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临床试验/NCT04814654
NCT04814654
已完成
不适用

CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.

Albert Einstein College of Medicine1 个研究点 分布在 1 个国家目标入组 1,004 人2022年4月22日
适应症Hiv

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Hiv
发起方
Albert Einstein College of Medicine
入组人数
1004
试验地点
1
主要终点
Verified HIV Testing
状态
已完成
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2022年4月22日
结束日期
2024年12月30日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

责任方
Sponsor

入排标准

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)

研究点 (1)

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