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Intervention for Sustained Testing and Retention Among HIV-infected Patients (iSTAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by University of Nevada, Las Vegas
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Echezona Ezeanolue, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT03018002
First received: January 6, 2017
Last updated: January 10, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with HIV.

Condition Intervention
HIV
Other: iSTAR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Intervention for Sustained Testing and Retention Among HIV-infected Patients

Resource links provided by NLM:


Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • Linkage in care [ Time Frame: 1 month ]
    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 ]
    Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.


Secondary Outcome Measures:
  • ART Initiation [ Time Frame: 1 month ]
    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 ]
    Viral suppression is defined as the percentage of participants whose most recent two viral load are <20 copies/mL.


Estimated Enrollment: 400
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)
Arms Assigned Interventions
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.
Experimental: iSTAR
HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.
Other: iSTAR

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.


Detailed Description:
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of iSTAR, a community-based social network intervention that combines trained church-based Health Advisors and clinic-based staff and uses motivational interview skills and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based approach (Control group; CG) on linkage, engagement, retention and viral suppression among HIV-infected women and children. Eighteen health facilities in identified local government areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9 health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The primary outcome will be the difference in the rate of linkage and engagement between the groups. The secondary outcome will be the difference in rate of retention and viral suppression among participants. Additionally, we will conduct network, mediation/moderation analysis to examine the roles of intermediate variables such as health team cohesion, turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and sustainment.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-infected pregnant women identified during baby showers programs at participating worship centers.

Exclusion Criteria:

  • HIV-infected women already on treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03018002

Contacts
Contact: Echezona Ezeanolue, MD, MPH 7028952687 echezona.ezeanolue@unlv.edu
Contact: Chima Onoka, MD, PhD +2348033802711 chima.onoka@unn.edu.ng

Locations
Nigeria
Catholic Caritas Foundation Recruiting
Makurdi, Benue, Nigeria
Contact: John Olawepo, MD, MSc    +234-805 564 8788    jolawepo@ccfng.org   
Principal Investigator: Echezona Ezeanolue, MD, MPH         
Principal Investigator: Chima Onoka, MD, PhD         
Sponsors and Collaborators
University of Nevada, Las Vegas
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Publications:
Responsible Party: Echezona Ezeanolue, Professor of Public Health and Pediatrics, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT03018002     History of Changes
Other Study ID Numbers: 845695-4
R01HD087994-01 ( US NIH Grant/Contract Award Number )
Study First Received: January 6, 2017
Last Updated: January 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Nevada, Las Vegas:
HIV, PMTCT

ClinicalTrials.gov processed this record on April 26, 2017