The dataset contains prospectively-collected routine data obtained from stable HIV+ patients on Antiretroviral therapy (ART) when attending one of two primary health care facilities, each of served a community in Lusaka, Zambia. The data was collected for Monitoring and Evaluation purposes as part of the Zambian ART program. It contains patient baseline characteristics (sex, age, years on ART, viral load measurement) and other information used to determine their eligibility, acceptability and the randomized interventions they were allocated to and whether they agreed to the model of delivery and their preferences.
The study was based on prospectively collected routine data, gathered for Monitoring and evaluation purposes of the Zambian ART program. Routine clinical data was collected at enrolment using patient clinical records and entered in our study registers. At baseline the following variables were collected for patient and their clinic records to determine influence on outcome (Age, sex, recent viral load, WHO staging, ART start date). At the time of enrolment, patient residential zones, allocated intervention model, whether they agreed to take up the offer or not and their preferences were collected in the study eligibility form.
Data collected in the eligibility forms were then entered in the database. Data was exported as comma separated values (CSV) files. CSV files were imported and merged tables by patient unique ID number using STATA and data was cleaned using STATA.
Data was analysed by STATA and storage of datasets, STATA files, codebook on at our research HQ server (Zambart).
Data was collected from two primary health care facilities each serving a community based in Lusaka, Zambia.
Quality assurance and controls were implemented throughout the study period and after the study was completed, we had to do a verification process with the routine collected data with the national database to verify the data recorded in our study/ source documents.
Validity of the entered data was checked through strongly typed validation as well as user input (UI) validation where necessary. As study PI, I ensured the research staff, data associates conducted quality assurance on the study forms on a monthly basis.
After the study, the research staff performed verifications on all study forms and any questions or clarifications during the verifications of the datasets were further rectified with source documents.
Quality control was also performed on the data recording as well as data entry into the database by independent data associates. Audit on 20% of the data to ensure valid data input and completeness. We also audited 10-15% of all study related documents to ensure completeness.
Data was securely stored according to Ministry of Health and Smart Care guidelines that were already in place for all health care centres providing HIV care. All CHiPs involved in community of ART model delivery had to sign a consent form as per smart care National Guidelines which explicitly explained data confidentiality and respect of clients. Access of all data in the health centre database was based on user right and every user in the facility had to agree to terms of use, which was currently in place. The Audit Trail in Smart Care that is currently in place in all ART health centres logs key events, which occur in the system. It logs information such as who logged into the system, which patient reports they run, changes to inventory and who created a backup. Every single interaction had the identifier of whoever entered the data as well. This trail was to be used for security and audit purposes.
Once the data was merged and sorted then only de-identified files were put on discs/laptops
In order to obtain the data for monitoring and evaluation as well as for research purposes both by implementing partners and Zambart research teams, permission will be sought from the Ministry of Health. The study team will then periodically extract this data for measuring the outcomes of the study.
The study obtained ethical clearance from the following:
HIV; Home-based ART delivery; Adherence clubs; AntiRetroviral Therapy
English
A comparison of different community models of ART delivery amongst stable HIV+ patients in an urban setting
HPTN 071 and this sub-study were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under Cooperative Agreements UM1-AI068619, UM1-AI068617, and UM1-AI068613, with funding from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Additional funding was provided by the International Initiative for Impact Evaluation (3ie) with support from the Bill & Melinda Gates Foundation, as well as by NIAID, the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH), all part of NIH. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID, NIMH, NIDA, PEPFAR, 3ie, or the Bill & Melinda Gates Foundation.
The dataset contains several variables: Study ID, Date of enrolment, Sex, Community, Age, Years on ART, Study consent, Residential zone, Trial arm, Agreed to model, Preference indicator, Preference.
As an HPTN ancillary study, data will be shared with the National institute Health (NIH) as policies which falls under the umbrella of the main HPTN 071 trial.
| Forename | Surname | Faculty / Dept | Institution | Role |
| Mohammed | Limbada | Faculty of Infectious and Tropical Diseases | Zambart /London School of Hygiene & Tropical Medicine | Data Creator/ Analysis |
| Osborn | Shibwela | Data | Zambart | Data Creator |
| David | Macleod | Faculty of Epidemiology and Population Health | London School of Hygiene & Tropical Medicine | Statistician |
| Helen | Ayles | Faculty of Infectious and Tropical Diseases | London School of Hygiene & Tropical Medicine / Zambart | Supervisor |
| Filename | Description | Access status | Licence | Embargo period |
| FinalEligibility.dta | The dataset contains prospectively-collected routine data obtained from stable HIV+ patients on Antiretroviral therapy (ART) when attending primary health care facilities in Lusaka, Zambia | Request | Data sharing agreement |