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2. High Asymptomatic Carriage With the Omicron Variant in South Africa

Author

Garrett, Nigel, Tapley, Asa, Andriesen, Jessica, Seocharan, Ishen, Fisher, Leigh H, Bunts, Lisa, Espy, Nicole, Wallis, Carole L, Randhawa, April Kaur, Miner, Maurine D, Ketter, Nzeera, Yacovone, Margaret, Goga, Ameena, Huang, Yunda, Hural, John, Kotze, Philip, Bekker, Linda Gail, Gray, Glenda E, Corey, Lawrence, Ahmed, Khatija, Badal-Faesen, Sharlaa, Barnabas, Shaun, Brumskine, William, Comline, Kim, Diacon, Andreas, Dubula, Thozama, Gill, Katherine, Grobbelaar, Coert, Innes, Craig, Kassim, Sheetal, Kotze, Sheena, Lazarus, Erica, Lombaard, Johannes, Luabeya, Angelique, Maboa, Rebone Molobane, Mahoney, Scott, Mahkaza, Disebo, Malahleha, Moelo, Malan, Daniel, Mngadi, Kathryn, Naicker, Nivashnee, Naicker, Vimla, Naidoo, Logashvari, Nchabeleng, Maphoshane, Rassool, Mohammed, Spooner, Elizabeth, Tempelman, Hugo, Mgodi, Nyaradzo, Dadabhai, Sufia, Makhema, Joe, Nuwagaba-Biribonwoha, Harriet, Samandari, Taraz, Elyanu, Peter James, Chilengi, Roma, Chirenje, Zvavahera, McElrath, Julie, Cohen, Myron, Kublin, James, Gilbert, Peter, Peda, Melissa, Andersen-Nissen, Erica, Ferrari, Guido, Villaran, Manuel, Takalani, Azwidhwi, Gildea, Marianne, Nebergall, Michelle, Sopher, Carrie, Proulx-Burns, Lori, Govender, Dhevium, Sanders, Lisa, Hanke, Jen, Baepanye, Kagisho, Le Roux, Bert, Wilvich, Haven, Sripathy, Smitha, Margineantu, Daciana, Brown, Valerie, Linton, Kim, Howell, Haley, Noronha, Bianca, Nikles, Sarah, Toledano, Alicia, May, Jeanine, El-Khorazaty, Jill, Naidoo, Keshani, Khuto, Kentse, Mayat, Fatima, Fairall, Lara, and Sanne, Ian

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Pneumonia & Influenza, Infectious Diseases, Vaccine Related, Lung, Prevention, Emerging Infectious Diseases, Clinical Research, Pneumonia, Biodefense, Clinical Trials and Supportive Activities, Infection, Good Health and Well Being, COVID-19, Humans, Polymerase Chain Reaction, SARS-CoV-2, South Africa, Omicron variant, asymptomatic carriage, PWH, Ubuntu Study Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

We report a 23% asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) Omicron carriage rate in participants being enrolled into a clinical trial in South Africa, 15-fold higher than in trials before Omicron. We also found lower CD4 + T-cell counts in persons with human immunodeficiency virus (HIV) strongly correlated with increased odds of being SARS-CoV-2 polymerase chain reaction (PCR) positive.

Published
2022

3. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study

Author

Brumskine, William, Naicker, Nivashnee, Makhaza, Disebo, Naicker, Vimla, Naidoo, Logashvari, Spooner, Elizabeth, van Nieuwenhuizen, Elane, Mngadi, Kathryn, Nchabeleng, Maphoshane, Innes, James Craig, Gill, Katherine, Petrick, Friedrich Georg, Barnabas, Shaun, Badal-Faesen, Sharlaa, Kassim, Sheetal, Mahoney, Scott Hayden, Lazarus, Erica, Nana, Anusha, Maboa, Rebone Molobane, Kotze, Philip, Lombaard, Johan, Malan, Daniel Rudolf, Kotze, Sheena, Mohlala, Phuthi, Ward, Amy, Meintjes, Graeme, Urbach, Dorothea, Patel, Faeezah, Diacon, Andreas, Ahmed, Khatija, Grobbelaar, Coert, Mda, Pamela, Dubula, Thozama, Luabeya, Angelique, Mamba, Musawenkosi Bhekithemba, Burgess, Lesley, Dawson, Rodney, Bekker, Linda-Gail, Garrett, Nigel, Goga, Ameena, Fairall, Lara, Reddy, Tarylee, Yende-Zuma, Nonhlanhla, Kassanjee, Reshma, Collie, Shirley, Sanne, Ian, Boulle, Andrew, Seocharan, Ishen, Engelbrecht, Imke, Davies, Mary-Ann, Champion, Jared, Chen, Tommy, Bennett, Sarah, Mametja, Selaelo, Semenya, Mabatlo, Moultrie, Harry, de Oliveira, Tulio, Lessells, Richard John, Cohen, Cheryl, Jassat, Waasila, Groome, Michelle, Von Gottberg, Anne, Le Roux, Engelbert, Khuto, Kentse, Barouch, Dan, Mahomed, Hassan, Wolmarans, Milani, Rousseau, Petro, Bradshaw, Debbie, Mulder, Michelle, Opie, Jessica, Louw, Vernon, Jacobson, Barry, Rowji, Pradeep, Peter, Jonny G, Takalani, Azwi, Odhiambo, Jackline, Mayat, Fatima, Takuva, Simbarashe, Corey, Lawrence, and Gray, Glenda E

Published
2022
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4. High STI burden among a cohort of adolescents aged 12–19 years in a youth-friendly clinic in South Africa.

