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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,004
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.
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.
The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.
The Humsafar Trust
Mumbai, Maharashtra, India
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.
Time frame: 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.
Time frame: Within 12 months from randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 18 months from randomization
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