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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Friends Research Institute, Inc.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Cathy Reback, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT02008526
First received: December 3, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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. Participants in all three conditions receive brief weekly text-message assessments on their methamphetamine use and HIV sexual behaviors in the previous seven days. Data related to intervention costs as well as relative exposure to each theoretical construct will be examined to determine cost- and mechanism-effectiveness, respectively. 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. 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).


Condition Intervention
Methamphetamine Abuse
HIV
Behavioral: Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE)
Behavioral: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Methamphetamine Use [ Time Frame: up to 9-months post randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.


Secondary Outcome Measures:
  • HIV Primary Care [ Time Frame: 8-weeks post randomization, 3-/6-/9-months post randomization ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 285
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TXT-PHE

Group 1: Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) with "Push and Pull" Interactions.

Participants assigned to this group receive text-messaging from PHEs. 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").

Following the initial welcome message, 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: Gay-specific, Theory-based 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.
Experimental: TXT-Auto

Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto) with "Push Only" interactions

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: Gay-specific, Theory-based 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008526

Contacts
Contact: Mitch Metzner, Ph.D. (323) 463-1601 mmetzner@friendsresearch.org
Contact: Jesse B Fletcher, Ph.D. (323) 463-1601 jfletcher@friendsresearch.org

Locations
United States, California
Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028 Recruiting
Los Angeles, California, United States, 90028
Contact: Mitch Metzner, Ph.D.    323-463-1601    mmetzner@friendsresearch.org   
Sponsors and Collaborators
Friends Research Institute, Inc.
University of California, Los Angeles
Investigators
Principal Investigator: Cathy J Reback, Ph.D. Friends Research Institute, Inc.
  More Information

Publications:
Responsible Party: Cathy Reback, Principal Investigator, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02008526     History of Changes
Other Study ID Numbers: R01DA035092
Study First Received: December 3, 2013
Last Updated: May 27, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Friends Research Institute, Inc.:
Text Messaging
mHealth
Methamphetamine
HIV
AIDS

Additional relevant MeSH terms:
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014