Overall, the Healthy Relationship Assessment Tool (HEART) performed as predicted and was consistent with past validation efforts of the tool, increasing the body of evidence supporting its use as a tool to guide tailored counseling to support women's pre-exposure prophylaxis (PrEP) adherence.

Counselors found the tool's recommendations appropriate and delivered the recommended counseling module despite being able to override recommendations based on additional knowledge of women's cases, indicating the HEART may help counselors more quickly and accurately assess a woman's relationship and tailor counseling.

As a result of receiving the counseling modules, participants' HEART scores changed over time as expected, with a small but statistically significant effect associated with the intervention and likely with the module received.

Clinicians and counselors should consider implementing the HEART as an easy, effective, and efficient way to tailor counseling for women to support improved PrEP adherence.

In response to the diverse roles and strong influence that male partners may have in women's decisions and ability to use HIV prevention products, we previously developed the counselor-administered Healthy Relationship Assessment Tool (HEART). This tool helps counselors tailor pre-exposure prophylaxis (PrEP) adherence support counseling to women's relationship dynamics with their sexual partners, suggesting modules for counselors to deliver. In this study, we examined the extent to which counselors used the HEART to guide the delivery of intervention modules and whether changes in subsequent HEART scores reflected the counseling module(s) received.

We conducted this study during a randomized controlled trial of the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) counseling intervention in Johannesburg, South Africa. Trained lay counselors administered the HEART to intervention group participants at enrollment (n=203) and at 3- and 6-month follow-up visits between October 2018 and April 2021. The HEART auto-calculated participants' response scores to recommend relevant counseling modules. We compared the mean scores for the 5 HEART scales across groups receiving different counseling modules. We also assessed changes in scale scores over time by the counseling module received.

Although counselors could override HEART counseling module recommendations based on additional knowledge of participants' cases, they consistently agreed with the HEART recommendations. The HEART also triggered the sorting of women into counseling modules that they were positioned to successfully leverage. Additionally, participants' HEART scores changed over time in predictable ways based on the type of counseling module received.

Overall, the tool performed as predicted and was consistent with past validation efforts of the HEART, indicating that the HEART may provide an efficient means to tailor women's counseling to address relationship-related challenges to PrEP adherence.

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