MedDataX Logo

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

NCT ID: NCT04814654

Last Updated: 2025-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1004 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hiv

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV screening HIV testing HIV prevention HIV linkage to care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CHALO! 2.0

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.

Group Type EXPERIMENTAL

CHALO! 2.0

Intervention Type 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.

Attention-matched control (AMC)

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.

Group Type ACTIVE_COMPARATOR

Attention-matched control (AMC)

Intervention Type 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.

Digital coupon only control (DCO)

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.

Group Type ACTIVE_COMPARATOR

Digital coupon only (DCO)

Intervention Type BEHAVIORAL

The components of the intervention are:

Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CHALO! 2.0

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.

Intervention Type BEHAVIORAL

Attention-matched control (AMC)

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.

Intervention Type BEHAVIORAL

Digital coupon only (DCO)

The components of the intervention are:

Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Humsafar Trust

UNKNOWN

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Hunter College of City University of New York

OTHER

Sponsor Role collaborator

Fenway Community Health

OTHER

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Viraj V Patel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Humsafar Trust

Mumbai, Maharashtra, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39499921 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH119001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-9471

Identifier Type: -

Identifier Source: org_study_id