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Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa (Sizanani)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
McCord Hospital
St Mary's Hospital, London
Brigham and Women's Hospital
Children's Hospital Medical Center, Cincinnati
Boston University
Information provided by (Responsible Party):
Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01188941
First received: August 13, 2010
Last updated: March 24, 2016
Last verified: March 2016
History of Changes
  Purpose
The purpose of this study is to test the effects of a health system navigator intervention on rates of linkage to human immunodeficiency virus (HIV) and tuberculosis (TB) care among newly diagnosed HIV-infected outpatients in Durban, South Africa. Subjects will be approached in the outpatient department and enrolled prior to an HIV test. Subjects will then be randomized to the navigator arm or the standard of care arm. Subjects in the navigator arm will receive scheduled phone and short message service (SMS) contacts throughout the follow-up period to help guide them through the HIV and TB care pathways. The navigator will provide personalized support to help subjects overcome barriers they may face along the way.

Condition Intervention
HIV
 Behavioral: Health System Navigator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Linkage and Retention in Care: ART-eligible Patients [ Time Frame: 9 Months after Enrollment ] [ Designated as safety issue: No ]
    For ART-eligible HIV-infected patients, 3 months on ART as documented by ART initiation date in the electronic medical record.

  • Linkage and Retention in Care: TB Patients [ Time Frame: 9 Months after Enrollment ] [ Designated as safety issue: No ]
    For patients co-infected with TB, 6 months of TB treatment as documented by a written discharge of treatment outcome from a TB clinic.

  • Linkage and Retention in Care: ART-eligible HIV/TB Co-infected Patients [ Time Frame: 9 Months after Enrollment ] [ Designated as safety issue: No ]
    For HIV and TB co-infected patients who are ART-eligible, completion of either the ART or TB treatment outcome will be considered successful completion of the Primary Outcome Measure.
Enrollment: 1899
Study Start Date: August 2010
Study Completion Date: April 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
Experimental: Assigned a Health System Navigator Behavioral: Health System Navigator
Subjects will be enrolled prior to an HIV test. Following TB screening, HIV infected subjects will meet with the health systems navigator who will administer a brief strengths-based interview. During this interview the participant and navigator will identify barriers to HIV and/or TB care and the resources and strengths that will be most helpful in overcoming these barriers. The health system navigator will stay in contact with participants for the next 4 months using phone calls and SMS on a standardized schedule. During the phone contacts the health system navigator will assess where the participant is on the care pathway. If the participant has not completed a step in his/her HIV or TB care, the health system navigator will help the participant draw on strengths identified in the initial interview and overcome any obstacles hindering him/her from accessing care.

Detailed Description:

This project is a randomized controlled trial of an intervention to improve linkage to HIV and TB care for South Africans undergoing HIV testing. Subjects undergoing HIV testing will be enrolled at three sites in the greater Durban area. These sites comprise two hospital-affiliated outpatient departments and primary health clinics served by a mobile health van. Routine TB screening, regardless of signs or symptoms, will be offered to all HIV-infected participants. HIV-infected participants will be randomized to determine whether they will be assigned to a health system navigator or will receive the current standard of care in Durban. Block randomization will be stratified by site and gender, with blocks of varying length.

The health system navigator will help patients identify barriers to entering care and devise solutions, optimize use of available resources, and serve as a trusted social supporter who is knowledgeable about the health care system but remains outside of it. The health system navigator will help subjects engage the HIV and TB care system through face-to-face contact, telephone conversations, and short messaging service SMS text reminders which are free for patients to receive. These phone contacts and SMS will follow a standardized protocol. We will evaluate the efficacy of the intervention, as measured by increased rates of antiretroviral therapy (ART) initiation and, for those with TB co-infection, TB treatment completion. We will also evaluate the cost and cost-effectiveness of this intervention.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English or Zulu speaking
  • Presenting for outpatient care
  • Voluntarily undergoing an HIV test
  • Able to give informed consent
  • Report no prior HIV test
  • Willing to share HIV and TB test results with research staff

Exclusion Criteria:

  • Pregnant
  • Lying in a stretcher
  • Not oriented to person, place and time
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188941

Locations
South Africa
St. Mary's Hospital
Durban, KwaZulu-Natal, South Africa, 3605
McCord Hospital
Durban, KwaZulu-Natal, South Africa, 4001
Mariannridge Clinic
Durban, KwaZulu-Natal, South Africa
Tshelimnyama Clinic
Durban, KwaZulu-Natal, South Africa
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
McCord Hospital
St Mary's Hospital, London
Brigham and Women's Hospital
Children's Hospital Medical Center, Cincinnati
Boston University
Investigators
Principal Investigator: Ingrid V Bassett, MD, MPH Massachusetts General Hospital
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ingrid V. Bassett, MD, MPH, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01188941     History of Changes
Other Study ID Numbers: 2006-P-001379/26  R01MH090326 
Study First Received: August 13, 2010
Last Updated: March 24, 2016
Health Authority: United States: Institutional Review Board
South Africa: Human Research Ethics Committee

ClinicalTrials.gov processed this record on September 23, 2016