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

NCT01188941 | Completed DMC

• 2 other identifiers: 2006-P-001379/26R01MH090326
• Study Type: interventional
• Target: 1,899
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• Linkage and Retention in Care: ART-eligible Patients

  For ART-eligible HIV-infected patients, 3 months on ART as documented by ART initiation date in the electronic medical record.

  9 Months after Enrollment

• Linkage and Retention in Care: TB Patients

  For patients co-infected with TB, 6 months of TB treatment as documented by a written discharge of treatment outcome from a TB clinic.

  9 Months after Enrollment

• Linkage and Retention in Care: ART-eligible HIV/TB Co-infected Patients

  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.

  9 Months after Enrollment

Study Arms (2)

Standard of Care

NO INTERVENTION

Assigned a Health System Navigator

EXPERIMENTAL

Behavioral: Health System Navigator

Interventions

Health System Navigator BEHAVIORAL

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.

Assigned a Health System Navigator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Lying in a stretcher
• Not oriented to person, place and time

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator
• McCord Hospital: collaborator
• St Mary's Hospital, London: collaborator
• Brigham and Women's Hospital: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Boston University: collaborator

Study Sites (4)

St. Mary's Hospital

Durban, KwaZulu-Natal, 3605, South Africa

Location

McCord Hospital

Durban, KwaZulu-Natal, 4001, South Africa

Location

Mariannridge Clinic

Durban, KwaZulu-Natal, South Africa

Location

Tshelimnyama Clinic

Durban, KwaZulu-Natal, South Africa

Location

Related Publications (15)

• Bassett IV, Regan S, Chetty S, Giddy J, Uhler LM, Holst H, Ross D, Katz JN, Walensky RP, Freedberg KA, Losina E. Who starts antiretroviral therapy in Durban, South Africa?... not everyone who should. AIDS. 2010 Jan;24 Suppl 1(Suppl 1):S37-44. doi: 10.1097/01.aids.0000366081.91192.1c.

  PMID: 20023438 BACKGROUND

• Losina E, Bassett IV, Giddy J, Chetty S, Regan S, Walensky RP, Ross D, Scott CA, Uhler LM, Katz JN, Holst H, Freedberg KA. The "ART" of linkage: pre-treatment loss to care after HIV diagnosis at two PEPFAR sites in Durban, South Africa. PLoS One. 2010 Mar 4;5(3):e9538. doi: 10.1371/journal.pone.0009538.

  PMID: 20209059 BACKGROUND

• Drain PK, Losina E, Parker G, Giddy J, Ross D, Katz JN, Coleman SM, Bogart LM, Freedberg KA, Walensky RP, Bassett IV. Risk factors for late-stage HIV disease presentation at initial HIV diagnosis in Durban, South Africa. PLoS One. 2013;8(1):e55305. doi: 10.1371/journal.pone.0055305. Epub 2013 Jan 28.

  PMID: 23383147 BACKGROUND

• Regan S, Losina E, Chetty S, Giddy J, Walensky RP, Ross D, Holst H, Katz JN, Freedberg KA, Bassett IV. Factors associated with self-reported repeat HIV testing after a negative result in Durban, South Africa. PLoS One. 2013 Apr 23;8(4):e62362. doi: 10.1371/journal.pone.0062362. Print 2013.

  PMID: 23626808 BACKGROUND

• Bassett IV, Giddy J, Chaisson CE, Ross D, Bogart LM, Coleman SM, Govender T, Robine M, Erlwanger A, Freedberg KA, Katz JN, Walensky RP, Losina E. A randomized trial to optimize HIV/TB care in South Africa: design of the Sizanani trial. BMC Infect Dis. 2013 Aug 26;13:390. doi: 10.1186/1471-2334-13-390.

  PMID: 23972276 BACKGROUND

• Drain PK, Losina E, Coleman SM, Giddy J, Ross D, Katz JN, Bassett IV. Rapid urine lipoarabinomannan assay as a clinic-based screening test for active tuberculosis at HIV diagnosis. BMC Pulm Med. 2016 Nov 14;16(1):147. doi: 10.1186/s12890-016-0316-z.

