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
|First Submitted Date ICMJE||August 3, 2020|
|First Posted Date ICMJE||August 7, 2020|
|Last Update Posted Date||August 13, 2021|
|Actual Study Start Date ICMJE||January 22, 2020|
|Estimated Primary Completion Date||June 30, 2022 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Y2Prevent: Preventing Drug Use and HIV Through Empowerment, Social Support and Mentorship (Y2P)|
|Official Title ICMJE||Y2Prevent: Preventing Drug Use and HIV Through Empowerment, Social Support and Mentorship (Y2P)|
|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.|
The overarching aim is to develop a culturally tailored and developmentally appropriate HIV prevention intervention for African American young men who have sex with men (AAYMSM), ages 18 to 24 years. No group is at greater risk for acquiring HIV than YMSM, especially those living in inner cities, with AAYMSM now accounting for the largest number of new HIV infections detected in cities each year. If these trends continue, it is estimated that as many as 1 in 2 AAYMSM will be diagnosed with HIV in their lifetime.
The investigators propose 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 (DEBI), 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. Through the facilitated activities, participants consider how their involvement in risky behaviors (e.g., illicit drug use, condomless sex, multiple sex partners) would interfere with achieving those goals. With funding from NIDA (R21 DA024588), the investigators developed YM-AIM in response to findings from our own research, as well as those reported in the literature, which demonstrate that experiences of minority stress (e.g., racism, homophobia) and exposure to violence and victimization (family, intimate partner, community) put AAYMSM at significantly greater risk for illicit drug use, HIV/STI sexual risk (condomless anal sex), and mental health problems (e.g., depression) as compared to Caucasian and Hispanic/Latino YMSM.
During our initial pilot, participants (n=36) were enormously enthusiastic about their participation in YM-AIM (all participants attended all six weekly sessions), they provided positive feedback about the various components, activities, and exercises, and they reported that YM-AIM should continue to be delivered using a group-based intervention because they enjoyed the support provided by other group members. Participants also reported they wanted (and needed) ongoing social support after completing the intervention, to help them achieve their short- and long-term goals and maintain positive changes in sexual risk behaviors. This feedback is consistent with the literature that suggests mentors are immensely beneficial, particularly for youth and young adults, because they can share their worldviews, experiences, knowledge, support and advice, as well as provide a positive influence. By introducing youth to new experiences and sharing positive values, mentors can help young people avoid negative behaviors and achieve success. Having a mentor has also been found to reduce youths' risk for delinquency, aggression and drug use and lead to increased academic satisfaction and performance. Based on this, the investigators 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 help young, low-income ethnic/racial minorities: a) build social capital to achieve immediate and long-term life goals, b) build social support networks, c) identify and engage natural mentors in their networks to address structural barriers encountered in their lives, and d) develop relationships with supportive adults.
YM-AIM was developed in 2011, before widespread availability of PrEP/PEP. The investigators are therefore also proposing to add three new components: 1) biomedical HIV prevention strategies (PrEP, PEP), 2) HIV/STI testing and treatment referral, and 3) drug screening and treatment referral. This new intervention, which is called Y2Prevent, will then be evaluated for its feasibility and acceptability. Intervention outcomes include drug use in past 30 days and 3 months, alcohol use, condomless sex, number of partners, condom use intention, condom use self-efficacy, HIV testing recency/frequency, and linkage to care. The specific aims are to:
SPECIFIC AIM 1: Conduct formative research to develop Y2Prevent and refine our assessment measures.
SPECIFIC AIM 2: Finalize Y2Prevent study protocols and consents and develop a manual of operations.
SPECIFIC AIM 3: Pilot and evaluate Y2Prevent to determine intervention feasibility and acceptability, and collect prelimiary efficacy data.
e propose to integrate YM-AIM and YIM into a single new intervention, called Y2Prevent. This intervention will then be implemented and evaluated for feasibility and acceptability, and manualized. Three phases of research are proposed. In Phase 1, the investigators will conduct formative research to integrate YM-AIM and YIM and refine our assessment battery (Aim 1). In Phase 2, the investigators will finalize the study protocols and consents and develop a manual of operations (Aim 2). In Phase 3, investigators will pilot test Y2Prevent with 30 participants. Assessment measures will also be pilot tested during three assessment sessions, at baseline (first study visit) and 3- and 6-month follow-up (after post-intervention test). Intervention outcomes include drug use in past 30 days and 3 months, alcohol use, condomless sex, number of partners, condom use intention, condom use self-efficacy, HIV testing recency/frequency, and linkage to care. Findings from this pilot research will inform selection of measures and outcomes for a future randomized clinical trial (RCT) and provide estimates of possible intervention effect sizes (group means, SDs) for trial planning. Process measures include data on sources of recruitment and recruitment rates, trial retention rates, and identification of barriers and facilitators to recruitment and retention.
WORKING GROUPS - PHASE 1:
During Phase 1, the investigators will convene two working groups of AAYMS to engage in a process of integrating the Young Men's Adult Identity Mentoring (YM-AIM) and Youth Initiated Mentoring (YIM). Each work group will include 8-10 young men. These men will be recruited from our existing HYM cohort.
Prior experience has taught us that creating groups with shared key characteristics (e.g. risk profile, sexual identity or age) is the most effective means of facilitating more in-depth discussions. Each group, consisting of 6-8 members, will be convened on a weekly basis and each meeting will focus on one specific topic (i.e.,common challenges that AAYMSM experience with HIV prevention; what AAYMSM want from a mentor) - there will be around 7 weekly lessons that participants will attend. During these meetings, participants will review each unit of the original YM-AIM and YIM curricula and discuss what components would be most relevant. Groups will be facilitated by the research assistant, and each week a volunteer from each group will be asked to serve as a co-facilitator in an effort to increase ownership for intervention adaptation and to assist in maintaining order within the group.
Guided discussions will focus on different aspects of the curricula such as: 1) common challenges that AAYMSM experience with HIV prevention; 2) what AAYMSM want from a mentor; 3) managing positive and negative influences in their lives; 4) challenges in accessing care; and 5) the role that intimate partners play in their lives. The investigators will brainstorm potential activities that can be integrated into our newly adapted Y2Prevent curriculum that focus on these areas (e.g., PrEP Myth or Truth game).
PILOT TEST - PHASE 3: In Phase 3, the investigators will pilot test Y2Prevent with three working 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. The investigators will continue to gather information, solicit input, and refine Y2Prevent until the investigators are satisfied that the intervention is truly relevant, acceptable, and appropriate for the target population. These group discussions will be audio-recorded and professionally transcribed for analysis. The focus groups are expected to last 1.5 - 2 hours each.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||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)
This is a pilot study with no comparison/control group so masking is not relevant.Primary Purpose: Prevention
|Intervention ICMJE||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
|Study Arms ICMJE||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.
Intervention: Behavioral: Y2Prevent
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||July 31, 2022|
|Estimated Primary Completion Date||June 30, 2022 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
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.
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.
|Ages ICMJE||18 Years to 24 Years (Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT04504981|
|Other Study ID Numbers ICMJE||R34 DA044106 - Y2Prevent
R34DA044106 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Michele D. Kipke, Children's Hospital Los Angeles|
|Study Sponsor ICMJE||Children's Hospital Los Angeles|
|Collaborators ICMJE||National Institute on Drug Abuse (NIDA)|
|PRS Account||Children's Hospital Los Angeles|
|Verification Date||August 2021|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP