HivNCT04814654
CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
A study testing CHALO! 2.0 and Digital coupon only (DCO) in people with Hiv, run by Albert Einstein College of Medicine at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- CHALO! 2.0 and Digital coupon only (DCO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- 1 siteIndia
- Study dates
- 22 Apr 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- participating in a concurrent HIV-related study
- intention to move out of the Mumbai metropolitan area in the next six months
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- CHALO! 2.0, Attention-matched control (AMC), Digital coupon only (DCO)
- Keywords
- HIV screening, HIV testing, HIV prevention, HIV linkage to care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHALO! 2.0Behavioural
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)Behavioural
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 (DCO)Behavioural
The components of the intervention are:
Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Digital coupon only (DCO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 12 months from randomization
Secondary outcomes (9)
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.
Measured: Within 18 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.
Measured: Within 12 and 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 12 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.
Measured: 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.
Measured: Within 18 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start22 Apr 2022
- Primary completion27 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Humsafar Trust, National Institute of Mental Health (NIMH), Hunter College of City University of New York, Fenway Community Health
- Responsible party
- Sponsor
- Investigators
- Viraj V Patel, MD, MPH, Principal investigator, Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814654
- Sponsor's protocol ID
- 2018-9471
- Other IDs
- R01MH119001
- Status last verified
- Dec 2025
- First submitted
- 15 Mar 2021
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 39499921
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
- ClinicalTrials.gov ID
- NCT04814654
- Acronym / sponsor ID
- 2018-9471
- Conditions
- Hiv
- Keywords
- HIV screening, HIV testing, HIV prevention, HIV linkage to care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- The Humsafar Trust, National Institute of Mental Health (NIMH), Hunter College of City University of New York, Fenway Community Health
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| CHALO! 2.0 | Experimental | Behavioral: CHALO! 2.0MSM 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. |
| Attention-matched control (AMC) | Active comparator | Behavioral: 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. |
| Digital coupon only control (DCO) | Active comparator | Behavioral: Digital coupon only (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- participating in a concurrent HIV-related study
- intention to move out of the Mumbai metropolitan area in the next six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHALO! 2.0The 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. | Behavioural | CHALO! 2.0 |
| 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. | Behavioural | Attention-matched control (AMC) |
| 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. | Behavioural | Digital coupon only control (DCO) |
Primary outcome
Verified HIV Testing
Time frame: Within 6 months from randomization
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.
Linkage to Prevention
Time frame: Within 12 months from randomization
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.
9 secondary outcomes
Frequency of HIV Testing
Time frame: Within 18 months from randomization
Receipt of a Verified HIV Test
Time frame: Within 12 and 18 months from randomization
Self-reported HIV Test
Time frame: Within 6 months from randomization
Linkage to HIV Treatment for HIV Positive Participants
Time frame: Within 12 months from randomization
Linkage to Antiretroviral Therapy (ART) Initiation for HIV Positive Participants
Time frame: Within 12 months from randomization
Linkage to Pre-Exposure Prophylaxis (PrEP) for HIV Negative Participants
Time frame: Within 12 months from randomization
Linkage to Counseling
Time frame: Within 12 months from randomization
Sexual Behaviors - Consistent Condom Use
Time frame: Within 18 months from randomization
Sexual Behaviors - Number of Sexual Partners
Time frame: Within 18 months from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39499921Chaudary 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viraj V Patel, MD, MPH principal investigator
Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHALO! 2.0 and Digital coupon only (DCO) in people with Hiv, run by Albert Einstein College of Medicine at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verified HIV Testing (time frame: Within 6 months from randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04814654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.