An interventional study of ACT in HIV/AIDS, sponsored by University of Nevada, Las Vegas. Status unknown at 5 sites in Nigeria. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-10-17.
Sponsored by University of Nevada, Las Vegas · Not applicable, Interventional, and Supportive care
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's planned enrollment of 216 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Nevada, Las Vegas is the lead sponsor of 75 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control arm does not receive the 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.
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
Time frame: 6 months
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
Time frame: 12 months
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
Time frame: 24 months
Viral Suppression
Proportion of participants with undetectable viral load
Time frame: Enrollment, baseline (12 months), 24 and 36 months
Mental Health and Wellbeing
Mental health continuum-short form Questionnaire
Time frame: Enrollment, baseline (12 months), 24 and 36 months
Health Locus of Control
Health Locus of control / Self-esteem Questionnaire
Time frame: Enrollment, baseline (12 months), 24 and 36 months
Social Support
Functional Social Support Questionnaire
Time frame: Enrollment, baseline (12 months), 24 and 36 months
Sexual Risk Behavior
Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire
Time frame: Enrollment, baseline (12 months), 24 and 36 months
Transition Readiness
Transition Readiness Assessment Questionnaire
Time frame: Enrollment, baseline (12 months), 24 and 36 months
Plan to share: No
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
University of Nevada, Las Vegas