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

NCT04504981 | Completed

• 2 other identifiers: CHLA-19-00029R34DA044106
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to pilot test a group level intervention, called Y2Prevent, which aims to decrease drug use and HIV/STI risk among Black/African American young men who have sex with men (AAYMSM). The main question it aims to answer is:

• determine if Y2Prevent is possible to engage in easily and is accepted by the participants, for potential expansion to other cities. Participants will engage in 7 weekly group sessions focused on helping AAYMSM identify life goals and safeguard their health to achieve those goals. This intervention will also include:
• HIV/STI testing and treatment referral
• drug screening and treatment referral
• positive youth development and future planning through a mentorship program

Conditions

HIV; Drug Use

Outcome Measures

Primary Outcomes (9)

• Sexual risk behaviors

  Condomless anal intercourse; frequency of this behavior during reporting period; # of sexual partners during the reporting period; use of PrEP/PEP during reporting period

  Baseline

• Alcohol and illincit drug use

  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

  Baseline; will asses past 30-day use; past 3 month

• Sexual risk behaviors

  Condomless anal intercourse; frequency of this behavior during reporting period; # of sexual partners during the reporting period; use of PrEP/PEP during reporting period

  3 months post intervention

• Alcohol and illincit drug use

  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 months post intervention

• Sexual risk behaviors

  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 months post intervention

• Alcohol and illincit drug use

  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

  6 months post intervention

• Illincit drug use

  Presence of marijuana, methamphetamines, cocaine, heroin, opiates, barbituates, benzodiazepines, ecstasty, GHB, PCP

  urine analysis for recent drug use (up to 1 week) at time of assessment (baseline)

• Illincit drug use

  Presence of marijuana, methamphetamines, cocaine, heroin, opiates, barbituates, benzodiazepines, ecstasty, GHB, PCP

  urine analysis for recent drug use (up to 1 week) at time of assessment (3 months post intervention)

• Illincit drug use

  Presence of marijuana, methamphetamines, cocaine, heroin, opiates, barbituates, benzodiazepines, ecstasty, GHB, PCP

  urine analysis for recent drug use (up to 1 week) at time of assessment (6 months post intervention)

Secondary Outcomes (2)

• PrEP Uptake

  Current PrEP use at time of assessment (3 months post)

• PrEP Uptake

  Current PrEP use at time of assessment (6 months post)

Study Arms (1)

Y2Prevent Intervention

OTHER

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

Interventions

Y2Prevent BEHAVIORAL

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

Y2Prevent Intervention

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old;
• identify as a cisgender male;
• identify as Black/African American;
• identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with a man;
• HIV-negative;
• not currently enrolled in an HIV prevention study;
• living in the Los Angeles metro area;
• 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
• 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.

You may not qualify if:

• outside age 18-24 years old;
• identify as a transgender man or woman;
• identify as White/Caucasian, Latino/Hispanic, Asian/Pacific Islander, Native American, Indigenous, or any other ethnicity besides African American;
• identify as straight;
• HIV-positive;
• currently enrolled in an HIV prevention study;
• currently living outside the Los Angeles metro area;
• 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
• 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.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Study Officials

• Michele D Kipke, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a pilot study with no comparison/control group so masking is not relevant.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profrssor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: January 22, 2020
• Primary Completion: December 22, 2022
• Study Completion: March 1, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: 7/1/23-6/30/26
• Access Criteria: Email requests can be submitted to the Senior Programs Manager Lindsay Slay at lslay@chla.usc.edu or PI Michele Kipke at mkipke@chla.usc.edu. Templates will be provided for the publication plan and data use agreement.

Locations

US (1)