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

Albert Einstein College of Medicine

Status: Completed

Conditions: Hiv

Treatments: Behavioral: Attention-matched control (AMC); Behavioral: Digital coupon only (DCO); Behavioral: CHALO! 2.0

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04814654

2018-9471

R01MH119001 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,004 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,004 participants in 3 patient groups

CHALO! 2.0

Experimental group

Description:

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.

Treatment:

Behavioral: CHALO! 2.0

Attention-matched control (AMC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention-matched control (AMC)

Digital coupon only control (DCO)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Digital coupon only (DCO)