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Evaluation of South Africa's National Adherence Strategy

NCT02536768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8020

Last updated 2019-07-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • World Bank (Lead institution)

    collaborator UNKNOWN

  • Republic of South Africa National Department of Health (Lead institution)

    collaborator UNKNOWN

  • Boston University

    lead OTHER

Principal Investigators

  • Matthew Fox, DSc · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536768 on ClinicalTrials.gov