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

Mass General Brigham

Status: Completed

Conditions: HIV

Treatments: Behavioral: Health System Navigator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01188941

2006-P-001379/26

R01MH090326 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,899 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,899 participants in 2 patient groups

Standard of Care

No Intervention group

Assigned a Health System Navigator

Experimental group

Treatment:

Behavioral: Health System Navigator