YMHP: Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse

Sponsor

Florida State University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03577301

Collaborator

(none)

180

Enrollment

Locations

Arms

43.9

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: Clinic-based Delivery Behavioral: Remote Delivery Behavioral: Multi-modal Delivery	N/A

Detailed Description

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 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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 :

Oct 4, 2018

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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. This arm is closed to enrollment.	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. This arm is closed to enrollment.	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.
Active Comparator: Multi-modal Delivery A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.	Behavioral: Multi-modal Delivery 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.
No Intervention: Treatment as Usual Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.

Outcome Measures

Primary Outcome Measures

Sexual Self Management Change [3 Month Interval]
Computer Assisted Self Interview (CASI) scored through Qualtrics
Sexual Health Management Change [3 Month Interval]
Serologic lab test of blood sample - positive or negative for HIV and other Sexually Transmitted Infections (STIs)
Substance Abuse Change [3 Month Interval]
Nucleic Acid Amplification (NAA) Urinalysis Drug Screen

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 24 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

HIV-negative test result from the past 90 days
15-24 years of age
Born biologically male or currently identifying as male
Sex with men in the past 90 days
≥ 3 days of illicit drug use in the past 90 days
≥ 1 episode of Condomless Anal Sex (CAS) in the past 90 days, or a positive STI test result in the past 90 days.
Able to communicate in English

Exclusion Criteria:

Serious cognitive or psychiatric impairments
Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Miller School of Medicine	Miami	Florida	United States	33136
2	Wayne State University	Detroit	Michigan	United States	48202
3	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104