Methamphetamine AbuseNCT02008526
Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
A study testing Text Messages Transmitted by Peer Health Educators (TXT-PHE) and Text Messages Transmitted by Automation (TXT-Auto) in people with Methamphetamine Abuse and HIV, run by Friends Research Institute, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Methamphetamine Abuse, HIV
- What is being tested?
- Text Messages Transmitted by Peer Health Educators (TXT-PHE) and Text Messages Transmitted by Automation (TXT-Auto)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028
Los Angeles, California, 90028
About this study
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.
Read the 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).
- Conditions
- Methamphetamine Abuse, HIV
- Being tested
- Text Messages Transmitted by Peer Health Educators (TXT-PHE), Text Messages Transmitted by Automation (TXT-Auto)
- Keywords
- Text Messaging, mHealth, Methamphetamine, HIV, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messages Transmitted by Peer Health Educators (TXT-PHE)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TXT-PHE | Experimental | 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. Receives: Behavioral: Text Messages Transmitted by Peer Health Educators (TXT-PHE) |
| TXT-Auto | Experimental | 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. Receives: Behavioral: Text Messages Transmitted by Automation (TXT-Auto) |
| Assessment Only (AO) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Methamphetamine Use
Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
Measured: 9-months post randomization
HIV Sexual Risk Behavior
Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
Measured: 9-months post randomization
Cost Effectiveness
Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
Measured: up to 36 months
Secondary outcomes (1)
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.
Measured: 8-weeks post randomization, 3-/6-/9-months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Cathy J Reback, Ph.D., Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008526
- Sponsor's protocol ID
- R01DA035092
- Status last verified
- Jun 2017
- First submitted
- 3 Dec 2013
- Last updated
- 18 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 20657827Reback 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.
PubMed 22610370
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
- ClinicalTrials.gov ID
- NCT02008526
- Acronym / sponsor ID
- R01DA035092
- Conditions
- Methamphetamine Abuse, HIV
- Keywords
- Text Messaging, mHealth, Methamphetamine, HIV, AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 18 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TXT-PHE | Experimental | Behavioral: Text Messages Transmitted by Peer Health Educators (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. |
| TXT-Auto | Experimental | Behavioral: Text Messages Transmitted by Automation (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. |
| Assessment Only (AO) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TXT-PHE |
| 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. | Behavioural | TXT-Auto |
Primary outcome
Methamphetamine Use
Time frame: 9-months post randomization
Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
HIV Sexual Risk Behavior
Time frame: 9-months post randomization
Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
Cost Effectiveness
Time frame: up to 36 months
Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
1 secondary outcome
HIV Primary Care
Time frame: 8-weeks post randomization, 3-/6-/9-months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20657827Reback 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.
- Background: PubMed 22610370Reback 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy J Reback, Ph.D. principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messages Transmitted by Peer Health Educators (TXT-PHE) and Text Messages Transmitted by Automation (TXT-Auto) in people with Methamphetamine Abuse and HIV, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methamphetamine Use (time frame: 9-months post randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02008526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.