Analytic Approach
In this analysis, we used the HEART scores and data from the CHARISMA RCT to validate the HEART. We compared (1) the HEART scale scores at enrollment by counseling module received, (2) the HEART scale scores over time for participants in the intervention arm, and (3) the HEART scale scores of the treatment and control groups at month 6. We hypothesized that if the HEART performed as expected, mean scale scores at enrollment should differ by counseling module recommendation. Hypothesized Direction of HEART Scale Scores at Enrollment in the CHARISMA PrEP Adherence Counseling Intervention, by Counseling ModuleAbbreviations: CHARISMA, Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence; HEART, Healthy Relationship Assessment Tool; IPV, intimate partner violence; PrEP, pre-exposure prophylaxis.