HIV/AIDS
Conditions
Keywords
Healthcare transition, Adolescents, Nigeria
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.
Interventions
OTHERACT
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Documented HIV infection * Aware of HIV diagnosis * Currently on ART
Exclusion criteria
* Medically unstable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in care in care 6 months post-transfer | 6 months | Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer |
| Retention in care 12 months post-transfer | 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 |
| Retention in care 24 months post-transfer | 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
| Measure | Time frame | Description |
|---|---|---|
| Social Support | Enrollment, baseline (12 months), 24 and 36 months | Functional Social Support Questionnaire |
| Viral Suppression | Enrollment, baseline (12 months), 24 and 36 months | Proportion of participants with undetectable viral load |
| Transition Readiness | Enrollment, baseline (12 months), 24 and 36 months | Transition Readiness Assessment Questionnaire |
| Sexual Risk Behavior | Enrollment, baseline (12 months), 24 and 36 months | Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire |
| Mental Health and Wellbeing | Enrollment, baseline (12 months), 24 and 36 months | Mental health continuum-short form Questionnaire |
| Health Locus of Control | Enrollment, baseline (12 months), 24 and 36 months | Health Locus of control / Self-esteem Questionnaire |
Countries
Nigeria
Contacts
Primary ContactEchezona Ezeanolue, MD, MPH
Backup ContactNadia Sam-Agudu, MD
Outcome results
None listed