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1. Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043).

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, and Susan H Eshleman

Subjects
Medicine, Science
Abstract

BackgroundNational 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.MethodsHIV 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.ResultsData 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%).ConclusionsIn 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.Trial registrationClinicalTrials.gov NCT00203749.

Published
2013
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7. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author

Jared M Baeten, Thesla Palanee-Phillips, Nyaradzo M Mgodi, Ashley J Mayo, Daniel W Szydlo, Gita Ramjee, Brenda Gati Mirembe, Felix Mhlanga, Portia Hunidzarira, Leila E Mansoor, Samantha Siva, Vaneshree Govender, Bonus Makanani, Logashvari Naidoo, Nishanta Singh, Gonasagrie Nair, Lameck Chinula, Urvi M Parikh, John W Mellors, Iván C Balán, Kenneth Ngure, Ariane van der Straten, Rachel Scheckter, Morgan Garcia, Melissa Peda, Karen Patterson, Edward Livant, Katherine Bunge, Devika Singh, Cindy Jacobson, Yuqing Jiao, Craig W Hendrix, Zvavahera M Chirenje, Clemensia Nakabiito, Taha E Taha, Judith Jones, Kristine Torjesen, Annalene Nel, Zeda Rosenberg, Lydia E Soto-Torres, Sharon L Hillier, Elizabeth R Brown, Dorothy Aanyu, John Abima, Janne Abullarade, Priyanka Agarwal, Surabhi Ahluwalia, Simon Africa Akasiima, Carolyne Agwau Akello, Samuel Albert, Motsamai Alphale, Calins Alphonse, Lucy Apeduno, Sara Aranda, Orly Aridor, Shakeera Arnolds, Prossy Asiimwe, Millicent Atujuna, Didas Atwebembere, Lakshmi Baboolall, Kiran Badana, Jared M. Baeten, David Balamusani, Iván C. Balán, Gabriel Banda, Towera Whitney Banda, Jennifer Baugh, James Amos Baziira, May Beamer, Sivuyisiwe Asanda Bebeza, Linda-Gail Bekker, Ian Bell, Meagan Bemer, Richard Berman, Jennifer Berthiaume, Linda Bezak, Yashveer Bhagwandin, Hassen Anwar Bhayat, Nokulunga Bhengu, Sonto Bhengu, Aruna Bhoola, Florence Asiimwe Biira, Daniel Bittoni, Roberta Black, Nombuso Jacqueline Blose, Pearl Boks, Stephen Gordon Bolton, Phathiswa Botya, Amanda Brown, Elizabeth Brown, Helen Brown, Robyn Helen Bruce, Luke Erismus Bukenya, Aidah Bukirwa, Lisa Bunts, Fezile Buthelezi, Mbongeleni William Buthelezi, Samkelisiwe Dumisile Buthelezi, Rose Byogero, Samiksha Byroo, Robert Byuma, Johanna Albertha Carstens, Allison Carter, Nazneen Cassim, Busisiwe Cebekhulu, Bongekile Cele, Dolly Judith Cele, Phindile Cele, Simangele Cele, Sithabile Cele, Mary Chadza, Nahida Chakhtoura, Claire Chapdu, Gift Tafadzwa Chareka, Charles Chasakara, Manju Chatani-Gada, Diana Chetty, Mary Chidanyika, Tafadzwa Tariro Lisa Chifambi, Emelder Chihota, Sungano Chikono, Anesu Chikonyora, Brett Dzidzai Chikukwa, Craig Chin, Mary Chindevu, Tendai Blessing Chinyanda, Thandiwe Hilda Chirenda, Zvavahera Mike Chirenje, Chiedza Chirisa, Patience Chisale, Angela Chishanga, Tobias Chitambo, Fred Chitema, Flora Chithila, Tinei Helen Chitowa, Catherine Chitsinde, Gladys Chitsulo, Miria Chitukuta, Spiwe Chiveso, Nelecy Chome, Phumelele Fortune Chonco, Emily Christopher, Kerusha Chunderduri, Vutomi Cibi, Naana Cleland, Thobeka Coba, Mandy Rae Cobbing, Clare Collins, Kim Comer, Shameen Cozzi, Danielle Crida, Sufia Dadabhai, Thembakazi Daki, Nwabisa Danster, Reshmi Dassaye, Renita David, Jontraye M. Davis, Sumaya Dawood, Pallabi Deb, Leslie Degnam, Tiffany Sharron Derrick, Bríd Teresa Devlin, Charlene Dezzutti, Patricia Mae Dhlakama, Lorna Dias, Jean Chivoniso Dimairo, Elaine Dinnie, Avile Dlabanta, Msizi Dladla, Thandeka Immaculate Dladla, Andile Princess Dlungele, Curtis Dolezal, Kristine