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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA041262 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will conduct an effectiveness trial of the 4-session evidence-based YMHP intervention for young men who have sex with men (YMSM) of color ages 15-29 at two CBOs in New York City, compared to usual care.
We will conduct a comparative effectiveness trial (CET) with two intensities of treatment to be offered following field-based HIV counseling and testing (C&T) - the young men's health project (YMHP) intervention and an enhanced "treatment as usual" (eTAU) condition involving HIV prevention services provided at two community based organizations (CBOs) to test their relative effectiveness in reducing substance use and sexual risk behavior among HIV-negative YMSM. In collaboration with two CBOs, our goals are to better understand substance use and sexual health-related outcomes among HIV-negative YMSM who are unlikely to be treatment seeking and to implement the YMHP intervention in a way that will maximize portability and scalability. Working together with our collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce substance use and HIV infection among YMSM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change. |
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| Enhanced Treatment as Usual | Other | The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YMHP Intervention | Behavioral |
| ||
| Enhanced Treatment as Usual |
| Measure | Description | Time Frame |
|---|---|---|
| Illicit Drug Use Days | The self-reported number of illicit drug use days (not including marijuana) in the past 90 days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
| Condomless Anal Sex Acts | The self-reported number of condomless anal sex acts with male partners in the past 90 days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
| Marijuana Use Days | The self-reported number of marijuana use days in the past 90 days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Days | The self-reported number of alcohol use days in the past 90 days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyrel J Starks, PhD | Hunter College, CUNY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridging Access to Care | Brooklyn | New York | 11226 | United States | ||
| BOOM!Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36273221 | Derived | Coyle K, Carcone AI, Butame S, Pooler-Burgess M, Chang J, Naar S. Adapting the self-assessment of contextual fit scale for implementation of evidence-based practices in adolescent HIV settings. Implement Sci Commun. 2022 Oct 22;3(1):115. doi: 10.1186/s43058-022-00349-4. | |
| 35394598 | Derived | Bradford-Rogers J, Lopez-Matos J, Cain D, Lopez D, Starks TJ. Comparing the Efficiency of Online and Field-Based Outreach for the Recruitment of Black and Latino Sexual Minority Men into an HIV Prevention Implementation Trial. Prev Sci. 2022 Aug;23(6):900-906. doi: 10.1007/s11121-022-01367-3. Epub 2022 Apr 8. |
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Data sharing with scientific and health service community: We will have compiled structured de-identified datasets and can make them available for additional/secondary data analyses. It is our explicit intention that these data be readily accessible. We will collaborate with and make our data available to other researchers for additional/secondary analyses. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes.
As per NIH policy
The dissemination of any and all data collected under the NIH data sharing agreement will be released: a) In a timely manner following the time line of the project provide; and b) To the broader community, in accordance with NIH guidelines. Active dissemination to collaborators, community groups and through peer-reviewed articles will facilitate access to the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change. YMHP Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Oct 1, 2021 |
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Randomization to YMHP or enhanced Treatment as Usual (eTAU)
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| The Bronx |
| New York |
| 10458 |
| United States |
| 31115346 | Derived | Parsons JT, Starks T, Gurung S, Cain D, Marmo J, Naar S. Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019 May 21;8(5):e11184. doi: 10.2196/11184. |
| FG001 | Enhanced Treatment as Usual | The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis. Enhanced Treatment as Usual |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change. YMHP Intervention |
| BG001 | Enhanced Treatment as Usual | The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis. Enhanced Treatment as Usual |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Site | Participants were enrolled at two different study sites. Site names have been de-identified. | Count of Participants | Participants |
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| Relationship Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| 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 | Illicit Drug Use Days | The self-reported number of illicit drug use days (not including marijuana) in the past 90 days | Intent-to-treat population | Posted | Mean | Standard Deviation | days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
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| Primary | Condomless Anal Sex Acts | The self-reported number of condomless anal sex acts with male partners in the past 90 days | intent-to-treat population | Posted | Mean | Standard Deviation | acts | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
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| Primary | Marijuana Use Days | The self-reported number of marijuana use days in the past 90 days | intent-to-treat population | Posted | Mean | Standard Deviation | days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
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| Secondary | Alcohol Use Days | The self-reported number of alcohol use days in the past 90 days | Posted | Mean | Standard Deviation | days | Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month |
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15-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change. YMHP Intervention | 0 | 47 | 0 | 47 | 0 | 47 |
| EG001 | Enhanced Treatment as Usual | The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis. Enhanced Treatment as Usual | 0 | 39 | 0 | 39 | 0 | 39 |
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Enrollment was delayed substantially by implementation challenges early in the trial. Due to the COVID pandemic, enrollment closed early. As a result, the sample enrolled was less than half of the original proposal.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tyrel Starks | Hunter College | 212-772-5550 | tstarks@hunter.cuny.edu |
| Nov 24, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2021 | Apr 15, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Latino |
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| White |
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| Other |
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| Study Site 2 |
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| Partnered |
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| Less than 4-Year Degree |
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| Missing |
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| Full-time |
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| Missing |
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| 6-Month |
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| 9-Month |
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| 12-Month |
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| 15-Month |
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Model testing whether condition predicted illicit drug use days at 6-months |
| .12 |
| negative binomial regression |
| -1.66 |
| 2-Sided |
| 95 |
| -3.78 |
| .48 |
| Superiority |
| negative binomial regression | Model testing whether condition predicted illicit drug use days at 9-months | .99 | Slope | .01 | 2-Sided | 95 | -2.05 | 2.07 | Superiority |
| negative binomial regression | Model testing whether condition predicted illicit drug use days at 12-months | .42 | Slope | -.78 | 2-Sided | 95 | -2.67 | 1.11 | Superiority |
| negative binomial regression | Model testing whether condition predicted illicit drug use days at 15-months | .18 | Slope | -1.09 | 2-Sided | 95 | -2.69 | .51 | Superiority |
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| Units | Counts |
|---|---|
| Participants |
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