Background:
Women seen for ante and postnatal care (ANC) remain at risk for HIV in rural sub-Saharan Africa, despite routine access to PrEP. Patient-centered prevention delivery models that offer structured choices in product, testing and visit location may increase coverage. Few studies evaluate actual prevention choices made by clients, nor the impacts of a dynamic choice delivery model on biomedical prevention coverage.
Methods:
We conducted an individually randomized trial (SEARCH; NCT04810650) among women (≥15 years) with current or anticipated risk of HIV infection seen at ANC clinics in rural Kenya and Uganda to evaluate the effect of a dynamic choice prevention (DCP) model (intervention) versus standard-of-care (control). DCP included: 1) product choice (daily oral PrEP [TDF/XTC] or post-exposure prophylaxis [PEP]) with option to switch over time; 2) service location choice; 3) HIV self-testing option; 4) 24/7 phone access to clinician; and, 5) provider training on patient-centered care. The primary outcome was biomedical prevention coverage over 48 weeks (proportion of months with self-reported PreP or PEP use); self-reported use during months a client retrospectively reported HIV risk was a secondary outcome.
Results:
We enrolled 400 women between April and July 2021 (203 intervention, 197 control); 38% were pregnant; 94% reported no PrEP or PEP use for prior 6 months; 52% were aged 15-24y. Among 384/400 (96%) of women with outcome ascertained, the intervention increased biomedical prevention coverage by 40.2% (95%CI: 33.8%-46.7%; p < 0.001); mean coverage was 70% in intervention vs. 29% in control. Similar effect sizes were seen across age and baseline pregnancy status. The intervention also increased coverage during months at risk of HIV: 81% in intervention vs. 43% in control (38.1% absolute increase; 95%CI: 31.2%-45.0%; p < 0.001). Among intervention participants, 100% chose PrEP and 11% chose PEP at least once during 48 weeks. Choice of off-site visits increased over time (61% selected out-of-facility delivery at week-48 vs. 22% at baseline), as did choice of HIV self-testing (59% selected self-testing at week-48 vs. 34% at baseline).
Conclusions:
In this randomized study, a patient-centered dynamic choice intervention that provided flexibility in product modality, testing and service location more than doubled biomedical HIV prevention coverage in a high-risk population already routinely offered access to biomedical prevention options.