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1. Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States

Author

Liu, Albert Y, Islas, Clara Dominguez, Gundacker, Holly, Neradilek, Blazej, Hoesley, Craig, Straten, Ariane van der, Hendrix, Craig W, Beamer, May, Jacobson, Cindy E, McClure, Tara, Harrell, Tanya, Bunge, Katherine, Devlin, Brid, Nuttall, Jeremy, Spence, Patrick, Steytler, John, Piper, Jeanna M, and Marzinke, Mark A

Subjects
Antiviral agents -- Testing -- Dosage and administration, Vagina, Medication by -- Testing -- Dosage and administration, HIV infection -- Prevention, Health
Abstract

Introduction: Vaginalrings are a promising approach to provide a woman-centred, long-acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV-1 infection. Extended duration rings replaced every three months may encourage user adherence, improve health service efficiency and reduce cost overall. We evaluated safety, pharmacokinetics, adherence and acceptability of two three-month rings with different DPV dosages, compared with the monthly DPV ring. Methods: From December 2017 to October 2018, MTN-036/IPM-047 enrolled 49 HIV-negative participant in Birmingham, Alabama and San Francisco, California into a phase 1, randomized trial comparing two extended duration (three-month) rings (100 or 200 mg DPV) to a monthly 25 mg DPV ring, each used over 13 weeks, with follow-up completed in January 2019. Safety was assessed by recording adverse events (AEs). DPV concentrations were quantified in plasma, cervicovaginalfluid (CVF) and cervicaltissue, at nominaltimepoints. Geometric mean ratios (GMRs) relative to the comparator ring were estimated from a regression model. Results: There were no differences in the proportion of participants with grade [greater than or equal to]2 genitourinary AEs or grade [greater than or equal to]3AEs in the extended duration versus monthly ring arms (p = 1.0). Plasma and CVF DPV concentrations were higher in the extended duration rings compared to the monthly ring. Plasma GMRs were 1.31 to 1.85 and 1.41 to 1.86 and CVF GMRs were 1.45 to 2.87 and 1.74 to 2.60 for the 100 and 200 mg ring respectively. Cervicaltissue concentrations were consistently higher in the 200 mg ring (GMRs 2.36 to 3.97). The majority of participants (82%) were fully adherent (ring inserted at alltimes, with no product discontinuations/outages) with no differences between the monthly versus three-month rings. Most participants found the ring acceptable (median = 8 on 10-point Likert scale), with a greater proportion of participants reporting high acceptability (9 or 10) in the 25 mg arm (73%) compared with the 100 mg (25%) and 200 mg (44%) arms (p = 0.01 and p = 0.15 respectively). Conclusions: The extended duration DPV rings were well-tolerated and achieved higher DPV concentrations compared with the monthly DPV ring. These findings support further evaluation of three-month DPV rings for HIV prevention. Keywords: dapivirine; vaginalring; pharmacokinetics; safety; microbicide; pre-exposure prophylaxis, 1 INTRODUCTION Over half of the 38 million people living with the human immunodeficiency virus (HIV) globally are women [1]. In sub-Saharan Africa, women and girls account for 59% of [...]

Published
2021
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2. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author

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

Published
2021
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3. Autosomal-Dominant Multiple Pterygium Syndrome Is Caused by Mutations in MYH3

