Evaluation of South Africa's National Adherence Strategy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Tuberculosis, Diabetes, Hypertension

Intervention / Treatment
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* Behavioral: Minimum package of interventions to improve ART adherence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Package of 5 interventions to antiretroviral therapy adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits<br>|
| No Intervention: Comparison<br>Standard of care HIV treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, ART, Counseling, Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)