Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043).
<h4>Background</h4>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 communit...
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2013
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oai:doaj.org-article:fe8f9227f4ab405085832b59c3b4eef82021-11-18T07:37:50ZEstimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043).1932-620310.1371/journal.pone.0068349https://doaj.org/article/fe8f9227f4ab405085832b59c3b4eef82013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23874597/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT00203749.Oliver LaeyendeckerEstelle Piwowar-ManningAgnes FiammaMichal KulichDeborah DonnellDeb BassukCaroline E MullisCraig ChinPriscilla SwansonJohn HackettWilliam ClarkeMark MarzinkeGreg SzekeresGlenda GrayLinda RichterMichel W AlexandreSuwat ChariyalertsakAlfred ChingonoDavid D CelentanoStephen F MorinMichael SweatThomas CoatesSusan H EshlemanPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 7, p e68349 (2013) |
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Medicine R Science Q Oliver Laeyendecker Estelle Piwowar-Manning Agnes Fiamma Michal Kulich Deborah Donnell Deb Bassuk Caroline E Mullis Craig Chin Priscilla Swanson John Hackett William Clarke Mark Marzinke Greg Szekeres Glenda Gray Linda Richter Michel W Alexandre Suwat Chariyalertsak Alfred Chingono David D Celentano Stephen F Morin Michael Sweat Thomas Coates Susan H Eshleman Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). |
| description |
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT00203749. |
| format |
article |
| author |
Oliver Laeyendecker Estelle Piwowar-Manning Agnes Fiamma Michal Kulich Deborah Donnell Deb Bassuk Caroline E Mullis Craig Chin Priscilla Swanson John Hackett William Clarke Mark Marzinke Greg Szekeres Glenda Gray Linda Richter Michel W Alexandre Suwat Chariyalertsak Alfred Chingono David D Celentano Stephen F Morin Michael Sweat Thomas Coates Susan H Eshleman |
| author_facet |
Oliver Laeyendecker Estelle Piwowar-Manning Agnes Fiamma Michal Kulich Deborah Donnell Deb Bassuk Caroline E Mullis Craig Chin Priscilla Swanson John Hackett William Clarke Mark Marzinke Greg Szekeres Glenda Gray Linda Richter Michel W Alexandre Suwat Chariyalertsak Alfred Chingono David D Celentano Stephen F Morin Michael Sweat Thomas Coates Susan H Eshleman |
| author_sort |
Oliver Laeyendecker |
| title |
Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). |
| title_short |
Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). |
| title_full |
Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). |
| title_fullStr |
Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). |
| title_full_unstemmed |
Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043). |
| title_sort |
estimation of hiv incidence in a large, community-based, randomized clinical trial: nimh project accept (hiv prevention trials network 043). |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2013 |
| url |
https://doaj.org/article/fe8f9227f4ab405085832b59c3b4eef8 |
| work_keys_str_mv |
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