Evaluation of South Africa's National Adherence Strategy

Not Applicable

Completed

• Conditions: HIV; Tuberculosis; Hypertension; Diabetes
• Interventions: Behavioral: Minimum package of interventions to improve ART adherence

• Registration Number: NCT02536768
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-29
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8020

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Minimum package of interventions to improve ART adherence	Minimum package of interventions to improve ART adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits

Primary Outcome Measures

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

Trial Locations

Locations (1)

Johannesburg Site; 🇿🇦 Johannesburg, South Africa