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NCT Number: NCT02008526

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.

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Key information

Conditions

Methamphetamine Abuse Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Los Angeles, California, 90028, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • University of California, Los Angeles

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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