Author

Price, Matt A., Kuteesa, Monica, Oladimeji, Matthew, Brumskine, William, Edward, Vinodh, Makkan, Heeran, Mthembu, Funeka, Muturi-Kioi, Vincent, Chetty-Makkan, Candice, and Maenetje, Pholo

Subjects
TEENAGE girls, UNPLANNED pregnancy, COVID-19 pandemic, MEDICAL needs assessment, TEENAGERS, SEXUAL intercourse
Abstract

Adolescents face a higher risk for HIV, STIs, and unintended pregnancy than any other age group in sub–Saharan Africa, and have unique health care needs as they navigate this period of growth and developmental milestones. We conducted the Youth Friendly Services study among adolescents in Rustenburg, South Africa to address some of these concerns. Participants aged 12–19 were followed quarterly for 12 months, asked at baseline about demographics, their sexual behavior, and tested for HIV, STIs, and pregnancy (girls). Report of sexual activity was not a requirement for enrollment. Assent and parental consent were obtained for participants under 18. Some follow up visits fell during COVID-mandated shutdowns, and we worked with participants to reschedule and extend follow up as appropriate. Here we present data on reported behaviors, participant attrition, risk of HIV, other STI, and pregnancy. From May 2018 to August 2019, we enrolled 223 HIV-negative, non-pregnant adolescents (64% girls). The median age was 17 (IQR: 14–18). Among the 119 (53%) participants who reported being sexually active at baseline, the median age at first sex was 16 years (IQR: 15–17). During follow-up, an additional 16 (7%) participants reported having their first sexual encounter. Among the sexually active participants, the incidence of HIV was 1.5 cases / 100 person-years at risk (PYAR, 95% CI: 0.4–6.0), the incidence of chlamydia was 15.7 cases (95% CI: 10.1–24.4), gonorrhea was 4.7 cases (95% CI: 2.1–10.5), and HSV was 6.3 cases (95% CI: 3.1–12.6); we observed no cases of incident syphilis. The incidence of pregnancy among sexually active girls was 15.0 pregnancies / 100 PYAR (95% CI: 8.5–26.5). Despite small numbers, the incidence of most STIs was significantly higher in females compared to males. We also observed two pregnancies and 5 incident STIs among participants who reported never having had sex, these tended to be younger participants. From March to September 2020, the clinic was shut down for COVID-19, and 53 study visits were postponed. Follow up was concluded in November 2020, a total of 19 participants were lost to follow up, however only one participant dropped off-study during COVID-19 shutdowns. Retention at the final visit was 91.5%. We successfully completed a prospective study of adolescents to learn more about the risks they face as they navigate sexual debut in the context of a program of youth-friendly counseling and services. Among self-reported sexually active participants, we observed a high rate of HIV, STI and pregnancy, however we also observed pregnancy and STIs among those who reported no sexual activity. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Validation of a host blood transcriptomic biomarker for pulmonary tuberculosis in people living with HIV: a prospective diagnostic and prognostic accuracy study

