Hiv
Conditions
Keywords
HIV screening, HIV testing, HIV prevention, HIV linkage to care
Brief summary
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.
Interventions
BEHAVIORALCHALO! 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.
BEHAVIORALAttention-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.
BEHAVIORALDigital 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.
Sponsors
Albert Einstein College of Medicine
The Humsafar Trust
National Institute of Mental Health (NIMH)
Hunter College of City University of New York
Fenway Community Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, 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.
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).
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verified HIV Testing | 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. |
| Linkage to Prevention | 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of HIV Testing | 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. |
| Receipt of a Verified HIV Test | 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. |
| Self-reported HIV Test | 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. |
| Linkage to HIV Treatment for HIV Positive Participants | 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. |
| Linkage to Antiretroviral Therapy (ART) Initiation for HIV Positive Participants | 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. |
| Linkage to Pre-Exposure Prophylaxis (PrEP) for HIV Negative Participants | 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. |
| Linkage to Counseling | 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. |
| Sexual Behaviors - Consistent Condom Use | 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. |
| Sexual Behaviors - Number of Sexual Partners | 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. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORViraj V Patel, MD, MPH
Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine
Participant flow
Pre-assignment details
For this study a total of 1191 were consented. Upon quality checking 187 participants were excluded after enrollment. After these exclusions 1004 participants were considered enrolled and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 339 |
| 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.
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. | 332 |
| 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.
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. | 333 |
| Total | 1,004 |
Baseline characteristics
| Characteristic | Total | CHALO! 2.0 | Digital Coupon Only Control (DCO) | Attention-matched Control (AMC) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1004 Participants | 339 Participants | 333 Participants | 332 Participants |
| Age, Continuous | 28 Years STANDARD_DEVIATION 7 | 28 Years STANDARD_DEVIATION 7 | 28 Years STANDARD_DEVIATION 7 | 28 Years STANDARD_DEVIATION 7 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment India | 1004 participants | 339 participants | 333 participants | 332 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1004 Participants | 339 Participants | 333 Participants | 332 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 339 | 0 / 332 | 0 / 333 |
| other Total, other adverse events | 1 / 339 | 0 / 332 | 0 / 333 |
| serious Total, serious adverse events | 0 / 339 | 0 / 332 | 0 / 333 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHALO! 2.0 | Linkage to Prevention | 31 Participants |
| Attention-matched Control (AMC) | Linkage to Prevention | 47 Participants |
| Digital Coupon Only Control (DCO) | Linkage to Prevention | 32 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHALO! 2.0 | Verified HIV Testing | 30 Participants |
| Attention-matched Control (AMC) | Verified HIV Testing | 30 Participants |
| Digital Coupon Only Control (DCO) | Verified HIV Testing | 29 Participants |
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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
Secondary
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 timepoint is summarized by study arm/group.
Time frame: Within 18 months from randomization
Secondary
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
Other Pre-specified
Alcohol and Substance Use
The alcohol and substance usage reported by participants
Time frame: within six months from randomization
Other Pre-specified
Condomless Anal Sex
A dichotomous measure (yes/no) of whether a participant engaged in condomless anal sex
Time frame: within six months from randomization
Other Pre-specified
HIV and MSM Stigma
Stigma related to HIV and men who have sex with men (MSM) reported by participants
Time frame: within six months from randomization
Other Pre-specified
HIV and PrEP Knowledge
The HIV and PrEP knowledge retained by participants
Time frame: within six months from randomization
Other Pre-specified
HIV Testing
a dichotomous measure (yes/no) of whether a participant intends to obtain an HIV test in the next one month
Time frame: within six months from randomization
Other Pre-specified
Linkage to Care
a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)
Time frame: Within 18 months from randomization
Other Pre-specified
PEP Use
a dichotomous measure (yes/no) of whether a participant sought PEP treatment
Time frame: within six months from randomization
Other Pre-specified
Risk Perception
The risk perception reported by participants
Time frame: within six months from randomization
Other Pre-specified
Self-efficacy
The self-efficacy reported by participants
Time frame: within six months from randomization
Other Pre-specified
Social Support
The social support reported by participants
Time frame: within six months from randomization
Other Pre-specified
STI Testing / Treatment
a dichotomous measure (yes/no) of whether a participant sought further STI testing or treatment
Time frame: within six months from randomization
Other Pre-specified
Type of Site Accessed
Type of prevention or treatment care site accessed (i.e., Humsafar Trust, public institution, private institution)
Time frame: within six months from randomization