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Y2Prevent: Preventing Drug Use and HIV Through Empowerment, Social Support and Mentorship (Y2P)

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ClinicalTrials.gov Identifier: NCT04504981
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michele D. Kipke, Children's Hospital Los Angeles

Brief Summary:
African Americans represent only 14% of the population, but account for 44% of all new HIV infections reported yearly. The situation is particularly grave for Black/African American young men who have sex with men (AAYMSM), with seroprevalence rates of 19% for ages 15-22 and 26% for ages 23-29 among AAYMSM. These health outcomes are influenced by important social and structural factors, including violence and victimization, homophobia, discrimination, institutional racism, and economic and social marginalization. These experiences are significantly associated with illicit drug use, alcohol misuse, transactional sex work, and HIV risk behaviors. In response to this crisis, the investigators are proposing to create a new theoretically driven, youth-centered intervention designed to build the capacity of AAYMSM to overcome these barriers to health. With this revised R34 application, the team proposes to further refine and pilot test an intervention, called Young Men's Adult Identity Mentoring (YM-AIM). Adapted from an existing CDC Diffusing Effective Behavioral Intervention, YM-AIM is a theory-driven, group-level intervention designed to help AAYMSM develop a healthy vision for their future (or "possible future self") by defining a set of short- and long-term goals in the areas of education, health, family and intimate relationships. We propose to further strengthen and refine YM-AIM by adding a youth mentoring/support component, called Youth Initiated Mentoring (YIM). YIM uses a positive youth development framework to: a) build social capital to achieve immediate and long-term goals, b) build social support, c) identify and engage natural mentors in one's networks to address structural barriers, and d) develop relationships with supportive adults. The investigators will integrate these two models into a single intervention called Y2Prevent. The investigators will then work to further adapt, tailor, and evaluate Y2Prevent as an intervention to reduce illicit drug use and HIV/STI risk among AAYMSM. This intervention will emphasize: a) biomedical HIV prevention strategies for primary prevention, b) HIV/STI testing and treatment referral, c) drug screening and treatment referral, and d) positive youth development and future planning. The investigators will conduct formative research to inform the adaptation/tailoring followed by a piloting of the new intervention to assess the feasibility, acceptability, and the preliminary efficacy. Our proposed positive youth development and resilience theory provide a strong, innovative framework for examining how AAYMSM with significant exposure to syndemic health and social disparities respond to engagement with prevention and treatment resources. The proposed intervention is intended to promote resilience, build social skills and assets among AAYMSM to help them recognize and overcome individual, social and structural barriers leading to risk, and adopt and maintain protective behaviors, such as safer sex, PrEP/PEP use, HIV/STI testing and healthcare utilization. The findings will inform the development of an R01 application that will propose a larger-scale, multi-city efficacy trail in a subsequent R01 application.

Condition or disease Intervention/treatment Phase
HIV Drug Use Behavioral: Y2Prevent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: In Phase 3, we will pilot test Y2Prevent with three groups of African American young men who have sex with men (AAYMSM) in Los Angeles. Each group will have up to 10 members (n=30). The intervention will be delivered to the three groups in a sequential order so that the experiences from the first group can be used to adapt and/or further refine the intervention before it is pilot tested with the second group. Feedback from the first group will be used to further adapt and refine the intervention. It will be pilot tested again with a second group of 10 participants. Y2Prevent will be further refined as needed, and it will then be pilot tested with a third and final group of up to ten participants.
Masking: None (Open Label)
Masking Description: This is a pilot study with no comparison/control group so masking is not relevant.
Primary Purpose: Prevention
Official Title: Y2Prevent: Preventing Drug Use and HIV Through Empowerment, Social Support and Mentorship (Y2P)
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Y2Prevent Intervention
Y2Prevent will include several intervention components (i.e., My Legacy, Sources of Influence, Healthy Relationships, Goal Setting, Health and Self-Efficacy, and Mentorship). These intervention components are intended to assist participants: a) explore future adult identity and envision a positive future, b) develop behavioral skills related to problem-solving and goal-setting, c) develop behavioral skills related to communication, negotiation and conflict resolution with romantic and sexual partners, d) identify ways to safeguard their future by taking responsibility for their health, e) obtain information about HIV transmission and HIV prevention, including HIV testing, treatment as prevention (TaSP) and the availability of PrEP and PEP for prevention, and f) a participant-identified mentor to provide support and encouragement related to behavior change and implementing their future goals and plans.
Behavioral: Y2Prevent
Y2Prevent (Y2P) is a groupl level intervention that consists of 7 weekly group sessions focused on helping young African American men who have sex with men (AAYMSM) identify life goals and safeguard their health to achieve those goals