Author

Chong, Jessica X, Burrage, Lindsay C, Beck, Anita E, Marvin, Colby T, McMillin, Margaret J, Shively, Kathryn M, Harrell, Tanya M, Buckingham, Kati J, Bacino, Carlos A, Jain, Mahim, Alanay, Yasemin, Berry, Susan A, Carey, John C, Gibbs, Richard A, Lee, Brendan H, Krakow, Deborah, Shendure, Jay, Nickerson, Deborah A, Genomics, University of Washington Center for Mendelian, Bamshad, Michael J, Abecasis, Gonçalo R, Anderson, Peter, Blue, Elizabeth Marchani, Annable, Marcus, Browning, Brian L, Chen, Christina, Chin, Jennifer, Cooper, Gregory M, Davis, Colleen P, Frazar, Christopher, He, Zongxiao, Jain, Preti, Jarvik, Gail P, Jimenez, Guillaume, Johanson, Eric, Jun, Goo, Kircher, Martin, Kolar, Tom, Krauter, Stephanie A, Krumm, Niklas, Leal, Suzanne M, Luksic, Daniel, McGee, Sean, O’Reilly, Patrick, Paeper, Bryan, Patterson, Karynne, Perez, Marcos, Phillips, Sam W, Pijoan, Jessica, Poel, Christa, Reinier, Frederic, Robertson, Peggy D, Santos-Cortez, Regie, Shaffer, Tristan, Shephard, Cindy, Siegel, Deborah L, Smith, Joshua D, Staples, Jeffrey C, Tabor, Holly K, Tackett, Monica, Underwood, Jason G, Wegener, Marc, Wang, Gao, Wheeler, Marsha M, and Yi, Qian

Subjects
Biological Sciences, Genetics, Brain Disorders, Intellectual and Developmental Disabilities (IDD), Clinical Research, Congenital Structural Anomalies, Rare Diseases, Pediatric, Arthrogryposis, Cytoskeletal Proteins, Exome, Genetic Predisposition to Disease, High-Throughput Nucleotide Sequencing, Humans, Mutation, Myosins, Osteogenesis, University of Washington Center for Mendelian Genomics, Medical and Health Sciences, Genetics & Heredity, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

Multiple pterygium syndrome (MPS) is a phenotypically and genetically heterogeneous group of rare Mendelian conditions characterized by multiple pterygia, scoliosis, and congenital contractures of the limbs. MPS typically segregates as an autosomal-recessive disorder, but rare instances of autosomal-dominant transmission have been reported. Whereas several mutations causing recessive MPS have been identified, the genetic basis of dominant MPS remains unknown. We identified four families affected by dominantly transmitted MPS characterized by pterygia, camptodactyly of the hands, vertebral fusions, and scoliosis. Exome sequencing identified predicted protein-altering mutations in embryonic myosin heavy chain (MYH3) in three families. MYH3 mutations underlie distal arthrogryposis types 1, 2A, and 2B, but all mutations reported to date occur in the head and neck domains. In contrast, two of the mutations found to cause MPS in this study occurred in the tail domain. The phenotypic overlap among persons with MPS, coupled with physical findings distinct from other conditions caused by mutations in MYH3, suggests that the developmental mechanism underlying MPS differs from that of other conditions and/or that certain functions of embryonic myosin might be perturbed by disruption of specific residues and/or domains. Moreover, the vertebral fusions in persons with MPS, coupled with evidence of MYH3 expression in bone, suggest that embryonic myosin plays a role in skeletal development.

Published
2015

4. De Novo Mutations in NALCN Cause a Syndrome Characterized by Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay

Author

Chong, Jessica X, McMillin, Margaret J, Shively, Kathryn M, Beck, Anita E, Marvin, Colby T, Armenteros, Jose R, Buckingham, Kati J, Nkinsi, Naomi T, Boyle, Evan A, Berry, Margaret N, Bocian, Maureen, Foulds, Nicola, Uzielli, Maria Luisa Giovannucci, Haldeman-Englert, Chad, Hennekam, Raoul CM, Kaplan, Paige, Kline, Antonie D, Mercer, Catherine L, Nowaczyk, Malgorzata JM, Wassink-Ruiter, Jolien S Klein, McPherson, Elizabeth W, Moreno, Regina A, Scheuerle, Angela E, Shashi, Vandana, Stevens, Cathy A, Carey, John C, Monteil, Arnaud, Lory, Philippe, Tabor, Holly K, Smith, Joshua D, Shendure, Jay, Nickerson, Deborah A, Genomics, University of Washington Center for Mendelian, Bamshad, Michael J, Abecasis, Gonçalo R, Anderson, Peter, Blue, Elizabeth Marchani, Annable, Marcus, Browning, Brian L, Chen, Christina, Chin, Jennifer, Cooper, Gregory M, Davis, Colleen P, Frazar, Christopher, Harrell, Tanya M, He, Zongxiao, Jain, Preti, Jarvik, Gail P, Jimenez, Guillaume, Johanson, Eric, Jun, Goo, Kircher, Martin, Kolar, Tom, Krauter, Stephanie A, Krumm, Niklas, Leal, Suzanne M, Luksic, Daniel, McGee, Sean, O’Reilly, Patrick, Paeper, Bryan, Patterson, Karynne, Perez, Marcos, Phillips, Sam W, Pijoan, Jessica, Poel, Christa, Reinier, Frederic, Robertson, Peggy D, Santos-Cortez, Regie, Shaffer, Tristan, Shephard, Cindy, Siegel, Deborah L, Staples, Jeffrey C, Tackett, Monica, Underwood, Jason G, Wegener, Marc, Wang, Gao, Wheeler, Marsha M, and Yi, Qian

