Uptake, accuracy, safety and linkage into care over two years of promoting annual self-testing for HIV in Blantyre, Malawi: a community-based prospective study – User Guide

Persistent identifier

10.17037/DATA.7

Description

A set of anonymised datasets produced in a community-based study to investigate self-testing for HIV in Blantyre, Malawi. Taken together the datasets enable replication of findings from the study including estimation of uptake of HIV self-testing (HIVST), analysis of sensitivity/specificity of self-reported self-test results compared to nurse-performed finger prick testing, and investigation of self-reported coercion to self-test.

Data collection methods

HIVST was made available to 14 neighbourhoods of ~1,200 adult residents each, two of whom were responsible for implementation of recruitment between February 2012 and April 2014. In general, paper-based data collection followed by electronic processing using optical mark reading software (OMR) with Microsoft Access database was used for all data collection tools. A register of all neighbourhood residents who requested (were given) an HIVST kit was kept by the volunteer neighbourhood counsellor. These data were later extracted and electronically processed and gave rise to the HIVST uptake dataset.

For the quality assurance dataset, a systematic sample of HIVST participants was selected for home-visit by study nurses aiming for minimum 5% coverage. Checks included age, confirmation of residency, whether or not HIVST kits had been used, and self-read result with offer of confirmatory testing (finger-prick blood parallel testing with Determine 1/2, Alere, Waltham, USA and Uni-Gold Recombigen HIV, Trinity Biotech, Bray, Ireland).

A self-completed questionnaire (SCQ) was given to all participants at the time a HIVST kit was given. The participant was requested to return both the SCQ and the used kit, and to drop them in a sealed ballot box. A self-reported self-test result was then recorded by the participant along with acceptability indicators and whether or not they had been forced to self-test. The returned used kit and the SCQ were sent to the laboratory where technicians re-read all used kits and recorded the result on the SCQ.

Data collection tools for this study may be obtained by emailing Liz Corbett (liz.corbett@lshtm.ac.uk).

Geographic regions

Blantyre, Malawi.

Key dates

Quality controls

~5% systematic sample of all HIV self-testing participants re-tested with finger-prick parallel testing by a study nurse.

Population

Adult residents in Blantyre, Malawi.

Privacy

Data collection was completely anonymous due to the nature of the study design i.e. involving neighbours to provide access to HIVST kits. Therefore, the SCQ which contained HIV results was completely unlinked to any other data collection tools and indeed from the entire process to ensure confidentiality. All the data were anonymised before undertaking any analysis by removing participant identifiers.

Ethics

Ethical approval was obtained from the College of Medicine Ethics Review Committee, University of Malawi; London; School of Hygiene and Tropical Medicine; and Liverpool School of Tropical Medicine. All participants opting for HIVST provided written (or witnessed thumbprint) informed consent.

Keywords

HIV, HIV self-testing, home-based; community-based.

Language of written material

English

Additional Information

User guide and data codebook reformatted and replaced with HTML instance on 16 June 2025. No changes to dataset.

Project Information

Project title Funder/sponsor Grant number Other information
Intensified HIV/TB prevention linking home-based HIV testing, including the option of self-testing, with HIV care:  a cluster-randomised trial in Blantyre, Malawi Wellcome Trust WT091769 ISRCTN02004005

Creators

Forename Surname Faculty / Dept Institution Role
Augustine Choko Epidemiology and Population Health / Infectious Disease Epidemiology London School of Hygiene & Tropical Medicine, UK Data Creator
Emily Webb Epidemiology and Population Health / Infectious Disease Epidemiology London School of Hygiene & Tropical Medicine, UK Data Creator
Elizabeth Corbett Infectious and Tropical Diseases / Department of Clinical Research London School of Hygiene & Tropical Medicine, UK Principal Investigator / Data Creator
Peter MacPherson Department of Public Health and Policy (UoL)
Department of Clinical Sciences (LSTM)
University of Liverpool, UK & Liverpool School of Tropical Medicine, UK Researcher
Barbara Willey   London School of Hygiene & Tropical Medicine, UK Project Member
Helena Feasy   Malawi-Liverpool Wellcome Trust Clinical Research Programme Blantyre, Malawi Project Member
Rodrick Sambakunsi   Malawi-Liverpool Wellcome Trust Clinical Research Programme; Blantyre, Malawi Data Collector
Aaron Mdolo   Malawi-Liverpool Wellcome Trust Clinical Research Programme; Blantyre, Malawi Project Member
Simon Makombe HIV Unit Ministry of Health, Lilongwe, Malawi Project Member
Nicola Desmond Department of Public Health and Policy University of Liverpool, UK Researcher
Richard Hayes   London School of Hygiene & Tropical Medicine, UK Sponsor
Hendramoorthy Maheswaran Division of Health Sciences (WMS) Malawi-Liverpool Wellcome Trust Clinical Research Programme, Blantyre, Malawi Warwick Medical School, Coventry, UK Researcher

File Description

Filename Description Access status Licence
census Age and sex denominators from enumeration of households in neighbourhoods included in the study between April and June 2011. Open Creative Commons Attribution (CCBY)
quality_assurance Contains two variables to enable estimation of sensitivity and specificity of self-reported HIVST results when compared to finger prick nurse-performed testing in parallel (using two rapid HIV diagnostic kits). Open Creative Commons Attribution (CCBY)
self_completed_questionnaire Data from self-testing participants who completed questionnaires given at the time of collecting HIVST kits from a volunteer neighbourhood resident. It contains socio-demographic data, self-reported coercion to self-test, self-reported self-test result and a laboratory technician re-read of returned used kits. Open Creative Commons Attribution (CCBY)
self_testing_individual_crude Data on people accessing HIV self-testing participants, including socio-demographic information and a variable to identify period of HIVST availability. Open Creative Commons Attribution (CCBY)
self_testing_individual_revised Data on people accessing HIV self-testing participants, including socio-demographic information and a variable to identify period of HIVST availability. Open Creative Commons Attribution (CCBY)
ConsentForm-HTC-TB-screening Participant information and consent for stage 2 HTC and TB screening in English Open Creative Commons Attribution (CCBY)
Self-testing_data_codebook Codebook for dataset tables Open Creative Commons Attribution (CCBY)
0007-UserGuide User guide for dataset (this document) Open Creative Commons Attribution (CCBY)