Donaty, Clare Dott, Jenna Dubbs, Vuyiseka Dubula-Majola, Pamella Dukwe, Cebo Ivan Duma, Portia Ignatia Makhosazana Duma, Promise Duma, Vimbai Kudzanai Duncan, Luis Duran, Lindelwa Dyabeni, Andrew Edwards, Radhika Etikala, Juliane Etima, Lee Fairlie, Henry Fischer, Jacqueline Fitzpatrick, Llewellyn Fleurs, Mary Glenn Fowler, Lester Freeman, Zakir Gaffoor, Lizzy Gama, Anita Garg, Vanesa Margret Gatsi, Clifford Gcwensa, Emmanuel Lwandile Gebashe, Samantha Geduld, Jennipher Gelant, Donna Germuga, Joseph Ggita, Rebecca Giguere, Lucy Godo, B. Jay Goetz, Litha Gogo, Esther Goliati, Daniel Kondwani Gondwe, Kelley C. Gordon, Rodney Goreraza, Jayandree Gounden, Dhevium Govender, Justin Sivalingum Govender, Nerusha Govender, Subramonien Govender, Nonkululeko Nosipho Gqwara, Anisa (Tracy) Gravelle, Phindile Guga, Victor Guma, Delisile Zilungile Gumede, Sibusiso Gumede, Thembelihle Gumede, Thobeka Winifred Gumede, Orgrah Gundani, Ravi Gunnam, Rahul Gupta, Mirriam Gwande, Xolani Gxako, Kim Hall, Wayne Hall, Perry Hargrave, Ishana Harkoo, Tanya Harrell, Amy L. Heaps, Simone Lara Hendricks, Craig W. Hendrix, Bongeka Hlabisa, Lungile Bongeka Hlabisa, Kudzai Hlahla, Thulebona Martin Hlela, Thandiwe Hobongwana, Eva Horn, Ridley Howard, Haixiao Huang, Portia Hunidzairia, Nivriti Hurbans, Marla Husnik, Tendai Doreen Hwehwe, Rabia Imamdin, Amina Ismail, Ebrahiema Jacobs, Ashleigh Catherine Jacques, Jane Jamabya, Grace James, Karla Janse van Rensburg, Ziningi Nobuhle Jaya, Nitesha Jeenarain, Lauren Jennings, Haoping Jiang, Ning Jiang, Nwabisa Laurianne Jijana, Godfrey Jokoniya, Mildred Kabasonga, Daniel Kizza Kabenge, Samuel Kabwigu, Evans Kachale, Lonely Kachenjera, Fiona Kachingamire, Emma Kachipapa, Mary Kadiwa, McLoddy Kadyamusuma, Bosco Kafufu, Mary Mukasa Kagwa, Clare Kajura-Manyindo, Brenda Catherine Kakayi, Victoria Kaliwo, Dishiki Jenny Kalonji, Nyasha Elizabeth Kamanga, Betty Kamira, Zerif Kampangire, Getrude Kamwana, Justine Kamya, La-Donna Kapa, Patrick Karugaba, Khumbo Kasambara, Priya Kassim, Sheetal Kassim, Milly Katana, Francis Katongole, Sulaiman Katongole, Alexis Katsis, Chaplain Katumbi, Ariana W.K. Katz, Edmore Kawanje, Caroline Nassozi Kawuma, Sowedi Kayongo, Emily Kekana, Doreen Kemigisha, Siphosihle Khanyile, Nombuso Happiness Khanyisile, Babalwa Khaya, Noluthando Khiya, Norah Ntombikayise Khoza, Thembisile Khumalo, Christina Khwela, Zamo Khwela, Edith Kibiribiri, Ismael Kibirige, Beatrice Kiiza, Florence Sempa Kikonyogo, Melissa Kin, Catherine Kirkwood, Girisha Kistnasami, Flavia Matovu Kiweewa, Max Kiweewa, Deepika Konatham, Lungile Kubheka, Terrence Kufakunesu, Phaleda Kumwenda, Wiza Wisdom Isaac Kumwenda, Maura Kush, Bryan A. Kutner, Ntomboxolo Kwatsha, Rosper Kwedza, Erinah Kyomukama, Debra Lands, Phumelele Nokuthula Langa, Kalkidan Lebeta, Cody Lentz, Brendley Tebogo Leremi, Michelle Leszczewski, Lisa Levy, Ted Livant, Irene Lukas, Lungile Pearl Mabanga, Nomusa Mabaso, Vimbainashe Machisa, Toni M. Maddox, Bernadette Madlala, Nocwaka Magobiane, Melda Magolela, Fungai Maguramhinga, Phumzile Desiree Magwaza, Keshnee Maharaj, Ferial Mahed, Tankiso Vuyiswa Mahlase, Moshukutjoane Lebogang Maila, Yvonne Makala, Patrick Makamure, Kgabo Phineas Makgoka, Pamela Makhamba, Nompumelelo Makhanya, Rulani Makondo, Rujeko Makoni, Henry Makooka, Jennie Makunganya, Sibongile Makwenda, Gakiema Malan, Agnes Malemia, Mariette Malherbe, Faith Malunga, Temantfulini Mamba Nhassengo, Mogau Mampa, Tendai Karen Mamvura, Elmah Manengamambo, Loreen Zandile Mangove, Nomvuyo Thelma Mangxilana, Tsungai Patience Manjera, Winifred Elizabeth Mans, Leila Mansoor, Memory Maoko, Annie Mapfunde, Nonhlanhla Yvonne Maphumulo, Francis E.A. Martinson, Abel Maruwo, Emmerentia Yvonne