Discussion
HIV risk reduction, HIV risk reduction behaviors, ’
SAID
Findings from this nested qualitative study among CHARISMA trial participants revealed numerous positive relationship outcomes among intervention participants as compared to controls, including identifying and ending unhealthy relationships, gaining a greater sense of personal empowerment, and enacting more positive behaviors and HIV risk reduction strategies subsequent relationships. These shifts were occasionally described as contributing to decisions to discontinue PrEP use, which may partly explain the limited impact of the intervention on PrEP adherence [In addition to their explanatory role, these findings are important for their role in contributing to refining an intervention theory of change, counselling practices, and outcome measurement in future trials of relationship-based counselling for PrEP users. The shifting motivation and need for PrEP use among women enacting positive relationship changes should be accounted for in an intervention theory of change and in PrEP use provision, more broadly. The concept of ‘seasons of risk’ is one that has been in the PrEP world for a number of years [While there seemed to be clear differences in relationship health and HIV risk reduction behaviors between intervention and control arm participants, we did see some indications of intervention contamination, as control participants reported receiving counselling on healthy relationships, communication, and conflict negation even if not successfully implemented. While the trial had numerous measures in place to minimize and measure contamination, including using different counsellors for intervention vs. control counselling and periodic structured observations of counselling sessions, all trial staff were highly trained in gender equitable care and gender-based violence, which may have contributed to contamination. Control arm participants in the trial received LIVES counselling, which focuses on inquiring, validating, and supporting someone, and it may have felt natural for counsellors to offer advice or comment on healthy relationships in this context. That said, as qualitatively described by this sample of women, however, it seems that CHARISMA counselling provided additional “actionable” skills to more directly make changes in their relationship dynamics therefore supporting the added value of CHARISMA to an approach like LIVES.Finally, women did note other challenges to PrEP use and access that were not driven by relationships. These barriers, including side effects, stigma associated with PrEP use, and logistical challenges with taking PrEP, have been demonstrated in numerous other studies [No study is without its limitations. For one, our study sample size was small and not generalizable to a broader population or even to the trial population. However, we did take care to ensure the sample was purposive in a way that we felt would capture a variety of experiences with the trial and we were able to see common themes indicating some level of saturation. Additionally, the longitudinal design of the study and our case analysis approach strengthened our ability to dive deeply into each individual’s circumstances, and to evaluate their individual stories in relation to the key variables of exposure (counseling receipt, relationship circumstances) and outcomes of PrEP use and IPV and relationship consequences over time. Another limitation to this study, however, was the uneven completion of both interviews by participants. Of the four participants who did not complete a second interview, two were from the control arm, which may indicate an important distinction in study experience. Finally, while we chose not to interview male partners given the intervention’s focus on empowering women to make their own choices about their relationships and PrEP use, we are missing information from male partners to understand their experiences of relationship change and HIV risk reduction, or lack thereof, from their female partners.