Clinical trial NCT03884946: The Getting Off App for Methamphetamine-Using Gay and Bisexual Men
Official title: Getting Off: : A Theory-based mHealth Intervention for Methamphetamine-using MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Abuse
HIV/AIDS
Keywords: MSM
mHealth
App
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-03-21
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomly assigned arms will receive the same intervention (i.e., an app) at staggered intervals. At the end of one month, participants in the immediate arm will have received the app, but participants in the delayed arm will not. At this point, the two groups represent an RCT.
Primary purpose: TREATMENT

Brief summary: A commonly used manualized outpatient methamphetamine intervention for gay and bisexual men, "Getting Off," is being translated into a mobile phone application (i.e., app) available for download through common app marketplaces. The application will provide games, guided lessons, informational support, and resources to gay and bisexual men seeking to reduce their methamphetamine use and risky sexual behaviors.

Detailed description: The research team will conduct formative research to translate the 24 Getting Off sessions from a group-based manual-driven intervention to a computerized app, conduct alpha phase post-development bug testing, conduct beta phase usability pilot testing, and refine the app according to alpha- and beta-phase testing. Four focus groups will provide input on the development of the Getting Off app (further input will be obtained through an ongoing Consumer Advisory Board and usability pilot testing) with: 1) out-of-treatment, methamphetamine-using MSM (n=\~8); 2) methamphetamine-using men who have sex with men (MSM) who are currently in outpatient treatment in the brick-and-mortar Getting Off program at the study site (n=\~8); 3) prior methamphetamine-using MSM with a minimum of one year recovery who have completed a minimum 18/24 sessions (75%) of the brick-and-mortar Getting Off program; and, 4) prior methamphetamine-using MSM with a minimum of one year recovery who have had no previous experience or knowledge of the Getting Off intervention (n=\~8). The focus groups will be structured to provide guidance on translating Getting Off into an app that is responsive to culture (e.g., sexuality; HIV prevention/care including pre-exposure prophylaxis (PrEP) uptake, adherence and persistence, antiretroviral therapy (ART) adherence, viral load suppression) and methamphetamine treatment needs.

Following app development, and to ensure benchmarks have been met, alpha phase testing will uncover and remove unwanted bugs, and beta phase usability pilot testing will be conducted with members of the target population (N=30) to test the feasibility, acceptability, and preliminary effects of the Getting Off app. Furthermore, the pilot testing will be utilized to ensure the functionality of the app (i.e., that the app is user-friendly and all features function appropriately).

Behavioral assessments will be conducted at baseline and at 1-month follow-up.

The study team will then conduct a randomized controlled trial (RCT) to evaluate reductions of methamphetamine use and HIV sexual risk behaviors, and increased advancement along the HIV Prevention or Care Continuum, using three approaches: 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) an observed treatment effects analysis powered for prospective sub-group to compare longitudinal pre/post data from the pooled ID and DD arms (N=300); and, c) 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).

Following screening, informed consent and baseline assessments, participants will be randomized into one of two arms: Arm A: Immediate access to the Getting Off app (ID); or, Arm B: Participants will have access to the Getting Off app after a delayed 30-day period (DD). Participants in both arms will receive the same Getting Off app and participants in both arms will be given 30-days to engage with the app. The randomized two-arm repeated measures design will assess participants at 1-, 2- (DD arm only), 3-, 6-, and 9-months post-randomization to determine longitudinal intervention effects, observed treatment effects, and a historical comparison with a matched sample of participants who have attended the brick-and-mortar group-based Getting Off intervention.

Eligibility criteria: Inclusion Criteria:

Self-identified man who has sex with men (MSM) Any methamphetamine use in the past 365 days Between the ages of 18-65 years Able and willing to provide informed consent.

Exclusion Criteria:

Did not identify as a man who had sex with a man No methamphetamine use in the past 365 days Younger than 18 or older than 65 years Not able or willing to provide informed consent.

Primary outcomes:
measure: Methamphetamine Use
timeFrame: 15-months post randomization
measure: Condomless Anal Intercourse
timeFrame: 15-months post randomization
Secondary outcomes:
measure: ART Adherence
timeFrame: 15-months post randomization
measure: PrEP Adherence
timeFrame: 15-months post randomization
measure: App Usage
timeFrame: 15-months post randomization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Community Center
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Cathy Reback, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reback CJ, Fletcher JB, Mata RP. A Theory-Based mHealth Intervention (Getting Off) for Methamphetamine-Using Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 22;10(2):e22572. doi: 10.2196/22572.