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Evaluation of the National Adherence Guidelines for Chronic Diseases 2016, A Cluster-Randomised Evaluation

South Africa, 2016 - 2017
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Reference ID
ZAF_2016_NAGCDIE_v01_M
Producer(s)
Matthew P.Fox, Sophie J. Pascoe, Amy N. Huber, Joshua Murphy, Mokgadi Phokojoe, Marelize Gorgens, Sydney Rosen, David Wilson, Yogan Pillay, Nicole Fraser-Hurt
Metadata
DDI/XML JSON
Created on
Dec 05, 2019
Last modified
Dec 05, 2019
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3727
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  • Study Description
  • Data Dictionary
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  • Identification
  • Coverage
  • Producers and sponsors
  • Sampling
  • Data collection
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  • Disclaimer and copyrights
  • Metadata production
  • Identification

    Survey ID number

    ZAF_2016_NAGCDIE_v01_M

    Title

    Evaluation of the National Adherence Guidelines for Chronic Diseases 2016

    Subtitle

    A Cluster-Randomised Evaluation

    Country
    Name Country code
    South Africa ZAF
    Abstract

    This dataset was used in the preparation of the report: “Adherence Clubs and Decentralized Medication Delivery to Support Retention and Sustained Viral Suppression: Results from a Cluster Randomized Evaluation of Differentiated ART delivery models in South Africa” presenting the evaluation results of two interventions which were assessed in the context of an impact evaluation of five differentiated HIV care and adherence interventions in 24 South African facilities. The South African Government implemented Chronic Disease Adherence Guidelines, including adherence clubs (AC) and decentralized medication delivery (DMD). We compared those receiving AC/DMD at intervention sites to those eligible for AC/DMD at control sites. Outcomes were retention and sustained viral suppression (<400 copies/mL) 12 months after AC/DMD enrolment (or comparable time for controls). Twelve facilities were randomly allocated to intervention and 12 to control arms.

    We saw comparable DMD outcomes vs. standard of care at facilities, an AC retention benefit and retention and sustained suppression benefits amongst men. This suggests the importance of alternative service delivery models for men and of community-based strategies to decongest primary healthcare facilities. As these strategies also reduce patient inconvenience and decongest clinics, comparable outcomes are a success.

    Coverage

    Geographic Coverage

    It is taking place at 24 public sector clinics in four provinces in South Africa.

    • Gauteng Province
    • Limpopo Province
    • North West Province
    • KwaZulu Natal Province

    Producers and sponsors

    Primary investigators
    Name Affiliation
    Matthew P.Fox Boston University School of Public Health
    Sophie J. Pascoe University of the Witwatersrand
    Amy N. Huber University of the Witwatersrand
    Joshua Murphy University of the Witwatersrand
    Mokgadi Phokojoe National Department of Health, Pretoria, South Africa
    Marelize Gorgens The World Bank Group, Washington DC
    Sydney Rosen Boston University School of Public Health
    David Wilson The World Bank Group, Washington DC
    Yogan Pillay National Department of Health, Pretoria, South Africa
    Nicole Fraser-Hurt The World Bank Group, Washington DC

    Sampling

    Sampling Procedure

    Selection and randomisation of study sites

    The evaluation is being conducted at 24 PHCs in South Africa. All study sites follow the current guidelines for HIV care and treatment, dated December 2014. Six clinics were chosen from one district each in Gauteng, KwaZulu-Natal, Limpopo and North West Provinces.

    These provinces were chosen in consultation with NDOH to represent high HIV burden regions with high-burden districts and high-volume clinics. The study team developed a list of all sites in each participating province that met these criteria and selected three matched pairs of clinics per province. Pairs were matched on ART patient volume (1000-1999, 2000-4999, or =5000 current ART
    patients), setting (urban, informal settlement, or rural), location (pairs should be located relatively nearby one another) and HIV viral suppression rate (see table 2 of the report).

    In each pair, one clinic was randomly assigned (using a computer-generated randomisation) to receive early implementation of the minimum package of interventions, while the other continued to provide standard of care. No blinding was used.

    Table 4 of the report provided under Related Materials shows the sample size that is required to detect meaningful differences for objectives 1-5. Sample sizes were determined using PASS software for cluster-randomised designs. Each sample size was determined to measure our short-term outcome for the objective. All calculations assume a site-clustered design with the clinic as the cluster and 24 clusters evenly split between intervention and comparison groups.

    We assumed power of 80% and an alpha of 0.05. Sample sizes accounted for the cluster-randomised design by assuming a coefficient of variation of 0.1. Each sample size was calculated assuming a baseline proportion of patients achieving the outcome in the absence of the intervention as determined from the literature or experience. Sample sizes were calculated based on being able to detect an absolute increase on outcomes deemed to be clinically meaningful, ranging from 15% to 20% as determined by consensus of the investigators. The total sample size was calculated to be 3456 including all of the five HIV cohorts.

    Data collection

    Dates of Data Collection
    Start End
    2016 2017
    Data Collection Notes

    The data was collected from patient files and clinic registers is covered in the ENHANCE Data collection Case Report Form (CRF) provided under Related Materials.

    Data Access

    Citation requirements

    Use of the dataset must be acknowledged using a citation which would include:

    • the Identification of the Primary Investigator
    • the title of the survey (including country, acronym and year of implementation)
    • the survey reference number
    • the source and date of download

    Disclaimer and copyrights

    Disclaimer

    The user of the data acknowledges that the original collector of the data, the authorized distributor of the data, and the relevant funding agency bear no responsibility for use of the data or for interpretations or inferences based upon such uses.

    Metadata production

    DDI Document ID

    DDI_ZAF_2016_NAGCDIE_v01_M_WB

    Producers
    Name Affiliation Role
    Development Economics Data Group The World Bank Documentation of the DDI
    Date of Metadata Production

    2019-06-25

    Metadata version

    DDI Document version

    Version 01 (June 2019)

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