Author

Abrahams, Charmaine, Africa, Hadn, Ahlers, Petri, Arendsen, Denis, Badimo, Tebogo, Baepanye, Kagiso, Baepanye, Kesenogile Edna, Bande, Bianca, Batyi, Nomfuneko Cynthia, Beukes, Roslyn, Bontsi, Laudicia Tshenolo, Booi, Obakeng Peter, Botha, Mari Cathrin, Braaf, Samentra, Buhlungu, Sivuyile, Carstens, Alida, Chauke, Kgomotso Violet, Chinappa, Thilagavathy, Chung, Eva, Chung, Michelle, Clarke, Ken, Cloete, Yolundi, Coetzee, Lorraine, Collignon, Marelize, Companie, Alessandro, Corris, Cara-mia, Cwaile, Mooketsi Theophillius, Cwele, Thobelani, Davids, Ilse, Davies, Isabella Johanna, De Klerk, Emilia, de Kock, Marwou, Dhlamini, Audrey Lebohang, Diamond, Bongani, Didloff, Maria, Dlamini, Celaphiwe, Dolo, Palesa, Eyre, Candice, Feni, Tebogo, Ferreira, Juanita, Ferus, Christal, Fisher, Michelle, Flinn, Marika, Fransman, Bernadine, Galane, Welseh Phindile, Geldenhuys, Hennie, Gempies, Diann, Goliath, Thelma, Govender, Dhineshree, Gregg, Yolande, Gumede, Goodness, Gwamada, Zanele, Halti, Senzo, Hassiem, Rieyaat, Herling, Roxane, Herselman, Yulandi, Hughes, Ellis, Issel, Henry, Iyemosolo, Blanchard Mbay, Jali, Zandile, Janse Van Rensburg, Bonita, Jansen, Ruwiyda, Jeleni, James Michael, Jonkane, Olebogeng, Julies, Fabio, Kafaar, Fazlin, Kasongo, Christian Mabika, Keffers, Sophie, Kekana, Boitumelo Sophy, Kekana, Sebaetseng Jeanette, Kelepu, Xoliswa, Khanyile, Lungile, Khobedi, Gomotsegang Virginia, Khomba, Gloria, Khoza, Lucky Sipho, King, Marietjie, Kolobe, Gloria Keitumetse, Kruger, Sandra, Kruger, Jaftha, Kunene, Ndlela Israel, Lakay, Sunelza, Lakhi, Aneesa, Langa, Nondumiso, Ledwaba, Hildah, Lekagane, Lerato Julia, Lekotloane, Sheiley Christina, Leopeng, Thelma, Louw, Ilze Jeanette, Luabeya, Angelique Kany Kany, Lusale, Sarah Teboso, Maatjie, Perfect Tiisetso, Mabasa, Immaculate, Mabe, Tshegofatso Dorah, Mabena, Kamogelo Fortunate, Mabuza, Nkosinathi Charles, Mabwe, Simbarashe, Madikwe, Johanna Thapelo, Madikwe, Octavia Mahkosazana, Maebana, Rapontwana Letlhogonolo, Magwasha, Malobisa Sylvester, Majola, Molly, Makhetha, Mantai, Makhethe, Lebohang, Malay, Vernon, Manzini, Vutlhari-I-Vunhenha Fairlord, Maphanga, Jabu, Maphanga, Nonhle, Market, Juanita, Maroele, Isholedi Samuel, Masibi, Omphile Petunia, Mathabanzini, July Rocky, Mathode, Tendamudzimu Ivan, Matsane, Ellen Ditaba, Mbata, Lungile, Meyer, Faheema, Mhandire, Nyasha Karen, Miga, Thembisiwe, Mkhize, Nosisa Charity Thandeka, Mkhokho, Caroline, Mkwalase, Neo Hilda, Mnqonywa, Nondzakazi, Moche, Karabo, Modisaotsile, Brenda Matshidiso, Mokgetsengoane, Patricia Pakiso, Mokone, Selemeng Matseliso Carol, Molatlhegi, Kegomoditswe Magdeline, Molefe, Thuso Andrew, Moloko, Joseph Panie, Molosi, Kabelo, Molotsi, Motlatsi Evelyn, Montwedi, Tebogo Edwin, Monyemangene, Boikanyo Dinah, Mooketsi, Hellen Mokopi, Moses, Miriam, Mosito, Boitumelo, Mosito, Tshplpfelo Mapula, Mosweu, Ireen Lesebang, Mothaga, Primrose, Motlagomang, Banyana Olga, Mouton, Angelique, Mpofu, Onesisa, Mthembu, Funeka Nomvula, Mtlali, Mpho, Ndlovu, Nhlamulo, Ngcobo, Nompumelelo, Noble, Julia, Ntamo, Bantubonke Bertrum, Ntanjana, Gloria, Ntshauba, Tedrius, Opperman, Fajwa, Padayatchi, Nesri, Papalagae, Thandiwe, Petersen, Christel, Phakathi, Themba, Phatshwane, Mapule Ozma, Plaatjie, Patiswa, Pretorius, Abe, Rameetse, Victor Kgothatso, Ramjit, Dirhona, Ratangee, Frances, Ratangee, Maigan, Sanyaka, Pearl Nomsa, Sato, Alicia, Schoeman, Elisma, Schreuder, Constance, Seabela, Letlhogonolo, Segaetsho, Kelebogile Magdeline, Sein, Ni Ni, Selepe, Raesibe Agnes Pearl, Senne, Melissa Neo, September, Alison, September, Cashwin, Serake, Moeti, Shenje, Justin, Shezi, Thandiwe, Shezi, Sifiso Cornelius, Sing, Phindile, Singh, Chandrapharbha, Sithetho, Zona, Solomons, Dorothy, Stanley, Kim, Steyn, Marcia, Stofile, Bongiwe, Stryers, Sonia, Swanepoel, Liticia, Swarts, Anne, Thaba, Mando Mmakhora, Theko, Lethabo Collen, Thembela, Philile, Thompo, Mugwena, Toefy, Asma, Toto, Khayalethu, Tsagae, Dimakatso Sylvia, Tsamane, Ayanda, Tshikovhi, Vincent, Tswaile, Lebogang Isaac, Tyambetyu, Petrus, Tönsing, Susanne, Valley, Habibullah, van der Merwe, Linda, van Rooyen, Elma, Veldsman, Ashley, Veldtsman, Helen, Vollenhoven, Kelvin, Zaca, Londiwe, Zimri, Elaine, Zulu, Mbali, Mendelsohn, Simon C, Fiore-Gartland, Andrew, Penn-Nicholson, Adam, Mulenga, Humphrey, Mbandi, Stanley Kimbung, Borate, Bhavesh, Hadley, Katie, Hikuam, Chris, Musvosvi, Munyaradzi, Bilek, Nicole, Erasmus, Mzwandile, Jaxa, Lungisa, Raphela, Rodney, Nombida, Onke, Kaskar, Masooda, Sumner, Tom, White, Richard G, Innes, Craig, Brumskine, William, Hiemstra, Andriëtte, Malherbe, Stephanus T, Hassan-Moosa, Razia, Tameris, Michèle, Walzl, Gerhard, Naidoo, Kogieleum, Churchyard, Gavin, Scriba, Thomas J, and Hatherill, Mark

