ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of South Africa's National Adherence Strategy (ENHANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02536768
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
World Bank (Lead institution)
Republic of South Africa National Department of Health (Lead institution)
Information provided by (Responsible Party):
Matthew Fox, Boston University

Brief Summary:
NOTE THAT THE STUDY IS LED BY SOUTH AFRICA NATIONAL DEPARTMENT OF HEALTH AND WORLD BANK WITH SUPPORT FROM BOSTON UNIVERSITY. The South Africa National Department of Health (NDOH) intends to launch its newly developed National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs) throughout South Africa in the coming year. Early implementation of the "minimum package" of interventions described in the Adherence Guidelines for HIV patients will take place at 12 primary health clinics and community health centres in four provinces starting in July 2015. To maximize the learning potential of this early implementation stage, NDOH will match the intervention clinics with 12 comparison clinics and randomly allocate intervention or comparison status within the pairs of clinics. This will allow the outcomes of the interventions to be evaluated using a cluster-randomized design and generate data on the costs of implementation and the potential need for adherence support for the other diseases addressed in the guidelines (tuberculosis, hypertension, and diabetes). This protocol is for the evaluation, which will generate information on the effectiveness of minimum package interventions and help improve the design, implementation, and budgeting of the guidelines.

Condition or disease Intervention/treatment Phase
HIV Tuberculosis Diabetes Hypertension Behavioral: Minimum package of interventions to improve ART adherence Not Applicable

Detailed Description:

The study will assess the effectiveness of five interventions in the minimum package: 1) Fast track initiation counseling for patients eligible for antiretroviral therapy; 2) Enhanced adherence counseling for unstable patients on HIV treatment; 3) adherence clubs for stable patients on HIV treatment; 4) decentralized medication delivery for stable patients on HIV treatment; and 5) early tracing of all patients who miss an appointment by two weeks. This study will also estimate for each study site an overall "adherence guideline impact" to provide an indication of the effectiveness of the package as a whole.

In addition, the study will estimate the cost of each of the interventions listed above compared to standard of care. Finally, the study will describe the cascade of care for tuberculosis, hypertension, and diabetes, three other chronic diseases for which little information currently exists. To evaluate these interventions the study team will work with the National Department of Health (which will implement the interventions) to randomize 24 clinics in 4 provinces 1:1 to receive the interventions or continue standard of care. All evaluations will use data routinely collected by the clinics, with no study interaction with subjects. A total of 8,256 patients will be enrolled and followed for up to 20 months to estimate short- and long-term outcomes.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the National Department of Health's National Adherence Guidelines for Chronic Diseases in South Africa Using Routinely Collected Data
Study Start Date : September 2015
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Minimum package of interventions to improve ART adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits
Behavioral: Minimum package of interventions to improve ART adherence
Package of 5 interventions to antiretroviral therapy adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits

No Intervention: Comparison
Standard of care HIV treatment



Primary Outcome Measures :
  1. Alive and in care using clinical records [ Time Frame: 3-12 months ]
    Patient has attended the clinic between 3 and 12 months after being eligible for an intervention

  2. HIV viral supression using lab data [ Time Frame: 4-12 months ]
    HIV viral load measure below 400 copies per ml between 4 and 12 months after eligibility for an intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • Meet the inclusion criteria for one or more intervention
  • Not resident in the facility's catchment area
  • Recorded intention to transfer care to a different facility within 12 months

Exclusion Criteria:

  • Pregnant and eligible for PMTCT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536768


Locations
South Africa
Johannesburg Site
Johannesburg, South Africa
Sponsors and Collaborators
Boston University
World Bank (Lead institution)
Republic of South Africa National Department of Health (Lead institution)
Investigators
Principal Investigator: Matthew Fox, DSc Boston University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Fox, Professor (Note: Not the PI, but one Co-PI), Boston University
ClinicalTrials.gov Identifier: NCT02536768     History of Changes
Other Study ID Numbers: H-34074
7173709 ( Other Grant/Funding Number: World Bank )
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew Fox, Boston University:
Medication adherence
ART
Counseling
Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)

Additional relevant MeSH terms:
Tuberculosis
Chronic Disease
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Disease Attributes
Pathologic Processes