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

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04814654

Collaborator

The Humsafar Trust (Other)

1,000

Enrollment

Location

Arms

32.3

Anticipated Duration (Months)

30.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Behavioral: CHALO! 2.0 Behavioral: Attention-matched control (AMC) Behavioral: Digital coupon only (DCO)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects meeting all eligibility criteria will be randomized to one of three study arms. Participants will be assigned either to CHALO! 2.0 (intervention), to an Attention-Matched Control, or to a Digital Coupon for free HIV testing only arm. After baseline survey completion, the research team will use random blocked design, with a fixed block size, to stratify randomization by prior HIV testing history (never tested vs. not tested in >6 months).Subjects meeting all eligibility criteria will be randomized to one of three study arms. Participants will be assigned either to CHALO! 2.0 (intervention), to an Attention-Matched Control, or to a Digital Coupon for free HIV testing only arm. After baseline survey completion, the research team will use random blocked design, with a fixed block size, to stratify randomization by prior HIV testing history (never tested vs. not tested in >6 months).

Masking:

Double (Participant, Investigator)

Masking Description:

The Data Manager (who has no contact with study participants) will assign participants to a study group and cross-reference encrypted files with our technology consultant. Participants will be unaware of arm assignment and will receive automated messages to complete online surveys. Study staff collecting HIV testing and linkage-to-care outcomes will also be blinded to the participants' study arm. Finally, the team of Virtual Peers will not be informed of study hypothesis.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHALO! 2.0 MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers.	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.
Active Comparator: Attention-matched control (AMC) MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers.	Behavioral: 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.
Active Comparator: Digital coupon only control (DCO) MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: CHALO! 2.0

MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers.

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.

Active Comparator: Attention-matched control (AMC)

MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers.

Behavioral: 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.

Active Comparator: Digital coupon only control (DCO)

MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

HIV testing [within six months from randomization]
dichotomous measure (yes/no) of receipt of a verified HIV test
HIV testing [within 12 months from randomization]
dichotomous measure (yes/no) of receipt of a verified HIV test
Linkage to care [within 12 months from randomization]
a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)

Secondary Outcome Measures

Follow-up HIV testing [within six months from randomization]
self-reported HIV test (unverified)
Linkage to PrEP [within 12 months from randomization]
a dichotomous measure (yes/no) of whether participants testing HIV negative sought out PrEP.
Linkage to HIV treatment [within 12 months from randomization]
a dichotomous measure (yes/no) of whether participants testing HIV positive sought out treatment.
Linkage to counseling [within 12 months from randomization]
a dichotomous measure (yes/no) of whether participants sought out counseling treatment.
Linkage to ART initiation [within 12 months from randomization]
a dichotomous measure (yes/no) of whether participants testing HIV positive initated ART treatment.
Follow-up HIV testing [within 18 months from randomization]
frequency of HIV testing (verified)
Linkage to care [within 18 months from randomization]
a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)

Other Outcome Measures

PEP use [within six months from randomization]
a dichotomous measure (yes/no) of whether a participant sought PEP treatment
HIV testing [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
STI testing / treatment [within six months from randomization]
a dichotomous measure (yes/no) of whether a participant sought further STI testing or treatment
Type of site accessed [within six months from randomization]
Type of prevention or treatment care site accessed (i.e., Humsafar Trust, public institution, private institution)
HIV and PrEP knowledge [within six months from randomization]
The HIV and PrEP knowledge retained by participants
HIV and MSM stigma [within six months from randomization]
Stigma related to HIV and men who have sex with men (MSM) reported by participants
Risk perception [within six months from randomization]
The risk perception reported by participants
Self-efficacy [within six months from randomization]
The self-efficacy reported by participants
Social support [within six months from randomization]
The social support reported by participants
Alcohol and substance use [within six months from randomization]
The alcohol and substance usage reported by participants
Condomless anal sex [within six months from randomization]
A dichotomous measure (yes/no) of whether a participant engaged in condomless anal sex

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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 greater than or equal to six months ago, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Humsafar Trust	Mumbai	Maharashtra	India

Sponsors and Collaborators

Albert Einstein College of Medicine
The Humsafar Trust

Investigators

Principal Investigator: Viraj V Patel, MD, MPH, Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine
Study Director: Nikhil S Chopra, BA, Research Coordinator, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Viraj V. Patel, Associate Professor, Department of Medicine (General Internal Medicine), Albert Einstein College of Medicine

ClinicalTrials.gov Identifier:

NCT04814654

Other Study ID Numbers:

2018-9471

First Posted:

Mar 24, 2021

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Viraj V. Patel, Associate Professor, Department of Medicine (General Internal Medicine), Albert Einstein College of Medicine

Study Results

No Results Posted as of Jul 13, 2022