Adolescent Coordinated Transition Nigerian HIV+ Youth (ACT)

Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth

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.

Study Overview

• Status: Unknown
• Conditions: HIV/AIDS
• Intervention / Treatment: Other: ACT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Abuja, Nigeria
    • Recruiting
    • Center for Integrated Health Program
    • Contact: Bolanle Oyeledu, MD
  • Abuja, Nigeria
    • Recruiting
    • Centre for Clinical Care and Research
    • Contact: Ayodotun Olutola, MD
  • Abuja, Nigeria
    • Recruiting
    • Family Health International
    • Contact: Hadiza Khamofu, MD
  • Lagos, Nigeria
    • Recruiting
    • AIDS Prevention Initiative Nigeria
    • Contact: Prosper Okonkwo
  • FCT
    • Abuja, FCT, Nigeria
      • Recruiting
      • Institute of Human Virology
      • Contact: Nadia Sam-Agudu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Medically unstable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control arm does not receive the ACT intervention.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral Suppression	Proportion of participants with undetectable viral load	Enrollment, baseline (12 months), 24 and 36 months
Mental Health and Wellbeing	Mental health continuum-short form Questionnaire	Enrollment, baseline (12 months), 24 and 36 months
Health Locus of Control	Health Locus of control / Self-esteem Questionnaire	Enrollment, baseline (12 months), 24 and 36 months
Social Support	Functional Social Support Questionnaire	Enrollment, baseline (12 months), 24 and 36 months
Sexual Risk Behavior	Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire	Enrollment, baseline (12 months), 24 and 36 months
Transition Readiness	Transition Readiness Assessment Questionnaire	Enrollment, baseline (12 months), 24 and 36 months

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• 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. Erratum In: Trials. 2018 Feb 13;19(1):104.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Anticipated): May 30, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 14, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Nigeria; Healthcare transition
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 990070-4; R01HD089871 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No