DDI_ZAF_2016_NAGCDIE_v01_M_WB Development Economics Data Group 2019-06-25 NADA Version 01 (June 2019) Evaluation of the National Adherence Guidelines for Chronic Diseases 2016 A Cluster-Randomised Evaluation NAGCD 2016 ZAF_2016_NAGCDIE_v01_M Matthew P.Fox Sophie J. Pascoe Amy N. Huber Joshua Murphy Mokgadi Phokojoe Marelize Gorgens Sydney Rosen David Wilson Yogan Pillay Nicole Fraser-Hurt NADA 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. South Africa 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 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. Other [oth] 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. 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 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. DMD Decentralized Medication Delivery Core data on HIV patients who are stable on antiretroviral treatment and eligible for two differentiated service delivery models. These patients were enrolled into an effectiveness evaluation of these two models and the data set provides information for each patient. This includes the type of cohort, enrolment clinic, intervention arm, age group, and whether the patient was co-infected with tuberculosis. The data file also provides the number of days each patient has been on HIV treatment, and the final outcome 12 months after enrolment. The data file supports an academic publication on the evaluation. Routine data were extracted into a Case Report Form provided under Related Materials. 578 8 AdherenceClub Adherence Clubs Core data on HIV patients who are stable on antiretroviral treatment and eligible for two differentiated service delivery models. These patients were enrolled into an effectiveness evaluation of these two models and the data set provides information for each patient. This includes the type of cohort, enrolment clinic, intervention arm, age group, and whether the patient was co-infected with tuberculosis. The data file also provides the number of days each patient has been on HIV treatment, and the final outcome 12 months after enrolment. The data file supports an academic publication on the evaluation. Routine data were extracted into a Case Report Form provided under Related Materials. 569 8 Unique (deidentified) study ID Unique (deidentified) study ID Unique (deidentified) study ID Unique (deidentified) study ID Unique (deidentified) study ID 578 30001 30578 Intervention cohort Intervention cohort Intervention cohort Intervention cohort Intervention cohort 578 Decentralized Medication Delivery Facility by province Facility by province Facility by province Facility by province Facility by province 578 GP Site 1 GP Site 2 GP Site 3 GP Site 4 GP Site 5 GP Site 6 KZN Site 1 KZN Site 2 KZN Site 3 KZN Site 4 KZN Site 5 KZN Site 6 LP Site 1 LP Site 2 LP Site 3 LP Site 4 LP Site 5 LP Site 6 NW Site 1 NW Site 2 NW Site 3 NW Site 4 NW Site 5 NW Site 6 Intervention/control status Intervention/control status Intervention/control status Intervention/control status Intervention/control status 578 DMD Control DMD Intervention Age categories Age categories Age categories Age categories Age categories 578 18-29 30-39 40-49 50+ TB diagnosis at baseline TB diagnosis at baseline TB diagnosis at baseline TB diagnosis at baseline TB diagnosis at baseline 578 Missing No Yes Time on ART at enrollment (days) Time on ART at enrollment (days) Time on ART at enrollment (days) Time on ART at enrollment (days) Time on ART at enrollment (days) 578 371 1691 Outcome at 12 months Outcome at 12 months Outcome at 12 months Outcome at 12 months Outcome at 12 months 577 Alive&InCare Death LTFU TransferOut Unique (deidentified) study ID Unique (deidentified) study ID Unique (deidentified) study ID Unique (deidentified) study ID Unique (deidentified) study ID 569 20001 20002 20003 20004 20005 20006 20007 20008 20009 20010 20011 20012 20013 20014 20015 20016 20017 20018 20019 20020 20021 20022 20023 20024 20025 20026 20027 20028 20029 20030 20031 20032 20033 20034 20035 20036 20037 20038 20039 20040 20041 20042 20043 20044 20045 20046 20047 20048 20049 20050 20051 20052 20053 20054 20055 20056 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20555 20556 20557 20558 20559 20560 20561 20562 20563 20564 20565 20566 20567 20568 20569 Intervention cohort Intervention cohort Intervention cohort Intervention cohort Intervention cohort 569 Adherence Club Facility by province Facility by province Facility by province Facility by province Facility by province 569 GP Site 1 GP Site 2 GP Site 3 GP Site 4 GP Site 5 GP Site 6 KZN Site 1 KZN Site 2 KZN Site 3 KZN Site 4 KZN Site 5 KZN Site 6 LP Site 1 LP Site 2 LP Site 3 LP Site 4 LP Site 5 LP Site 6 NW Site 1 NW Site 2 NW Site 3 NW Site 4 NW Site 5 NW Site 6 Intervention/control status Intervention/control status Intervention/control status Intervention/control status Intervention/control status 569 Control Intervention Age categories Age categories Age categories Age categories Age categories 569 18-29 30-39 40-49 50+ TB diagnosis at baseline TB diagnosis at baseline TB diagnosis at baseline TB diagnosis at baseline TB diagnosis at baseline 569 No Yes Time on ART at enrollment (days) Time on ART at enrollment (days) Time on ART at enrollment (days) Time on ART at enrollment (days) Time on ART at enrollment (days) 569 290 1694 Outcome at 12 months Outcome at 12 months Outcome at 12 months Outcome at 12 months Outcome at 12 months 569 Alive&InCare Death LTFU TransferOut