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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008526
• Other study ID #: R01DA035092
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: June 16, 2017
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Methamphetamine Abuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum in: AIDS Behav. 2012 Oct;16(7):2003. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methamphetamine Use	Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.	9-months post randomization
Primary	HIV Sexual Risk Behavior	Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.	9-months post randomization
Primary	Cost Effectiveness	Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.	up to 36 months
Secondary	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