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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.
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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: 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 286
Study Start Date: January 2014
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
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.

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.
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.

Detailed Description:
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).
  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
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): NCT02008526


Locations
United States, California
Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028
Los Angeles, California, United States, 90028
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: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02008526     History of Changes
Other Study ID Numbers: R01DA035092 ( U.S. NIH Grant/Contract )
First Submitted: December 3, 2013
First Posted: December 11, 2013
Results First Submitted: April 4, 2017
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors