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Completed

NCT Number: NCT02872805

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

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.

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Key information

Conditions

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

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Human Virology, Nigeria

Abuja, Federal Capital Territory, Nigeria

About this study

The specific aims of ADAPT are: 1. To inform strategies for transition services in resource-limited settings; 2. To examine the developmental, clinical, and other factors that predict a successful transition; and, 3. To gain fundamental insight on implementation barriers among African adolescents through the application of the ego-network defined social support that will inform targets for structured intervention. ADAPT will be conducted in central, southern, and northern Nigeria at selected PEPFAR sites supported by the Institute of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six focus groups including: Adolescent patients, parents and health care providers. To address aim 2, the investigators will conduct a cluster randomized clinical trial. The two interventions are based on prior evidence-informed engagement strategies: 1) educational interventions and 2) interventions that use a peer transition advocate who prepares the adolescent and their parents for transition. The investigators will enroll 300 patients (150 patients in each arm). The sites will be assigned to either the intervention arm or a control arm. The primary outcome will be successful transition, keeping two follow-up appointments within a nine months period following transition. Secondary outcomes, as recommended by focus group participants will also be measured. To examine the potential role of social network components and characteristics of both egos and alters on primary outcomes, a Generalized Estimating Equation (GEE) approach will be used to explore the associations between primary outcomes and factors at the ego, alter, and network levels. The finding from this study will guide institution of best practices for transitioning adolescents in Nigeria and other countries lower and middle income countries with similar challenges and potential for high impact.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Other names: Enhanced Standard of Care

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.

Primary outcomes

  1. Successful transition

    Time frame: 9 months after transition occurs

    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

  2. Viral load suppression

    Time frame: 12 months after transition occurs

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

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Acronym: ADAPT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2016
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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