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

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Behavioral: CHALO! 2.0; Behavioral: Attention-matched control (AMC); Behavioral: Digital coupon only (DCO)

• Study Type: Interventional
• Enrollment (Actual): 1004
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India
      • The Humsafar Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of HIV Testing	Among participants who were tested, frequency of HIV testing is defined as the average (mean) number of verified HIV tests per participant within 18 months from randomization. Frequency of HIV testing is a measure of public health intervention effectiveness. Results are summarized by study arm/group using descriptive statistics.	Within 18 months from randomization
Self-reported HIV Test	Self-reported HIV test within 6 months of randomization was assessed as a dichotomous (yes/no) measure. The number/percentage of participants who self-reported as having been HIV tested, but were unverified, within 6 months from randomization is summarized by study arm/group.	Within 6 months from randomization
Linkage to HIV Treatment for HIV Positive Participants	Linkage to HIV treatment was assessed as a dichotomous (yes/no) measure of whether participants who tested HIV-positive formally sought treatment. The number/percentage of HIV positive participants who sought treatment within 12 months from randomization is summarized by study arm/group.	Within 12 months from randomization
Linkage to Antiretroviral Therapy (ART) Initiation for HIV Positive Participants	Linkage to ART initiation was assessed as a dichotomous (yes/no) measure of whether participants who tested HIV positive initiated ART treatment. The number/percentage of HIV positive participants who initiated ART within 12 months from randomization is summarized by study arm/group.	Within 12 months from randomization
Linkage to Pre-Exposure Prophylaxis (PrEP) for HIV Negative Participants	Linkage to PrEP was assessed as a dichotomous (yes/no) measure of whether participants who tested HIV negative were on a PrEP regimen. The number/percentage of HIV negative participants who were on a PrEP regimen within 12 months from randomization is summarized by study arm/group.	Within 12 months from randomization
Linkage to Counseling	Linkage to counseling was assessed as a dichotomous (yes/no) measure of whether participants received counseling treatment. The number/percentage of participants who received status neutral counseling treatment within 12 months from randomization is summarized by study arm/group.	Within 12 months from randomization
Receipt of a Verified HIV Test	Receipt of a verified HIV test within 18 months of randomization was assessed as a dichotomous (yes/no) measure. The number/percentage of participants who were verified to have received HIV testing at each protocol-specified timepoint (i.e., within 12 months and within 18 months of randomization) is summarized by study arm/group.	Within 12 and 18 months from randomization
Sexual Behaviors - Consistent Condom Use	Sexual Behavior will be evaluated based on consistent condom use. Specifically, this measure will be assessed as a dichotomous (yes/no) measure as to whether participants engaged in condomless anal sex during the study. Results will be summarized by study arm.	Within 18 months from randomization
Sexual Behaviors - Number of Sexual Partners	Sexual Behavior will be also be evaluated based on the number of sexual partners a participant had during the course of the study. This measure will be summarized by study arm using basic descriptive statistics.	Within 18 months from randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy	The self-efficacy reported by participants	within six months from randomization
Linkage to Care	a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)	Within 18 months from randomization
PEP Use	a dichotomous measure (yes/no) of whether a participant sought PEP treatment	within six months from randomization
HIV Testing	a dichotomous measure (yes/no) of whether a participant intends to obtain an HIV test in the next one month	within six months from randomization
STI Testing / Treatment	a dichotomous measure (yes/no) of whether a participant sought further STI testing or treatment	within six months from randomization
Type of Site Accessed	Type of prevention or treatment care site accessed (i.e., Humsafar Trust, public institution, private institution)	within six months from randomization
HIV and PrEP Knowledge	The HIV and PrEP knowledge retained by participants	within six months from randomization
HIV and MSM Stigma	Stigma related to HIV and men who have sex with men (MSM) reported by participants	within six months from randomization
Risk Perception	The risk perception reported by participants	within six months from randomization
Social Support	The social support reported by participants	within six months from randomization
Alcohol and Substance Use	The alcohol and substance usage reported by participants	within six months from randomization

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute of Mental Health (NIMH); Fenway Community Health; Hunter College of City University of New York; The Humsafar Trust
• Investigators: Principal Investigator: Viraj V Patel, MD, MPH, Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): June 27, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HIV prevention; HIV testing; HIV screening; HIV linkage to care
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2018-9471; R01MH119001 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD results will not be publicly deposited. IPD will be available on appropriate request and IRB/ethics review board approval. An executed Data Use Agreement must accompany all requests for data.
• IPD Sharing Time Frame: Following study publication
• IPD Sharing Access Criteria: Data requestor must obtain an executed Data Use Agreement and IRB/ethics board approvals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No