Clinical trial NCT03152006: Adolescent Coordinated Transition Nigerian HIV+ Youth
Official title: Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
Keywords: Healthcare transition
Adolescents
Nigeria
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-12
Enrollment: 216
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Medically unstable

Primary outcomes:
measure: Retention in care in care 6 months post-transfer
timeFrame: 6 months
measure: Retention in care 12 months post-transfer
timeFrame: 12 months
measure: Retention in care 24 months post-transfer
timeFrame: 24 months
Secondary outcomes:
measure: Viral Suppression
timeFrame: Enrollment, baseline (12 months), 24 and 36 months
measure: Mental Health and Wellbeing
timeFrame: Enrollment, baseline (12 months), 24 and 36 months
measure: Health Locus of Control
timeFrame: Enrollment, baseline (12 months), 24 and 36 months
measure: Social Support
timeFrame: Enrollment, baseline (12 months), 24 and 36 months
measure: Sexual Risk Behavior
timeFrame: Enrollment, baseline (12 months), 24 and 36 months
measure: Transition Readiness
timeFrame: Enrollment, baseline (12 months), 24 and 36 months
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: Institute of Human Virology
state: FCT
city: Abuja
country: Nigeria
facility: Center for Integrated Health Program
city: Abuja
country: Nigeria
facility: Centre for Clinical Care and Research
city: Abuja
country: Nigeria
facility: Family Health International
city: Lagos
country: Nigeria
facility: AIDS Prevention Initiative Nigeria
Study officials:
References:
citation: 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.