Background:
We hypothesized that an oral PrEP, PEP and CAB-LA biomedical prevention package with structured choice between products and opportunities to switch would increase biomedical prevention coverage compared to standard-of-care (SoC) among men and women at risk for HIV in rural Uganda and Kenya.
Methods:
Participants were recruited from three randomized studies of the SEARCH dynamic choice HIV prevention (DCP) intervention vs SoC in antenatal clinics, outpatient departments and the community. Eligible participants were > 15 years and reported risk of acquiring HIV. Participants in the SoC arm had access to oral PrEP (TDF/XTC) and PEP (TLD) at local Ministry of Health (MoH) clinics. The SEARCH DCP model included person-centered, structured choice between oral PrEP, PEP (MoH-supplied) or CAB-LA (study-supplied at MoH clinics) and the ability to switch between or stop products over time based on patient product preference and risk. Primary outcome was biomedical covered time over 48 weeks (proportion of follow-up covered by PrEP/PEP/CAB-LA), assessed via study logs and self-report; secondary outcomes included coverage during periods of retrospectively self-assessed HIV risk and incident HIV infections.
Results:
We enrolled 984 participants (487 DCP; 497 SoC). 73% were women, 30% aged 15-24. Mean biomedical covered time was higher in DCP (69.7%) vs. SoC (13.3%), a difference of 56.4% (95% CI 50.8-62.1%; p<0.001). Biomedical covered time with DCP vs SoC was 65.6% and 52.8% higher for men and women, respectively. Intervention effect on coverage during periods at risk of HIV was larger; mean at-risk covered time was 76.5% in the DCP arm vs. 16.2% in SoC (difference 60.2%; 95%CI: 53.8-66.6%; p<0.001). In the DCP arm, 56%, 53%, 2% ever used CAB-LA, PrEP or PEP, respectively. 43% of persons who used CAB-LA were not using prior oral PrEP or PEP, showing benefit of adding the CAB- LA option. 28% and 0.4% of participants used at least 2 different products in the DCP and SoC arms, respectively. There were 7 participants who acquired HIV infection and one perinatal transmission in the SoC arm (incidence rate: 1.8%) and 0 in the DCP arm (p=0.01).
Conclusions:
In the first randomized study of a person-centered model offering structured choice between CAB-LA, oral PREP and PEP with option to change over time, enrolling both women and men at risk of HIV, the SEARCH DCP intervention increased biomedical covered time by >5 fold to 69.7% and reduced HIV incidence to 0% compared to 1.8% in standard-of-care.