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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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