CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,004
- 试验地点
- 1
- 主要终点
- Verified HIV Testing
研究概览
简要总结
While HIV prevalence among Men Seeking Men (MSM) in India is 10-15 times higher than in the general population (4.3% vs 0.3%), current interventions for Indian MSM have limited reach. In order to reduce the burden of HIV in MSM, innovative, far-reaching prevention and treatment strategies are needed. Guided by the increase access to internet-based social and mobile technologies (SMT) (e.g., SMS, WhatsApp, dating apps) globally and in India, this is a 3-arm parallel, pragmatic randomized controlled trial of community-developed, theory based behavioral intervention (CHALO! 2.0) delivered via WhatsApp (secure SMS application) compared to an Attention-Matched Control, or a Digital Coupon for free HIV testing only control conditions. The primary outcomes are HIV-testing at 6 months (3 months after the end of the intervention) and linkage-to-preventive care (counseling or pre-exposure prophylaxis) at 12 months. The secondary outcomes are the frequency of HIV-testing by 18 months.
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
- Double (Participant, Investigator)
盲法说明
The Data Manager (who has no contact with study participants) will assign participants to a study group and cross-reference encrypted files with our technology consultant. Participants will be unaware of arm assignment and will receive automated messages to complete online surveys. Study staff collecting HIV testing and linkage-to-care outcomes will also be blinded to the participants' study arm. Finally, the team of Virtual Peers will not be informed of study hypothesis.
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
- •live or work in Mumbai or Thane
- •fluent in Hindi or English
- •have had anal sex with men in the past one year
- •report that they have either never been tested for HIV, are unaware of HIV test results, or are HIV-negative with last HIV test at any time, and have engaged in anal sex since last HIV test
- •able to provide and verify a WhatsApp mobile number and email address
- •willing to answer online surveys for 18 months
排除标准
- •participating in a concurrent HIV-related study
- •intention to move out of the Mumbai metropolitan area in the next six months
结局指标
主要结局
Verified HIV Testing
时间窗: Within 6 months from randomization
Verified HIV testing was assessed as a dichotomous measure (yes/no) of receipt of a documented HIV test. The number/percentage of participants who were verified to have been HIV tested within 6 months of randomization is summarized by study arm/group.
Linkage to Prevention
时间窗: Within 12 months from randomization
Linkage to prevention was assessed as a dichotomous (yes/no) measure and defined as a composite of either receipt of counseling or PrEP use within 12 months of randomization. The number/percentage of participants who meet the linkage to care composite criteria is summarized by study arm/group.
次要结局
- Frequency of HIV Testing(Within 18 months from randomization)
- Receipt of a Verified HIV Test(Within 18 months from randomization)
- Self-reported HIV Test(Within 6 months from randomization)
- Linkage to HIV Treatment for HIV Positive Participants(Within 12 months from randomization)
- Linkage to Antiretroviral Therapy (ART) Initiation for HIV Positive Participants(Within 12 months from randomization)
- Linkage to Pre-Exposure Prophylaxis (PrEP) for HIV Negative Participants(Within 12 months from randomization)
- Linkage to Counseling(Within 12 months from randomization)