CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.

Hiv Clinical Trial

Official title:

CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04814654
• Other study ID #: 2018-9471
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

While HIV prevalence among 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1005
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Behavioral:
• CHALO! 2.0
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)
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)
The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.

Locations

Country	Name	City	State
India	The Humsafar Trust	Mumbai	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	The Humsafar Trust

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PEP use	a dichotomous measure (yes/no) of whether a participant sought PEP treatment	within six months from randomization
Other	HIV testing	a dichotomous measure (yes/no) of whether a participant intends to obtain an HIV test in the next one month	within six months from randomization
Other	STI testing / treatment	a dichotomous measure (yes/no) of whether a participant sought further STI testing or treatment	within six months from randomization
Other	Type of site accessed	Type of prevention or treatment care site accessed (i.e., Humsafar Trust, public institution, private institution)	within six months from randomization
Other	HIV and PrEP knowledge	The HIV and PrEP knowledge retained by participants	within six months from randomization
Other	HIV and MSM stigma	Stigma related to HIV and men who have sex with men (MSM) reported by participants	within six months from randomization
Other	Risk perception	The risk perception reported by participants	within six months from randomization
Other	Self-efficacy	The self-efficacy reported by participants	within six months from randomization
Other	Social support	The social support reported by participants	within six months from randomization
Other	Alcohol and substance use	The alcohol and substance usage reported by participants	within six months from randomization
Other	Condomless anal sex	A dichotomous measure (yes/no) of whether a participant engaged in condomless anal sex	within six months from randomization
Primary	HIV testing	dichotomous measure (yes/no) of receipt of a verified HIV test	within six months from randomization
Primary	HIV testing	dichotomous measure (yes/no) of receipt of a verified HIV test	within 12 months from randomization
Primary	Linkage to care	a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)	within 12 months from randomization
Secondary	Follow-up HIV testing	self-reported HIV test (unverified)	within six months from randomization
Secondary	Linkage to PrEP	a dichotomous measure (yes/no) of whether participants testing HIV negative sought out PrEP.	within 12 months from randomization
Secondary	Linkage to HIV treatment	a dichotomous measure (yes/no) of whether participants testing HIV positive sought out treatment.	within 12 months from randomization
Secondary	Linkage to counseling	a dichotomous measure (yes/no) of whether participants sought out counseling treatment.	within 12 months from randomization
Secondary	Linkage to ART initiation	a dichotomous measure (yes/no) of whether participants testing HIV positive initiated ART treatment.	within 12 months from randomization
Secondary	Follow-up HIV testing	frequency of HIV testing (verified)	within 18 months from randomization
Secondary	Linkage to care	a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)	within 18 months from randomization