Intervention for Sustained Testing and Retention Among HIV-infected Patients

NCT03018002 | Unknown DMC

• 2 other identifiers: 845695-4R01HD087994-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Keywords

HIV, PMTCT

Outcome Measures

Primary Outcomes (2)

• Linkage in care

  Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.

  1 month

• Retention in care

  Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.

  12 months

Secondary Outcomes (2)

• ART Initiation

  1 month

• Viral Suppression

  12 months

Study Arms (2)

Control group

NO INTERVENTION

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.

iSTAR

EXPERIMENTAL

HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.

Other: iSTAR

Interventions

iSTAR OTHER

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.

iSTAR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• HIV-infected women already on treatment

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Catholic Caritas Foundation

Makurdi, Benue State, Nigeria

RECRUITING

Related Publications (1)

• Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.

  PMID: 23758933 BACKGROUND

Central Study Contacts

Echezona Ezeanolue, MD, MPH

CONTACT

7028952687; echezona.ezeanolue@unlv.edu

Chima Onoka, MD, PhD

CONTACT

+2348033802711; chima.onoka@unn.edu.ng

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Public Health and Pediatrics

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 11, 2017
• Study Start: July 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)