Subjects
Biological Sciences, Bioinformatics and Computational Biology, Biomedical and Clinical Sciences, Genetics, Rare Diseases, Congenital Structural Anomalies, Pediatric, Clinical Research, Aetiology, 2.1 Biological and endogenous factors, Congenital, Arthrogryposis, Contracture, Craniofacial Dysostosis, Cytoskeletal Proteins, Exome, Extremities, Face, Female, Gene Frequency, High-Throughput Nucleotide Sequencing, Homozygote, Humans, Infant, Ion Channels, Male, Membrane Proteins, Muscle Hypotonia, Mutation, Missense, Sodium Channels, University of Washington Center for Mendelian Genomics, Medical and Health Sciences, Genetics & Heredity, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

Freeman-Sheldon syndrome, or distal arthrogryposis type 2A (DA2A), is an autosomal-dominant condition caused by mutations in MYH3 and characterized by multiple congenital contractures of the face and limbs and normal cognitive development. We identified a subset of five individuals who had been putatively diagnosed with "DA2A with severe neurological abnormalities" and for whom congenital contractures of the limbs and face, hypotonia, and global developmental delay had resulted in early death in three cases; this is a unique condition that we now refer to as CLIFAHDD syndrome. Exome sequencing identified missense mutations in the sodium leak channel, non-selective (NALCN) in four families affected by CLIFAHDD syndrome. We used molecular-inversion probes to screen for NALCN in a cohort of 202 distal arthrogryposis (DA)-affected individuals as well as concurrent exome sequencing of six other DA-affected individuals, thus revealing NALCN mutations in ten additional families with "atypical" forms of DA. All 14 mutations were missense variants predicted to alter amino acid residues in or near the S5 and S6 pore-forming segments of NALCN, highlighting the functional importance of these segments. In vitro functional studies demonstrated that NALCN alterations nearly abolished the expression of wild-type NALCN, suggesting that alterations that cause CLIFAHDD syndrome have a dominant-negative effect. In contrast, homozygosity for mutations in other regions of NALCN has been reported in three families affected by an autosomal-recessive condition characterized mainly by hypotonia and severe intellectual disability. Accordingly, mutations in NALCN can cause either a recessive or dominant condition characterized by varied though overlapping phenotypic features, perhaps based on the type of mutation and affected protein domain(s).

Published
2015

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

Author

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

Published
2021
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6. Assessing pregnancy and neonatal outcomes in Malawi, South Africa, Uganda, and Zimbabwe: Results from a systematic chart review.

Author

Balkus, Jennifer E., Neradilek, Moni, Fairlie, Lee, Makanani, Bonus, Mgodi, Nyaradzo, Mhlanga, Felix, Nakabiito, Clemensia, Mayo, Ashley, Harrell, Tanya, Piper, Jeanna, and Bunge, Katherine E.

