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

Study Overview
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Brief Summary
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While HIV prevalence among 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.

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

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: CHALO! 2.0
* Behavioral: Attention-matched control (AMC)
* Behavioral: Digital coupon only (DCO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: participating in a concurrent HIV-related study intention to move out of the Mumbai metropolitan area in the next six months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects meeting all eligibility criteria will be randomized to one of three study arms. Participants will be assigned either to CHALO! 2.0 (intervention), to an Attention-Matched Control, or to a Digital Coupon for free HIV testing only arm. After baseline survey completion, the research team will use random blocked design, with a fixed block size, to stratify randomization by prior HIV testing history (never tested vs. not tested in >6 months).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHALO! 2.0<br>MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers. | Behavioral: CHALO! 2.0<br>* The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) on the following topics: HIV testing, prevention, treatment, linkage-to-care; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.<br>|
| Active Comparator: Attention-matched control (AMC)<br>MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers. | Behavioral: Attention-matched control (AMC)<br>* The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) only related to general health information; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.<br>|
| Active Comparator: Digital coupon only control (DCO)<br>MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services. | Behavioral: Digital coupon only (DCO)<br>* The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV testing | dichotomous measure (yes/no) of receipt of a verified HIV test | within six months from randomization | 
| HIV testing | dichotomous measure (yes/no) of receipt of a verified HIV test | within 12 months from randomization | 
| Linkage to care | a composite of linkage to PrEP, counseling, or HIV treatment (yes/no) | within 12 months from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up HIV testing | self-reported HIV test (unverified) | within six months from randomization | 
| Linkage to PrEP | a dichotomous measure (yes/no) of whether participants testing HIV negative sought out PrEP. | within 12 months from randomization | 
| Linkage to HIV treatment | a dichotomous measure (yes/no) of whether participants testing HIV positive sought out treatment. | within 12 months from randomization | 
| Linkage to counseling | a dichotomous measure (yes/no) of whether participants sought out counseling treatment. | within 12 months from randomization | 
| Linkage to ART initiation | a dichotomous measure (yes/no) of whether participants testing HIV positive initiated ART treatment. | within 12 months from randomization | 
| Follow-up HIV testing | frequency of HIV testing (verified) | within 18 months from randomization | 
| Linkage to care | a composite of linkage to PrEP, counseling, or HIV treatment (yes/no) | within 18 months from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV screening, HIV testing, HIV prevention, HIV linkage to care