MedDataX Logo

Adolescent Coordinated Transition Nigerian HIV+ Youth

NCT ID: NCT03152006

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of ACT, a coordinated protocol for transitioning adolescents living with HIV (ALHIV) from pediatric to adult care (Intervention Group; IG) versus the usual abrupt transfer to adult care (Control group; CG) on rates of retention in care and viral suppression, and differences in perceived psychosocial wellbeing. Twelve health facilities, two in each of the six geopolitical zones of Nigeria will be pair-matched and randomly assigned to either IG (N=6 health facilities) or CG (N=6 health facilities). A total of 216 ALHIV will be enrolled in the study over a 36-month period. The primary outcome will be the difference in the rate of retention between the groups. Secondary outcomes will be difference in the rate of viral suppression and the difference in perceived psychosocial wellbeing. Additionally, the investigators will conduct mediation/moderation analysis to examine the role of intermediate variables such as transition readiness, perceived mental health, social support, health locus of control, self-esteem and sexual risk behavior self-efficacy on the primary outcomes. Implementation factors will be assessed using the hybrid 2 model.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV/AIDS

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthcare transition Adolescents Nigeria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

The control arm does not receive the ACT intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

ACT Intervention

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.

Group Type EXPERIMENTAL

ACT

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACT

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Medically unstable
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Echezona Ezeanolue

Professor of Public Health and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Human Virology

Abuja, Federal Capital Territory, Nigeria

Site Status RECRUITING

Center for Integrated Health Program

Abuja, , Nigeria

Site Status RECRUITING

Centre for Clinical Care and Research

Abuja, , Nigeria

Site Status RECRUITING

Family Health International

Abuja, , Nigeria

Site Status RECRUITING

AIDS Prevention Initiative Nigeria

Lagos, , Nigeria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Nigeria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Echezona Ezeanolue, MD, MPH

Role: CONTACT

Phone: 702-895-2687

Email: [email protected]

Nadia Sam-Agudu, MD

Role: CONTACT

Phone: +2347063501205

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nadia Sam-Agudu

Role: primary

Bolanle Oyeledu, MD

Role: primary

Ayodotun Olutola, MD

Role: primary

Hadiza Khamofu, MD

Role: primary

Prosper Okonkwo

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29237487 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HD089871

Identifier Type: NIH

Identifier Source: secondary_id

View Link

990070-4

Identifier Type: -

Identifier Source: org_study_id