Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH119001 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Humsafar Trust | UNKNOWN |
| National Institute of Mental Health (NIMH) | NIH |
| Hunter College of City University of New York | OTHER |
| Fenway Community Health |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHALO! 2.0 | Experimental | 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. |
|
| Attention-matched control (AMC) | Active Comparator | 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. |
|
| Digital coupon only control (DCO) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 12 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 18 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Linkage to Care | a composite of linkage to PrEP, counseling, or HIV treatment (yes/no) | Within 18 months from randomization |
| PEP Use | a dichotomous measure (yes/no) of whether a participant sought PEP treatment |
Inclusion Criteria:
Exclusion Criteria:
Self-identified cis-gendered men
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Viraj V Patel, MD, MPH | Associate Professor, Division of General Internal Medicine, Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Humsafar Trust | Mumbai | Maharashtra | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39499921 | Derived | Chaudary J, Rawat S, Dange A, Golub SA, Kim RS, Chakrapani V, Mayer KH, Arnsten J, Patel VV. The CHALO! 2.0 mHealth-Based Multilevel Intervention to Promote HIV Testing and Linkage-to-Care Among Men Who Have Sex with Men in Mumbai, India: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 5;13:e59873. doi: 10.2196/59873. |
Not provided
Not provided
IPD results will not be publicly deposited. IPD will be available on appropriate request and IRB/ethics review board approval. An executed Data Use Agreement must accompany all requests for data.
Following study publication
Data requestor must obtain an executed Data Use Agreement and IRB/ethics board approvals.
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Within 6 months from randomization |
|
Approximately 18 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emotional distress | Social circumstances | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Viraj Patel | Albert Einstein College of Medicine | 718-920-5256 | viraj.patel@einsteinmed.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2023 | Sep 18, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2024 | Feb 4, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
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).
Not provided
Not provided
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.
|
| 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Within 18 months from randomization |
| within six months from randomization |
| 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 |
| STI Testing / Treatment | a dichotomous measure (yes/no) of whether a participant sought further STI testing or treatment | within six months from randomization |
| 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 |
| HIV and PrEP Knowledge | The HIV and PrEP knowledge retained by participants | within six months from randomization |
| HIV and MSM Stigma | Stigma related to HIV and men who have sex with men (MSM) reported by participants | within six months from randomization |
| Risk Perception | The risk perception reported by participants | within six months from randomization |
| Self-efficacy | The self-efficacy reported by participants | within six months from randomization |
| Social Support | The social support reported by participants | within six months from randomization |
| Alcohol and Substance Use | The alcohol and substance usage reported by participants | within six months from randomization |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Within 12 months from randomization |
|
|
|
|
| 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. | This analysis is among the total of N=164 total who had a verified HIV test within 18 months of randomization. | Posted | Mean | Standard Deviation | HIV tests per participant | Within 18 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 protocol-specified timepoint (i.e., within 12 months and within 18 months of randomization) is summarized by study arm/group. | Posted | Count of Participants | Participants | Within 12 and 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. | Posted | Count of Participants | Participants | Within 6 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. | This analysis is among people who tested positive and had a confirmed positive HIV test. | Posted | Count of Participants | Participants | Within 12 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. | This analysis is among people who tested positive and had a confirmed positive HIV test. | Posted | Count of Participants | Participants | 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. | This outcome was only among individuals who tested HIV negative. | Posted | Count of Participants | Participants | 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. | Linkage to counselling is for all participants irrespective of whether participants were HIV positive or negative. | Posted | Count of Participants | Participants | Within 12 months from randomization |
|
|
|
|
| Secondary | 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. | Analyzed among all participants. | Posted | Count of Participants | Participants | Within 18 months from randomization |
|
|
|
|
| Other Pre-specified | Linkage to Care | a composite of linkage to PrEP, counseling, or HIV treatment (yes/no) | Not Posted | Within 18 months from randomization | Participants |
| Other Pre-specified | PEP Use | a dichotomous measure (yes/no) of whether a participant sought PEP treatment | Not Posted | within six months from randomization | Participants |
| 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 | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | STI Testing / Treatment | a dichotomous measure (yes/no) of whether a participant sought further STI testing or treatment | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | Type of Site Accessed | Type of prevention or treatment care site accessed (i.e., Humsafar Trust, public institution, private institution) | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | HIV and PrEP Knowledge | The HIV and PrEP knowledge retained by participants | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | HIV and MSM Stigma | Stigma related to HIV and men who have sex with men (MSM) reported by participants | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | Risk Perception | The risk perception reported by participants | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | Self-efficacy | The self-efficacy reported by participants | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | Social Support | The social support reported by participants | Not Posted | within six months from randomization | Participants |
| Other Pre-specified | Alcohol and Substance Use | The alcohol and substance usage reported by participants | Not Posted | within six months from randomization | Participants |
| Secondary | 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. | Analyzed among all participants. | Posted | Median | Inter-Quartile Range | sexual partners | Within 18 months from randomization |
|
|
|
|
| 0 |
| 339 |
| 0 |
| 339 |
| 1 |
| 339 |
| EG001 | 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. | 0 | 332 | 0 | 332 | 0 | 332 |
| EG002 | 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. | 0 | 333 | 0 | 333 | 0 | 333 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Superiority |
| Kruskal-Wallis | .0766 | Superiority |
| Title | Measurements |
|---|---|
|
| .127 |
| Superiority |