Primary Outcome Measures :
  1. Sexual risk behaviors [ Time Frame: Baseline ]
    Condomless anal intercourse; frequency of this behavior during reporting period; # of sexual partners during the reporting period; use of PrEP/PEP during reporting period

  2. Alcohol and illincit drug use [ Time Frame: Baseline; will asses past 30-day use; past 3 month ]
    Frequency of acohol and illiict drug use including cocain, ecstasy, methamphetamines, psychedilic drugs (e.g., LSD, shrooms); heroin, opiates, prescription drugs without a prescription; marijuana

  3. Sexual risk behaviors [ Time Frame: 3 months post intervention ]
    Condomless anal intercourse; frequency of this behavior during reporting period; # of sexual partners during the reporting period; use of PrEP/PEP during reporting period

  4. Alcohol and illincit drug use [ Time Frame: 3 months post intervention ]
    Frequency of acohol and illiict drug use including cocain, ecstasy, methamphetamines, psychedilic drugs (e.g., LSD, shrooms); heroin, opiates, prescription drugs without a prescription; marijuana

  5. Sexual risk behaviors [ Time Frame: 6 months post intervention ]
    Condomless anal intercourse; frequency of this behavior during reporting period; # of sexual partners during the reporting period; use of PrEP/PEP during reporting period

  6. Alcohol and illincit drug use [ Time Frame: 6 months post intervention ]
    Frequency of acohol and illiict drug use including cocain, ecstasy, methamphetamines, psychedilic drugs (e.g., LSD, shrooms); heroin, opiates, prescription drugs without a prescription; marijuana

  7. Illincit drug use [ Time Frame: urine analysis for recent drug use (up to 1 week) at time of assessment (baseline) ]
    Presence of marijuana, methamphetamines, cocaine, heroin, opiates, barbituates, benzodiazepines, ecstasty, GHB, PCP

  8. Illincit drug use [ Time Frame: urine analysis for recent drug use (up to 1 week) at time of assessment (3 months post intervention) ]
    Presence of marijuana, methamphetamines, cocaine, heroin, opiates, barbituates, benzodiazepines, ecstasty, GHB, PCP

  9. Illincit drug use [ Time Frame: urine analysis for recent drug use (up to 1 week) at time of assessment (6 months post intervention) ]
    Presence of marijuana, methamphetamines, cocaine, heroin, opiates, barbituates, benzodiazepines, ecstasty, GHB, PCP


Secondary Outcome Measures :
  1. PrEP Uptake [ Time Frame: Current PrEP use at time of assessment (3 months post) ]
    Measured with urine analysis

  2. PrEP Uptake [ Time Frame: Current PrEP use at time of assessment (6 months post) ]
    Measured with urine analysis



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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We are recruiting only African American men ages 18-24 for this study. This study includes only men who have sex with men as participants due to their potential risk for HIV and the disproportionately high rates of HIV among African American men. Young men, ages 18-24, will be the target age due to the lack of data on this particular population of men.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1) 18-24 years old; 2) identify as a cisgender male; 3) identify as Black/African American; 3) identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with a man; 4) HIV-negative; 5) not currently enrolled in an HIV prevention study; 6) living in the Los Angeles metro area; 7) has access to a device (laptop, tablet or phone) with internet access in order to participate in virtual group sessions, complete online surveys, and receive payment via Venmo or Cash App; and 8) has access to a telephone in order to be able to participate in and complete the qualitative exit interview, which will be conducted via telephone.

Exclusion Criteria:

  1. outside age 18-24 years old;
  2. identify as a transgender man or woman;
  3. identify as White/Caucasian, Latino/Hispanic, Asian/Pacific Islander, Native American, Indigenous, or any other ethnicity besides African American;

3) identify as straight; 4) HIV-positive; 5) currently enrolled in an HIV prevention study; 6) currently living outside the Los Angeles metro area; 7) does not have access to a device (laptop, tablet or phone) with internet access, which is necessary to participate in weekly group sessions, complete online surveys and receive payment for participation via Venmo or Cash App; and 8) does not have access to a telephone, which is necessary to participate in the qualitative exit interview at the end of the seventh and final study session.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504981


Contacts
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Contact: Lindsay Slay, MSW 323-361-3586 lslay@chla.usc.edu

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Katrina Kubicek    323-361-8452    kkubicek@chla.usc.edu   
Principal Investigator: Michele D Kipke, PhD         
Sub-Investigator: marco Hidalgo, PhD         
Sponsors and Collaborators
Children's Hospital Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Michele D Kipke, PhD Children's Hospital Los Angeles
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Responsible Party: Michele D. Kipke, Profrssor of Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT04504981    
Other Study ID Numbers: R34 DA044106 - Y2Prevent
R34DA044106 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No