Evaluation of South Africa's National Adherence Strategy

NCT ID: NCT02536768

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8020 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-04-30

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.

Conditions

HIV; Tuberculosis; Diabetes; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Minimum package of interventions to improve ART adherence

Intervention Type: 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

Comparison

Standard of care HIV treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

World Bank (Lead institution)

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Matthew Fox

Professor (Note: Not the PI, but one Co-PI)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Fox, DSc

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Johannesburg Site

Johannesburg, , South Africa

Countries

South Africa

References

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.

Reference Type: DERIVED

PMID: 33735206 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32585077 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31335865 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29358446 (View on PubMed)

Other Identifiers

7173709

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-34074

Identifier Type: -

Identifier Source: org_study_id