Feasibility and Acceptability of an Electronic Health HIV Prevention Toolkit Intervention With Concordant HIV-Negative, Same-Sex Male Couples on Sexual Agreement Outcomes: Pilot Randomized Controlled Trial.

Background There is a need to develop innovative and accessible dyadic interventions that provide male couples with the behavioral skills to manage the risk of HIV transmission within their relationship. Objective We conducted a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the electronic health (eHealth) HIV prevention toolkit intervention to encourage seroconcordant negative male couples in the United States to establish and adhere to a sexual agreement (SA). Methods Eligible, consented couples were randomly assigned to the intervention or education control and followed up for 6 months, with assessments occurring every 3 months after baseline. Acceptability items were assessed at both follow-up assessments. Descriptive and comparative statistics summarized cohort characteristics, relationship dynamics, and SA outcomes for the entire cohort and by trial arm. To examine the association between couples' relationship dynamics and their establishment of an SA over time and by trial arm, multilevel logistic regression analyses were performed with a random intercept to account for correlations of repeated measurements of relationship dynamics at months 3 and 6; the odds ratio (OR) of establishment of an SA and the corresponding 95% confidence interval were then reported. Results Overall, 7959 individuals initiated screening. Reasons for individual ineligibility varied. An electronic algorithm was used to assess couple-level eligibility, which identified 1080 ineligible and 266 eligible dyads. Eligible couples (n=149) were enrolled in the pilot RCT: 68 received the intervention and 81 received the education control. Retention was 71.5% (213/298 partnered men) over the 6 months. Participants reported high acceptability of the intervention along with some areas for improvement. A significantly higher proportion of couples who received the intervention established an SA at 6 months compared with those who received the education control (32/43, 74% vs 27/50, 54%; P=.05). The OR of establishing an SA for couples in the intervention versus those in the control condition was greater than 2 when controlling for a number of different relationship dynamics. In addition, the odds of establishing an SA increased by 88% to 322% for each unit increase in a variety of averaged relationship dynamic scores; the opposite result was found for dynamics of stigma. Differences between trial arms for SA type and adherence were nonsignificant at each assessment. However, changes in these 2 SA aspects were noted over time. The average number of items couples included in their SA was 18, and about one-fourth to one-third of couples included HIV prevention items. Conclusions The findings demonstrate strong evidence for the acceptability and feasibility of the eHealth toolkit as a brief, stand-alone, couples-based HIV prevention intervention. These findings support the need to update the toolkit and evaluate it in a larger clinical trial powered for efficacy. Trial registration ClinicalTrials.gov NCT02494817; http://clinicaltrials.gov/ct2/show/NCT02494817.