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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02008526
First Posted: December 11, 2013
Last Update Posted: September 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Friends Research Institute, Inc.
Results First Submitted: April 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Methamphetamine Abuse
HIV
Interventions: Behavioral: Text Messages Transmitted by Peer Health Educators (TXT-PHE)
Behavioral: Text Messages Transmitted by Automation (TXT-Auto)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TXT-PHE

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.

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.

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.

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.

Participant Flow:   Overall Study
    TXT-PHE   TXT-Auto   Assessment Only (AO)
STARTED   94   99   93 
COMPLETED   86   85   84 
NOT COMPLETED   8   14   9 
Death                0                2                1 
Withdrawal by Subject                3                3                2 
Lost to Follow-up                5                9                6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TXT-PHE

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.

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.

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.

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.
Total Total of all reporting groups

Baseline Measures
   TXT-PHE   TXT-Auto   Assessment Only (AO)   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   99   93   286 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.04  (11.31)   41.00  (11.12)   41.43  (10.15)   41.48  (10.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      94 100.0%      99 100.0%      93 100.0%      286 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
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   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1   1.0%      0   0.0%      1   0.3% 
Asian      3   3.2%      2   2.0%      2   2.2%      7   2.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      40  42.6%      45  45.5%      40  43.0%      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 
[Units: Participants]
Count of Participants
       
United States   94   99   93   286 
HIV Status 
[Units: Participants]
Count of Participants
       
HIV Negative   57   57   54   168 
HIV Positive   37   42   39   118 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Methamphetamine Use   [ Time Frame: 9-months post randomization ]

2.  Primary:   HIV Sexual Risk Behavior   [ Time Frame: 9-months post randomization ]

3.  Primary:   Cost Effectiveness   [ Time Frame: up to 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   HIV Primary Care   [ Time Frame: 8-weeks post randomization, 3-/6-/9-months post randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Cathy Reback
Organization: Friends Research Institute
phone: 3234631601
e-mail: reback@friendsresearch.org


Publications:

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02008526     History of Changes
Other Study ID Numbers: R01DA035092 ( U.S. NIH Grant/Contract )
First Submitted: December 3, 2013
First Posted: December 11, 2013
Results First Submitted: April 4, 2017
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017