Association of various factors with false positive Determine RDT results in plasma; uni- and multi-variable log-link binomial regression results adjusted for clustering within household (N = 11732).

<p>PR  =  probability ratio for a false positive result; p  =  p-value; 95% CI  = 95% confidence interval.</p>*<p>covariates were only included in multi-variable model if uni-variable p-value <0.2.</p

Diagnostic Test performance of Determine and STAT-PAK RDT sensitivity, specificity, predictive values and likelihood ratios.

a<p>Prevalences differ from total population prevalence due to exclusion of participants.</p>b<p>No confidence interval can be calculated if sensitivity  = 100%.</p

Diagnostic Test performance of Determine and STAT-PAK RDT numbers of positive and negative results.

<p>Diagnostic Test performance of Determine and STAT-PAK RDT numbers of positive and negative results.</p

Association of various factors with false positive STAT-PAK RDT results in plasma; uni- and multi-variable log-link binomial regression results adjusted for clustering within household (N = 11969).

<p>PR  =  probability ratio for a false positive result; p  =  p-value; 95% CI  = 95% confidence interval.</p><p><i>P. falciparum</i> infection not included due to empty cells (no false positive results in <i>P. falciparum</i> infected participants because of low <i>P. falciparum</i> prevalence in survey 2).</p>*<p>variables were only retained in multi-variable model if uni-variable p-value <0.2.</p

HIV-Testing Algorithm and Exclusion criteria Survey 1.

<p>In Survey 1 we tested 1,889 whole blood specimen and 14,448 plasma specimen with the Determine HIV1/2 RDT. The confirmation algorithm included two different ELISAs and one Western Blot. If both ELISAs were in agreement their result was used as the reference standard result. Samples with discordant ELISA results were retested by Western Blot and the Western Blot result used. Samples with indeterminate Western Blot results were excluded from analysis. Negative RDT results were not directly confirmed, but regarded as true negative if the result of the following survey was also negative. Whole blood results where confirmation by ELISA testing was impossible due to lack of plasma, were regarded as true positive if the result in the next survey was confirmed positive and as false positive if a negative test result in the next survey was confirmed using the above reference algorithm. Results where the true HIV status could not be verified according to the reference algorithm were excluded from this analysis.</p

HIV-Testing Algorithm and Exclusion criteria Survey 2.

<p>In Survey 2 we tested only plasma samples from 15,957 participants using the STAT-PAK-HIV1/2 RDT. The confirmation algorithm was essentially the same as in Survey 1.It included two different ELISAs and one Western Blot for RDT positive samples. Participants, who’s positive RDT result had been confirmed in Survey 1 already were not re-tested. 319 negative RDT results were directly confirmed by Behring ELISA, 11563 were regarded as true negative because the result of the following survey was also negative.</p

Use of Hormonal Contraceptives by Participant Characteristics^*

*<p>Response variable coded as: 0 = Did not use hormonal contraceptives, 1 = Used hormonal contraceptives.</p>**<p>Significant observation.</p

Duration of Contraceptive use prior to Screening, Contraceptive Methods Used at enrollment and Pregnancies Reported

<p>Duration of Contraceptive use prior to Screening, Contraceptive Methods Used at enrollment and Pregnancies Reported</p

Demographic Characteristics of Female Study Participants by Site

<p>Demographic Characteristics of Female Study Participants by Site</p

Pattern of Contraceptive Use at Enrolment by Selected Demographic Factors (All Sites)

<p>Pattern of Contraceptive Use at Enrolment by Selected Demographic Factors (All Sites)</p