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

• Sponsor: Friends Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02008526
• Collaborator: University of California, Los Angeles (Other)
• Enrollment: 286
• Location: 1
• Arms: 3
• Duration (Months): 36
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Abuse; HIV	Behavioral: Text Messages Transmitted by Peer Health Educators (TXT-PHE); Behavioral: Text Messages Transmitted by Automation (TXT-Auto)	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 286 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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.	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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Methamphetamine Use [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 [9-months post randomization]

   Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.

3. Cost Effectiveness [up to 36 months]

   Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.

Secondary Outcome Measures

1. HIV Primary Care [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Friends Research Institute, Inc.
• University of California, Los Angeles

Investigators

• Principal Investigator: Cathy J Reback, Ph.D., Friends Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT02008526
• Other Study ID Numbers: R01DA035092
• First Posted: Dec 11, 2013
• Last Update Posted: Sep 18, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Friends Research Institute, Inc.: Text Messaging; mHealth; Methamphetamine; HIV; AIDS

Study Results

Participant Flow

Arm/Group Title	TXT-PHE	TXT-Auto	Assessment Only (AO)
Arm/Group Description	Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages. Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back. 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 Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.	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. 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.	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.
Period Title: Overall Study
STARTED	94	99	93
COMPLETED	86	85	84
NOT COMPLETED	8	14	9

Baseline Characteristics

Arm/Group Title	TXT-PHE	TXT-Auto	Assessment Only (AO)	Total
Arm/Group Description	Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages. Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back. 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 Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.	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. 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.	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.	Total of all reporting groups
Overall Participants	94	99	93	286
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.04 (11.31)	41.00 (11.12)	41.43 (10.15)	41.48 (10.85)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	94 100%	99 100%	93 100%	286 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	20 21.3%	29 29.3%	23 24.7%	72 25.2%
Not Hispanic or Latino	74 78.7%	70 70.7%	70 75.3%	214 74.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 1%	0 0%	1 0.3%
Asian	3 3.2%	2 2%	2 2.2%	7 2.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	40 42.6%	45 45.5%	40 43%	125 43.7%
White	20 21.3%	16 16.2%	20 21.5%	56 19.6%
More than one race	10 10.6%	6 6.1%	6 6.5%	22 7.7%
Unknown or Not Reported	21 22.3%	29 29.3%	25 26.9%	75 26.2%
Region of Enrollment (Count of Participants)
United States	94 100%	99 100%	93 100%	286 100%
HIV Status (Count of Participants)
HIV Negative	57 60.6%	57 57.6%	54 58.1%	168 58.7%
HIV Positive	37 39.4%	42 42.4%	39 41.9%	118 41.3%

Outcome Measures

1. Primary Outcome

Title	Methamphetamine Use
Description	Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
Time Frame	9-months post randomization

Outcome Measure Data

Analysis Population Description

Number of participants retained through 9-month follow-up.

Arm/Group Title	TXT-PHE	TXT-Auto	Assessment Only (AO)
Arm/Group Description	Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages. Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back. 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 Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.	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. 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.	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.
Measure Participants	94	99	93
Baseline Meth Use	11.13 (9.53)	10.75 (9.48)	10.34 (9.00)
9-Month Follow-up Meth Use	7.79 (9.83)	7.05 (9.87)	5.66 (7.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TXT-PHE, TXT-Auto, Assessment Only (AO)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3137
	Comments
	Method	ANOVA
	Comments	2 Degrees of Freedom
Method of Estimation	Estimation Parameter	F
	Estimated Value	1.16
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	HIV Sexual Risk Behavior
Description	Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
Time Frame	9-months post randomization

Outcome Measure Data

Analysis Population Description

Participants retained through nine months post randomization.

Arm/Group Title	TXT-PHE	TXT-Auto	Assessment Only (AO)
Arm/Group Description	Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages. Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back. 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 Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.	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. 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.	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.
Measure Participants	94	99	93
Baseline Condomless Anal Intercourse	11.44 (15.58)	14.05 (19.49)	7.39 (12.91)
9-Month Follow-up Condomless Anal Intercourse	5.19 (12.84)	4.34 (11.56)	4.31 (9.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TXT-PHE, TXT-Auto, Assessment Only (AO)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8494
	Comments
	Method	ANOVA
	Comments	2 Degrees of Freedom
Method of Estimation	Estimation Parameter	F
	Estimated Value	0.16
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Cost Effectiveness
Description	Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
Time Frame	up to 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	For up to 9-months post randomization
Arm/Group Title	TXT-PHE		TXT-Auto		Assessment Only (AO)
Arm/Group Description	Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) Interactive and tailored to the needs of the individual participant. PHEs initiate text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages. Participants receive five pre-written messages per day. Participants who respond to the pre-written text messages or initiate queries or requests for support are sent additional messages back. 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 Peer Health Educators (TXT-PHE): Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. Participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.		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. 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.		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.
All Cause Mortality
	TXT-PHE		TXT-Auto		Assessment Only (AO)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		2/99 (2%)		1/93 (1.1%)
Serious Adverse Events
	TXT-PHE		TXT-Auto		Assessment Only (AO)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		2/99 (2%)		1/93 (1.1%)
General disorders
Death	0/94 (0%)	0	2/99 (2%)	2	1/93 (1.1%)	1
Other (Not Including Serious) Adverse Events
	TXT-PHE		TXT-Auto		Assessment Only (AO)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/94 (0%)		0/99 (0%)		0/93 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.