ABSTRACT
This randomized controlled study assessed the feasibility, acceptability, and preliminary impact of the PrEP iT! mHealth intervention designed to improve PrEP adherence among young men who have sex with men (YMSM). A national sample of 80 YMSM in the U.S. (Mage = 25 years; 54% racial/ethnic minority), recruited through social media ads, were randomized to either the PrEP iT! or usual PrEP care conditions. Participants completed online surveys and submitted self-collected dried blood sample (DBS) data as measures of PrEP adherence. Differences in PrEP adherence across treatment arms and between participants with high versus low engagement in PrEP iT! were assessed. Retention was high at the three (94%) and six (93%) month assessment, and participants in PrEP iT! reported satisfactory acceptability of the intervention. There were no significant differences in self-reported or DBS-derived PrEP adherence between randomized groups. However, YMSM in the PrEP iT! group with high PrEP adherence (the equivalent of four or more doses/week through self-report and DBS-derived measures) demonstrated significantly higher engagement in the intervention than those with low PrEP adherence (the equivalent of 3 or fewer doses/week). Overall, the PrEP iT! intervention demonstrated strong feasibility and acceptability. The finding that high PrEP iT! intervention engagement was associated with protective levels of PrEP adherence suggests it is a viable adherence support tool that should be further evaluated in definitive trial among YMSM who need basic support, or as part of a more comprehensive adherence support package for those who need greater assistance.Trial registration Clinical Trials # NCT04509076 (registered August 10, 2020).
ABSTRACT
BACKGROUND: Pre-exposure prophylaxis (PrEP) and HIV treatment as prevention, which underlies the Undetectable = Untransmittable (U = U) campaign, are two effective biomedical approaches for HIV prevention among sexual minority men (SMM). Attitudes toward PrEP and U = U may differ between SMM emerging adults (EA: 18-24 years old) and young adults (YA: 25-29 years old) to drive differences in sexual behavior. However, to date, few studies assessed the degree to which YAs and EAs differ in their beliefs in the effectiveness of PrEP and U = U. METHOD: A national sample of 80 SMM in the USA (Mage = 25.1 years; 53.7% racial/ethnic minority; 38.8% EA; 61.3% YA) participated in a 6-month mHealth intervention for PrEP adherence. Non-parametric tests assessed differences in sexual behaviors and attitudes toward the effectiveness of PrEP and U = U between EAs and YAs using baseline data. RESULTS: Compared to EAs, higher proportions of YAs trusted PrEP's effectiveness and considered condom use unnecessary after taking PrEP. More YAs than EAs were willing to engage in sexual behaviors that they felt too risky before learning about U = U and were more comfortable having condomless sex with HIV-positive partners. Conversely, a greater proportion of EAs than YAs preferred to use condoms even when their partners are on anti-HIV medications. CONCLUSION: Overall, YAs trusted the effectiveness of U = U and PrEP more than EAs, underscoring developmental differences in SMM's perspectives on biomedical HIV prevention tools. Our findings underscore the importance of tailoring messages on biomedical HIV prevention options differently for EAs and YAs to optimize uptake.
ABSTRACT
BACKGROUND: Coagulation activity among persons with HIV is associated with end-organ disease risk, but the pathogenesis is not well characterized. We tested a hypothesis that hypercoagulation contributes to disease risk, in part, via upregulation of inflammation. METHODS: Treatment effects of edoxaban (30 mg), a direct factor Xa inhibitor, vs placebo were investigated in a randomized, double-blind crossover trial among participants with HIV and viral suppression and D-dimer levels ≥100 ng/mL. During each 4-month crossover period, blood measures of coagulation, inflammation, and immune activation were assessed. Analyses of change on edoxaban vs change on placebo used linear mixed models. RESULTS: Forty-four participants were randomized, and 40 completed at least 1 visit during each study period. The mean age was 49 years, and the CD4+ count was 739 cells/mm3. Edoxaban treatment led to declines in D-dimer (44%) and thrombin-antithrombin complex (26%) but did not lower inflammatory or immune activation measures. More bruising or bleeding events occurred during edoxaban (n = 28) than during placebo or no drug periods (n = 15). CONCLUSIONS: The direct factor Xa inhibitor edoxaban led to a substantial reduction in coagulation but no effect on inflammation or immune activation. These results do not support that hypercoagulation contributes to ongoing inflammation during chronic antiretroviral therapy-treated HIV disease.