Clinical trial NCT02008526: Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
Official title: Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Abuse
HIV
Keywords: Text Messaging
mHealth
Methamphetamine
HIV
AIDS
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2013-12-11
Enrollment: 286
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Methamphetamine Use
timeFrame: 9-months post randomization
measure: HIV Sexual Risk Behavior
timeFrame: 9-months post randomization
measure: Cost Effectiveness
timeFrame: up to 36 months
Secondary outcomes:
measure: HIV Primary Care
timeFrame: 8-weeks post randomization, 3-/6-/9-months post randomization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Cathy J Reback, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.