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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008526
First Posted: December 11, 2013
Last Update Posted: September 18, 2017
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. Read our disclaimer for details.
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.
December 3, 2013
December 11, 2013
April 4, 2017
September 18, 2017
September 18, 2017
January 2014
January 2017   (Final data collection date for primary outcome measure)
  • Methamphetamine Use [ Time Frame: 9-months post randomization ]
    Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
  • HIV Sexual Risk Behavior [ Time Frame: 9-months post randomization ]
    Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
  • Cost Effectiveness [ Time Frame: up to 36 months ]
    Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
  • Methamphetamine Use [ Time Frame: up to 9-months post randomization ]
    Self-reported and/or biomarker-confirmed methamphetamine use is assessed at baseline, weekly throughout the 8-week intervention, and at 3-, 6-, and 9-month follow-up assessments.
  • HIV Sexual Risk Behavior [ Time Frame: up to 9-months post randomization ]
    Self-reported HIV sexual risk behaviors and/or biomarkers for HIV and STIs are assessed at baseline, weekly throughout the 8-week intervention, and at 3-, 6-, and 9-month post-randomization follow-up.
  • Cost Effectiveness [ Time Frame: up to 36 months ]
    Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
Complete list of historical versions of study NCT02008526 on ClinicalTrials.gov Archive Site
HIV Primary Care [ Time Frame: 8-weeks post randomization, 3-/6-/9-months post randomization ]
HIV-positive participants will be assessed according to their linkage/retention in HIV primary care and adherence to ART medication at 8-weeks, 3-, 6-, and 9-months post-randomization.
Same as current
Not Provided
Not Provided
 
Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
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.
The randomized three-group design uses repeated assessments at baseline, at the end of the 8-week intervention period, and at 3-, 6-, and 9-month post randomization follow-up. Participants in all three conditions receive brief weekly text-message assessments on their methamphetamine use and HIV sexual behaviors in the previous seven days. This study will determine the differential immediate and sustained effects of transmitting theory-based text messages by PHE (TXT-PHE) versus by automation (TXT-Auto), compared to an assessment-only (AO) control condition among out-of-treatment, methamphetamine-using MSM for reductions of methamphetamine use and HIV sexual risk behaviors. It is hypothesized that there will be significantly greater reductions in methamphetamine use and HIV sexual risk behaviors from text messages transmitted by PHE than by text messages transmitted by automation, which in turn will produce significantly greater reductions than the AO condition (PHE > TXT > AO). In addition, this study will determine the cost-effectiveness of TXT-PHE vs. TXT-Auto compared to AO for reducing methamphetamine use and HIV sexual risk behaviors. The investigators hypothesize that the TXT-PHE intervention will prove more cost-effective than TXT-Auto in reducing methamphetamine use and HIV sexual risk behaviors, while the TXT-Auto condition will prove more cost effective than the AO condition in reducing these same outcomes (PHE > TXT > AO).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Methamphetamine Abuse
  • HIV
  • Behavioral: Text Messages Transmitted by Peer Health Educators (TXT-PHE)
    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.
  • Behavioral: Text Messages Transmitted by Automation (TXT-Auto)
    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.
  • Experimental: TXT-PHE

    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.

    Intervention: Behavioral: Text Messages Transmitted by Peer Health Educators (TXT-PHE)
  • Experimental: TXT-Auto

    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.

    Intervention: Behavioral: Text Messages Transmitted by Automation (TXT-Auto)
  • No Intervention: Assessment Only (AO)
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
January 2017
January 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02008526
R01DA035092( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Friends Research Institute, Inc.
Friends Research Institute, Inc.
University of California, Los Angeles
Principal Investigator: Cathy J Reback, Ph.D. Friends Research Institute, Inc.
Friends Research Institute, Inc.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP