A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in two Urban Settings in Zambia - Research Protocol

Persistent identifier

https://doi.org/10.17037/DATA.00002116

Data description

The protocol contains sections on data collection tools and informed consent.

The study was based on prospectively collected routine data , gathered for M&E 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. At the end of the study patient outcomes were also collected from the study documents and clinical records

Data collected via study forms were then entered in the database. Data was exported as comma separated values (csv) files. CVS 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).

Geographic regions

The study was conducted in 2 primary health care facilities serving two urban communities in Lusaka, Zambia.

Key dates

• May 2017 – December 2017 (this was the enrolment phase)
• May 2017 – 30th April 2019 (recruitment and follow-up phase till the study exit)
• Between May 2019 – July 2019(After the study ended), some missing information was collected, and some errors rectified.
• Data was cleaned between May and July 2019 and the final dataset was created in December 2019.

Quality controls

Quality assurance and quality control was conducted 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 that was recorded in our study/ source documents.

Validity of the entered data was checked through strongly typed validation as well as UI validation where necessary. As a PI of the study, I ensured that the research staff, data associates conducted quality assurance on the study forms on a monthly basis.

After the study, the research staff did verifications on all study forms and any questions or clarifications during the verifications of the datasets was further rectified with source documents.

Quality control was also done 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.

Population

Human Populations (stable HIV+ patients on ART)

Privacy

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 was be sought from the Ministry of Health. The study team then periodically extract this data for measuring the outcomes of the study. 

Ethics

The study obtained ethical clearance from the following:

1. University of Zambia Biomedical research Ethics (UNZABREC)
2. MINISTRY OF HEALTH
3. LSHTM ethics committee
4. Approval by DAIDS who granted permission to carry this study as an ancillary study to the main HPTN 071 study

Keywords

HIV; Home based ART delivery;  Adherence clubs, human immunodeficiency virus, Antiretroviral therapy

Language of written material

English

Project title

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.

Additional information

For articles that will be published by journals, all articles accepted will require a link to the full protocol published at the LSHTM institution.

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.

Data creators

File description