Evaluation of South Africa's National Adherence Strategy

Hypertension Clinical Trial

— ENHANCE  

Official title:

Evaluation of the National Department of Health's National Adherence Guidelines for Chronic Diseases in South Africa Using Routinely Collected Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536768
• Other study ID #: H-34074
• Secondary ID: 7173709
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2019
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8020
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes
• HIV
• Hypertension
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
South Africa	Johannesburg Site	Johannesburg

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Republic of South Africa National Department of Health (Lead institution), World Bank (Lead institution)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alive and in care using clinical records	Patient has attended the clinic between 3 and 12 months after being eligible for an intervention	3-12 months
Primary	HIV viral supression using lab data	HIV viral load measure below 400 copies per ml between 4 and 12 months after eligibility for an intervention	4-12 months