The CHARISMA RCT
Between October 2018 and October 2019, the CHARISMA RCT enrolled 407 women in Johannesburg, South Africa. Per the CHARISMA RCT eligibility requirements, participants were HIV-seronegative, nonpregnant, currently in a relationship with a male primary sexual partner, sexually active (by self-report), willing to use daily oral PrEP, and had no prior history of participation in clinical trials or longitudinal studies of HIV prevention. Participants who enrolled were offered oral PrEP for 6 months and were randomized 1:1 to additionally receive either the CHARISMA empowerment counseling intervention (treatment group, n=203) or standard of care (SOC) counseling (control group, n=204). CHARISMA counseling was composed of tailored empowerment counseling at enrollment through various counseling modules and ongoing follow-up with counseling as needed at month 1, month 3, and month 6 visits (though a longer follow-up period would be preferable, follow-up was limited to a maximum of 6 months by time and resource constraints). Tailored counseling topics included partner communication, PrEP disclosure, and responding to IPV. Also, all women received a healthy relationships module. SOC counseling consisted of supportive counseling with onward referrals to public facilities for further management.