Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study

NCT02872805 | Completed DMC

• 1 other identifier: HP-00070099
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

Brief Summary

One of the distinct challenges faced by emerging adults with HIV is the transition of their care from their long-term pediatric HIV provider to treatment within an adult HIV program. The consequences of an unsuccessful transition can range from difficult to catastrophic. The Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a prospective cohort trial of an innovative intervention targeting gaps in care that are major drivers of loss in the ART continuum of care cascade among adolescents and increasing missed opportunities to engage adolescents into care.

Conditions

HIV; AIDS

Outcome Measures

Primary Outcomes (2)

• Successful transition

  ADAPT focuses on a service primary outcome, successful transition, which is defined as two consecutive kept appointments at the designated adult clinic within 9 months of transition

  9 months after transition occurs

• Viral load suppression

  viral load (VL)\<400 at 12 months post-transition

  12 months after transition occurs

Study Arms (2)

PEPFAR Enhanced Standard of Care (PESCA)

ACTIVE COMPARATOR

This arm reflects an enhanced standard of care comparison group for PEPFAR supported sites. We will provide standardized materials to be used by current clinical staff to help support whatever the site specific activities are related to transition from pediatric to adult medical care

Other: PEPFAR Enhanced Standard of Care (PESCA)

Peer Transition Advocate (PTA)

EXPERIMENTAL

The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues.

Behavioral: Peer Transition Advocate (PTA)

Interventions

PEPFAR Enhanced Standard of Care (PESCA) OTHER

Standardized materials will be provided to PEPFAR supported clinical sites to assist clinic teams with supporting patients in the transition from pediatric to adult medical care

Also known as: Enhanced Standard of Care

PEPFAR Enhanced Standard of Care (PESCA)

Peer Transition Advocate (PTA) BEHAVIORAL

The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues.

Peer Transition Advocate (PTA)

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV infected patients between the ages of 16-19 years of age
• Patients who have been in care at the study site facility for a minimum of 1 year
• Patients who plan to transition their HIV care to one of the selected study sites
• Patients who are able to provide informed consent

You may not qualify if:

• HIV infected patients who have significant cognitive impairments(e.g., Mental retardation)
• Patients planning to transition their HIV care outside the selected study facilities

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Institute of Human Virology, Nigeria

Abuja, Federal Capital Territory, Nigeria

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Vicki J Tepper, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: November 1, 2019
• Primary Completion: December 20, 2023
• Study Completion: December 21, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)