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Clinical Trials/NCT03018002
NCT03018002UnknownNot Applicable

Intervention for Sustained Testing and Retention Among HIV-infected Patients

University of Nevada, Las Vegas1 site in 1 country400 target enrollmentStarted: July 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
400
Locations
1
Primary Endpoint
Linkage in care

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • HIV-infected women already on treatment

Outcomes

Primary Outcomes

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 Outcomes

  • ART Initiation(1 month)
  • Viral Suppression(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Echezona Ezeanolue

Professor of Public Health and Pediatrics

University of Nevada, Las Vegas

Study Sites (1)

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