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

NCT ID: NCT02008526

Last Updated: 2017-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-01-31

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).

Conditions

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Methamphetamine Abuse HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Text Messages Transmitted by Peer Health Educators (TXT-PHE)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Text Messages Transmitted by Automation (TXT-Auto)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cathy J Reback, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Reback CJ, Ling D, Shoptaw S, Rohde J. Developing a Text Messaging Risk Reduction Intervention for Methamphetamine-Using MSM: Research Note. Open AIDS J. 2010 May 14;4:116-22. doi: 10.2174/1874613601004030116.

Reference Type BACKGROUND
PMID: 20657827 (View on PubMed)

Reback CJ, Grant DL, Fletcher JB, Branson CM, Shoptaw S, Bowers JR, Charania M, Mansergh G. Text messaging reduces HIV risk behaviors among methamphetamine-using men who have sex with men. AIDS Behav. 2012 Oct;16(7):1993-2002. doi: 10.1007/s10461-012-0200-7.

Reference Type BACKGROUND
PMID: 22610370 (View on PubMed)

Other Identifiers

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R01DA035092

Identifier Type: NIH

Identifier Source: org_study_id

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