Mobile Messaging Intervention to Present New HIV Prevention Options for MSM - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,229
- 试验地点
- 4
- 主要终点
- Change in engagement in HIV care
研究概览
简要总结
The study will evaluate the use and effectiveness of mobile-messaging platforms as a public health strategy for improving sexual health outcome measures among men who have sex with men (MSM) by determining whether exposure to the message-delivery platform results in improvements in participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll men into a randomized controlled trial. Participants randomized to the messaging intervention will have access to a smartphone-based messaging platform for three months while those assigned to the waitlist group will be offered access to the messaging platform after all follow up is complete. Participants will complete surveys at baseline, after the end of the 3 month intervention, and follow up surveys 6 and 9 months after the baseline survey.
详细描述
This study aims to evaluate the use and effectiveness of a smartphone-based messaging platform as a public health strategy for improving participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll 1,206 men into a randomized controlled trial. They will be assigned to either the immediate intervention group ("intervention arm") or the waitlist-control group ("waitlist-control arm"). All participants will take an assessment survey at baseline, and the intervention group will be oriented on the installation and use of the messaging app upon randomization to that group. All men in the randomized controlled trial will complete short follow-up surveys at 3-month intervals during the 9-month follow-up period. When the intervention arm activities and assessments have concluded, participants in the waitlist-control arm will then be given the option of accessing to the intervention app and participation in intervention post-test activities.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Assigned male at birth
- •Current, self-reported gender identity as "Male"
- •Aged 18 or over
- •Self-reported ability to read and understand English-language
- •Resides in the Atlanta, Georgia (GA), New York, New York (NY), or Detroit, Michigan (MI) Metropolitan Statistical Area.
- •Self-reported anal sex with a male partner in the past 12 months
- •Owns and uses an Android or Apple (iOS) smartphone
- •Is included in one of the following risk groups, by self-report:
- •HIV seropositive
- •HIV seronegative at "higher risk" (condomless anal sex and not taking PrEP as prescribed in the past 3 months)
- •HIV seronegative at "lower risk" (no condomless anal sex in the past 3 months, or condomless and sex while taking PrEP as prescribed in the past 3 months)
排除标准
- •Currently participating in another HIV prevention research study or program
- •Participant's phone or device does not support HealthMindr application
- •Tested positive for HIV for the first time in the past 6 months
- •Has a plan to move out of the Atlanta, GA, New York, NY or Detroit, MI, Metropolitan Statistical Area within in the next 9 months
结局指标
主要结局
Change in engagement in HIV care
时间窗: Baseline, Month 3, Month 6, Month 9
HIV-positive men will be asked if they have seen a doctor, nurse, or other health provider for HIV care (ever for the baseline measure and in the past 3 months for follow up surveys).
Change in pre-exposure prophylaxis (PrEP) uptake
时间窗: Baseline, Month 3, Month 6, Month 9
HIV-negative men will be asked if they are taking PrEP (baseline measure) or if they began taking PrEP in the past 3 months (for follow-up measurements).
Change in condom use
时间窗: Baseline, Month 3, Month 6, Month 9
Participants will be asked if they have had any anal sex in which a condom was not used from start to finish in the past 3 months.
Change in HIV testing
时间窗: Baseline, Month 3, Month 6, Month 9
HIV-negative men will be asked if they have received an HIV test (ever for the baseline measure and in the past 3 months for follow up surveys).
Change in ART adherence
时间窗: Baseline, Month 3, Month 6, Month 9
HIV-positive men currently taking antiretroviral medications to treat HIV will be asked if they have been taking their ART as prescribed in the past 3 months.
Change in engagement in HIV preventative care
时间窗: Baseline, Month 3, Month 6, Month 9
HIV-negative men will be asked if they have seen a doctor, nurse, or other health care provider (ever for the baseline measure and in the past 3 months for follow up surveys).
Change in PrEP adherence
时间窗: Baseline, Month 3, Month 6, Month 9
HIV-negative MSM currently taking PrEP will be asked if they have been taking their PrEP medication as prescribed during the past 3 months.
Change in condom use compliance
时间窗: Baseline, Month 3, Month 6, Month 9
Proportion of men reporting 100% condom use (stratified by partner type) during the prior 3 months.
Change in antiretroviral therapy (ART) uptake
时间窗: Baseline, Month 3, Month 6, Month 9
HIV-positive men will be asked if they have ever been prescribed and taken antiretroviral medications to treat HIV.
Change in testing for sexually transmitted infections (STIs)
时间窗: Baseline, Month 3, Month 6, Month 9
Sexually active participants will be asked if they have been tested for STIs in the past 3 months.
次要结局
- Change in communication with partner(Baseline, Month 3, Month 6, Month 9)
- Change in intention to engage in preventive behaviors(Baseline, Month 3, Month 6, Month 9)
- Change in intention to seek treatment(Baseline, Month 3, Month 6, Month 9)
- Change in intention to engage in risky behaviors(Baseline, Month 3, Month 6, Month 9)
- Change in intention to seek information(Baseline, Month 3, Month 6, Month 9)
研究者
Patrick S Sullivan
Professor
Emory University