Intervention for Sustained Testing and Retention Among HIV-infected Patients
- Conditions
- HIV
- Interventions
- Other: iSTAR
- Registration Number
- NCT03018002
- Lead Sponsor
- University of Nevada, Las Vegas
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 400
- HIV-infected pregnant women identified during baby showers programs at participating worship centers.
- HIV-infected women already on treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iSTAR iSTAR HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.
- Primary Outcome Measures
Name Time Method Linkage in care 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 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
Name Time Method ART Initiation 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 12 months Viral suppression is defined as the percentage of participants whose most recent two viral load are \<20 copies/mL.
Trial Locations
- Locations (1)
Catholic Caritas Foundation
🇳🇬Makurdi, Benue, Nigeria