Clinic-based Delivery
BehavioralA minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
NCT Number: NCT03577301
YMHP is a counseling intervention program for which the goals are to better understand HIV-prevention focused self-management behaviors among HIV-negative YMSM, and to study the implementation of YMHP to improve portability and scalability. The clinic sites will help investigators to assess and address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM that reflects the complexities of real world adolescent HIV clinics.
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Notify Me15 year–24 year
Male
Interventional
Not applicable
University of Miami Miller School of Medicine, Miami, Florida, United States
Aims will be achieved over two phases of the study.
Phase I: Investigators will conduct research (Exploration and Preparation phases of EPIS model) to obtain implementation feedback to best adapt YMHP for clinic-based CHWs, further incorporate PrEP navigation services, and expand the YMHP protocol to be relevant for Telephone-based Motivational Interviewing (TBMI). We will train a minimum of 2 CHWs at each clinic drawing on the Implementation Science Core (ISC) to apply best-practices in training. Once CHWs demonstrate competence according to the Motivational Interviewing Treatment Integrity (MITI), Phase 2 will begin.
Phase II: Personnel will recruit and enroll 180 YMSM, ages 15-24, 60 at each of the three sites. Sessions will be audio-recorded for MITI fidelity coding, and CHWs and supervisors will be given implementation support throughout. Prior to implementation, immediately at the conclusion of the intervention delivery phase, and one year after, the ISC will conduct interviews with CHWs, supervisors, and clinic leaders to obtain information about the barriers and facilitators of implementation and sustainment.
Target n: 180 YMSM across three sites (60 per site).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
The self-reported number of condomless anal sex acts with male partners in the last 30 days prior to assessment point.
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
The self-reported number of marijuana use days in the past 30 days prior to assessment point.
Time frame: baseline, 3 months, 6 months, 9 months, 12 months
The self-reported number of alcohol use days in the past 30 days
Florida State University
Other
Comparative Effectiveness Trial of Clinic-Based Delivery of an HIV Risk Reduction Intervention for Young Men Who Have Sex With Men (YMSM)
Acronym: YMHP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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