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

NCT04814654 | Completed Results DMC

• 2 other identifiers: 2018-9471R01MH119001
• Study Type: interventional
• Target: 1,004
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hiv

Keywords

HIV screening; HIV testing; HIV prevention; HIV linkage to care

Outcome Measures

Primary Outcomes (2)

• Verified HIV Testing

  Verified HIV testing was assessed as a dichotomous measure (yes/no) of receipt of a documented HIV test. The number/percentage of participants who were verified to have been HIV tested within 6 months of randomization is summarized by study arm/group.

  Within 6 months from randomization

• Linkage to Prevention

  Linkage to prevention was assessed as a dichotomous (yes/no) measure and defined as a composite of either receipt of counseling or PrEP use within 12 months of randomization. The number/percentage of participants who meet the linkage to care composite criteria is summarized by study arm/group.

  Within 12 months from randomization

Secondary Outcomes (9)

• Frequency of HIV Testing

  Within 18 months from randomization

• Receipt of a Verified HIV Test

  Within 12 and 18 months from randomization

• Self-reported HIV Test

  Within 6 months from randomization

• Linkage to HIV Treatment for HIV Positive Participants

  Within 12 months from randomization

• Linkage to Antiretroviral Therapy (ART) Initiation for HIV Positive Participants

  Within 12 months from randomization

Other Outcomes (11)

• Linkage to Care

  Within 18 months from randomization

• PEP Use

  within six months from randomization

• HIV Testing

  within six months from randomization

Study Arms (3)

CHALO! 2.0

EXPERIMENTAL

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

Attention-matched control (AMC)

ACTIVE COMPARATOR

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)

Digital coupon only control (DCO)

ACTIVE COMPARATOR

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)

Interventions

CHALO! 2.0 BEHAVIORAL

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.

CHALO! 2.0

Attention-matched control (AMC) BEHAVIORAL

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.

Attention-matched control (AMC)

Digital coupon only (DCO) BEHAVIORAL

The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.

Digital coupon only control (DCO)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified cis-gendered men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• participating in a concurrent HIV-related study
• intention to move out of the Mumbai metropolitan area in the next six months

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• The Humsafar Trust: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Fenway Community Health: collaborator
• Hunter College of City University of New York: collaborator

Study Sites (1)

The Humsafar Trust

Mumbai, Maharashtra, India

Location

Related Publications (1)

• Chaudary J, Rawat S, Dange A, Golub SA, Kim RS, Chakrapani V, Mayer KH, Arnsten J, Patel VV. The CHALO! 2.0 mHealth-Based Multilevel Intervention to Promote HIV Testing and Linkage-to-Care Among Men Who Have Sex with Men in Mumbai, India: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 5;13:e59873. doi: 10.2196/59873.

  PMID: 39499921 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Viraj Patel
• Organization: Albert Einstein College of Medicine

viraj.patel@einsteinmed.edu

718-920-5256

Study Officials

• Viraj V Patel, MD, MPH

  Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Data Manager (who has no contact with study participants) will assign participants to a study group and cross-reference encrypted files with our technology consultant. Participants will be unaware of arm assignment and will receive automated messages to complete online surveys. Study staff collecting HIV testing and linkage-to-care outcomes will also be blinded to the participants' study arm. Finally, the team of Virtual Peers will not be informed of study hypothesis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 24, 2021
• Study Start: April 22, 2022
• Primary Completion: June 27, 2024
• Study Completion: December 30, 2024
• Last Updated: January 20, 2026
• Results First Posted: November 6, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following study publication
• Access Criteria: Data requestor must obtain an executed Data Use Agreement and IRB/ethics board approvals.

Locations

IN (1)