Published
2021
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6. Biomarker-guided tuberculosis preventive therapy (CORTIS): a randomised controlled trial

Author

Baepanye, Kesenogile, Baepanye, Tshepiso, Clarke, Ken, Collignon, Marelize, Dlamini, Audrey, Eyre, Candice, Feni, Tebogo, Fikizolo, Moogo, Galane, Phinda, Goliath, Thelma, Gangat, Alia, Malefo-Grootboom, Shirley, Janse van Rensburg, Elba, Janse van Rensburg, Bonita, Kekana, Sophy, Zietsman, Marietjie, Kock, Adrianne, Kunene, Israel, Lakhi, Aneessa, Langa, Nondumiso, Ledwaba, Hilda, Luphoko, Marillyn, Mabasa, Immaculate, Mabe, Dorah, Mabuza, Nkosinathi, Majola, Molly, Makhetha, Mantai, Makoanyane, Mpho, Makhubalo, Blossom, Malay, Vernon, Market, Juanita, Matshego, Selvy, Mbipa, Nontsikelelo, Mmotsa, Tsiamo, Modipa, Sylvester, Mopati, Samuel, Moswegu, Palesa, Mothaga, Primrose, Muller, Dorothy, Nchwe, Grace, Nel, Maryna, Nhlangulela, Lindiwe, Ntamo, Bantubonke, Ntoahae, Lawerence, Ntshauba, Tedrius, Sanyaka, Nomsa, Seabela, Letlhogonolo, Selepe, Pearl, Senne, Melissa, Serake, MG, Thlapi, Maria, Tshikovhi, Vincent, Tswaile, Lebogang, van Aswegen, Amanda, Mbata, Lungile, Takavamanya, Constance, Pinho, Pedro, Mdlulu, John, Taljaard, Marthinette, Slabbert, Naydene, Sayed, Sharfuddin, Nielson, Tanya, Ni Sein, Ni, Govender, Dhineshree, Chinappa, Tilagavathy, Zulu, Mbali Ignatia, Maphanga, Nonhle Bridgette, Hlathi, Senzo Ralph, Gumede, Goodness Khanyisile, Shezi, Thandiwe Yvonne, Maphanga, Jabulisiwe Lethabo, Jali, Zandile Patrica, Cwele, Thobelani, Gwamanda, Nonhlanhla Zanele Elsie, Dlamini, Celaphiwe, Sing, Zibuyile Phindile Penlee, Ntanjana, Ntombozuko Gloria, Nzimande, Sphelele Simo, Mbatha, Siyabonga, Maharaj, Bhavna, Moosa, Atika, Corris, Cara-Mia, Kafaar, Fazlin, Geldenhuys, Hennie, Luabeya, Angelique Kany Kany, Shenje, Justin, Botes, Natasja, Rossouw, Susan, Africa, Hadn, Diamond, Bongani, Braaf, Samentra, Stryers, Sonia, Carstens, Alida, Jansen, Ruwiyda, Mabwe, Simbarashe, Mulenga, Humphrey, Herling, Roxane, Veldsman, Ashley, Makhete, Lebohgang, Steyn, Marcia, Buhlungu, Sivuyile, Erasmus, Margareth, Davids, Ilse, Plaatjie, Patiswa, Companie, Alessandro, Ratangee, Frances, Veldtsman, Helen, Petersen, Christel, Abrahams, Charmaine, Moses, Miriam, Kelepu, Xoliswa, Gregg, Yolande, Swanepoel, Liticia, Magawu, Nomsitho, Cetywayo, Nompumelelo, Mactavie, Lauren, Valley, Habibullah, Filander, Elizabeth, Nqakala, Nambitha, Maasdorp, Elizna, Khoury, Justine, Kriel, Belinda, Smith, Bronwyn, Muller, Liesel, Tonsing, Susanne, Loxton, Andre, Hiemstra, Andriette, Ahlers, Petri, Flinn, Marika, Chung, Eva, Chung, Michelle, Sato, Alicia, Scriba, Thomas J, Fiore-Gartland, Andrew, Penn-Nicholson, Adam, Kimbung Mbandi, Stanley, Borate, Bhavesh, Mendelsohn, Simon C, Hadley, Katie, Hikuam, Chris, Kaskar, Masooda, Musvosvi, Munyaradzi, Bilek, Nicole, Self, Steven, Sumner, Tom, White, Richard G, Erasmus, Mzwandile, Jaxa, Lungisa, Raphela, Rodney, Innes, Craig, Brumskine, William, Hiemstra, Andriëtte, Malherbe, Stephanus T, Hassan-Moosa, Razia, Tameris, Michèle, Walzl, Gerhard, Naidoo, Kogieleum, Churchyard, Gavin, and Hatherill, Mark

