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

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).

SUBMITTER: Stephenson R

PROVIDER: S-EPMC5599729 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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

Stephenson Rob R Suarez Nicolas A NA Garofalo Robert R Hidalgo Marco A MA Hoehnle Samuel S Thai Jennie J Mimiaga Matthew J MJ Brown Emily E Bratcher Anna A Wimbly Taylor T Sullivan Patrick P

JMIR research protocols 20170831 8

<h4>Background</h4>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.<h4>Objective</h4>The o ...[more]

PMID: 28860107

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Project description:Engagement in HIV care and a high level of antiretroviral therapy (ART) adherence for people living with HIV is crucial to treatment success and can minimize the population burden of the disease. Despite this, there is a critical gap in HIV prevention science around the development of interventions for serodiscordant male couples. This paper reports on the results of a randomized controlled trial to assess the efficacy of Stronger Together, a dyadic counseling intervention aimed at increasing engagement in and optimizing HIV care among serodiscordant male couples in Atlanta, GA, Boston, MA, and Chicago, IL. Between 2014 and 2017, 159 male serodiscordant couples (total N = 318) in Atlanta, GA, Boston, MA, and Chicago, IL were enrolled and equally randomized to either the Stronger Together intervention arm (a three-session dyadic intervention involving HIV testing and adherence counseling) or a standard of care (SOC) control arm. Couples completed individual study assessments via an audio computer assisted self-interviewing (ACASI) system at baseline, 6, 12 and 18 months. Primary outcomes included being prescribed and currently taking ART, and fewer missed doses of ART in the past 30 days; because the trial was not powered to examine viral suppression, we examined this as an exploratory outcome. Longitudinal data analysis was by an intention-to-treat approach. Participants ages ranged from 18 to 69 (mean = 35.9), and are predominantly white (77.5%), and college educated (68.4% earned a college degree or higher). Participants randomized to the Stronger Together arm had a significantly greater odds of being prescribed and currently taking ART over time than those in the SOC arm (at 12 months OR 2.75, 95%CI 1.35-4.67, p-value 0.020, and at 18 months OR 2.91, 95%CI 1.61-4.88, p-value 0.013). Similarly, those in the Stronger Together arm had a significantly lower odds of missing a dose of ART in the past 30 days over time compared to those in the SOC arm (at 12 months OR 0.28, 95%CI 0.09-0.81, p-value 0.019, and at 18 months OR 0.25, 95%CI 0.07-0.82, p-value 0.023). Among male couples in serodiscordant relationships, the Stronger Together intervention resulted in significantly improved HIV treatment outcomes at both 12 and 18 months of follow-up. This trial is the first to date to demonstrate evidence of efficacy for a dyadic counseling intervention and has the potential to fill a critical gap in secondary HIV prevention interventions for serodiscordant male couples.

Project description:BackgroundA substantial number of new HIV infections in sub-Saharan Africa occur within stable couples. Biomedical prevention (pre-exposure prophylaxis, PrEP) and treatment (antiretroviral therapy, ART) can provide benefits to sexual partners and can be used to prevent infection within HIV serodiscordant couples. However, research is typically focused on individuals, not dyads, even when the intervention may directly or indirectly impact sexual partners. Gaps remain in understanding best practices for recruitment, informed consent, and intervention implementation in studies involving HIV prevention and treatment among heterosexual serodiscordant couples. This qualitative study was undertaken to understand and describe decision-making and dyadic-level influence among members of serodiscordant couples regarding (1) participation in a dyadic-based research study involving HIV self-testing and access to PrEP, and (2) utilization of PrEP and ART.MethodsThis qualitative study was nested within an observational cohort study assessing the acceptability of home-based couples' HIV self-testing and uptake of dyadic care for serodiscordant couples involving facilitated referral for HIV-positive partners and access to PrEP for HIV-negative partners. Semi-structured in-depth interviews were conducted among a subset of study participants (n = 22) as well as individuals involved in serodiscordant relationships who chose not to participate (n = 9). Interviews focused on couples' decision-making regarding study participation and dyadic-level influence on medication use. Interviews were transcribed verbatim and translated from Kiswahili into English. Data were analyzed using thematic analysis.ResultsThree major themes were identified: (1) HIV as "two people's secret" and the elevated role of partner support in serodiscordant relationships; (2) the intersectional role of HIV-status and gender on decision-making; (3) the relational benefits of PrEP, including psychosocial benefits for the couple that extend beyond prevention.ConclusionsThe study found that couples made joint decisions regarding study participation and uptake of HIV-related medication. Relational autonomy and dyadic-level influence should be considered within research and programs involving HIV serodiscordant couples.

Dataset Information

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

Publications

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

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