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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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 20, 2013
Last verified: March 2013

August 13, 2010
March 20, 2013
August 2010
April 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01188941 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa
Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
HIV
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.
  • No Intervention: Standard of Care
  • Experimental: Assigned a Health System Navigator
    Intervention: Behavioral: Health System Navigator

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1674
January 2015
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01188941
2006-P-001379/26, R01MH090326
Yes
Ingrid V. Bassett, MD, MPH, Massachusetts General Hospital
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
Principal Investigator: Ingrid V Bassett, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP