Evaluation of South Africa's National Adherence Strategy

NCT02536768 | Completed DMC

• 2 other identifiers: H-340747173709
• Study Type: interventional
• Target: 8,020
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Tuberculosis; Diabetes; Hypertension

Keywords

Medication adherence; ART; Counseling; Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Comparison

NO INTERVENTION

Standard of care HIV treatment

Interventions

Minimum package of interventions to improve ART adherence BEHAVIORAL

Package of 5 interventions to antiretroviral therapy adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Not resident in the facility's catchment area
• Recorded intention to transfer care to a different facility within 12 months

You may not qualify if:

• Pregnant and eligible for PMTCT

Sponsors & Collaborators

• Boston University: lead
• World Bank (Lead institution): collaborator
• Republic of South Africa National Department of Health (Lead institution): collaborator

Study Sites (1)

Johannesburg Site

Johannesburg, South Africa

Location

Related Publications (4)

• Larson BA, Pascoe SJS, Huber A, Long LC, Murphy J, Miot J, Fraser-Hurt N, Fox MP, Rosen S. Fast-track treatment initiation counselling in South Africa: A cost-outcomes analysis. PLoS One. 2021 Mar 18;16(3):e0248551. doi: 10.1371/journal.pone.0248551. eCollection 2021.

  PMID: 33735206 DERIVED

• Pascoe SJS, Scott NA, Fong RM, Murphy J, Huber AN, Moolla A, Phokojoe M, Gorgens M, Rosen S, Wilson D, Pillay Y, Fox MP, Fraser-Hurt N. "Patients are not the same, so we cannot treat them the same" - A qualitative content analysis of provider, patient and implementer perspectives on differentiated service delivery models for HIV treatment in South Africa. J Int AIDS Soc. 2020 Jun;23(6):e25544. doi: 10.1002/jia2.25544.

  PMID: 32585077 DERIVED

• Fox MP, Pascoe S, Huber AN, Murphy J, Phokojoe M, Gorgens M, Rosen S, Wilson D, Pillay Y, Fraser-Hurt N. Adherence clubs and decentralized medication delivery to support patient retention and sustained viral suppression in care: Results from a cluster-randomized evaluation of differentiated ART delivery models in South Africa. PLoS Med. 2019 Jul 23;16(7):e1002874. doi: 10.1371/journal.pmed.1002874. eCollection 2019 Jul.

  PMID: 31335865 DERIVED

• Fox MP, Pascoe SJ, Huber AN, Murphy J, Phokojoe M, Gorgens M, Rosen S, Wilson D, Pillay Y, Fraser-Hurt N. Assessing the impact of the National Department of Health's National Adherence Guidelines for Chronic Diseases in South Africa using routinely collected data: a cluster-randomised evaluation. BMJ Open. 2018 Jan 21;8(1):e019680. doi: 10.1136/bmjopen-2017-019680.

  PMID: 29358446 DERIVED

MeSH Terms

Conditions

Tuberculosis; Diabetes Mellitus; Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Matthew Fox, DSc

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Note: Not the PI, but one Co-PI)

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)