N/A
Completed N=1,004
CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.
Source: ClinicalTrials.gov NCT04814654 ↗Enrolled (actual)
1,004
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Verified HIV Testing — 30; 30; 29 Participants — p=0.989
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verified HIV Testing |
30; 30; 29 | 0.989 |
| PRIMARY Linkage to Prevention |
31; 47; 32 | .0726 |
| SECONDARY Frequency of HIV Testing |
1.77; 1.27; 1.78 | 0.918 |
| SECONDARY Receipt of a Verified HIV Test |
41; 52; 37; 57; 63; 44 | 0.1839 |
| SECONDARY Self-reported HIV Test |
119; 107; 113 | 0.7313 |
| SECONDARY Linkage to HIV Treatment for HIV Positive Participants |
3; 6; 5 | 0.1839 |
| SECONDARY Linkage to Antiretroviral Therapy (ART) Initiation for HIV Positive Participants |
3; 6; 5 | 0.2667 |
| SECONDARY Linkage to Pre-Exposure Prophylaxis (PrEP) for HIV Negative Participants |
1; 1; 0 | 0.999 |
| SECONDARY Linkage to Counseling |
50; 59; 41 | 0.1414 |
| SECONDARY Sexual Behaviors - Consistent Condom Use |
63; 73; 60 | 0.425 |
| SECONDARY Sexual Behaviors - Number of Sexual Partners |
3; 3; 2 | 0.9183 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04814654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.