Comparison of the p24 ELISA (Vironostika) and Combo test (antigen component) against serially diluted p24 antigen-positive controls.

*<p>Average OD (Optical Density) of two runs. An OD ≥0.10 is considered a positive result.</p

Map showing the distribution of 110 research sites as of July 2014.

<p>Map showing the distribution of 110 research sites as of July 2014.</p

Performance of the Determine Ag/Ab Combo test.

<p>Group 1: Antigen positive, antibody negative acute HIV infection (Ag+Ab−).</p><p>Group 2: Antigen positive, antibody positive early HIV infection (Ag+Ab+).</p><p>Group 3: Antigen negative, antibody positive chronic HIV infection (Ag−Ab+).</p><p>Group 4: Antigen negative, antibody negative volunteers without HIV infection (Ag−Ab−).</p><p>Group 5: Antigen false positive, antibody negative volunteers without HIV infection (Ag−Ab−).</p><p>Ag: p24 antigen, Ab: HIV antibody, weak pos: the respective assay indicator was fainter than the control indicator. This is considered “positive” in our analyses, as per the package insert.</p

HIV incidence and sex at each study site.

<p>*Cases per 100 person-years (95% CI). Stratified by sex only when the difference was statistically significant (p<0.05)</p><p>For more details, see [<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0134438#pone.0134438.ref015" target="_blank">15</a>]</p><p>HIV incidence and sex at each study site.</p

ELISA p24 Antigen Concentration and Viral Load Summary Statistics.

*<p>Upper limit of detection for the VL assay  = 15,000,000, any observation that exceeded 15,000,000 recorded as 15,000,001.</p><p>Group 1: Antigen positive, antibody negative i.e. acute HIV infection (Ag+ Ab−).</p><p>Group 2: Antigen positive, antibody positive i.e. early HIV infection (Ag+ Ab+).</p

Demographic characteristics of the suspected transmitting partners of incident cases reported to be in HIV discordant couple relationships.

<p>* Data or sample not available from one or both volunteers</p><p>** Transmitting partner reports use of antiretroviral therapy, EDI: Estimated date of infection in the incident case</p><p>°An additional 6 volunteers reported being on ART at or around the time of the transmission event, however their viral load was too low to sequence for linkage analysis</p><p>^▪ Comparing linked vs. unlinked across volunteer characteristic</p><p>^▪▪ Divorced, separated or widowed</p><p>Demographic characteristics of the suspected transmitting partners of incident cases reported to be in HIV discordant couple relationships.</p

First available CD4 count in 272 linked transmitting partners following HIV transmission. Vertical dashed line shows the analysis cut point of 90 days post EDI.

<p>First available CD4 count in 272 linked transmitting partners following HIV transmission. Vertical dashed line shows the analysis cut point of 90 days post EDI.</p

Screened, enrolled and analyzed volunteers by site and gender.

<p>Screened, enrolled and analyzed volunteers by site and gender.</p

Summary of reasons for screen-outs and exclusion from analysis by site.

<p>Percentages shown as a proportion of either total screened (above), or total enrolled (below)</p><p>* Volunteers may be excluded for multiple reasons therefore columns may sum to >100%</p><p>** Systolic blood pressure >140 mm Hg and/or diastolic blood pressure >90 mm Hg</p><p>*** Including headaches, cough, fever, suspected and confirmed malaria</p><p>**** Active STI, including candidiasis, one possible HSV-1 infection, lower abdominal pain in women, and Bartholin's abscess</p>‡<p>Including suspected and confirmed TB, pneumonia</p>†<p>Includes 125/184 (67.9%) medical exclusions not linked to infectious disease (e.g., trauma, diabetes, cancer)</p>§<p>Includes 4/17 (23.5%) medical exclusions not linked to infectious disease (3 peripheral neuropathy and 1 inebriation at time of visit)</p

Map of study sites showing source populations, elevation (meters above sea level) and target enrolment.

<p>Map of study sites showing source populations, elevation (meters above sea level) and target enrolment.</p