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Adolescent Coordinated Transition Nigerian HIV+ Youth (ACT)

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ClinicalTrials.gov Identifier: NCT03152006
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Echezona Ezeanolue, University of Nevada, Las Vegas

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: ACT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Retention in care in care 6 months post-transfer [ Time Frame: 6 months ]
    Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer

  2. Retention in care 12 months post-transfer [ Time Frame: 12 months ]
    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

  3. Retention in care 24 months post-transfer [ Time Frame: 24 months ]
    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


Secondary Outcome Measures :
  1. Viral Suppression [ Time Frame: Enrollment, baseline (12 months), 24 and 36 months ]
    Proportion of participants with undetectable viral load

  2. Mental Health and Wellbeing [ Time Frame: Enrollment, baseline (12 months), 24 and 36 months ]
    Mental health continuum-short form Questionnaire

  3. Health Locus of Control [ Time Frame: Enrollment, baseline (12 months), 24 and 36 months ]
    Health Locus of control / Self-esteem Questionnaire

  4. Social Support [ Time Frame: Enrollment, baseline (12 months), 24 and 36 months ]
    Functional Social Support Questionnaire

  5. Sexual Risk Behavior [ Time Frame: Enrollment, baseline (12 months), 24 and 36 months ]
    Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire

  6. Transition Readiness [ Time Frame: Enrollment, baseline (12 months), 24 and 36 months ]
    Transition Readiness Assessment Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Medically unstable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152006


Contacts
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Contact: Echezona Ezeanolue, MD, MPH 702-895-2687 echezona.ezeanolue@unlv.edu
Contact: Nadia Sam-Agudu, MD +2347063501205 nsamagudu@ihvnigeria.org

Locations
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Nigeria
Institute of Human Virology Recruiting
Abuja, FCT, Nigeria
Contact: Nadia Sam-Agudu         
Center for Integrated Health Program Recruiting
Abuja, Nigeria
Contact: Bolanle Oyeledu, MD         
Centre for Clinical Care and Research Recruiting
Abuja, Nigeria
Contact: Ayodotun Olutola, MD         
Family Health International Recruiting
Abuja, Nigeria
Contact: Hadiza Khamofu, MD         
AIDS Prevention Initiative Nigeria Recruiting
Lagos, Nigeria
Contact: Prosper Okonkwo         
Sponsors and Collaborators
University of Nevada, Las Vegas
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Echezona Ezeanolue, Professor of Public Health and Pediatrics, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT03152006     History of Changes
Other Study ID Numbers: 990070-4
R01HD089871 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Echezona Ezeanolue, University of Nevada, Las Vegas:
Healthcare transition
Adolescents
Nigeria