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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Methamphetamine Abuse, HIV

Intervention / Treatment
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* Behavioral: Text Messages Transmitted by Peer Health Educators (TXT-PHE)
* Behavioral: Text Messages Transmitted by Automation (TXT-Auto)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXT-PHE<br>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)<br>* 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.<br>|
| Experimental: TXT-Auto<br>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)<br>* 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.<br>|
| No Intervention: Assessment Only (AO)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Primary Care | 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. | 8-weeks post randomization, 3-/6-/9-months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Text Messaging, mHealth, Methamphetamine, AIDS