Brief Summary
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.
Brief Title
CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hiv
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Male
Gender Based
false
Keywords
HIV screening
HIV testing
HIV prevention
HIV linkage to care
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04814654
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2018-9471
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
Primary Outcomes
Outcome Description
dichotomous measure (yes/no) of receipt of a verified HIV test
Outcome Measure
HIV testing
Outcome Time Frame
within six months from randomization
Outcome Description
dichotomous measure (yes/no) of receipt of a verified HIV test
Outcome Measure
HIV testing
Outcome Time Frame
within 12 months from randomization
Outcome Description
a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)
Outcome Measure
Linkage to care
Outcome Time Frame
within 12 months from randomization
Secondary Ids
Secondary Id
R01MH119001
Secondary Outcomes
Outcome Description
self-reported HIV test (unverified)
Outcome Time Frame
within six months from randomization
Outcome Measure
Follow-up HIV testing
Outcome Description
a dichotomous measure (yes/no) of whether participants testing HIV negative sought out PrEP.
Outcome Time Frame
within 12 months from randomization
Outcome Measure
Linkage to PrEP
Outcome Description
a dichotomous measure (yes/no) of whether participants testing HIV positive sought out treatment.
Outcome Time Frame
within 12 months from randomization
Outcome Measure
Linkage to HIV treatment
Outcome Description
a dichotomous measure (yes/no) of whether participants sought out counseling treatment.
Outcome Time Frame
within 12 months from randomization
Outcome Measure
Linkage to counseling
Outcome Description
a dichotomous measure (yes/no) of whether participants testing HIV positive initiated ART treatment.
Outcome Time Frame
within 12 months from randomization
Outcome Measure
Linkage to ART initiation
Outcome Description
frequency of HIV testing (verified)
Outcome Time Frame
within 18 months from randomization
Outcome Measure
Follow-up HIV testing
Outcome Description
a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)
Outcome Time Frame
within 18 months from randomization
Outcome Measure
Linkage to care
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Viraj Patel
Investigator Email
vpatel@montefiore.org
Investigator Phone
vpatel