Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Messages Transmitted by Peer Health Educators (TXT-PHE) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Methamphetamine Use | Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment. | 9-months post randomization |
| HIV Sexual Risk Behavior | Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up. | 9-months post randomization |
| Cost Effectiveness | Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template. | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8-weeks post randomization, 3-/6-/9-months post randomization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cathy J Reback, Ph.D. | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028 | Los Angeles | California | 90028 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20657827 | Background | 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. | |
| 22610370 | Background | 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. doi: 10.1007/s10461-012-0200-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Methamphetamine Use | Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment. | Number of participants retained through 9-month follow-up. | Posted | Mean | Standard Deviation | Days Used in the Past 30 Days | 9-months post randomization |
|
For up to 9-months post randomization
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Participant death. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cathy Reback | Friends Research Institute | 3234631601 | reback@friendsresearch.org |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Text Messages Transmitted by Automation (TXT-Auto) | Behavioral | 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. |
|
| Lost to Follow-up |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| HIV Status | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| Primary | HIV Sexual Risk Behavior | Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up. | Participants retained through nine months post randomization. | Posted | Mean | Standard Deviation | # Episodes (Past 30 Days) | 9-months post randomization |
|
|
|
|
| Primary | Cost Effectiveness | Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template. | Not Posted | up to 36 months | Participants |
| 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. | Not Posted | 8-weeks post randomization, 3-/6-/9-months post randomization | Participants |
| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| EG001 | 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. | 2 | 99 | 2 | 99 | 0 | 99 |
| EG002 | 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. | 1 | 93 | 1 | 93 | 0 | 93 |
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 9-Month Follow-up Condomless Anal Intercourse |
|
|