Adolescent Coordinated Transition Nigerian HIV+ Youth

HIV/AIDS Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152006
• Other study ID #: 990070-4
• Secondary ID: R01HD089871
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: October 14, 2017
• Start date: June 28, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2017
• Source: University of Nevada, Las Vegas
• Contact: Echezona Ezeanolue, MD, MPH
• Phone: 702-895-2687
• Email: echezona.ezeanolue[@]unlv.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Documented HIV infection

• Aware of HIV diagnosis

• Currently on ART

Exclusion Criteria:

• Medically unstable

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Nigeria	Center for Integrated Health Program	Abuja
Nigeria	Centre for Clinical Care and Research	Abuja
Nigeria	Family Health International	Abuja
Nigeria	Institute of Human Virology	Abuja	FCT
Nigeria	AIDS Prevention Initiative Nigeria	Lagos

Sponsors (2)

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

Country where clinical trial is conducted

Nigeria, 

Outcome

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