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

Nevada System of Higher Education (NSHE)

Status: Unknown

Conditions: HIV

Treatments: Other: iSTAR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03018002

845695-4

R01HD087994-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• HIV-infected women already on treatment

Trial design

400 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: iSTAR