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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Health System Navigator

• Registration Number: NCT01188941
• Lead Sponsor: Massachusetts General Hospital

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.

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-26
• Primary Completion: 2014-04
• Study Completion: 2015-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1899

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assigned a Health System Navigator	Health System Navigator	-

Primary Outcome Measures

Name	Time	Method
Linkage and Retention in Care: TB Patients	9 Months after Enrollment	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 Patients	9 Months after Enrollment	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: ART-eligible HIV/TB Co-infected Patients	9 Months after Enrollment	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.

Trial Locations

Locations (4)

Tshelimnyama Clinic; 🇿🇦 Durban, KwaZulu-Natal, South Africa

St. Mary's Hospital; 🇿🇦 Durban, KwaZulu-Natal, South Africa

Mariannridge Clinic; 🇿🇦 Durban, KwaZulu-Natal, South Africa

McCord Hospital; 🇿🇦 Durban, KwaZulu-Natal, South Africa