Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM

NCT02008526 | Completed Results DMC

• 1 other identifier: R01DA035092
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

Participants receive culturally relevant and specifically tailored text messages based on the behavioral change theoretical constructs of Social Support Theory, Health Belief Model, and Social Cognitive Theory. Participants are randomized into one of three conditions for an 8-week intervention period: Group 1: culturally relevant theory-based text messages interactively transmitted by peer health educators (TXT-PHE); or, Group 2: the same culturally relevant theory-based text messages transmitted by automation (TXT-Auto); or, Group 3: assessment-only (AO) control with no theoretically based text messages.

Conditions

Methamphetamine Abuse; HIV

Keywords

Text Messaging; mHealth; Methamphetamine; HIV; AIDS

Outcome Measures

Primary Outcomes (3)

• Methamphetamine Use

  Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.

  9-months post randomization

• HIV Sexual Risk Behavior

  Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.

  9-months post randomization

• Cost Effectiveness

  Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.

  up to 36 months

Secondary Outcomes (1)

• HIV Primary Care

  8-weeks post randomization, 3-/6-/9-months post randomization

Study Arms (3)

TXT-PHE

EXPERIMENTAL

Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) This condition is interactive and tailored to the needs of the individual participant. PHEs initiate (i.e., "push") text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages (i.e., "pull"). Participants receive five pre-written messages per day sent on a predetermined schedule. Participants who respond to the pre-written text messages or initiate queries or requests for support ("pull") are sent additional real-time messages back from the PHE. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.

Behavioral: Text Messages Transmitted by Peer Health Educators (TXT-PHE)

TXT-Auto

EXPERIMENTAL

Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto) Participants assigned to this group receive automatic text-messages. Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.

Behavioral: Text Messages Transmitted by Automation (TXT-Auto)

Assessment Only (AO)

NO INTERVENTION

During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.

Interventions

Text Messages Transmitted by Peer Health Educators (TXT-PHE) BEHAVIORAL

Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. Participants who respond to the pre-written text messages or initiate queries or requests for support ("pull") are sent additional real-time messages back from the PHE. Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.

TXT-PHE

Text Messages Transmitted by Automation (TXT-Auto) BEHAVIORAL

Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.

TXT-Auto

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 MSM
• Between the ages of 18 and 65 years
• Methamphetamine use within the previous 3 months
• Unprotected anal intercourse (insertive or receptive) with a non-primary male partner in the previous 6 months
• Not currently in treatment or seeking methamphetamine abuse treatment
• Able and willing to fully charge a cellular phone daily
• Able and willing to provide informed consent
• Able and willing to comply with study requirements

You may not qualify if:

• Does not identify as a MSM
• Not between the ages of 18 and 65 years
• Has not used methamphetamine in the previous 3 months
• Has not had unprotected anal intercourse (insertive or receptive) with a non-primary male partner in the previous 6 months
• Currently in treatment or seeking methamphetamine abuse treatment
• Unable or unwilling to fully charge a cellular phone daily
• Unable or unwilling to provide informed consent
• Unable or unwilling to comply with study requirements
• Unable to understand the Informed Consent Form
• Determined to have a more serious psychiatric condition (SCID verified) that is beyond the safe enrollment of study procedures

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028

Los Angeles, California, 90028, United States

Location

Related Publications (2)

• Reback CJ, Ling D, Shoptaw S, Rohde J. Developing a Text Messaging Risk Reduction Intervention for Methamphetamine-Using MSM: Research Note. Open AIDS J. 2010 May 14;4:116-22. doi: 10.2174/1874613601004030116.

  PMID: 20657827 BACKGROUND

• Reback CJ, Grant DL, Fletcher JB, Branson CM, Shoptaw S, Bowers JR, Charania M, Mansergh G. Text messaging reduces HIV risk behaviors among methamphetamine-using men who have sex with men. AIDS Behav. 2012 Oct;16(7):1993-2002. doi: 10.1007/s10461-012-0200-7.

  PMID: 22610370 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Results Point of Contact

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

reback@friendsresearch.org

3234631601

Study Officials

• Cathy J 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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 11, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)