Substance UseYMHP-CBONCT03488914
Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
A study testing YMHP Intervention and Enhanced Treatment as Usual in people with Substance Use and Sexual Risk, run by Hunter College of City University of New York at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use, Sexual Risk
- What is being tested?
- YMHP Intervention and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2016to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- HIV-negative test result from the past 90 days
- 15-29 years of age
- Born biologically male or currently identifying as male
- Sex with men in the past 90 days
- ≥ 5 days of illicit drug use in the past 90 days
- ≥ 1 episode of condomless anal sex (CAS) in the past 90 days, or a positive sexually transmitted infection test result in the past 90 days.
- Living in the New York City area
- Able to communicate in English
Who cannot join
- Serious cognitive or psychiatric impairments
- ≥5 days of injection drug use in the past 90 days
- Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bridging Access to Care
Brooklyn, New York, 11226
BOOM!Health
The Bronx, New York, 10458
About this study
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.
Read the detailed description
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.
- Conditions
- Substance Use, Sexual Risk
- Being tested
- YMHP Intervention, Enhanced Treatment as Usual
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMHP InterventionBehavioural
Enhanced Treatment as UsualBehavioural
Also called eTau
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: YMHP Intervention |
| 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. Receives: Behavioral: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit Drug Use Days
The self-reported number of illicit drug use days (not including marijuana) in the past 90 days
Measured: 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
Measured: 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
Measured: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Secondary outcomes (1)
Alcohol Use Days
The self-reported number of alcohol use days in the past 90 days
Measured: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start15 Jun 2016
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tyrel Starks, Hunter College of City University of New York
- Investigators
- Tyrel J Starks, PhD, Principal investigator, Hunter College, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488914
- Sponsor's protocol ID
- R01DA041262
- Other IDs
- R01DA041262
- Acronym
- YMHP-CBO
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2018
- Last updated
- 8 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36273221Bradford-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.
PubMed 35394598Parsons 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.
PubMed 31115346
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
- ClinicalTrials.gov ID
- NCT03488914
- Acronym / sponsor ID
- YMHP-CBO / R01DA041262
- Conditions
- Substance Use, Sexual Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 8 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: YMHP InterventionThe 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. |
| Enhanced Treatment as Usual | Other | Behavioral: Enhanced Treatment as UsualThe 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. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- HIV-negative test result from the past 90 days
- 15-29 years of age
- Born biologically male or currently identifying as male
- Sex with men in the past 90 days
- ≥ 5 days of illicit drug use in the past 90 days
Key exclusion criteria (3 listed)
- Serious cognitive or psychiatric impairments
- ≥5 days of injection drug use in the past 90 days
- Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YMHP Intervention | Behavioural | Intervention |
| Enhanced Treatment as UsualAlso: eTau | Behavioural | Enhanced Treatment as Usual |
Primary outcome
Illicit Drug Use Days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
The self-reported number of illicit drug use days (not including marijuana) in the past 90 days
Condomless Anal Sex Acts
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
The self-reported number of condomless anal sex acts with male partners in the past 90 days
Marijuana Use Days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
The self-reported number of marijuana use days in the past 90 days
1 secondary outcome
Alcohol Use Days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36273221Coyle 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.
- Derived from this study: PubMed 35394598Bradford-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.
- Derived from this study: PubMed 31115346Parsons 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyrel J Starks, PhD principal investigator
Hunter College, CUNY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YMHP Intervention and Enhanced Treatment as Usual in people with Substance Use and Sexual Risk, run by Hunter College of City University of New York at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illicit Drug Use Days (time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488914, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.