JMIR Publications

ABSTRACT

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 eHealth HIV prevention toolkit intervention to encourage seroconcordant HIV-negative male couples in the US to establish and adhere to a sexual agreement (SA).

Methods:

Eligible, consented couples were randomly assigned to receive either the intervention or education control and followed for 6 months, with assessments occurring every three months after baseline. Acceptability items were assessed at both follow-up assessments. Descriptive and comparative statistics were used to summarize 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 a 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 a SA and the corresponding 95% confidence interval were then reported.

Results:

In total, 7,959 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. In sum, 149 eligible couples enrolled into the pilot RCT: 68 received the intervention and 81 received the education control. Retention was 71.5% over the 6 months. Participants reported high acceptability of the intervention along with a few areas for improvement. A significantly higher proportion of couples who received the intervention established a SA at 6 months compared to those who received the education control (74.4% vs. 54.0%, p=0.05). The OR of establishing a 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, respectively. Additionally, the odds of establishing a SA increased by 88% to 322% for each unit increase in a variety of different averaged relationship dynamic scores; the opposite result was found for dynamics of stigma. Differences between trial arms for SA type and adherence were non-significant at each assessment. However, changes in these two SA aspects were noted over time. The average number of items couples included in their SA was 18, and about one-quarter to one-third of couples included HIV prevention items.

Conclusions:

Findings demonstrate strong evidence for the acceptability and feasibility of the eHealth toolkit as a brief, stand-alone, couples-based HIV/STI prevention intervention. These findings further support the need to update the toolkit and to then evaluate it in a larger clinical trial powered for efficacy. Clinical Trial: The pilot RCT was registered on ClinicalTrials.gov [NCT02494817].