RCT期间只有13对伴侣分手。在这13对分手的伴侣中，13名HIV阳性伴侣中的10名被保留在队列中；这些HIV阳性伴侣中没有一人将新伴侣纳入RCT。