Published
2021
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7. HIV Incidence Among Pregnant and Nonpregnant Women in the FACTS-001 Trial: Implications for HIV Prevention, Especially PrEP Use

Author

Rees, Helen, Chersich, Matthew Francis, Munthali, Richard J., Brumskine, William, Palanee-Phillips, Thesla, Nkala, Busi, Ahmed, Khatija, Sebe, Modulakgotla, Mabude, Zonke, Nchabeleng, Maphoshane, Bekker, Linda-Gail, Kotze, Philip, Mogodiri, Thembisile, Naidoo, Ishana, Panchia, Ravindre, Myer, Landon, Lombard, Carl, Doncel, Gustavo F., Gray, Glenda, and Delany-Moretlwe, Sinead

Published
2021
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8. Tenofovir 1% vaginal gel for prevention of HIV-1 infection in women in South Africa (FACTS-001): a phase 3, randomised, double-blind, placebo-controlled trial

Author

Delany-Moretlwe, Sinead, Lombard, Carl, Baron, Deborah, Bekker, Linda-Gail, Nkala, Busi, Ahmed, Khatija, Sebe, Modulakgotla, Brumskine, William, Nchabeleng, Maposhane, Palanee-Philips, Thesla, Ntshangase, Julius, Sibiya, Sidney, Smith, Emilee, Panchia, Ravindre, Myer, Landon, Schwartz, Jill L, Marzinke, Mark, Morris, Lynn, Brown, Elizabeth R, Doncel, Gustavo F, Gray, Glenda, and Rees, Helen

Published
2018
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9. Additional file 1 of Data quality in an HIV vaccine efficacy clinical trial in South Africa: through natural disasters and with discipline

Author

Laher, Fatima, Malahleha, Mookho, Ramirez, Shelly, Brumskine, William, Otwombe, Kennedy, Moodie, Zoe, and Allen, Mary

Abstract

Additional file 1: Supplementary Table 1. Distribution of categories of deviations (N=4074) across the 14 trial sites. Supplementary Figure 1. Box and whisker plot of number of participants enrolled by high- and low-enrolling sites.

Published
2023
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10. Analysis of the HIV Vaccine Trials Network 702 Phase 2b–3 HIV-1 Vaccine Trial in South Africa Assessing RV144 Antibody and T-Cell Correlates of HIV-1 Acquisition Risk

Author

Moodie, Zoe, primary, Dintwe, One, additional, Sawant, Sheetal, additional, Grove, Doug, additional, Huang, Yunda, additional, Janes, Holly, additional, Heptinstall, Jack, additional, Omar, Faatima Laher, additional, Cohen, Kristen, additional, De Rosa, Stephen C, additional, Zhang, Lu, additional, Yates, Nicole L, additional, Sarzotti-Kelsoe, Marcella, additional, Seaton, Kelly E, additional, Laher, Fatima, additional, Bekker, Linda Gail, additional, Malahleha, Mookho, additional, Innes, Craig, additional, Kassim, Sheetal, additional, Naicker, Nivashnee, additional, Govender, Vaneshree, additional, Sebe, Modulakgotla, additional, Singh, Nishanta, additional, Kotze, Philip, additional, Lazarus, Erica, additional, Nchabeleng, Maphoshane, additional, Ward, Amy M, additional, Brumskine, William, additional, Dubula, Thozama, additional, Randhawa, April K, additional, Grunenberg, Nicole, additional, Hural, John, additional, Kee, Jia Jin, additional, Benkeser, David, additional, Jin, Yutong, additional, Carpp, Lindsay N, additional, Allen, Mary, additional, D’Souza, Patricia, additional, Tartaglia, James, additional, DiazGranados, Carlos A, additional, Koutsoukos, Marguerite, additional, Gilbert, Peter B, additional, Kublin, James G, additional, Corey, Lawrence, additional, Andersen-Nissen, Erica, additional, Gray, Glenda E, additional, Tomaras, Georgia D, additional, and McElrath, M Juliana, additional

Published
2022
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11. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study

