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

• ClinicalTrials.gov Identifier: NCT03018002
• Recruitment Status: Unknown
• First Posted: January 11, 2017
• Last Update Posted: January 11, 2017
• Sponsor: University of Nevada, Las Vegas
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Echezona Ezeanolue, University of Nevada, Las Vegas

Tracking Information

• First Submitted Date: January 6, 2017
• First Posted Date: January 11, 2017
• Last Update Posted Date: January 11, 2017
• Study Start Date: July 2016
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2017)

• Linkage in care [ Time Frame: 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 [ Time Frame: 12 months ]
  Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 10, 2017)

• ART Initiation [ Time Frame: 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 [ Time Frame: 12 months ]
  Viral suppression is defined as the percentage of participants whose most recent two viral load are <20 copies/mL.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intervention for Sustained Testing and Retention Among HIV-infected Patients
• Official Title: Intervention for Sustained Testing and Retention Among HIV-infected Patients
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
• Condition: 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.

Study Arms

• No Intervention: 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.
• Experimental: iSTAR
  HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.
  Intervention: Other: iSTAR

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 10, 2017): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2020
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Nigeria

Administrative Information

• NCT Number: NCT03018002
• Other Study ID Numbers: 845695-4; R01HD087994-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Echezona Ezeanolue, University of Nevada, Las Vegas
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Nevada, Las Vegas
• Original Study Sponsor: Same as current
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Not Provided
• PRS Account: University of Nevada, Las Vegas
• Verification Date: January 2017