DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men.

Young men who have sex with men (YMSM) are highly vulnerable to HIV. While pre-exposure prophylaxis (PrEP) has demonstrated effectiveness, adherence has been low among YMSM and difficult to measure accurately. In collaboration with a healthcare company, we configured an automated directly-observed therapy (aDOT) platform for monitoring and supporting PrEP use. Based on interest expressed in focus groups among 54 YMSM, we combined aDOT with an electronic sexual diary to provide feedback on level of protection during sex and to motivate app use. In an 8-week optimization pilot with 20 YMSM in San Francisco and Atlanta, the app was found to be highly acceptable, with median System Usability Scale scores in the "excellent" range (80/100). App use was high, with median PrEP adherence of 91% based on aDOT-confirmed dosing. Most (84%) participants reported the app helped with taking PrEP. These promising findings support further evaluation of DOT Diary in future effectiveness studies.

Pre-exposure Prophylaxis Uptake and Discontinuation Among Young Black Men Who Have Sex With Men in Atlanta, Georgia: A Prospective Cohort Study.

BACKGROUND: Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) has great potential to reduce HIV incidence among young black men who have sex with men (YBMSM); however, initiation and persistence for this group remain low. We sought to understand the patterns and predictors of PrEP uptake and discontinuation among YBMSM in Atlanta, Georgia. METHODS: PrEP was offered to all participants in a prospective cohort of YBMSM aged 18-29 years not living with HIV. Time to PrEP uptake, first discontinuation, and final discontinuation were assessed using the Kaplan-Meier method. Cox proportional hazard models were used to identify predictors of uptake and discontinuation. RESULTS: After 440 person-years of follow-up, 44% of YBMSM initiated PrEP through the study after a median of 122 days. Of PrEP initiators, 69% had a first discontinuation and 40% had a final discontinuation during the study period. The median time to first PrEP discontinuation was 159 days. Factors associated with PrEP uptake included higher self-efficacy, sexually transmitted infection (STI), and condomless anal intercourse. Factors associated with discontinuation included younger age, cannabis use, STI, and fewer sex partners. HIV incidence was 5.23/100 person-years (95% confidence interval [CI], 3.40-7.23), with a lower rate among those who started PrEP (incidence rate ratio, 0.39; 95% CI, .16-.92). CONCLUSIONS: Persistent PrEP coverage in this cohort of YBMSM was suboptimal, and discontinuations were common despite additional support services available through the study. Interventions to support PrEP uptake and persistence, especially for younger and substance-using YBMSM, are necessary to achieve full PrEP effectiveness. CLINICAL TRIALS REGISTRATION: NCT02503618.

Lack of health insurance is associated with delays in PrEP initiation among young black men who have sex with men in Atlanta, US: a longitudinal cohort study.

INTRODUCTION: Delays between receiving a PrEP prescription and taking a first dose increase the risk of HIV infection. This is especially relevant in populations with high HIV incidence, such as young black men who have sex with men (YBMSM) in the United States. Additionally, YBMSM have relatively low levels of health insurance. We investigated whether lack of health insurance and reliance on PrEP funding through the manufacturer assistance programme (MAP) leads to delays in initiation of PrEP. METHODS: HIV-negative YBMSM were offered PrEP as part of a prospective cohort. Enrolment began in June 2015 with follow-up through February 2019. Interested participants attended a PrEP clinician visit and received a prescription. Those with health insurance received a copay assistance card; those without insurance accessed PrEP using the MAP. The primary outcome was the days between prescription and initiation. The effect of insurance status on this delay was modelled using a Cox proportional hazards model. RESULTS AND DISCUSSION: The median delay between receipt of a PrEP prescription and taking a first dose was 12 days (IQR 3 to 32). Compared to uninsured participants, the adjusted hazard ratio for PrEP initiation for those with insurance was 2.72 (95% CI 1.82 to 4.06). The adjusted median time to initiation for insured participants was 5 days versus 21 days for those without insurance (p < 0.0001). Older age and STI diagnosis were also associated with faster PrEP initiation. Despite equivalent access to PrEP provided by the study, YBMSM without insurance had longer delays in initiation after receipt of a prescription. Overall, the observed delay in PrEP initiation increases the chances of HIV infection and the possibility of PrEP initiation after undetected seroconversion. CONCLUSIONS: The extended time period between PrEP prescription and taking a first dose increases the risk of HIV transmission. Younger YBMSM and those without health insurance had longer delays in PrEP initiation. Immediate PrEP initiation programmes could decrease the likelihood of this occurrence and mitigate the disparity in initiation between those with and without health insurance. Clinical Trial Number: NCT02503618.