Marx, Mark A. Marzinke, Moira Masango, Mmathabo Nnana Mashego, Gwendoline Thotele Refilwe Mashinini, Shingirayi Irene Masuko, Kudzai Viviana Matambanadzo, Florence Tintswalo Mathebula, Matheus Mathipa, Jacob Munyaradzi Matsa, Eleanor Agnes Matta, Allen Taguma Matubu, Ayanda Comfort Mavundla, Sandile Mavundla, Billy Mawindo, Josiah Mayani, Emmanuel Mayanja, Nombongo Mayekiso, Nonkululeko Precious Mayisela, Ashley J. Mayo, Mary Speciosa Mbabali, Nonhlakanipho Masibonge Gciniwe Mbanjwa, Constance Seanokeng Mbatha, Nomcedo Janice Mbatha, Dorica Mbewe, Tinkhani Mbichila, Yamikani Rose Mbilizi, Sithokoza Mbokazi, Mwandifitsa Mbwerera, Zethu Mchunu, Laura McKinstry, Bongiwe Mdlongwa, John W. Mellors, Sihle Perfect Meyiwa, Nyaradzo Mavis Mgodi, Erasmus Samuel Mhizha, Nomsa Sibongile Mhlanga, Brenda Gail Mirembe, Dorothy Mirembe, Fumbani Mkandawire, Ntombizethu Hazel Mkhabela, Baningi Mkhize, Princess Hlengiwe Mkhize, Zaba Mkhize, Elizabeth Gugu Mlangeni, Margaret Mlingo, Bukiwe Mngqebisa, Noluxolo Mngxekeza, Anele Mninzi, Nonzwakazi Mnqonywa, Mammekwa Mogkoro, Thembisile Wilmah Mogodiri, Rebone Frengelina Mohuba, Maseponki Cecilia Mokoena, Noxolo Mona, Deidra Montoya, Willie Monyethabeng, Jayajothi Moodley, Jeeva Moodley, Kerushini Moodley, Suri Moonsamy, Neetha Shagan Morar, Sophie Nomsa Morudu, Angela Mpekula, Gerald Thsepo Mphisa, Jayne Mpofu, Hlengiwe Theodora Mposula, Avril Mqadi, Emmie Msiska, Lusungu Msumba, Nana Mtambo, Emmanuel Sinothi Mthalane, Thabisile Susan Mthembu, Zanoxolo Mthethi, Magdeline Judith Mthethwa, Ntokozo Zabathethwa Mthethwa, Sicelo Samuel Mthimkhulu, Itsepheng Mtlokoa, Michael Charles Mubiru, Mary Mudavanhu, Anna Zvirevo Mufumisi, Agnes Mary Mugagga, Joanita Muganga, Michelle Mugava, Margaret Mugenyi, Caroline Mugocha, Faith Mugodhi, Norma Mugwagwa, Felix Godwin Sivhukile Muhlanga, Shorai Mukaka, Dick Mukasa, Restituta Mukasa, Mathews Mukatipa, Shedina Mukova, Sarah Mulebeke, Joyce Mulima, Julio Muller, Faith Mulumba, Tsitsi Mupamombe, Constance Murandu, Tarisai Murefu, Fungai Murewa, Kudakwashe Muringayi, Caroline Murombedzi, Petina Musara, Jane Nsubuga Musisi, Mary Maria Musisi, Philippa Musoke, Joseph Mutebo, Prisca Mutero, Kudzai Santana Mutiti, Shadreck Mutizira, Sharon Mutsvunguma, Netsai Muungani, Tariro Muvunzi, Rosemary Muwawu, Samkelisiwe Mvelase, Priscilla Pamela Mvinjelwa, Goodness Zoh Mvuyane, Liness Mwafulirwa, Pokiwe Mwagomba, Thoko Gift Mwakhwawa, Deborah Mwebaza, Wezi Longwe Mwenda, Nqobile Myeni, Angeline Doreen Nonhlanhla Mzolo, Regina Bukenya Nabatanzi, Joselyne Nabisere, Josephine Nabukeera, Christine Valerie Nagawa, Cherise Naicker, Kumari Naicker, Vimla Naicker, Ishana Naidoo, Jason Naidoo, Jayganthie Naidoo, Kalendri Naidoo, Renissa Naidoo, Sandy Naidoo, Nalini Naidu, Gonasagrie Lulu Nair, Susan Nakacwa, Joyce Gladys Nakakande, Rita Nakalega, Maria Gorreti Nakalema, Jesca Nakibuka, Teopista Nakyanzi, Justine Nakyeyune, Stella Nalusiba, Rhoda Namakula, Felix Namalueso, Paula Mubiru Namayanja, Christine Tapuwa Nampala, Suzan Nkalubo Nampiira, Agnes Namuddu, Norah Nandundu, Winnie Nansamba, Stella Nanyonga, Sophie Clare Nanziri, Zainab Nakivumbi Nassoma, Duduzile Ethel Ncube, Eva Ncube, Sithabile Ncube, Pepukayi Ndadziyira, Pamella Pumla Ndamase, Walter Seth Taurayi Nderecha, Zanele Ndhlovu-Forde, Thembelihle Cynthia Ndimande, Bukekile Ndlovu, Grecenia Ndlovu, James Ndlovu, Nontokozo Happiness Ndlovu, Thakisile Nontokozo Ndlovu, Zodwa Ndlovu, Margret Ndovie, Beauty Nemasango, Blazej Neradilek, Susan Ngani, Nokwanda Queeneth Ngcebethsha, Lizbon Ngcobela, Nolwazi Ngcobo, Nompumelelo Ngcobo, Sindisiwe Promise Ngcobo, Nidleka Ngcukana, Julie Ngo, Nontshukumo Ngqabe, Siyabonga Ngqame, Mduduzi Dawood Ngubane, Nancy