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

Not Applicable

Completed

• Conditions: Hiv

• Registration Number: NCT04814654
• Lead Sponsor: Albert Einstein College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-24
• Study Start: 2022-04-22
• Primary Completion: 2024-06-27
• Study Completion: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1005

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV testing	within 12 months from randomization	dichotomous measure (yes/no) of receipt of a verified HIV test
Linkage to care	within 12 months from randomization	a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)

Secondary Outcome Measures

Name	Time	Method
Linkage to HIV treatment	within 12 months from randomization	a dichotomous measure (yes/no) of whether participants testing HIV positive sought out treatment.
Linkage to counseling	within 12 months from randomization	a dichotomous measure (yes/no) of whether participants sought out counseling treatment.
Linkage to ART initiation	within 12 months from randomization	a dichotomous measure (yes/no) of whether participants testing HIV positive initiated ART treatment.
Follow-up HIV testing	within 18 months from randomization	frequency of HIV testing (verified)
Linkage to PrEP	within 12 months from randomization	a dichotomous measure (yes/no) of whether participants testing HIV negative sought out PrEP.
Linkage to care	within 18 months from randomization	a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)

Trial Locations

Locations (1)

The Humsafar Trust; 🇮🇳 Mumbai, Maharashtra, India