  PMID: 27842535 BACKGROUND

• Bassett IV, Coleman SM, Giddy J, Bogart LM, Chaisson CE, Ross D, Flash MJ, Govender T, Walensky RP, Freedberg KA, Losina E. Barriers to Care and 1-Year Mortality Among Newly Diagnosed HIV-Infected People in Durban, South Africa. J Acquir Immune Defic Syndr. 2017 Apr 1;74(4):432-438. doi: 10.1097/QAI.0000000000001277.

  PMID: 28060226 BACKGROUND

• Drain PK, Losina E, Coleman SM, Bogart L, Giddy J, Ross D, Katz JN, Bassett IV. Social support and mental health among adults prior to HIV counseling and testing in Durban, South Africa. AIDS Care. 2015;27(10):1231-40. doi: 10.1080/09540121.2015.1046417. Epub 2015 Jul 25.

  PMID: 26213142 BACKGROUND

• Drain PK, Losina E, Coleman SM, Giddy J, Ross D, Katz JN, Bassett IV. Value of urine lipoarabinomannan grade and second test for optimizing clinic-based screening for HIV-associated pulmonary tuberculosis. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):274-80. doi: 10.1097/QAI.0000000000000436.

  PMID: 25415288 BACKGROUND

• Drain PK, Losina E, Coleman SM, Giddy J, Ross D, Katz JN, Walensky RP, Freedberg KA, Bassett IV. Diagnostic accuracy of a point-of-care urine test for tuberculosis screening among newly-diagnosed HIV-infected adults: a prospective, clinic-based study. BMC Infect Dis. 2014 Feb 26;14:110. doi: 10.1186/1471-2334-14-110.

  PMID: 24571362 BACKGROUND

• Cohen GM, Drain PK, Noubary F, Cloete C, Bassett IV. Diagnostic delays and clinical decision making with centralized Xpert MTB/RIF testing in Durban, South Africa. J Acquir Immune Defic Syndr. 2014 Nov 1;67(3):e88-93. doi: 10.1097/QAI.0000000000000309.

  PMID: 25314255 BACKGROUND

• Bassett IV, Coleman SM, Giddy J, Bogart LM, Chaisson CE, Ross D, Jacobsen MM, Robine M, Govender T, Freedberg KA, Katz JN, Walensky RP, Losina E. Sizanani: A Randomized Trial of Health System Navigators to Improve Linkage to HIV and TB Care in South Africa. J Acquir Immune Defic Syndr. 2016 Oct 1;73(2):154-60. doi: 10.1097/QAI.0000000000001025.

  PMID: 27632145 RESULT

• Bassett IV, Xu A, Giddy J, Bogart LM, Boulle A, Millham L, Losina E, Parker RA. Changing contextual factors from baseline to 9-months post-HIV diagnosis predict 5-year mortality in Durban, South Africa. AIDS Care. 2021 Dec;33(12):1543-1550. doi: 10.1080/09540121.2020.1837338. Epub 2020 Nov 2.

  PMID: 33138630 DERIVED

• Platt L, Xu A, Giddy J, Bogart LM, Boulle A, Parker RA, Losina E, Bassett IV. Identifying and predicting longitudinal trajectories of care for people newly diagnosed with HIV in South Africa. PLoS One. 2020 Sep 21;15(9):e0238975. doi: 10.1371/journal.pone.0238975. eCollection 2020.

  PMID: 32956380 DERIVED

• Bajema KL, Bassett IV, Coleman SM, Ross D, Freedberg KA, Wald A, Drain PK. Subclinical tuberculosis among adults with HIV: clinical features and outcomes in a South African cohort. BMC Infect Dis. 2019 Jan 5;19(1):14. doi: 10.1186/s12879-018-3614-7.

  PMID: 30611192 DERIVED

Study Officials

• Ingrid V Bassett, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 26, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

ZA (4)