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).