Changes in relationships, HIV risk, and feelings towards PrEP: findings from a qualitative explanatory study among participants in the CHARISMA intervention trial.

BACKGROUND: Intimate partner violence (IPV) and other relationship-based challenges have been demonstrated to reduce women's ability to use pre-exposure prophylaxis (PrEP) effectively for HIV prevention. The Community Health Clinical Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) intervention was designed to mitigate these challenges and increase South African women's agency to use PrEP. The CHARISMA randomized controlled trial did not identify statistically significant differences in PrEP adherence or relationship dynamics between the intervention and control arms. As such, the aim of this explanatory qualitative sub-study was to understand women's experiences with the CHARISMA trial and explore reasons for the null results. METHODS: Twelve CHARISMA trial participants were purposively selected to participate in serial in-depth interviews, which took place at the trial end and 3 months later. Participants represented individuals who had received each of the three counselling modules, 1) healthy communication counselling, 2) PrEP disclosure counselling, or 3) IPV counselling, as well as those in the control arm who received IPV standard-of-care counselling. RESULTS: A thematic case analysis revealed numerous positive relationship outcomes among intervention participants, including identifying and ending unhealthy relationships, gaining a sense of personal empowerment, and enacting more positive behaviors and HIV risk reduction strategies in subsequent relationships. These positive 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. CONCLUSIONS: Future investigations of counselling interventions addressing relationship-based barriers to PrEP use should account for changing risk dynamics and need for PrEP.

Development of a relationship counselling website to identify and mitigate risk of intimate partner violence in the context of women's PrEP use.

Discreet, accessible interventions are urgently needed to mitigate the risk of intimate-partner violence (IPV) and other relationship barriers that women encounter to using HIV prevention methods such as pre-exposure prophylaxis (PrEP). We adapted a counsellor-administered intervention, CHARISMA, into a mobile-optimized website to enhance accessibility and reduce human resources required for HIV prevention and relationship counseling. Using human-centered design and participatory methods, CHARISMA was adapted through workshops with former CHARISMA in-person intervention participants (n = 14; ages 18-45) and web development 'sprints' combined with cognitive interviews (n = 24). 'CHARISMA mobile' was then beta-tested with 81 women naïve to the in-person intervention. In beta-testing, participants used a 'think aloud' process to provide feedback on ease of use and rated design, functionality, comprehension, confidentiality, safety, and usefulness on a scale of 1 to 5 via a survey. Data were conducted in four rounds, interspersed with rapid assessment according to go/no-go criteria, and website adaptations. The updated website was pilot tested for 'real-world' feasibility and acceptability among 159 women using their own smartphones at a location of their choice. Feedback was measured via surveys and website analytics. Workshops and cognitive interviews generated insights on technology use, contextual adaptations, and confidentiality, which were integrated into the beta version. The beta version met all 'go' criteria and was further adapted for pilot testing. In pilot testing, users found the website was useful (mean rating 4.54 out of 5), safe (4.5 out of 5), and had few concerns about confidentiality (1.75, representing low concern). On average, users rated the website more than 4 stars out of 5. Beta and pilot-testing suggested the smartphone-optimized website was well-accepted, relevant, engaging, feasible to administer, discreet and safe. Results contributed to a refined website, suitable for adaptations to other contexts and further evaluation where outcomes related to PrEP use and relationships should be assessed.