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Background:The majority of new HIV infections are attributed to male-to-male sexual contact in the United States (US). However only two-thirds of sexual minority men (SMM) living with HIV achieve an undetectable viral load (VL), which is important to both optimize individual health and to substantially reduce onward HIV transmission. We tested a web-based antiretroviral therapy (ART) adherence intervention, called Thrive with Me (TWM), with core features that included medication self-monitoring and feedback, HIV and ART information, and a peer-to-peer exchange. Objective:We assessed the efficacy of TWM on undetectable VL among adult (18+ years) SMM. As a secondary analysis, we assessed the impact of overall engagement and engagement with specific intervention features on undetectable VL.Methods: 401 SMM (Mean = 39 years old; 72% racial/ethnic minority) in New York City were recruited between October 2016 and December 2019 and randomized to receive TWM (intervention) or a weekly email newsletter (control). Assessments occurred at baseline and months 5, 11, and 17. The primary outcome was a dichotomous measure of undetectable VL (<20 copies). Generalized Estimating Equations with robust standard errors were used to assess the effect of the TWM intervention on undetectable VL over follow-up in an unadjusted model, a model adjusted for baseline differences, and then stratified by baseline urinalysis (i.e., positive vs negative drug use). In secondary analyses, Generalized Linear Models were utilized to estimate risk differences of the association of overall engagement with TWM and engagement with specific TWM components on VL throughout the 17-month intervention period.Results: Retention at each time point was: 88% (month 5), 82% (month 11), and 78% (month 17). No difference in DVL was found between those randomized to receive TWM or the control, or when stratified by baseline recent drug use. However, those TWM-assigned participants with high levels of engagement (in the 25th percentile) were more likely to have an undetectable VL at the end of the 5-month active intervention period compared to those with low engagement (below the 75th percentile) or no engagement in the intervention. Moreover, high engagement with the peer-to-peer exchange was associated with undetectable VL over time in unadjusted models.Conclusions: TWM did not have overall impacts on viral suppression, however it may be beneficial to SMM who engage at high levels with this web-based intervention. Clinical Trial: ClinicalTrials.gov NCT02704208
Background:The majority of new HIV infections are attributed to male-to-male sexual contact in the United States (US). However only two-thirds of sexual minority men (SMM) living with HIV achieve an undetectable viral load (VL), which is important to both optimize individual health and to substantially reduce onward HIV transmission. We tested a web-based antiretroviral therapy (ART) adherence intervention, called Thrive with Me (TWM), with core features that included medication self-monitoring and feedback, HIV and ART information, and a peer-to-peer exchange. Objective:We assessed the efficacy of TWM on undetectable VL among adult (18+ years) SMM. As a secondary analysis, we assessed the impact of overall engagement and engagement with specific intervention features on undetectable VL.Methods: 401 SMM (Mean = 39 years old; 72% racial/ethnic minority) in New York City were recruited between October 2016 and December 2019 and randomized to receive TWM (intervention) or a weekly email newsletter (control). Assessments occurred at baseline and months 5, 11, and 17. The primary outcome was a dichotomous measure of undetectable VL (<20 copies). Generalized Estimating Equations with robust standard errors were used to assess the effect of the TWM intervention on undetectable VL over follow-up in an unadjusted model, a model adjusted for baseline differences, and then stratified by baseline urinalysis (i.e., positive vs negative drug use). In secondary analyses, Generalized Linear Models were utilized to estimate risk differences of the association of overall engagement with TWM and engagement with specific TWM components on VL throughout the 17-month intervention period.Results: Retention at each time point was: 88% (month 5), 82% (month 11), and 78% (month 17). No difference in DVL was found between those randomized to receive TWM or the control, or when stratified by baseline recent drug use. However, those TWM-assigned participants with high levels of engagement (in the 25th percentile) were more likely to have an undetectable VL at the end of the 5-month active intervention period compared to those with low engagement (below the 75th percentile) or no engagement in the intervention. Moreover, high engagement with the peer-to-peer exchange was associated with undetectable VL over time in unadjusted models.Conclusions: TWM did not have overall impacts on viral suppression, however it may be beneficial to SMM who engage at high levels with this web-based intervention. Clinical Trial: ClinicalTrials.gov NCT02704208
BACKGROUND Although highly effective HIV pre-exposure prophylaxis (PrEP) is available, its usage and adherence among young men who have sex with men and young transgender women remain low, reducing its overall effectiveness. While digital tools are promising strategies to impact PrEP adherence, engagement in these interventions is often low, limiting their efficacy at changing health behaviors. We conducted a three-arm randomized clinical trial of Prepared, Protected, emPowered (P3) a comprehensive PrEP adherence digital health intervention compared to an enhanced version, P3+, which incorporates in-app adherence coaching. OBJECTIVE This paper seeks to analyze data P3/P3+ study participants to understand how different levels of user engagement with the app's features were associated with adherence to PrEP as well as the costs of each intervention. METHODS Descriptive statistics for study variables at baseline were calculated. To examine the differences in intervention engagement and acceptability by arm, independent samples t-tests for continuous variables and a chi-square analysis for categorical variables were conducted. To examine the effect of arm and engagement categories on PrEP adherence at 3-months, three logistic regression analyses were conducted: 1) the effect of arm on PrEP adherence, 2) the effect of engagement categories (high vs. moderate and low) on PrEP adherence, and 3) the interaction effect of arm and engagement categories on PrEP adherence, along with the main effects of arm and engagement categories. We adopted a provider perspective and estimated the costs of P3/P3+ implementation in a community setting using activity-based costing. RESULTS A total of 163 participants were randomized to the P3 intervention (82 to the P3 arm and 81 to the P3+ arm). Participants in the P3+ arm earned higher incentives ($90.6 vs. $75.4; p=.038), had more app log-ins (96.6 vs 76.1; p=.013), used the app on more days (63.3 days vs. 53.2 days; p=.037), and spent more time in the intervention (378.8 minutes vs. 186.66 minutes; p<.001) compared to those in the P3 arm. There was no significant association between intervention arm and PrEP adherence at 3-months (p=.989). Engagement category (high vs. mod/low) was significantly associated with PrEP adherence at 3-months (p=.003). The average total monthly cost of P3 was $1118 (305.1). Additional average monthly costs for on-going management of the P3+ coaching intervention were $1200 (60.0). CONCLUSIONS This study highlights the critical role of user engagement in enhancing PrEP adherence among young individuals at high risk for HIV. While the P3+ intervention led to increased engagement, this did not translate into significantly better adherence compared to the standard P3 arm. This, coupled with the increased cost and complexity of P3+ delivery, indicates that further studies are necessary to determine whether this intensified intervention is the appropriate fit. CLINICALTRIAL NCT03320512 INTERNATIONAL REGISTERED REPORT RR2-10.2196/10448
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