Subjects
PREGNANCY outcomes, PREGNANCY complications, NEONATAL death, PREMATURE labor, HIV prevention, CHILDBIRTH at home
Abstract

A systematic chart review was performed to estimate the frequency of pregnancy outcomes, pregnancy complications and neonatal outcomes at facilities in Blantyre, Malawi; Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza and Harare, Zimbabwe to provide comparisons with estimates from an ongoing clinical trial evaluating the safety of two biomedical HIV prevention interventions in pregnancy. A multi-site, cross-sectional chart review was conducted at Maternal Obstetric Units and hospitals where women participating in the ongoing clinical trial would be expected to deliver. All individuals delivering at the designated facilities or admitted for postpartum care within seven days of a delivery elsewhere (home, health clinic, etc.) were included in the review. Data were abstracted for pregnancy outcomes, pregnancy complications, maternal and neonatal death, and congenital anomalies. Data from 10,138 records were abstracted across all four sites (Blantyre n = 2,384; Johannesburg n = 1,888; Kampala n = 3,708; Chitungwiza and Harare n = 2,158), which included 10,426 pregnancy outcomes. The prevalence of preterm birth was 13% (range across sites: 10.4–20.7) and 4.1% of deliveries resulted in stillbirth (range: 3.1–5.5). The most commonly noted pregnancy complication was gestational hypertension, reported among 4.4% of pregnancies. Among pregnancies resulting in a live birth, 15.5% were low birthweight (range: 13.8–17.4) and 2.0% resulted in neonatal death (range:1.2–3.2). Suspected congenital anomalies were noted in 1.2% of pregnancies. This study provides systematically collected data on background rates of pregnancy outcomes, pregnancy complications and neonatal outcomes that can be used as a reference in support of ongoing HIV prevention studies. In addition, estimates from this study provide important background data for future studies of investigational products evaluated in pregnancy in these urban settings. [ABSTRACT FROM AUTHOR]

Published
2021
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7. A Qualitative Analysis of How Anthropologists Interpret the Race Construct

Author

Ifekwunigwe, Jayne O., Wagner, Jennifer K., Yu, Joon-Ho, Harrell, Tanya M., Bamshad, Michael J., and Royal, Charmaine D.

Subjects
Article
Abstract

This article assesses anthropological thinking about the race concept and its applications. Drawn from a broader national survey of geneticists' and anthropologists' views on race, in this analysis, we provide a qualitative account of anthropologists' perspectives. We delve deeper than simply asserting that "race is a social construct." Instead, we explore the differential ways in which anthropologists describe and interpret how race is constructed. Utilizing the heuristic ofEste artículo evalúa el pensamiento antropológico acerca del concepto de raza y sus aplicaciones. Derivado de una encuesta nacional más amplia de las opiniones de genetistas y antropólogos sobre la raza, en este análisis proveemos un reporte cualitativo, de las perspectivas de los antropólogos. Ahondamos más que simplemente afirmar que “la raza es un constructo social”. En cambio, exploramos las formas diferenciales en que los antropólogos describen e interpretan cómo la raza es construida. Utilizando la heurística de

Published
2017

11. The Genetic Basis of Mendelian Phenotypes: Discoveries, Challenges, and Opportunities

Author

Chong, Jessica X., primary, Buckingham, Kati J., additional, Jhangiani, Shalini N., additional, Boehm, Corinne, additional, Sobreira, Nara, additional, Smith, Joshua D., additional, Harrell, Tanya M., additional, McMillin, Margaret J., additional, Wiszniewski, Wojciech, additional, Gambin, Tomasz, additional, Coban Akdemir, Zeynep H., additional, Doheny, Kimberly, additional, Scott, Alan F., additional, Avramopoulos, Dimitri, additional, Chakravarti, Aravinda, additional, Hoover-Fong, Julie, additional, Mathews, Debra, additional, Witmer, P. Dane, additional, Ling, Hua, additional, Hetrick, Kurt, additional, Watkins, Lee, additional, Patterson, Karynne E., additional, Reinier, Frederic, additional, Blue, Elizabeth, additional, Muzny, Donna, additional, Kircher, Martin, additional, Bilguvar, Kaya, additional, López-Giráldez, Francesc, additional, Sutton, V. Reid, additional, Tabor, Holly K., additional, Leal, Suzanne M., additional, Gunel, Murat, additional, Mane, Shrikant, additional, Gibbs, Richard A., additional, Boerwinkle, Eric, additional, Hamosh, Ada, additional, Shendure, Jay, additional, Lupski, James R., additional, Lifton, Richard P., additional, Valle, David, additional, Nickerson, Deborah A., additional, and Bamshad, Michael J., additional

Published
2015
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12. Anthropologists' views on race, ancestry, and genetics.