Author

Bekker, Linda-Gail, primary, Garrett, Nigel, additional, Goga, Ameena, additional, Fairall, Lara, additional, Reddy, Tarylee, additional, Yende-Zuma, Nonhlanhla, additional, Kassanjee, Reshma, additional, Collie, Shirley, additional, Sanne, Ian, additional, Boulle, Andrew, additional, Seocharan, Ishen, additional, Engelbrecht, Imke, additional, Davies, Mary-Ann, additional, Champion, Jared, additional, Chen, Tommy, additional, Bennett, Sarah, additional, Mametja, Selaelo, additional, Semenya, Mabatlo, additional, Moultrie, Harry, additional, de Oliveira, Tulio, additional, Lessells, Richard John, additional, Cohen, Cheryl, additional, Jassat, Waasila, additional, Groome, Michelle, additional, Von Gottberg, Anne, additional, Le Roux, Engelbert, additional, Khuto, Kentse, additional, Barouch, Dan, additional, Mahomed, Hassan, additional, Wolmarans, Milani, additional, Rousseau, Petro, additional, Bradshaw, Debbie, additional, Mulder, Michelle, additional, Opie, Jessica, additional, Louw, Vernon, additional, Jacobson, Barry, additional, Rowji, Pradeep, additional, Peter, Jonny G, additional, Takalani, Azwi, additional, Odhiambo, Jackline, additional, Mayat, Fatima, additional, Takuva, Simbarashe, additional, Corey, Lawrence, additional, Gray, Glenda E, additional, Brumskine, William, additional, Naicker, Nivashnee, additional, Makhaza, Disebo, additional, Naicker, Vimla, additional, Naidoo, Logashvari, additional, Spooner, Elizabeth, additional, van Nieuwenhuizen, Elane, additional, Mngadi, Kathryn, additional, Nchabeleng, Maphoshane, additional, Innes, James Craig, additional, Gill, Katherine, additional, Petrick, Friedrich Georg, additional, Barnabas, Shaun, additional, Badal-Faesen, Sharlaa, additional, Kassim, Sheetal, additional, Mahoney, Scott Hayden, additional, Lazarus, Erica, additional, Nana, Anusha, additional, Maboa, Rebone Molobane, additional, Kotze, Philip, additional, Lombaard, Johan, additional, Malan, Daniel Rudolf, additional, Kotze, Sheena, additional, Mohlala, Phuthi, additional, Ward, Amy, additional, Meintjes, Graeme, additional, Urbach, Dorothea, additional, Patel, Faeezah, additional, Diacon, Andreas, additional, Ahmed, Khatija, additional, Grobbelaar, Coert, additional, Mda, Pamela, additional, Dubula, Thozama, additional, Luabeya, Angelique, additional, Mamba, Musawenkosi Bhekithemba, additional, Burgess, Lesley, additional, and Dawson, Rodney, additional

Published
2022
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12. Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial

Author

Churchyard, Gavin, Cárdenas, Vicky, Chihota, Violet, Mngadi, Kathy, Sebe, Modulakgotla, Brumskine, William, Martinson, Neil, Yimer, Getnet, Wang, Shu-Hua, Garcia-Basteiro, Alberto L, Nguenha, Dinis, Masilela, LeeAnne, Waggie, Zainab, van den Hof, Susan, Charalambous, Salome, Cobelens, Frank, Chaisson, Richard E, Grant, Alison D, and Fielding, Katherine L

Abstract

Between November 2016 and November 2017, 4027 participants were enrolled; 4014 were included in the analyses (median age, 41 years; 69.5% women; all using antiretroviral therapy). Treatment completion in the first year for the combined rifapentine-isoniazid groups (n = 3610) was 90.4% versus 50.5% for the isoniazid group (n = 404) (risk ratio, 1.78 [95% CI, 1.61 to 1.95]). Tuberculosis incidence among participants receiving the rifapentine-isoniazid regimen twice (n = 1808) or once (n = 1802) was similar (hazard ratio, 0.96 [CI, 0.61 to 1.50]).

Published
2021

13. Validation of a host blood transcriptomic biomarker for pulmonary tuberculosis in people living with HIV: a prospective diagnostic and prognostic accuracy study

