Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Methamphetamine Use
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Text Messages Transmitted by Peer Health Educators (TXT-PHE) (Behavioral)
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.
干预措施: Text Messages Transmitted by Automation (TXT-Auto) (Behavioral)
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.
结局指标
主要结局
Methamphetamine Use
时间窗: 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
时间窗: 9-months post randomization
Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
Cost Effectiveness
时间窗: up to 36 months
Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
次要结局
- HIV Primary Care(8-weeks post randomization, 3-/6-/9-months post randomization)