Nokuthula Ngwenya, Mugowe Nhkoma, Bongiwe Ntombizodwa Nhlapho, Sibusiso Nhleko, Hlengiwe Nkwanyana, Heather Noble, Lumka Lucia Nobula, Monica Nolan, Mluleki Nompondwana, Busiwe Notshokovu, Vukani Sandile Ntanzi, Nishi Nursaye, Jeremy Peter Nutall, Omega Nyabadza, Evelesi Nyaka, Sandra Nyakudya, Envioletta Chiedza Nyakura, Shingayi Nyamadzawo, Tsitsi Nyamuzihwa, Zubayiri Nyanzi, Angel Tinny Nyathi, Fadire Nyirenda, Makandwe Nyirenda, Mary Nyirenda, Sinqobile Charity Nzama, Lamec Sbongisomi Nzuza, Bhavesha O'Byrne, Fabian Okello, Eunice Okumu, Emmanuel Oluka, Francis Onen, Carolyne Peris Onyango, Katherine Ostbye, Kerusha Padayachee, Victor Palichina, Zhenyu Pan, Colin Pappajohn, Levanya Paramanund, Urvi M. Parikh, Nazmie Pearce, Kerri J. Penrose, Bathandekile Molly Phahlamohlaka, Nokulunga Ruth Phidane, Omisha Pillay, Anamika Premrajh, Nikita Prosad, Lorna Rabe, Alishka Rajman, Keneoe Maphuti Rampai, Hlalifi Sylvia Rampyapedi, April Randhawa, Sabelo Rasmeni, Dianne Rausch, Avanita Reddy, Isayum Reddy, Jerusha Reddy, Krishnaveni Reddy, Vera Helen Rees, Andrea Repetto, Cheryl Richards, Sharon Riddler, Nobubele Rini, Brendon Roeber, Lisa Rohan, Zachary Romer, Matthew Rose, Zeda Fran Rosenberg, Lisa Rossi, Aviva Ruch, Christine Rullo, Sinazo Runeyi, Olivia Rupemba, Chenai Rushwaya, Marisa Russell, Patience Sharai Ruzive, Godfrey Rwanzogyera, Margaret Nakato Saava, Tshepo Jimmy Sagela, Rebecca Sakwa, Fathima Sayed, Jennifer Schille, Nokwayintombi Scotch, William Scott, Caitlin Scoville, Richard Sebagala, Elaine Sebastian, Natasha Tina Sedze, Nasreen Hoosen Seedat, Joseph Semakula, Teri Senn, Francis Serugo, Linly Seyama, Bhekanani Khumulani Shabalala, Charlotte Phumzile Shangase, Pamela Caroline Shanhinga, Jeremy Shaver, Hanjie Shen, Mogobalale Corlett Shogole, Rachel Shonhiwa, Claudia Shozi, Marvelous Sibanda, Sylvia Sibongile Sibeko, Ncamisile Teressa Sibisi, Samuel Siphelele Sibisi, Brighty Zweni Sibiya, Happiness Sibiya, Dorothy Sichali, Phumzile Yvonne Sikosana, Craig Silva, Ayanda Purity Simelane, Melissa Simon, Triesha Sing, Hailey Virginia Sithole, Edith Sitima, Alex Siyasiya, Vuyane Sizane, Bekezela Siziba, Edward Slezinger, Daria Smolinski, Katie Snapinn, Olwethu Sogoni, Dean Soko, Leonard Nichiren Solai, Mandiphumle Somga, Mei Song, Xiaoling Song, Devarani Soobryan, Lydia Soto-Torres, Patrick Lawrence Spence, Elizabeth Spooner, Vincent Sseguya, Augustine Ssentongo, Mark Ssenyonga, Lawrence Lollian Sseremba, Michael Stais, John Steytler, Sharon Stockton, Julie Stofel, Tinyiko Reginah Stuurman, Sizakele Sukazi, Jasmin Lynn Sukdao, Kranthi Swarna, Daniel Szydlo, Christine Tagliaferri Rael, Dorothy Rumbidzai Taguta, Taha Taha, Eunice Tahuringana, Joshua Tamale, Penelope Tambama, Edna Taulo, Frank Taulo, Thelma Tonderai Tauya, Gerald Tegha, Sindisiwe Lucia Tembe, Tchangani Tembo, Constance Lebo Thatelo, Pinky Mery Thobela, Annie Thom, Christine Thompson, Monica Thompson, Linda Thusi, Lauri Tock, Thandokazi Tofile, Carol Tranfaglia, Jenny Tseng, Themba Tshabalala, Nomvuselelo Tshongoyi, Mercy Tsidya, Wendy Rufaro Tsikiwa, NoCamagu Tuswa-Haynes, Bomkazi Onini Tutshana, Andile Premrose Twala, Ashvir Viren Udith, Christine Unten, Neliette van Niekerk, Amanda Varela, Nangamso Vatsha, Gayathri Vijayendran, Amukelani California Vuma, Deo Ogema Wabwire, Madalo Walani, Bhekisisa Wanda, Lisa Wasberg, Rhonda R. White, Kathleen Marie Windle, Kubashni Woeber, Danica Wright, Tiffanee Wright, Thembalethu Nontokozo Xaba, Makanaka Jean Savie Yambira, Ntando Yola, Sindisiwe Lydia Zaca, Aisha Zalwango, Jullian Zemanek, Chifundo Zimba, Tsitsi Zinyengere, Margaret Zinyongo, Thabile Goodness Zondi, Chun Zou, Jabulisile Zuma, Nokuthula Princess Zungu, and Nompumelelo Zungu