Author

Mendelsohn, Simon C, primary, Fiore-Gartland, Andrew, additional, Penn-Nicholson, Adam, additional, Mulenga, Humphrey, additional, Mbandi, Stanley Kimbung, additional, Borate, Bhavesh, additional, Hadley, Katie, additional, Hikuam, Chris, additional, Musvosvi, Munyaradzi, additional, Bilek, Nicole, additional, Erasmus, Mzwandile, additional, Jaxa, Lungisa, additional, Raphela, Rodney, additional, Nombida, Onke, additional, Kaskar, Masooda, additional, Sumner, Tom, additional, White, Richard G, additional, Innes, Craig, additional, Brumskine, William, additional, Hiemstra, Andriëtte, additional, Malherbe, Stephanus T, additional, Hassan-Moosa, Razia, additional, Tameris, Michèle, additional, Walzl, Gerhard, additional, Naidoo, Kogieleum, additional, Churchyard, Gavin, additional, Scriba, Thomas J, additional, Hatherill, Mark, additional, Abrahams, Charmaine, additional, Africa, Hadn, additional, Ahlers, Petri, additional, Arendsen, Denis, additional, Badimo, Tebogo, additional, Baepanye, Kagiso, additional, Baepanye, Kesenogile Edna, additional, Bande, Bianca, additional, Batyi, Nomfuneko Cynthia, additional, Beukes, Roslyn, additional, Bontsi, Laudicia Tshenolo, additional, Booi, Obakeng Peter, additional, Botha, Mari Cathrin, additional, Braaf, Samentra, additional, Buhlungu, Sivuyile, additional, Carstens, Alida, additional, Chauke, Kgomotso Violet, additional, Chinappa, Thilagavathy, additional, Chung, Eva, additional, Chung, Michelle, additional, Clarke, Ken, additional, Cloete, Yolundi, additional, Coetzee, Lorraine, additional, Collignon, Marelize, additional, Companie, Alessandro, additional, Corris, Cara-mia, additional, Cwaile, Mooketsi Theophillius, additional, Cwele, Thobelani, additional, Davids, Ilse, additional, Davies, Isabella Johanna, additional, De Klerk, Emilia, additional, de Kock, Marwou, additional, Dhlamini, Audrey Lebohang, additional, Diamond, Bongani, additional, Didloff, Maria, additional, Dlamini, Celaphiwe, additional, Dolo, Palesa, additional, Eyre, Candice, additional, Feni, Tebogo, additional, Ferreira, Juanita, additional, Ferus, Christal, additional, Fisher, Michelle, additional, Flinn, Marika, additional, Fransman, Bernadine, additional, Galane, Welseh Phindile, additional, Geldenhuys, Hennie, additional, Gempies, Diann, additional, Goliath, Thelma, additional, Govender, Dhineshree, additional, Gregg, Yolande, additional, Gumede, Goodness, additional, Gwamada, Zanele, additional, Halti, Senzo, additional, Hassiem, Rieyaat, additional, Herling, Roxane, additional, Herselman, Yulandi, additional, Hughes, Ellis, additional, Issel, Henry, additional, Iyemosolo, Blanchard Mbay, additional, Jali, Zandile, additional, Janse Van Rensburg, Bonita, additional, Jansen, Ruwiyda, additional, Jeleni, James Michael, additional, Jonkane, Olebogeng, additional, Julies, Fabio, additional, Kafaar, Fazlin, additional, Kasongo, Christian Mabika, additional, Keffers, Sophie, additional, Kekana, Boitumelo Sophy, additional, Kekana, Sebaetseng Jeanette, additional, Kelepu, Xoliswa, additional, Khanyile, Lungile, additional, Khobedi, Gomotsegang Virginia, additional, Khomba, Gloria, additional, Khoza, Lucky Sipho, additional, King, Marietjie, additional, Kolobe, Gloria Keitumetse, additional, Kruger, Sandra, additional, Kruger, Jaftha, additional, Kunene, Ndlela Israel, additional, Lakay, Sunelza, additional, Lakhi, Aneesa, additional, Langa, Nondumiso, additional, Ledwaba, Hildah, additional, Lekagane, Lerato Julia, additional, Lekotloane, Sheiley Christina, additional, Leopeng, Thelma, additional, Louw, Ilze Jeanette, additional, Luabeya, Angelique Kany Kany, additional, Lusale, Sarah Teboso, additional, Maatjie, Perfect Tiisetso, additional, Mabasa, Immaculate, additional, Mabe, Tshegofatso Dorah, additional, Mabena, Kamogelo Fortunate, additional, Mabuza, Nkosinathi Charles, additional, Mabwe, Simbarashe, additional, Madikwe, Johanna Thapelo, additional, Madikwe, Octavia Mahkosazana, additional, Maebana, Rapontwana Letlhogonolo, additional, Magwasha, Malobisa Sylvester, additional, Majola, Molly, additional, Makhetha, Mantai, additional, Makhethe, Lebohang, additional, Malay, Vernon, additional, Manzini, Vutlhari-I-Vunhenha Fairlord, additional, Maphanga, Jabu, additional, Maphanga, Nonhle, additional, Market, Juanita, additional, Maroele, Isholedi Samuel, additional, Masibi, Omphile Petunia, additional, Mathabanzini, July Rocky, additional, Mathode, Tendamudzimu Ivan, additional, Matsane, Ellen Ditaba, additional, Mbata, Lungile, additional, Meyer, Faheema, additional, Mhandire, Nyasha Karen, additional, Miga, Thembisiwe, additional, Mkhize, Nosisa Charity Thandeka, additional, Mkhokho, Caroline, additional, Mkwalase, Neo Hilda, additional, Mnqonywa, Nondzakazi, additional, Moche, Karabo, additional, Modisaotsile, Brenda Matshidiso, additional, Mokgetsengoane, Patricia Pakiso, additional, Mokone, Selemeng Matseliso Carol, additional, Molatlhegi, Kegomoditswe Magdeline, additional, Molefe, Thuso Andrew, additional, Moloko, Joseph Panie, additional, Molosi, Kabelo, additional, Molotsi, Motlatsi Evelyn, additional, Montwedi, Tebogo Edwin, additional, Monyemangene, Boikanyo Dinah, additional, Mooketsi, Hellen Mokopi, additional, Moses, Miriam, additional, Mosito, Boitumelo, additional, Mosito, Tshplpfelo Mapula, additional, Mosweu, Ireen Lesebang, additional, Mothaga, Primrose, additional, Motlagomang, Banyana Olga, additional, Mouton, Angelique, additional, Mpofu, Onesisa, additional, Mthembu, Funeka Nomvula, additional, Mtlali, Mpho, additional, Ndlovu, Nhlamulo, additional, Ngcobo, Nompumelelo, additional, Noble, Julia, additional, Ntamo, Bantubonke Bertrum, additional, Ntanjana, Gloria, additional, Ntshauba, Tedrius, additional, Opperman, Fajwa, additional, Padayatchi, Nesri, additional, Papalagae, Thandiwe, additional, Petersen, Christel, additional, Phakathi, Themba, additional, Phatshwane, Mapule Ozma, additional, Plaatjie, Patiswa, additional, Pretorius, Abe, additional, Rameetse, Victor Kgothatso, additional, Ramjit, Dirhona, additional, Ratangee, Frances, additional, Ratangee, Maigan, additional, Sanyaka, Pearl Nomsa, additional, Sato, Alicia, additional, Schoeman, Elisma, additional, Schreuder, Constance, additional, Seabela, Letlhogonolo, additional, Segaetsho, Kelebogile Magdeline, additional, Sein, Ni Ni, additional, Selepe, Raesibe Agnes Pearl, additional, Senne, Melissa Neo, additional, September, Alison, additional, September, Cashwin, additional, Serake, Moeti, additional, Shenje, Justin, additional, Shezi, Thandiwe, additional, Shezi, Sifiso Cornelius, additional, Sing, Phindile, additional, Singh, Chandrapharbha, additional, Sithetho, Zona, additional, Solomons, Dorothy, additional, Stanley, Kim, additional, Steyn, Marcia, additional, Stofile, Bongiwe, additional, Stryers, Sonia, additional, Swanepoel, Liticia, additional, Swarts, Anne, additional, Thaba, Mando Mmakhora, additional, Theko, Lethabo Collen, additional, Thembela, Philile, additional, Thompo, Mugwena, additional, Toefy, Asma, additional, Toto, Khayalethu, additional, Tsagae, Dimakatso Sylvia, additional, Tsamane, Ayanda, additional, Tshikovhi, Vincent, additional, Tswaile, Lebogang Isaac, additional, Tyambetyu, Petrus, additional, Tönsing, Susanne, additional, Valley, Habibullah, additional, van der Merwe, Linda, additional, van Rooyen, Elma, additional, Veldsman, Ashley, additional, Veldtsman, Helen, additional, Vollenhoven, Kelvin, additional, Zaca, Londiwe, additional, Zimri, Elaine, additional, and Zulu, Mbali, additional

