Table 1.
Project DETECT part 2 procedures.
| Study procedure | Group 1: HIV negative or unknown | Group 2: established HIV infection (>90 days since diagnosis) | Group 3: newly diagnosed HIV positive (≤90 days since diagnosis) |
| Obtain verbal consent | X | X |
|
| Obtain written consent |
|
|
X |
| Release of information to obtain previous HIV resultsa |
|
|
X |
| Oral fluid testsb | X | X | X |
| Venipuncture whole blood testsc | X | X | X |
| Fingerstick whole blood testsd |
|
|
X |
| Geenius HIV 1/2 confirmatory teste | Xf | X | X |
| Collection of DBSg and samples for storageh | Xi | X | X |
| Laboratory Ag/Abj test performed through STDk clinicl | Xm |
|
|
| Laboratory Ag/Ab test performed through researchl |
|
X | X |
| Pooled NATn,o | Xp |
|
|
| Individual NATq | Xr | X | X |
| Complete part 2 of behavioral survey | X | X | X |
| Offer and consent, if applicable, part 3 enrollment if POCs tests are discordant | X |
|
X |
aRelease of information is sent to the provider who performed first positive HIV test and/or last negative HIV test if within 365 days.
bOral fluid tests include Dual Path Platform (DPP) HIV 1/2 Assay (Chembio Diagnostics System, Inc) and OraQuick ADVANCE Rapid HIV 1/2 Antibody test (Orasure Technologies, Inc).
cVenipuncture whole blood tests include DPP HIV 1/2 Assay, OraQuick ADVANCE Rapid HIV 1/2 Antibody test, INSTI HIV-1/HIV-2 Rapid Antibody Test (bioLytical Laboratories, Inc), Determine HIV 1/2 Ag/Ab Combo (Abbott Laboratories), and SAMBA II HIV-1 Qual test (Diagnostics for the Real World). SAMBA II HIV-1 Qual test was added to the Project DETECT study protocol in June 2018.
dFingerstick whole blood tests include DPP HIV 1/2 Assay, OraQuick ADVANCE Rapid HIV 1/2 Antibody test, INSTI HIV-1/HIV-2 Rapid Antibody Test, Determine HIV 1/2 Ag/Ab Combo, and SAMBA II HIV-1 Qual test. SAMBA II HIV-1 Qual test was added to the Project DETECT study protocol in June 2018.
eGeenius HIV 1/2 Supplemental Assay (Bio-Rad Laboratories, Inc).
fGeenius HIV 1/2 Supplemental Assay performed as point-of-care test on venipuncture whole blood if at least one point-of-care test is positive.
gDBS: dried blood spot.
hIncludes DPP HIV 1/2 oral fluid swabs, HIV-1 Oral Specimen Collection Device (Orasure Technologies, Inc), and a Whatman 903 Protein Saver Card (dried blood spot; GE Healthcare).
iIf point-of-care results are discordant, the point-of-care oral fluid and venipuncture whole blood DPP HIV 1/2 Assays are saved and stored.
jAb/Ag: antibody/antigen.
kSTD: sexually transmitted disease.
lGS HIV-1/HIV-2 Combo EIA (Bio-Rad Laboratories, Inc).
mIf the STD clinic does not order an Ab/Ag test for clinical purposes, the Project DETECT research team will order the test to be performed by PHSKC Public Health Laboratory.
nNAT: nucleic acid testing.
o10-member pools using RealTime HIV-1 (Abbott Laboratories).
pPooled NAT is performed only if participant is concordant negative on all point-of-care tests.
qRealTime HIV-1.
rIndividual NAT is performed if participant has discordant point-of-care test results. Individual NAT has been validated for diagnostic and monitoring purposes.
sPOC: point-of-care.