Author

Wagner, Jennifer K., Yu, Joon‐Ho, Ifekwunigwe, Jayne O., Harrell, Tanya M., Bamshad, Michael J., and Royal, Charmaine D.

Subjects
ANTHROPOLOGISTS, RACE & society, GENETICS, GENEALOGY, SURVEYS, ANTHROPOLOGY
Abstract

Controversies over race conceptualizations have been ongoing for centuries and have been shaped, in part, by anthropologists. Objective To assess anthropologists' views on race, genetics, and ancestry. Methods In 2012 a broad national survey of anthropologists examined prevailing views on race, ancestry, and genetics. Results Results demonstrate consensus that there are no human biological races and recognition that race exists as lived social experiences that can have important effects on health. Discussion Racial privilege affects anthropologists' views on race, underscoring the importance that anthropologists be vigilant of biases in the profession and practice. Anthropologists must mitigate racial biases in society wherever they might be lurking and quash any sociopolitical attempts to normalize or promote racist rhetoric, sentiment, and behavior. [ABSTRACT FROM AUTHOR]

Published
2017
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14. The Degree of Clinical and Anatomic Response to Cardiac Resynchronization Therapy Correlates Significantly with Clinical Outcomes

Author

Ajijola, Olujimi A., primary, Makovey, Iryna, additional, Barantke, Melanie, additional, Heist, E. Kevin, additional, Harrell, Tanya, additional, Upadhyay, Gaurav, additional, Blandea, Dan, additional, McCarty, David, additional, Macklin, Eric A., additional, Orencole, Mary, additional, Semigran, Marc, additional, Ruskin, Jeremy N., additional, Picard, Michael, additional, and Singh, Jagmeet P., additional

Published
2009
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15. Attitudes of Genetics Professionals Toward the Return of Incidental Results from Exome and Whole-Genome Sequencing.

Author

Joon-Ho Yu, Harrell, Tanya M., Jamal, Seema M., Tabor, Holly K., and Bamshad, Michael J.

Subjects
*GENETIC research, *SCIENTISTS' attitudes, *GENOMICS, *PROFESSIONAL associations, *MOLECULAR biologists, *NUCLEOTIDE sequencing, *INTERNET surveys
Abstract

Professional recommendations for the return of results from exome and whole-genome sequencing (ES/WGS) have been controversial. The lack of clear guidance about whether and, if so, how to return ES/WGS incidental results limits the extent to which individuals and families might benefit from ES/WGS. The perspectives of genetics professionals, particularly those at the forefront of using ES/WGS in clinics, are largely unknown. Data on stakeholder perspectives could help clarify how to weigh expert positions and recommendations. We conducted an online survey of 9,857 genetics professionals to learn their attitudes on the return of incidental results from ES/WGS and the recent American College of Medical Genetic and Genomics Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. Of the 847 respondents, 760 completed the survey. The overwhelming majority of respondents thought that incidental ES/WGS results should be offered to adult patients (85%), healthy adults (75%), and the parents of a child with a medical condition (74%). The majority thought that incidental results about adult-onset conditions (62%) and carrier status (62%) should be offered to the parents of a child with a medical condition. About half thought that offered results should not be limited to those deemed clinically actionable. The vast majority (81%) thought that individual preferences should guide return. Genetics professionals' perspectives on the return of ES/WGS results differed substantially from current recommendations, underscoring the need to establish clear purpose for recommendations on the return of incidental ES/WGS results as professional societies grapple with developing and updating recommendations. [ABSTRACT FROM AUTHOR]

Published
2014
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