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Completed

NCT Number: NCT04814654

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Humsafar Trust

Mumbai, Maharashtra, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHALO! 2.0

Behavioral

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)

Behavioral

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)

Behavioral

The components of the intervention are:

Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Frequency of HIV Testing

    Time frame: Within 18 months from randomization

    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.

  2. Receipt of a Verified HIV Test

    Time frame: Within 12 and 18 months from randomization

    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.

  3. Self-reported HIV Test

    Time frame: Within 6 months from randomization

    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.

  4. Linkage to HIV Treatment for HIV Positive Participants

    Time frame: Within 12 months from randomization

    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.

  5. Linkage to Antiretroviral Therapy (ART) Initiation for HIV Positive Participants

    Time frame: Within 12 months from randomization

    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.

  6. Linkage to Pre-Exposure Prophylaxis (PrEP) for HIV Negative Participants

    Time frame: Within 12 months from randomization

    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.

  7. Linkage to Counseling

    Time frame: Within 12 months from randomization

    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.

  8. Sexual Behaviors - Consistent Condom Use

    Time frame: Within 18 months from randomization

    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.

  9. Sexual Behaviors - Number of Sexual Partners

    Time frame: Within 18 months from randomization

    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.

Other outcomes

  1. Linkage to Care

    Time frame: Within 18 months from randomization

    a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)

  2. PEP Use

    Time frame: within six months from randomization

    a dichotomous measure (yes/no) of whether a participant sought PEP treatment

  3. HIV Testing

    Time frame: within six months from randomization

    a dichotomous measure (yes/no) of whether a participant intends to obtain an HIV test in the next one month

  4. STI Testing / Treatment

    Time frame: within six months from randomization

    a dichotomous measure (yes/no) of whether a participant sought further STI testing or treatment

  5. Type of Site Accessed

    Time frame: within six months from randomization

    Type of prevention or treatment care site accessed (i.e., Humsafar Trust, public institution, private institution)

  6. HIV and PrEP Knowledge

    Time frame: within six months from randomization

    The HIV and PrEP knowledge retained by participants

  7. HIV and MSM Stigma

    Time frame: within six months from randomization

    Stigma related to HIV and men who have sex with men (MSM) reported by participants

  8. Risk Perception

    Time frame: within six months from randomization

    The risk perception reported by participants

  9. Self-efficacy

    Time frame: within six months from randomization

    The self-efficacy reported by participants

  10. Social Support

    Time frame: within six months from randomization

    The social support reported by participants

  11. Alcohol and Substance Use

    Time frame: within six months from randomization

    The alcohol and substance usage reported by participants

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Fenway Community Health
  • Hunter College of City University of New York
  • National Institute of Mental Health (NIMH)
  • The Humsafar Trust

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2021
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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