Baseline and primary data for the partner-provided HIV self-testing and linkage (PASTAL) adaptive multi-arm multi-stage cluster randomized trial in Blantyre, Malawi

Permanent Identifier:

https://doi.org/10.17037/DATA.00000923

Data Description

An anonymised dataset of 2,349 pregnant women accessing antenatal care in three primary health centres in urban Blantyre, Malawi who gave informed consent to participate in a an adaptive multi-arm multi-stage cluster randomized trial. The unit of randomization was the antenatal care (ANC) clinic day. On a given ANC day, women could receive standard of care (SOC) of receiving just an invitation letter to deliver to their male partner who was absent at this ANC visit. Or, the women could receive SOC plus two oral self-test kits alone or in combination with a guaranteed financial incentive of $3 or $10 conditional on clinic attendance following self-testing for HIV care or prevention. Two other arms offered a lottery-based incentive with 10% chance of winning $30 to male partners achieving the primary outcome, or a phone call reminder to the male partner immediately following collection of kits by the woman repeated after five days.

The dataset contains variables on baseline data for the women and their male partners as reported by the woman as well as data underlying the trial outcomes by arm. Recruitment and follow-up were completed between 8 August 2016 and 30 June 2017.

Data Collection Methods

The primary outcome of clinic attendance following HIV testing was measured by the male partner presenting to the clinic with a pre-allocated letter to seek HIV testing in the standard of care arm or to have their HIV self-test results confirmed by an HIV counsellor by returning a used test kit. The counsellor then recorded these events including referral to HIV treatment if confirmed HIV positive and the eventual initiation of ART or undergoing voluntary medical male circumcision if HIV negative and uncircumcised.

Women were interviewed at their next antenatal care visit (within 28 days of enrolment) to ascertain male partner testing, incidence of adverse events and linkage to clinic for HIV care or prevention.

Data Analysis and Preparation

Data were managed in Stata and R before final analysis.

Geographic regions

Blantyre, Malawi in Africa

Key dates

Data collection and follow-up completed between 8 August 2016 and 30 June 2017.

Quality Controls

Duplicate entries were checked before merging the baseline and the main outcome data. on-spot quality consistency and completeness checks were implemented using pre-programmed electronic questionnaires. Upon presentation at the clinic, men’s partners’ identity was confirmed by scanning a pre-allocated barcode.

Species:

Human population

Privacy:

The data do not contain any identifying information for the participants. All participants are identified by a unique number allocated to them during the study.

Ethics

Ethics approval was obtained locally from the College of Medicine Research Ethics Committee (COMREC) in Malawi (approval number P.04/16/1932) and from the London School of Hygiene & Tropical Medicine Ethics Committee (approval number 11308).

Keywords

HIV, HIV self-testing, secondary distribution, Malawi, Antenatal care.

Language of written material

English

Project title

PArtner-provided Self-Testing and Linkage (PASTAL) in antenatal care clinics: methodology and delivery of an adaptive cluster randomized trial in Blantyre, Malawi

Funder/Sponsor

Wellcome Trust, UK

Grant Number

105828/Z/14/Z

Additional Information

At baseline, women who were eligible gave consent and gave information about themselves and their male partners. During the woman’s next antenatal care visit (within 28 days of enrolment), the woman was interviewed through audio computer assisted self-interview (ACASI) to capture any adverse events and outcomes related to the male partner including if the partner had tested for HIV since enrolment. Male partners who tested and presented to the clinic completed a personal data capture while receiving HIV services including testing, starting treatment and being circumcised at the clinic.

Data Creators

File Description