NCT03152006

Brief Summary

The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

2.9 years

First QC Date

May 9, 2017

Last Update Submit

October 14, 2017

Conditions

HIV/AIDS

Keywords

Healthcare transitionAdolescentsNigeria

Outcome Measures

Primary Outcomes (3)

  • Retention in care in care 6 months post-transfer

    Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer

    6 months

  • Retention in care 12 months post-transfer

    Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within the 1 year period post-transfer

    12 months

  • Retention in care 24 months post-transfer

    Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within a 1 year period during the second year post-transfer

    24 months

Secondary Outcomes (6)

  • Viral Suppression

    Enrollment, baseline (12 months), 24 and 36 months

  • Mental Health and Wellbeing

    Enrollment, baseline (12 months), 24 and 36 months

  • Health Locus of Control

    Enrollment, baseline (12 months), 24 and 36 months

  • Social Support

    Enrollment, baseline (12 months), 24 and 36 months

  • Sexual Risk Behavior

    Enrollment, baseline (12 months), 24 and 36 months

  • +1 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

The control arm does not receive the ACT intervention.

ACT Intervention

EXPERIMENTAL

Intervention activities include the three components of the ACT intervention: (1) alternating pediatric and adult clinic visits in the 12 month pre-transfer period (2) peer facilitated organized support group during the 24-month graduated transition period and (3) patient advocate and case management team to coordinate transfer process.

Other: ACT

Interventions

ACTOTHER

Coordinated, graduated transition which includes an early introduction to the adult clinician during the PAPA pre-transfer period, a peer-facilitated organized support group aimed at improving transition readiness and addressing critical psychosocial skills including self-efficacy and locus of control and a case management team including a patient advocate who coordinates the transfer between pediatric and adult care teams.

ACT Intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Documented HIV infection
  • Aware of HIV diagnosis
  • Currently on ART

You may not qualify if:

  • Medically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Institute of Human Virology

Abuja, Federal Capital Territory, Nigeria

RECRUITING

Center for Integrated Health Program

Abuja, Nigeria

RECRUITING

Centre for Clinical Care and Research

Abuja, Nigeria

RECRUITING

Family Health International

Abuja, Nigeria

RECRUITING

AIDS Prevention Initiative Nigeria

Lagos, Nigeria

RECRUITING

Related Publications (1)

  • Sam-Agudu NA, Pharr JR, Bruno T, Cross CL, Cornelius LJ, Okonkwo P, Oyeledun B, Khamofu H, Olutola A, Erekaha S, Menson WNA, Ezeanolue EE. Adolescent Coordinated Transition (ACT) to improve health outcomes among young people living with HIV in Nigeria: study protocol for a randomized controlled trial. Trials. 2017 Dec 14;18(1):595. doi: 10.1186/s13063-017-2347-z.

    PMID: 29237487DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Echezona Ezeanolue, MD, MPH

CONTACT

702-895-2687echezona.ezeanolue@unlv.edu

Nadia Sam-Agudu, MD

CONTACT

+2347063501205nsamagudu@ihvnigeria.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Public Health and Pediatrics

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 12, 2017

Study Start

June 28, 2017

Primary Completion

May 30, 2020

Study Completion

June 30, 2021

Last Updated

October 17, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

NG(5)