Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse (YMHP)
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|ClinicalTrials.gov Identifier: NCT03577301|
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : October 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Clinic-based Delivery Behavioral: Remote Delivery||Not Applicable|
- Adapt YMHP for clinic and phone delivery by existing HIV clinic staff community health workers (CHWs), who work with YMSM ages 15-24. Investigators will conduct focus groups with staff to obtain input on how best to implement YMHP to maximize feasibility, acceptability, and sustainability, as well as issues with adapting the YMHP for delivery to YMSM ages 15-18 and for phone delivery.
Compare the effectiveness of clinic-based versus phone-based delivery of YMHP in the context of health care access. In order to inform future implementation, investigators will test the effectiveness of YMHP delivered via these two modalities.
- Assess the cost-effectiveness of both delivery formats of YMHP to enhance the likelihood of uptake of this best evidence intervention. The hypothesis is that phone-based will be more cost-effective than clinic-based
- Assess the Five Components of the Self-Management Model and how these components vary over time, are directly improved by the interventions, and mediate intervention effects.
- Test a sustainable model of YMHP implementation in real world adolescent clinics. Investigators will utilize local supervisors within the clinic setting to sustain the CHWs fidelity to delivering the motivational interviewing (MI)-based YMHP intervention. Fidelity will be monitored throughout the trial and assessments and qualitative interviews will be conducted with key stakeholders to determine the barriers and facilitators of YMHP implementation utilizing the Exploration, Preparation, Implementation, Sustainment model (EPIS).
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 270 YMSM, ages 15-24, 90 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: 270 YMSM across three sites (90 per site), 135 in each condition
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparative Effectiveness Trial of Clinic-Based Delivery of an HIV Risk Reduction Intervention for Young Men Who Have Sex With Men (YMSM)|
|Actual Study Start Date :||October 4, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Clinic-based Delivery
Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants.
Behavioral: Clinic-based Delivery
A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
Active Comparator: Remote Delivery
Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants.
Behavioral: Remote Delivery
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.
- Sexual Self Management Change [ Time Frame: 3 Month Interval ]Computer Assisted Self Interview (CASI) scored through Qualtrics
- Sexual Health Management Change [ Time Frame: 3 Month Interval ]Serologic lab test of blood sample - positive or negative for HIV and other Sexually Transmitted Infections (STIs)
- Substance Abuse Change [ Time Frame: 3 Month Interval ]Nucleic Acid Amplification (NAA) Urinalysis Drug Screen
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): NCT03577301
|Contact: Tyrel Starks, PhDemail@example.com|
|United States, Florida|
|University of Miami Miller School of Medicine||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Lawrence Friedman, PhD firstname.lastname@example.org|
|Contact: Donna Maturo email@example.com|
|Principal Investigator: Lawrence Friedman|
|United States, Michigan|
|Wayne State University||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Anguliqe Outlaw, PhD firstname.lastname@example.org|
|Contact: Monique Green-Jones, PhD 313-577-0792 email@example.com|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Mary Tanney firstname.lastname@example.org|
|Contact: Kim Desir email@example.com|
|Principal Investigator: Mary Tanney|
|Principal Investigator:||Sylvie Naar, PhD||Florida State University|