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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03577301
Other study ID # ATN145
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2018
Est. completion date May 31, 2022

Study information

Verified date September 2022
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 24 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Clinic-based Delivery
A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
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.
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.

Locations

Country Name City State
United States Wayne State University Detroit Michigan
United States University of Miami Miller School of Medicine Miami Florida
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

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