Trial Outcomes & Findings for Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM (NCT NCT02008526)
NCT ID: NCT02008526
Last Updated: 2017-09-18
Results Overview
Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
286 participants
Primary outcome timeframe
9-months post randomization
Results posted on
2017-09-18
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
94
|
99
|
93
|
|
Overall Study
COMPLETED
|
86
|
85
|
84
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
6
|
Baseline Characteristics
Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
Baseline characteristics by cohort
| Measure |
TXT-PHE
n=94 Participants
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
n=99 Participants
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)
n=93 Participants
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
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.04 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
41.00 years
STANDARD_DEVIATION 11.12 • n=7 Participants
|
41.43 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
41.48 years
STANDARD_DEVIATION 10.85 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
286 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
214 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
94 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
286 Participants
n=4 Participants
|
|
HIV Status
HIV Negative
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
HIV Status
HIV Positive
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 9-months post randomizationPopulation: Number of participants retained through 9-month follow-up.
Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
Outcome measures
| Measure |
TXT-PHE
n=94 Participants
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
n=99 Participants
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)
n=93 Participants
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.
|
|---|---|---|---|
|
Methamphetamine Use
Baseline Meth Use
|
11.13 Days Used in the Past 30 Days
Standard Deviation 9.53
|
10.75 Days Used in the Past 30 Days
Standard Deviation 9.48
|
10.34 Days Used in the Past 30 Days
Standard Deviation 9.00
|
|
Methamphetamine Use
9-Month Follow-up Meth Use
|
7.79 Days Used in the Past 30 Days
Standard Deviation 9.83
|
7.05 Days Used in the Past 30 Days
Standard Deviation 9.87
|
5.66 Days Used in the Past 30 Days
Standard Deviation 7.89
|
PRIMARY outcome
Timeframe: 9-months post randomizationPopulation: Participants retained through nine months post randomization.
Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
Outcome measures
| Measure |
TXT-PHE
n=94 Participants
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
n=99 Participants
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)
n=93 Participants
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.
|
|---|---|---|---|
|
HIV Sexual Risk Behavior
Baseline Condomless Anal Intercourse
|
11.44 # Episodes (Past 30 Days)
Standard Deviation 15.58
|
14.05 # Episodes (Past 30 Days)
Standard Deviation 19.49
|
7.39 # Episodes (Past 30 Days)
Standard Deviation 12.91
|
|
HIV Sexual Risk Behavior
9-Month Follow-up Condomless Anal Intercourse
|
5.19 # Episodes (Past 30 Days)
Standard Deviation 12.84
|
4.34 # Episodes (Past 30 Days)
Standard Deviation 11.56
|
4.31 # Episodes (Past 30 Days)
Standard Deviation 9.41
|
PRIMARY outcome
Timeframe: up to 36 monthsCost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8-weeks post randomization, 3-/6-/9-months post randomizationHIV-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.
Outcome measures
Outcome data not reported
Adverse Events
TXT-PHE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TXT-Auto
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Assessment Only (AO)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TXT-PHE
n=94 participants at risk
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
n=99 participants at risk
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)
n=93 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Death
|
0.00%
0/94 • For up to 9-months post randomization
|
2.0%
2/99 • Number of events 2 • For up to 9-months post randomization
|
1.1%
1/93 • Number of events 1 • For up to 9-months post randomization
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place