DISCUSSION
ABUSE
In this study, we examined the effectiveness of the HEART in guiding the delivery of the CHARISMA intervention counseling modules and measured the change in HEART scale scores over time after their implementation. Overall, the tool performed as predicted within an RCT and was consistent with past validation efforts of the HEART. These results further increase the body of evidence supporting use of the HEART as a tool to guide tailored counseling to support women's PrEP adherence.At enrollment, the counselors bore the ultimate decision about which module a participant would receive. In the small number of cases in which there were differences, the most frequent difference was to opt to include the module on responding to IPV even when not recommended. This demonstrates the importance of allowing some flexibility in the implementation of the HEART, as these cases could be informed by additional outside information or by counselor choice to select a more protective, risk-averse path for the participant in the face of any uncertainty (receiving the module when not indicated by HEART may still be beneficial and is unlikely to be harmful). However, most counselors, when considering the full scope of information known about a woman's specific case, agreed with the HEART's module recommendation. This indicates that the HEART may help counselors more quickly but still accurately assess a woman's relationship and tailor counseling.Most counselors, when considering the full scope of information known about a woman's specific case, agreed with the HEART's module recommendation.Because the counselor's module recommendations were largely aligned with the HEART module recommendations, these differences in the HEART scores naturally reflect the module assignment mechanism. Specifically, the Partner Support, Partner Abuse and Control, and Partner Resistance scales contributed to the module assignment mechanism. It is worth emphasizing that although counselors were given the faculty to override the HEART module recommendation, in most cases, they chose to follow the recommendation. By doing so, they implicitly also validated the scale scores (counselors were shown the HEART recommendation but not the actual scale scores). We also note the groups differed not only on the scales used to make the recommendations, as expected, but also on other scales that did not inform the recommendations.Additionally, women referred to the partner communication module had significantly higher HEART scores in Partner Support and HIV Prevention Readiness and lower scores in Partner Abuse and Control and Partner Resistance to HIV Prevention that positioned them to successfully leverage the module to communicate with their partners. Similarly, women referred to the responding to IPV module were prime candidates to benefit from this module, according to the HEART, being the only group with significantly higher Partner Abuse and Control scores (in addition to higher scores in Partner Resistance to HIV Prevention and lower scores in Partner Support and HIV Prevention Readiness). Women recommended to receive the PrEP disclosure module were not significantly different on HEART scores than those not recommended to the module, but their scores did trend in an expected direction. These women scored higher on Partner Resistance to HIV Prevention and lower on HIV Prevention Readiness but not higher on Partner Abuse and Control, which may describe relationships in which women feel a relatively low risk of IPV but have difficulty discussing HIV prevention with their partners.The Traditional Values scale is not currently used to recommend counseling modules, nor does it seem to identify differences in women as strongly as the other scales. However, because these items were positioned as the first to be asked in the HEART, this scale may have provided additional helpful background information for counselors when determining whether to follow the HEART recommendation. Although removal of the Traditional Values scale could shorten the tool, making it easier and quicker to implement, this might also reduce the utility of the HEART by varying either participants' openness to respond to the more personally focused scales that follow or by varying counselors' perceptions of participants' responses and, therefore, counselor trust in HEART recommendations. Further research into counselors' assessments of the HEART and its recommendations should be conducted before alterations are made.We were also interested in how participants' HEART scores changed over time as a result of receiving the counseling modules. The results were generally consistent with expectations; we note a small but statistically significant effect associated with the intervention and likely with the counseling module received. Considering that participants were randomized to SOC versus CHARISMA, one can reasonably assume that these 2 groups were comparable at enrollment and that these differences are due to the intervention, partly because of the counseling module to which participants were assigned. Unfortunately, by not obtaining HEART scores for the control group at enrollment or month 3, we are limited to the month 6 comparison and thus unable to confirm that the 2 groups were statistically comparable at baseline. It is difficult to know if this trend would continue based on the 1-time implementation of the CHARISMA intervention. But, a systematic review of behavioral IPV interventions by Arroyo et al. found lingering significant behavioral outcomes for several interventions at 1-year follow-up,