Subjects
0301 basic medicine, Adult, Zimbabwe, medicine.medical_specialty, Malawi, Epidemiology, Anti-HIV Agents, Immunology, Dapivirine, HIV Infections, Placebo, Article, 03 medical and health sciences, South Africa, 0302 clinical medicine, Virology, Internal medicine, Microbicide, medicine, Humans, Uganda, 030212 general & internal medicine, Tenofovir, business.industry, Surrogate endpoint, Incidence (epidemiology), Contraceptive Devices, Female, 030112 virology, Vaginal ring, Clinical trial, Administration, Intravaginal, Infectious Diseases, Clinical research, Pyrimidines, Treatment Outcome, Seroconversion, HIV-1, Patient Compliance, Female, Patient Safety, business
Abstract

Two phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation.We did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037.Between July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p0·0001). HIV-1 incidence was 2·7 per 100 person-years (95% CI 1·9-3·8, 35 infections), compared with an expected incidence of 4·4 per 100 person-years (3·2-5·8) among a population matched on age, site, and presence of a sexually transmitted infection from the placebo group of ASPIRE. No serious adverse events or grade 3 or higher adverse events observed were assessed as related to the DVR.High uptake and persistent use in this open-label extension study support the DVR as an HIV-1 prevention option for women. With an increasing number of HIV-1 prophylaxis choices on the horizon, these results suggest that the DVR will be an acceptable and practical option for women in Africa.The Microbicide Trials Network and the National Institute of Allergy and Infectious Diseases, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health, all components of the US National Institutes of Health.

