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

HIV Clinical Trial

Official title: Intervention for Sustained Testing and Retention Among HIV-infected Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV

• NCT number: NCT03018002
• Study type: Interventional
• Source: University of Nevada, Las Vegas
• Contact: Echezona Ezeanolue, MD, MPH
• Phone: 7028952687
• Email: echezona.ezeanolue@unlv.edu
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Completion date: March 2020