The Getting Off App for Methamphetamine-Using Gay and Bisexual Men

Getting Off: : A Theory-based mHealth Intervention for Methamphetamine-using MSM

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Methamphetamine Abuse
• Intervention / Treatment: Other: Getting Off App

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.

• Study Type: Interventional
• Enrollment (Actual): 226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90038
      • Friends Community Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate Delivery; Participants randomized into the Immediate Delivery arm (n = 113) receive access to the app immediately upon enrollment, and are given a pre- (baseline) and post- (one month post-baseline) test.	Other: Getting Off App; A mobile phone application based on the "Getting Off" methamphetamine treatment manual. Participants download the app and progress through the sessions of the Getting Off intervention through the administration of games, activities, lessons, quizzes, and tutorials. There are 24 sessions total in the app, each addressing a different component of the methamphetamine treatment process. The fundamental basis of the app is gay-specific cognitive behavioral therapy, with elements of motivational interviewing, social support theory, and health belief model dynamics included.
Placebo Comparator: Delayed Delivery; Participants randomized into the Delayed Delivery arm (n = 113) don't receive access to the app until one month post-baseline. For the RCT portion of the analysis, they will also be assessed at baseline and one month post-baseline (i.e., a pre- and post- prior to app exposure, making them the placebo comparator).	Other: Getting Off App; A mobile phone application based on the "Getting Off" methamphetamine treatment manual. Participants download the app and progress through the sessions of the Getting Off intervention through the administration of games, activities, lessons, quizzes, and tutorials. There are 24 sessions total in the app, each addressing a different component of the methamphetamine treatment process. The fundamental basis of the app is gay-specific cognitive behavioral therapy, with elements of motivational interviewing, social support theory, and health belief model dynamics included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Methamphetamine Use	Days of participant self-reported methamphetamine use in the past 30 days.	from baseline to 9-months post randomization
Methamphetamine Injection	Days participants self-reported methamphetamine injection use in past 30 days	From baseline to 9-months post randomization
Condomless Anal Intercourse	Reporting condomless anal intercourse in the past 30 days (yes/no)	baseline to 9-months post randomization
Condomless Anal Intercourse While High on Methamphetamine	Reporting condomless anal intercourse while high on methamphetamine in the past 30 days (yes/no)	9-months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART Initiation	Starting to receive ART among HIV sero-positive participants who were not on ART at baseline (yes/no)	9-months post randomization
PrEP Initiation	Starting to receive PrEP among HIV sero-negative participants who were not on PrEP at baseline (Yes/No)	9-months post randomization

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Cathy Reback, Ph.D., Friends Research Institute, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): April 26, 2024

Study Registration Dates

• First Submitted: March 16, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: App; mHealth; MSM
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Alzheimer Disease; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01DA045562 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No