The CHARISMA Randomized Controlled Trial: A Relationship-Focused Counseling Intervention Integrated Within Oral PrEP Delivery for HIV Prevention Among Women in Johannesburg, South Africa

Consistent use of oral pre-exposure prophylaxis (PrEP) has been a challenge among women, particularly when in relationships with lack of partner support or intimate partner violence (IPV). Methods. We conducted a randomized controlled trial (RCT) of an empowerment counseling intervention called "CHARISMA" delivered to women within a PrEP demonstration project in Johannesburg, South Africa. The trial tested the effectiveness of CHARISMA to increase PrEP adherence; decrease social harms (SHs) and IPV; and improve partnership dynamics (e.g. communication, disclosure and support) as compared to those who received the standard of care (SOC) counselling support and referrals. 407 HIV-seronegative, non-pregnant women aged 18-45 years were enrolled for 6 months of PrEP use, with 203 randomized (1:1) to the intervention. All participants reporting IPV received counseling and referrals that followed the WHO five-step Listen, Inquire, Validate, Enhance Safety, and Support approach. Results. This RCT did not identify statistically significant differences between study arms for PrEP adherence or relationship dynamics, with the exception of an increase in PrEP disclosure among intervention arm women. In our study, we cannot determine whether the lack of detectable findings may have been due to lack of intervention effect, strength of SOC services, low risk in the study population or other factors. Conclusions: Addressing IPV and relationship dynamics remain important factors influencing HIV risk, and addressing these within the context of PrEP delivery is an important synergistic opportunity. CHARISMA was highly acceptable to participants, and further adaptation and testing of the intervention to other populations and settings will augment the evidence base.