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

NCT03884946 | Completed Results

• 1 other identifier: R01DA045562
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Abuse; HIV/AIDS

Keywords

MSM; mHealth; App

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• ART Initiation

  9-months post randomization

• PrEP Initiation

  9-months post randomization

Study Arms (2)

Immediate Delivery

ACTIVE COMPARATOR

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

Delayed Delivery

PLACEBO COMPARATOR

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

Interventions

Getting Off App OTHER

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.

Delayed Delivery; Immediate Delivery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Friends Community Center

Los Angeles, California, 90038, United States

Location

Related Publications (1)

• 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.

  PMID: 33616547 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alzheimer Disease

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Cathy J. Reback
• Organization: Friends Research Institute

reback@friendsresearch.org

800-705-7757

Study Officials

• Cathy Reback, Ph.D.

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 21, 2019
• Study Start: January 30, 2019
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)