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

  • End date
    May 31, 2022
  • participants needed
  • sponsor
    Florida State University
Updated on 26 January 2021
Tyrel Starks, PhD
Primary Contact
Children's Hospital of Philadelphia (81.4 mi away) Contact
+2 other location
drug use
HIV Vaccine


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.


  1. 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.
  2. 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.
    1. 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
    2. 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.
    3. 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).

Condition HIV infection, Immunodeficiency, Primary Immunodeficiency Disorders, HIV Infections, human immunodeficiency virus, hiv disease
Treatment Clinic-based Delivery, Remote Delivery, Multi-modal Delivery
Clinical Study IdentifierNCT03577301
SponsorFlorida State University
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

HIV-negative test result from the past 90 days
-24 years of age
Born biologically male or currently identifying as male
Sex with men in the past 90 days
days of illicit drug use in the past 90 days
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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note