Quality Assurance & Control Scores for All Sites.

<p>Quality Assurance & Control Scores for All Sites.</p

Post-Test Support Services Quality Assurance & Control Scores by Site.

<p>Post-Test Support Services Quality Assurance & Control Scores by Site.</p

Quality Assurance & Control Reporting System and Responsibilities.

<p>Quality Assurance & Control Reporting System and Responsibilities.</p

VCT Quality Assurance & Control Scores by Site.

<p>VCT Quality Assurance & Control Scores by Site.</p

Rates of post-intervention preventive behavior among CSA or CPA men.

<p>Rates of post-intervention preventive behavior among CSA or CPA men.</p

Demographic characteristics among men at post-intervention assessment.

<p>Demographic characteristics among men at post-intervention assessment.</p

Estimation of HIV Incidence in a Large, Community-Based, Randomized Clinical Trial: NIMH Project Accept (HIV Prevention Trials Network 043)

<div><p>Background</p><p>National Institute of Mental Health Project Accept (HIV Prevention Trials Network [HPTN] 043) is a large, Phase III, community-randomized, HIV prevention trial conducted in 48 matched communities in Africa and Thailand. The study intervention included enhanced community-based voluntary counseling and testing. The primary endpoint was HIV incidence, assessed in a single, cross-sectional, post-intervention survey of >50,000 participants.</p><p>Methods</p><p>HIV rapid tests were performed in-country. HIV status was confirmed at a central laboratory in the United States. HIV incidence was estimated using a multi-assay algorithm (MAA) that included the BED capture immunoassay, an avidity assay, CD4 cell count, and HIV viral load.</p><p>Results</p><p>Data from Thailand was not used in the endpoint analysis because HIV prevalence was low. Overall, 7,361 HIV infections were identified (4 acute, 3 early, and 7,354 established infections). Samples from established infections were analyzed using the MAA; 467 MAA positive samples were identified; 29 of those samples were excluded because they contained antiretroviral drugs. HIV prevalence was 16.5% (range at study sites: 5.93% to 30.8%). HIV incidence was 1.60% (range at study sites: 0.78% to 3.90%).</p><p>Conclusions</p><p>In this community-randomized trial, a MAA was used to estimate HIV incidence in a single, cross-sectional post-intervention survey. Results from this analysis were subsequently used to compare HIV incidence in the control and intervention communities.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT00203749" target="_blank">NCT00203749</a></p></div

Algorithms used for quality assurance testing of study samples.

<p>The figure illustrates the testing algorithms that were used to determine and/or confirm the HIV status of study samples. This quality assurance testing was performed at the HPTN Network Laboratory (see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0068349#s2" target="_blank">Methods</a>). The algorithm used for quality assurance testing was determined by results obtained from HIV rapid testing performed at the study sites (for samples initially designated as HIV NEG, HIV DISC, and HIV POS, see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0068349#s2" target="_blank">Methods</a>). Quality assurance testing was performed for HIV POS samples if results from the avidity assay suggested absent or very low levels of anti-HIV antibodies (weird avidity). In this case, the HIV DISC algorithm was used to determine HIV status. Neg indicates that a negative or non-reactive test result was obtained. Pos indicates that a positive or reactive test result was obtained. Arrows (non-bolded) indicate the next step in sample testing. The following abbreviations were used to describe assays and tests used in the analysis (see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0068349#s2" target="_blank">Methods</a>): HIV Combo: ARCHITECT® HIV Ag/Ab Combo assay; EIA: Vitros EIA Human Immunodeficiency Virus Type 1 and/or 2 (HIV-1/2) Antibody Detection in Human Serum and Plasma; GA RNA: APTIMA® HIV-1 RNA Qualitative Assay; WB: Genetics System HIV-1 Western Blot.</p