Intervention for Sustained Testing and Retention Among HIV-infected Patients

HIV Clinical Trial

— iSTAR  

Official title:

Intervention for Sustained Testing and Retention Among HIV-infected Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018002
• Other study ID #: 845695-4
• Secondary ID: R01HD087994-01
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 10, 2017
• Start date: July 2016
• Est. completion date: March 2020

Study information

• Verified date: January 2017
• Source: University of Nevada, Las Vegas
• Contact: Echezona Ezeanolue, MD, MPH
• Phone: 7028952687
• Email: echezona.ezeanolue[@]unlv.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• HIV-infected women already on treatment

Study Design

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Nigeria	Catholic Caritas Foundation	Makurdi	Benue

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage in care	Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.	1 month	No
Primary	Retention in care	Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.	12 months	No
Secondary	ART Initiation	The secondary outcome is engagement in care defined as the percentage of participants initiated on ART at 1 month following enrollment.	1 month	No
Secondary	Viral Suppression	Viral suppression is defined as the percentage of participants whose most recent two viral load are <20 copies/mL.	12 months	No