Published
2020

9. Biometric identification using 3D face scans

Author

Chao, Li, Armando, Barreto, Craig, Chin, and Jing, Zhai

Subjects
Biometry, Imaging, Three-Dimensional, Artificial Intelligence, Face, Image Interpretation, Computer-Assisted, Humans, Information Storage and Retrieval, Image Enhancement, Algorithms, Pattern Recognition, Automated
Abstract

Biometrics is an emerging area of bioengineering that pursues the characterization of a person by means of something that the person is or produces. Face recognition is a particularly attractive biometric challenge. Most of the face recognition research performed in the past used 2D intensity images. However, algorithms based on 2D images are not robust to changes of illumination in the environment or orientation of the subject. The ability to acquire 3D scans of human faces removes those ambiguities, since they capture the exact geometry of the subject, invariant to illumination and orientation changes. Unencumbered by those limitations, research in 3D face recognition is now beginning to address a different source of error in biometric recognition: facial geometry deformation caused by facial expressions, which can make 3D algorithms which treat 3D faces as rigid surfaces fail. In this paper, a 3D face recognition framework is proposed to tackle this problem. The framework is composed of three subsystems: expression recognition system, expressional face recognition system and neutral face recognition system. In particular, a system for the recognition of faces with one type of expression (smile) and neutral faces was implemented and tested on a database of 30 subjects. The results proved the feasibility of this framework.

Published
2006

10. Hands-free human computer interaction via an electromyogram-based classification algorithm

Author

Craig, Chin, Armando, Barreto, Chao, Li, and Jing, Zhai

Subjects
Male, Electromyography, Facial Muscles, Information Storage and Retrieval, Reproducibility of Results, Signal Processing, Computer-Assisted, Sensitivity and Specificity, Pattern Recognition, Automated, Communication Aids for Disabled, User-Computer Interface, Humans, Female, Algorithms, Muscle Contraction
Abstract

A four-electrode system for hands-free computer cursor control, based on the digital processing of Electromyogram (EMG) signals is proposed. The electrodes are located over the right frontalis, the procerus, the left temporalis and the right temporalis muscles in the head. This system is meant to enable individuals paralyzed from the neck down (e.g., due to Spinal Cord Injury) to interact with computers using point-and-click graphic interfaces. The intention is to translate electromyograms derived from muscle contractions associated with specific facial movements into five cursor actions, namely: Left, Right, Up, Down and Left-click. This translation is accomplished by a digital signal processing classification algorithm that takes advantage of the divergent spectral nature of the EMG signals produced by the frontalis, temporalis, and procerus muscles, respectively. The effectiveness of the algorithm is evaluated by comparing its performance to that of a previously developed three-electrode EMG-based algorithm, using Matlab simulations. The results indicate that the algorithm classifies with great accuracy and provides a marked improvement over the previous three-electrode system.

