Clinical trial NCT04814654: CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
Official title: CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Keywords: HIV screening
HIV testing
HIV prevention
HIV linkage to care
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: The Humsafar Trust
name: National Institute of Mental Health (NIMH)
name: Hunter College of City University of New York
name: Fenway Community Health
First posted: 2021-03-24
Enrollment: 1005
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: HIV testing
timeFrame: within six months from randomization
measure: HIV testing
timeFrame: within 12 months from randomization
measure: Linkage to care
timeFrame: within 12 months from randomization
Secondary outcomes:
measure: Follow-up HIV testing
timeFrame: within six months from randomization
measure: Linkage to PrEP
timeFrame: within 12 months from randomization
measure: Linkage to HIV treatment
timeFrame: within 12 months from randomization
measure: Linkage to counseling
timeFrame: within 12 months from randomization
measure: Linkage to ART initiation
timeFrame: within 12 months from randomization
measure: Follow-up HIV testing
timeFrame: within 18 months from randomization
measure: Linkage to care
timeFrame: within 18 months from randomization
Other outcomes:
measure: PEP use
timeFrame: within six months from randomization
measure: HIV testing
timeFrame: within six months from randomization
measure: STI testing / treatment
timeFrame: within six months from randomization
measure: Type of site accessed
timeFrame: within six months from randomization
measure: HIV and PrEP knowledge
timeFrame: within six months from randomization
measure: HIV and MSM stigma
timeFrame: within six months from randomization
measure: Risk perception
timeFrame: within six months from randomization
measure: Self-efficacy
timeFrame: within six months from randomization
measure: Social support
timeFrame: within six months from randomization
measure: Alcohol and substance use
timeFrame: within six months from randomization
measure: Condomless anal sex
timeFrame: within six months from randomization
Locations:
city: Mumbai
country: India
facility: The Humsafar Trust
state: Maharashtra
Study officials:
affiliation: Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine
name: Viraj V Patel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: