Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 28, 2024
Date Accepted: Sep 6, 2024
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 control trial
ABSTRACT
Background:
Current programs to engage marginalized populations such as gay, bisexual, and other men who have sex with men (MSM) for HIV prevention interventions do not often reach all MSM who may benefit. To reduce the global burden of HIV, far-reaching strategies are needed to engage MSM in HIV prevention and treatment. Globally, including in low- and middle-income countries, MSM are now widely using Internet-based social and mobile technologies (SMT – e.g., dating apps, social media, WhatsApp) to socialize and meet partners. While this shift in how individuals meet has disrupted traditional face-to-face outreach, SMT provides an unprecedented opportunity to reach and engage historically marginalized groups, such as MSM for HIV prevention and treatment.
Objective:
This study aims to assess the effectiveness of a multi-level mHealth-based intervention to improve HIV testing uptake and status neutral linkage-to-care among sexually active MSM reached via Internet-based platforms in Mumbai, India.
Methods:
In a pragmatic randomized controlled trial, we will determine whether CHALO! 2.0 (a theory-based multi-level intervention delivered in part via WhatsApp) results in increased HIV testing and linkage-to-care (prevention or treatment). This study will be conducted among 1000 sexually active MSM who are unaware of their HIV status (never tested or tested >6 months ago) and are recruited via SMT in Mumbai, India. We will conduct a 12-week, three-arm randomized trial comparing CHALO! 2.0 with two control conditions: an attention-matched SMT-based control (also including a digital coupon for free HIV testing), and a digital coupon only control. The primary outcomes will be HIV testing and status neutral linkage-to care by 6-months post enrollment. Participants will be followed through for a total of 18 months to evaluate longer term impact.
Results:
The study was launched in 2022 and completed enrollment in July 2023, with participants currently being actively followed. The final 18-month follow-up will be completed in December 2024.
Conclusions:
While global health agencies have called for Internet-based interventions to engage populations vulnerable to HIV who are not being reached, few proven effective and scalable models exist and none in India, which has one of the world’s largest HIV epidemics. This study will address this gap by testing a multi-component mHealth intervention to engage MSM at high priority for HIV interventions and link them to HIV testing and prevention or treatment. Clinical Trial: The trial has been registered with ClinicalTrials.gov (ID: NCT04814654) and Clinical Trial Registry of India (CTRI) (CTRI/2021/03/032280).
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