Intervention for Sustained Testing and Retention Among HIV-infected Patients

NCT ID: NCT03018002

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-03-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

iSTAR

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

Group Type: EXPERIMENTAL

iSTAR

Intervention Type: 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.

Interventions

iSTAR

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• HIV-infected women already on treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Echezona Ezeanolue

Professor of Public Health and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic Caritas Foundation

Makurdi, Benue State, Nigeria

Site Status: RECRUITING

Countries

Nigeria

Central Contacts

Echezona Ezeanolue, MD, MPH

Role: CONTACT

echezona.ezeanolue@unlv.edu

7028952687

Chima Onoka, MD, PhD

Role: CONTACT

chima.onoka@unn.edu.ng

+2348033802711

Facility Contacts

John Olawepo, MD, MSc

Role: primary

jolawepo@ccfng.org

+234-805 564 8788

References

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.

Reference Type: BACKGROUND

PMID: 23758933 (View on PubMed)

Other Identifiers

R01HD087994-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

845695-4

Identifier Type: -

Identifier Source: org_study_id