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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884946
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.

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.

Condition or disease Intervention/treatment Phase
Methamphetamine Abuse HIV/AIDS Other: Getting Off App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Getting Off: : A Theory-based mHealth Intervention for Methamphetamine-using MSM
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Immediate Delivery
Participants randomized into the Immediate Delivery arm (n = 150) 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 = 150) 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.




Primary Outcome Measures :
  1. Methamphetamine Use [ Time Frame: 15-months post randomization ]
    Days of participant self-reported methamphetamine use.

  2. Condomless Anal Intercourse [ Time Frame: 15-months post randomization ]
    Episodes of condomless anal intercourse


Secondary Outcome Measures :
  1. ART Adherence [ Time Frame: 15-months post randomization ]
    Number of missed ART doses in the past 30 days (HIV-positive participants only)

  2. PrEP Adherence [ Time Frame: 15-months post randomization ]
    Number of missed HIV pre-exposure prophylaxis (PrEP) doses in the past 30 days (HIV-negative participants only)

  3. App Usage [ Time Frame: 15-months post randomization ]
    Diagnostic back-end data representing time spent using the app.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884946


Contacts
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Contact: Cathy J Reback 13234631601 reback@friendsresearch.org
Contact: Jesse B Fletcher 13234631601 jfletcher@friendsresearch.org

Locations
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United States, California
Friends Community Center Recruiting
Los Angeles, California, United States, 90028
Contact: Jesse Fletcher, PhD    323-512-7014    jfletcher@friendsresearch.org   
Contact: Ray Mata    323-463-1601    rmata@friendsresearch.org   
Principal Investigator: Cathy J Reback, Ph.D.         
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
  Study Documents (Full-Text)

Documents provided by Friends Research Institute, Inc.:
Informed Consent Form  [PDF] October 24, 2018

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Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03884946    
Other Study ID Numbers: R01DA045562 ( U.S. NIH Grant/Contract )
R01DA045562 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Friends Research Institute, Inc.:
MSM
mHealth
App
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases