Table 1 Three pilots of HIV recent infection testing in routine service settings (adapted from [17]
Siaya County, Kenya | Nairobi, Kenya | Sisters with a Voice, Zimbabwe |
|---|---|---|
Study population | Study population | Study population |
Pregnant women seeking antenatal care in 14 medical facilities | Clients attending any of the 14 EDARP HTC facilities | FSW attending one of six static facilities of the Sisters with a Voice Programme |
Collaborative partner | Collaborative partner | Collaborative partner |
Kenya Medical Research Institute (KEMRI) and the KEMRI/CDC Siaya HDSS | Eastern Deanery AIDS Relief Programme (EDARP) | Centre for Sexual Health and HIV AIDS Research Zimbabwe (CeSHHAR-Zimbabwe) |
Study period | Study period | Study period |
February – November 2018 | March – November 2018 | June – November 2018 |
Assay | Assay | Assay |
Maxim HIV-1 LAg-Avidity EIA venous blood | Maxim HIV-1 LAg-Avidity EIA DBS | Maxim HIV-1 LAg-Avidity EIA venous blood & Maxim HIV-1 LAg-Avidity EIA DBS |
Inclusion criteria | Inclusion criteria | Inclusion criteria |
• Women aged 13 or older seeking antenatal care in one of the included medical facilities in Siaya County • Willing and able to provide informed consent • Received an HIV-antibody positive test result | • Aged 18 or older • Unknown HIV status prior to visit • Attending an EDARP HTC facility • Willing and able to provide informed consent • Received an HIV-antibody positive test result, or presumptive positive | • FSW aged 18 or older • Willing and able to provide informed consent • Received an HIV-antibody positive test result |
Exclusion criteria | Exclusion criteria | |
• Indeterminate HIV result • Not willing to enrol on follow-up at facility • Taking pre-exposure prophylaxis | • Indeterminate HIV result • Prior history of testing HIV-positive (> 1 year ago) • On ART | |
Specimen collection and testing | Specimen collection and testing | Specimen collection and testing |
• Facility nurse or laboratory phlebotomist drew a maximum of 10 ml of venous blood • Samples packed and transferred to KEMRI-Centre for Global Health Research HIV Research Laboratory in Kisumu on a daily basis where they were processed and stored for testing | Study nurse drew 6 mL of venous blood collected in an ethylenediaminetetraacetic (EDTA) tube and a pipette was used to dispense venous blood on two Whatman™ 903 Snap-Apart Cards with 5 dried blood spots (DBS) of 70 μL each, for a total of 10 filled spots per participant | • Study or clinic nurse drew venous blood collected in an ethylenediaminetetraacetic (EDTA) tube. • DBS samples were collected from fingerprick on one Whatman™ 903 Snap-Apart Cards with 5 dried blood spots (DBS) of 70 μL. • Both samples were packed and transferred to laboratory in Harare within 36 h and stored at -20C or below prior to testing |