Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa (Sizanani)
|ClinicalTrials.gov Identifier: NCT01188941|
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : April 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Health System Navigator||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1899 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Linkage and Retention: A Randomized Trial to Optimize HIV/TB Care in South Africa|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2015|
|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.
- Linkage and Retention in Care: ART-eligible Patients [ Time Frame: 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: TB Patients [ Time Frame: 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 HIV/TB Co-infected Patients [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188941
|St. Mary's Hospital|
|Durban, KwaZulu-Natal, South Africa, 3605|
|Durban, KwaZulu-Natal, South Africa, 4001|
|Durban, KwaZulu-Natal, South Africa|
|Durban, KwaZulu-Natal, South Africa|
|Principal Investigator:||Ingrid V Bassett, MD, MPH||Massachusetts General Hospital|