Intervention for Sustained Testing and Retention Among HIV-infected Patients (iSTAR)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Intervention for Sustained Testing and Retention Among HIV-infected Patients|
- Linkage in care [ Time Frame: 1 month ] [ Designated as safety issue: No ]Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.
- Retention in care [ Time Frame: 12 months ] [ Designated as safety issue: No ]Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.
- ART Initiation [ Time Frame: 1 month ] [ Designated as safety issue: No ]The secondary outcome is engagement in care defined as the percentage of participants initiated on ART at 1 month following enrollment.
- Viral Suppression [ Time Frame: 12 months ] [ Designated as safety issue: No ]Viral suppression is defined as the percentage of participants whose most recent two viral load are <20 copies/mL.
|Study Start Date:||July 2016|
|Estimated Study Completion Date:||March 2020|
|Estimated Primary Completion Date:||March 2020 (Final data collection date for primary outcome measure)|
No Intervention: Control group
HIV-infected participants identified from the churches randomized to CG will be referred to PEPFAR-supported HIV clinics that provide comprehensive care including counseling, laboratory testing, ART and ongoing support during treatment as the standard of care. The study team will not be involved in their care beyond data collection.
HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.
Each component of the iSTAR intervention targets a specific point along the HIV continuum: confidential, onsite integrated laboratory tests during baby showers targets HIV diagnosis (b) church-based Health Advisors (CHAs) trained in motivational interviewing and quality improvement skills as promotoras target linkage, engagement and adherence by providing counseling and other support to HIV-infected women and children (c) integrated network of community and clinic case management targets reduction in loss to follow-up.
CHAs will support participants during the study period by being available to accompany them to clinic visits, review laboratory results and medications after clinic visits. They will be available to speak with them at intervals to see how they are doing either by phone or through home visits as they prefer. At each follow-up study visit, the trained CHA will review and collect data on participants' clinic visits, treatment, and laboratory results.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03018002
|Contact: Echezona Ezeanolue, MD, MPHfirstname.lastname@example.org|
|Contact: Chima Onoka, MD, PhDemail@example.com|
|Catholic Caritas Foundation||Recruiting|
|Makurdi, Benue, Nigeria|
|Contact: John Olawepo, MD, MSc +234-805 564 8788 firstname.lastname@example.org|
|Principal Investigator: Echezona Ezeanolue, MD, MPH|
|Principal Investigator: Chima Onoka, MD, PhD|