Published
2005

11. User stress detection in human-computer interactions

Author

Jing, Zhai, Armando B, Barreto, Craig, Chin, and Chao, Li

Subjects
Adult, Male, Blood Volume, Sympathetic Nervous System, Statistics as Topic, Iris, Reproducibility of Results, Blood Pressure, Galvanic Skin Response, Sensitivity and Specificity, Pattern Recognition, Automated, User-Computer Interface, Artificial Intelligence, Heart Rate, Humans, Diagnosis, Computer-Assisted, Man-Machine Systems, Algorithms, Stress, Psychological
Abstract

The emerging research area of Affective Computing seeks to advance the field of Human-Computer Interaction (HCI) by enabling computers to interact with users in ways appropriate to their affective states. Affect recognition, including the use of psychophysiologcal measures (e.g. heart rate), facial expressions, speech recognition etc. to derive an assessment of user affective state based on factors from the current task context, is an important foundation required for the development of Affective Computing. Our research focuses on the use of three physiological signals: Blood Volume Pulse (BVP), Galvanic Skin Response (GSR) and Pupil Diameter (PD), to automatically monitor the level of stress in computer users. This paper reports on the hardware and software instrumentation development and signal processing approach used to detect the stress level of a subject interacting with a computer, within the framework of a specific experimental task, which is called the 'Stroop Test'. For this experiment, a computer game was implemented and adapted to make the subject experience the Stroop Effect, evoked by the mismatch between the font color and the meaning of a certain word (name of a color) displayed, while his/her BVP, GSR and PD signals were continuously recorded. Several data processing techniques were applied to extract effective attributes of the stress level of the subjects throughout the experiment. Current results indicate that there exists interesting similarity among changes in those three signals and the shift in the emotional states when stress stimuli are applied to the interaction environment.

Published
2005

12. Testing reminder and motivational telephone calls to increase screening mammography: a randomized study

Author

Dolores M. Meyer, Richard MacLehos, Douglas F. Herta, William E. Barlow, Craig Chin, Evette J. Ludman, Susan J. Curry, Stephen H. Taplin, and Deborah Seger

Subjects
Risk, Cancer Research, medicine.medical_specialty, Health Knowledge, Attitudes, Practice, Social Values, Breast Neoplasms, law.invention, Randomized controlled trial, law, medicine, Mammography, Humans, Mass Screening, Prospective Studies, Prospective cohort study, Aged, Proportional Hazards Models, Gynecology, Motivation, medicine.diagnostic_test, Proportional hazards model, business.industry, Telephone call, Hazard ratio, Middle Aged, Confidence interval, Telephone, Clinical trial, Affect, Treatment Outcome, Oncology, Family medicine, Female, business
Abstract

Background Prospective randomized trials have demonstrated that motivational telephone calls increase adherence to screening mammography. To better understand the effects of motivational calls and to maximize adherence, we conducted a randomized trial among women aged 50-79 years. Methods We created a stratified random sample of 5062 women due for mammograms within the Group Health Cooperative of Puget Sound, including 4099 women with prior mammography and 963 without it. We recruited and surveyed 3743 (74%) of the women before mailing a recommendation. After 2 months, 1765 (47%) of the 3743 women had not scheduled a mammogram and were randomly assigned to one of three intervention groups: a reminder post-card group (n = 590), a reminder telephone call group (n = 585), and a motivational telephone call addressing barriers group (n = 590). The telephone callers could schedule mammography. We used Cox proportional hazards models to estimate the hazard ratio (HR) and 95% confidence interval (CI) for documented mammography use by 1 year. Results Women who received reminder calls were more likely to get mammograms (HR = 1.9; 95% CI = 1.6-2.4) than women who were mailed postcards. The motivational and reminder calls (average length, 8.5 and 3.1 minutes, respectively) had equivalent effects (HR = 0.97; 95% CI = 0.8-1.2). After we controlled for the intervention effect, women with prior mammography (n = 1277) were much more likely to get a mammogram (HR = 3.4; 95% CI = 2.7-4.3) than women without prior use (n = 488). Higher income, but not race or more education, was associated with higher adherence. Conclusions Reminding women to schedule an appointment was as efficacious as addressing barriers. Simple intervention groups should be included as comparison groups in randomized trials so that we better understand more complex intervention effects.

