HIV, Methamphetamine Abuse
Conditions
Keywords
Text Messaging, mHealth, Methamphetamine, HIV, AIDS
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).
Interventions
BEHAVIORALText 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.
BEHAVIORALText 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.
Sponsors
University of California, Los Angeles
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness | up to 36 months | Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template. |
| Methamphetamine Use | 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 | 9-months post randomization | Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 94 |
| 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. | 99 |
| 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. | 93 |
| Total | 286 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 5 | 9 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 2 |
Baseline characteristics
| Characteristic | TXT-PHE | TXT-Auto | Assessment Only (AO) | Total |
|---|---|---|---|---|
| Age, Continuous | 42.04 years STANDARD_DEVIATION 11.31 | 41.00 years STANDARD_DEVIATION 11.12 | 41.43 years STANDARD_DEVIATION 10.15 | 41.48 years STANDARD_DEVIATION 10.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 29 Participants | 23 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 70 Participants | 70 Participants | 214 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HIV Status HIV Negative | 57 Participants | 57 Participants | 54 Participants | 168 Participants |
| HIV Status HIV Positive | 37 Participants | 42 Participants | 39 Participants | 118 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 45 Participants | 40 Participants | 125 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 6 Participants | 6 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 29 Participants | 25 Participants | 75 Participants |
| Race (NIH/OMB) White | 20 Participants | 16 Participants | 20 Participants | 56 Participants |
| Region of Enrollment United States | 94 Participants | 99 Participants | 93 Participants | 286 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 94 Participants | 99 Participants | 93 Participants | 286 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 2 / 99 | 1 / 93 |
| other Total, other adverse events | 0 / 94 | 0 / 99 | 0 / 93 |
| serious Total, serious adverse events | 0 / 94 | 2 / 99 | 1 / 93 |
Outcome results
Primary
Cost Effectiveness
Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
Time frame: up to 36 months
Primary
HIV Sexual Risk Behavior
Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
Time frame: 9-months post randomization
Population: Participants retained through nine months post randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TXT-PHE | HIV Sexual Risk Behavior | Baseline Condomless Anal Intercourse | 11.44 # Episodes (Past 30 Days) | Standard Deviation 15.58 |
| TXT-PHE | HIV Sexual Risk Behavior | 9-Month Follow-up Condomless Anal Intercourse | 5.19 # Episodes (Past 30 Days) | Standard Deviation 12.84 |
| TXT-Auto | HIV Sexual Risk Behavior | Baseline Condomless Anal Intercourse | 14.05 # Episodes (Past 30 Days) | Standard Deviation 19.49 |
| TXT-Auto | HIV Sexual Risk Behavior | 9-Month Follow-up Condomless Anal Intercourse | 4.34 # Episodes (Past 30 Days) | Standard Deviation 11.56 |
| Assessment Only (AO) | HIV Sexual Risk Behavior | Baseline Condomless Anal Intercourse | 7.39 # Episodes (Past 30 Days) | Standard Deviation 12.91 |
| Assessment Only (AO) | HIV Sexual Risk Behavior | 9-Month Follow-up Condomless Anal Intercourse | 4.31 # Episodes (Past 30 Days) | Standard Deviation 9.41 |
p-value: 0.8494ANOVA
Primary
Methamphetamine Use
Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
Time frame: 9-months post randomization
Population: Number of participants retained through 9-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TXT-PHE | Methamphetamine Use | Baseline Meth Use | 11.13 Days Used in the Past 30 Days | Standard Deviation 9.53 |
| TXT-PHE | Methamphetamine Use | 9-Month Follow-up Meth Use | 7.79 Days Used in the Past 30 Days | Standard Deviation 9.83 |
| TXT-Auto | Methamphetamine Use | Baseline Meth Use | 10.75 Days Used in the Past 30 Days | Standard Deviation 9.48 |
| TXT-Auto | Methamphetamine Use | 9-Month Follow-up Meth Use | 7.05 Days Used in the Past 30 Days | Standard Deviation 9.87 |
| Assessment Only (AO) | Methamphetamine Use | 9-Month Follow-up Meth Use | 5.66 Days Used in the Past 30 Days | Standard Deviation 7.89 |
| Assessment Only (AO) | Methamphetamine Use | Baseline Meth Use | 10.34 Days Used in the Past 30 Days | Standard Deviation 9 |
p-value: 0.3137ANOVA
Secondary
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.
Time frame: 8-weeks post randomization, 3-/6-/9-months post randomization