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

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.

RESUMEN: La medición de la adherencia a la profilaxis oral previa a la exposición (PrEP) en tiempo real ha constituido un desafío. Hemos desarrollado DOT Diary, una aplicación para teléfonos inteligentes que combina la terapia automatizada observada de forma directa con un kit de herramientas para visualizar la adherencia a la PrEP, y testeamos su capacidad para medir la adherencia a la PrEP, así como para aumentar la adherencia entre una cohorte variada de hombres jóvenes que tienen sexo con hombres (HSH). Reclutamos a 100 HSH en San Francisco y Atlanta y los asignamos aleatoriamente 2:1 a DOT Diary con respecto a la asistencia estándar. La concordancia entre la medición del DOT Diary y los niveles de fármacos en gotas de sangre seca fue sustancial, con un 91,0% y un 85,3% de concordancia entre el uso del DOT Diary y el de emtricitabina-trifosfato y tenofovir-difosfato, respectivamente. No hubo diferencias significativas en la proporción de participantes con niveles detectables del fármaco de la PrEP a las 24 semanas entre los brazos del estudio. Estos resultados sugieren que DOT Diary es sustancialmente superior a las medidas de adherencia que se notifican de forma personal, aunque hacen falta intervenciones adicionales para mejorar la adherencia a la PrEP a largo plazo.

From declining PrEP to PrEP initiation as "first nature" - what changes PrEP initiation decisions among young, Black MSM.

Young Black men who have sex with men (YBMSM) bear a disproportionate burden of HIV, and HIV pre-exposure prophylaxis (PrEP) uptake has been slow. Decisions regarding PrEP initiation change in different life contexts over time. Our YBMSM cohort study found about 1/3 of those who initially declined PrEP subsequently changed and initiated PrEP care. This study explores the process of their PrEP decision changes. The study interviewed participants who initially voiced strong and clear reservations about PrEP, but subsequently started PrEP 1-14 months later. In "review/renew" follow-up interviews, participants reviewed their past statements from a time they declined PrEP, and renew their understanding regarding perspective and behavioral change. Analyzing the data with a positive deviance framework, we found that shifting the decisional balance in favor of PrEP initiation only required change in some areas. There were not consistent factors that prevented or facilitated PrEP uptake. Instead, YBMSM initiated PrEP while maintaining an array of substantial reservations. PrEP initiation discussions should be viewed by health practitioners as a longitudinal process, and routine PrEP offers should be made over time. To optimally facilitate PrEP use among YBMSM, the diverse benefits of PrEP should be emphasized rather than focusing on allaying all concerns.

Contrasting Self-Perceived Need and Guideline-Based Indication for HIV Pre-Exposure Prophylaxis Among Young, Black Men Who Have Sex with Men Offered Pre-Exposure Prophylaxis in Atlanta, Georgia.

Despite high HIV incidence among young black men who have sex with men (YBMSM), pre-exposure prophylaxis (PrEP) uptake in this group is low. In a cohort of HIV-negative YBMSM in Atlanta, GA, all participants were offered PrEP as standard of care with free clinician visits and laboratory testing. We explored self-perceived need for PrEP among 29 in-depth interview participants by asking about reasons for PrEP uptake or refusal and factors that may lead to future reconsideration. Self-perceived need was compared to US Center for Disease Control and Prevention guidance for clinical PrEP indication using behavioral data and laboratory testing data. Self-perceived need for PrEP consistently underestimated clinical indication, primarily due to optimism for choosing other HIV prevention strategies, such as condom use, abstinence, or monogamy. Many participants cited consistent condom use and lack of sexual activity as reasons for not starting PrEP; however, follow-up survey data frequently demonstrated low condom use and high levels of sexual activity in the period after the interview. Study participants endorsed perceptions that PrEP is only for people with very high levels of sexual activity. Only one participant perceived incident sexually transmitted infection (STI) to be an indication for PrEP, despite the fact that several of the participants had a history of an STI diagnosis. These findings point to an opportunity for clinician intervention at diagnosis. Disconnect between self-perceived and guidance-based PrEP indications, as well as other factors such as medical mistrust or difficulty with access, may contribute to low PrEP uptake among YBMSM. A better understanding of the ways in which these issues manifest may be one tool for clinicians to support PrEP uptake.

Beyond the Biomedical: Preexposure Prophylaxis Failures in a Cohort of Young Black Men Who Have Sex With Men in Atlanta, Georgia.

Human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) has high biomedical efficacy; however, awareness, access, uptake, and persistence on therapy remain low among black men who have sex with men (BMSM), who are at highest risk of HIV in the United States. To date, discussions of "PrEP failure" have focused on one typology: rare, documented HIV acquisitions among PrEP users with adequate serum drug levels (ie, biomedical failure). In our cohort of HIV-negative young BMSM in Atlanta, Georgia, we continue to observe a high HIV incidence (6.2% annually at interim analysis) despite access to free PrEP services. Among 14 seroconversions, all were offered PrEP before acquiring HIV. Among these participants, we identified 4 additional typologies of PrEP failure that expand beyond biomedical failure: low PrEP adherence, PrEP discontinuation, PrEP contemplation without initiation, and PrEP refusal. We describe the 5 typologies and suggest interventions to improve PrEP effectiveness among those at highest risk.

Acceptability of Couples' Voluntary HIV Testing Among HIV-infected Patients in Care and Their HIV-negative Partners in the United States.

INTRODUCTION: Couples' voluntary HIV counseling and testing (CHTC) is an HIV risk reduction strategy not widely available in the US. METHODS: We assessed willingness to participate in CHTC among US HIV-infected clinic patients via tablet-based survey and among HIV-negative persons with HIV-infected partners in care via mixed-method phone interviews. RESULTS: Most of the N=64 HIV-infected partners surveyed were men (89%), on antiretroviral treatment (ART) (92%), and many self-identified homosexual (62%). We observed high levels of willingness to participate in CHTC (64%) among HIV-infected partners. Reasons for not wanting to participate included perceived lack of need (26%), desire to self-disclose their status (26%), and fear of being asked sensitive questions with their partner present (17%). HIV-infected partners were interested in discussing ART (48%), other sexually transmitted infections (STIs) (44%), and relationship agreements like monogamy (31%) during CHTC sessions. All N=15 HIV-negative partners interviewed were men, most identified as homosexual (73%), and about half (54%) reported consistent condom use with HIV-infected partners. We observed high levels of willingness to participate in CHTC (87%) among HIV-negative partners, who were also interested in discussing ART (47%), other STIs (47%), mental health services (40%), and relationship agreements (33%). Most negative partners (93%) indicated that they believed their HIV-infected partner was virally suppressed, but in the event that they were not, many (73%) were willing to take pre-exposure prophylaxis (PrEP). CONCLUSION: These results indicate that CHTC for serodiscordant couples is acceptable and should emphasize aspects most pertinent to these couples, such as discussion of ART/PrEP, STIs, and relationship agreements.