Published
2000

13. Meryl Mantione, mezzo-soprano, Craig Priebe, baritone, Yu-Ching Chin, piano, [and] James Helton, piano

Author

Mantione, Meryl; Priebe, Craig; Chin, Yu-Ching; Helton, James, Ball State University. School of Music, Mantione, Meryl; Priebe, Craig; Chin, Yu-Ching; Helton, James, and Ball State University. School of Music

Abstract

Part of the 2010-2011 Faculty Artist Series.; Includes a list of upcoming BSU School of Music events (for Jan. 2011-Feb. 2011)., Series LXV, Number 106., This archival material has been provided for educational purposes. Ball State University Libraries recognizes that some historic items may include offensive content. Our statement regarding objectionable content is available at: https://dmr.bsu.edu/digital/about

Published
2011

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

Author

Craig Chin, Michal Kulich, Glenda Gray, Stephen F. Morin, Agnès Fiamma, Michel W. Alexandre, Deb Bassuk, Estelle Piwowar-Manning, Greg Szekeres, David D. Celentano, Susan H. Eshleman, John Hackett, Suwat Chariyalertsak, Priscilla Swanson, Caroline E. Mullis, Mark A. Marzinke, Thomas J. Coates, Linda Richter, Deborah Donnell, William Clarke, Oliver Laeyendecker, Michael D. Sweat, and Alfred Chingono

Subjects
Epidemiology, Cross-sectional study, HIV Infections, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Prevalence, Clinical endpoint, Medicine, 030212 general & internal medicine, Young adult, National Institute of Mental Health (U.S.), 0303 health sciences, education.field_of_study, Multidisciplinary, Applied Mathematics, Incidence, Incidence (epidemiology), virus diseases, HIV diagnosis and management, Viral Load, Thailand, 3. Good health, Anti-Retroviral Agents, HIV epidemiology, Infectious diseases, Viral load, Algorithms, Research Article, Adult, medicine.medical_specialty, Adolescent, Science, Voluntary counseling and testing, HIV prevention, Population, Viral diseases, Microbiology, Infectious Disease Epidemiology, Young Adult, 03 medical and health sciences, Virology, Internal medicine, Humans, education, Biology, Acquired Immunodeficiency Syndrome, Population Biology, 030306 microbiology, business.industry, HIV, United States, CD4 Lymphocyte Count, Viral Disease Diagnosis, Cross-Sectional Studies, Computer Science, Africa, Immunology, business, Mathematics
Abstract

BackgroundNational 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.MethodsHIV 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.ResultsData 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%).ConclusionsIn 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.Trial registrationClinicalTrials.gov NCT00203749.

Published
2013
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16. Nanosecond time-resolved emission anisotropy of the fluorescent probe 1,6-diphenyl-1,3,5-hexatriene in human amniotic fluid

Author

Andrzej A. Kowalczyk, Lesley Davenport, Craig Chin, Ludwig Brand, and Ralph L. Cavalieri

Subjects
Diphenylhexatriene, Amniotic fluid, Steady state, Time Factors, Kinetics, Biophysics, Analytical chemistry, Polyenes, Nanosecond, Amniotic Fluid, Biochemistry, Fluorescence, Exponential function, chemistry.chemical_compound, Endocrinology, Nuclear magnetic resonance, Spectrometry, Fluorescence, chemistry, Pregnancy, Humans, Female, Anisotropy
Abstract

The fluorescence emission anisotropy of 1,6-diphenyl-1,3,5-hexatriene in human amniotic fluid has been studied using nanosecond time-resolved emission techniques. These studies demonstrate that the previously reported decrease in the steady state emission anisotropy, [r], with gestational age is due to a change in the rate of rotational motion of the probe. The emission anisotropy decays to a limiting value (r infinity) greater than zero, suggesting a hindered rotation of the probe, and this is independent of gestational age. The decay function for the emission anisotropy of amniotic fluids from 17, 29, 40 and 41 weeks in gestational age can be best expressed as a single exponential plus a constant term, with rotational correlation times varying from 17 ns to 2.2 ns, respectively. The zero time emission anisotropy remains approx. 0.30 for both early and late gestational times.

Published
1984

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