Randomized Controlled Trial of Automated Directly Observed Therapy for Measurement and Support of PrEP Adherence Among Young Men Who have Sex with Men

Abstract

Measurement of adherence to oral pre-exposure prophylaxis (PrEP) in real-time has been challenging. We developed DOT Diary, a smartphone application that combines automated directly observed therapy with a PrEP adherence visualization toolkit, and tested its ability to measure PrEP adherence and to increase adherence among a diverse cohort of young men who have sex with men (MSM). We enrolled 100 MSM in San Francisco and Atlanta and randomly assigned them 2:1 to DOT Diary versus standard of care. Concordance between DOT Diary measurement and drug levels in dried blood spots was substantial, with 91.0% and 85.3% concordance between DOT Diary and emtricitabine-triphosphate and tenofovir-diphosphate, respectively. There was no significant difference in the proportion of participants with detectable PrEP drug levels at 24 weeks between study arms. These results suggest DOT Diary is substantially better than self-reported measures of adherence, but additional interventions are needed to improve PrEP adherence over time.

Digital intervention engagement mediates the relationship between intrapersonal measures and pre-exposure prophylaxis adherence: a secondary analysis of a randomized controlled trial of sexual orientation and gender minority youth on pre-exposure prophylaxis (Preprint)

“…For example, digital pill systems have documented barriers to engagement and have not shown that they independently improve PrEP adherence compared to a standard of care. [26][27][28][29] Further, DHIs implemented to address other health problems in target youth populations have encountered problems effectively engaging participants. For example, one study which developed a mobile app for self-management of Type 1 diabetes among adolescents found no association between intervention condition and primary or secondary clinical outcomes.…”

The Impact of Generative Conversational Artificial Intelligence on the Lesbian, Gay, Bisexual, Transgender, and Queer Community: Scoping Review

“…After removing 98.23% (1163/1184) of irrelevant items, 21 studies were examined in depth. Of these 21 studies, 12 (57%) [17][18][19][20][21][22][23][24][25][26][27][28] were excluded with reasons (Textbox 3): 3 (25%) [21,23,25] were excluded as they were chatbot acceptance studies only without implementation of the chatbot project; 3 (25%) [17,18,22] were excluded as they described digital tools, which, despite being AI-enhanced, did not fully meet our inclusion criteria (not being able to dynamically interact with the client or patient); 1 (8%) [17] was a usability study that lacked the implementation part; 1 (8%) [19] was not retained as it performed a content analysis of health-related information concerning HIV pre-exposure prophylaxis (PrEP); another study (8%) [20] was excluded as it explored how text-based conversational agents express their gender and sexual identity, which was not related to our topic of interest and research aims or objectives; and 3 (25%) further studies [24,27,28] were excluded as the population also comprised non-LGBTQ individuals. Finally, an app called Rainbow Austin [26] was excluded because of lack of details.…”

Adapting mHealth Interventions (PrEPmate and DOT Diary) to Support PrEP Retention in Care and Adherence Among English and Spanish-Speaking Men Who Have Sex With Men and Transgender Women in the United States: Formative Work and Pilot Randomized Trial

“…Development and prior testing of PrEPmate and DOT Diary in English-speaking MSM have been described previously [ 31 , 34 - 35 ]. Briefly, PrEPmate is a text messaging–based intervention grounded in the information, motivation, behavioral skills theory of behavior change [ 36 ].…”