Intervention
At enrollment, participants were randomized in a 1:1 ratio to receive either the CHARISMA intervention (intervention arm) or standard of care (control arm). The CHARISMA intervention included a lay counsellor-administered relationship assessment tool called the HEAlthy Relationship Assessment Tool (HEART), followed by targeted empowerment-based counselling delivered upon enrollment with a follow-up session at month 1. All intervention participants received counselling in healthy relationships, as well as counselling on either 1) general partner communication and relationship skills, 2) partner disclosure and communication around PrEP, or 3) responding to IPV and safety planning. The choice for the follow-on topic was guided by an algorithm embedded within the HEART delivery, which assessed factors such as risk of IPV and whether a woman had disclosed PrEP use to her partner. Figure Control arm participants received standard of care PrEP counselling, as well as basic IPV screening followed by first-line support using the WHO LIVES approach to counselling and referrals to external support. In brief, the LIVES approach includes: Listening to women, Inquiring about their experiences, Validating their emotions, Ensuring safety, and Supporting through referrals [