Methamphetamine (MA) use among men who have sex with men (MSM) is associated with increased rates of HIV prevalence and transmission, as well as substandard advancement along the HIV Prevention and Care Continua. MA use among MSM is deeply integrated into socio-sexual networks including the use of smartphone applications (?app?) and websites to find sexual partners. Given the growth of mobile health technology, it is no longer necessary or reasonable to limit MA treatment options to physical sites, clustered in urban areas, and administered using generic, non-tailored content. The project builds upon the established efficacy of our manualized MA-abuse treatment intervention, ?Getting Off: A Behavioral Treatment Intervention for Gay and Bisexual Male Methamphetamine Users,? and the highly promising findings from our successful Stage I proof-of-concept study, to complete translation of Getting Off into a cross-platform (iOS and Android) app and assess the app?s efficacy and non-inferiority in a scientifically rigorous randomized trial. The Getting Off app, like the group-based intervention before it, will use the principles of Cognitive Behavioral Theory and Stages of Change to help MSM reduce or eliminate MA use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum (including uptake of HIV testing, pre-, and post- exposure prophylaxis [PEP/PrEP] and PrEP adherence and persistence for those who are HIV negative; ART uptake and adherence for those who are HIV positive). This project will 1) refine and enhance the first 8 sessions of the Getting Off MA-abuse treatment intervention developed in Stage I based on feasibility pilot test user feedback, 2) conduct formative research to develop the remaining 16 sessions of the Getting Off MA- abuse treatment intervention into a cross-platform computerized mobile app targeted to reduce MA use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum, and 3) conduct a RCT to evaluate reductions of MA use and HIV sexual risk behaviors, and increased advancement along the HIV Prevention or Care Continuum, using three approaches: a) Efficacy Trial ? a two-arm RCT to determine intervention effects through comparison of the Immediate Delivery (ID; n=150) and Delayed Delivery (DD; n=150) arms; b) Efficacy Trial ? an observed treatment effects analysis to compare pre/post data from the pooled ID and DD conditions (N=300); and, c) Non-inferiority Trial ? a two-arm historical matched comparison design to evaluate the outcomes of the Getting Off app (ID + DD; N=300) relative to a matched sample of participants having previously attended the brick-and-mortar group-based Getting Off intervention (N~600; total N=900). The RCT uses repeated measures to assess participants at baseline, 1-, 2- (DD condition only), 3-, 6-, and 9-month follow-up. This study could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent and highly scalable MA treatment to this very high-risk population.

Public Health Relevance

Methamphetamine (MA) use among MSM is strongly associated with HIV infection and interrupted progression along the HIV Prevention and Care Continua. This study will complete the development and evaluation of an evidence-based, theory-driven, and culturally competent treatment app for MA-using MSM, designed to reduce or eliminate MA use and HIV sexual risks, increase uptake of HIV testing and pre- and post-exposure prophylaxis (PrEP/PEP), including PrEP adherence and persistence for those who are HIV negative, and increase retention in HIV care and adherence to ART for those who are HIV positive. Given the severe personal and public health consequences of MA use, the public health significance of this app is very high as it will provide this population with a tailored treatment opportunity that is easily accessible, affordable, private, and highly scalable.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA045562-02
Application #
9742448
Study Section
Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section (BSPH)
Program Officer
Lao, Guifang
Project Start
2018-07-15
Project End
2023-04-30
Budget Start
2019-05-01
Budget End
2020-04-30
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Friends Research Institute, Inc.
Department
Type
DUNS #
010095032
City
Baltimore
State
MD
Country
United States
Zip Code
21201