Published
2021
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14. Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120–MF59 in Adults

Author

Gray, Glenda E., primary, Bekker, Linda-Gail, additional, Laher, Fatima, additional, Malahleha, Mookho, additional, Allen, Mary, additional, Moodie, Zoe, additional, Grunenberg, Nicole, additional, Huang, Yunda, additional, Grove, Doug, additional, Prigmore, Brittany, additional, Kee, Jia J., additional, Benkeser, David, additional, Hural, John, additional, Innes, Craig, additional, Lazarus, Erica, additional, Meintjes, Graeme, additional, Naicker, Nivashnee, additional, Kalonji, Dishiki, additional, Nchabeleng, Maphoshane, additional, Sebe, Modulakgotla, additional, Singh, Nishanta, additional, Kotze, Philip, additional, Kassim, Sheetal, additional, Dubula, Thozama, additional, Naicker, Vimla, additional, Brumskine, William, additional, Ncayiya, Cleon N., additional, Ward, Amy M., additional, Garrett, Nigel, additional, Kistnasami, Girisha, additional, Gaffoor, Zakir, additional, Selepe, Pearl, additional, Makhoba, Philisiwe B., additional, Mathebula, Matsontso P., additional, Mda, Pamela, additional, Adonis, Tania, additional, Mapetla, Katlego S., additional, Modibedi, Bontle, additional, Philip, Tricia, additional, Kobane, Gladys, additional, Bentley, Carter, additional, Ramirez, Shelly, additional, Takuva, Simbarashe, additional, Jones, Megan, additional, Sikhosana, Mpho, additional, Atujuna, Millicent, additional, Andrasik, Michele, additional, Hejazi, Nima S., additional, Puren, Adrian, additional, Wiesner, Lubbe, additional, Phogat, Sanjay, additional, Diaz Granados, Carlos, additional, Koutsoukos, Marguerite, additional, Van Der Meeren, Olivier, additional, Barnett, Susan W., additional, Kanesa-Thasan, Niranjan, additional, Kublin, James G., additional, McElrath, M. Juliana, additional, Gilbert, Peter B., additional, Janes, Holly, additional, and Corey, Lawrence, additional

Published
2021
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15. Biomarker-guided tuberculosis preventive therapy (CORTIS): a randomised controlled trial

Author

Scriba, Thomas J, primary, Fiore-Gartland, Andrew, additional, Penn-Nicholson, Adam, additional, Mulenga, Humphrey, additional, Kimbung Mbandi, Stanley, additional, Borate, Bhavesh, additional, Mendelsohn, Simon C, additional, Hadley, Katie, additional, Hikuam, Chris, additional, Kaskar, Masooda, additional, Musvosvi, Munyaradzi, additional, Bilek, Nicole, additional, Self, Steven, additional, Sumner, Tom, additional, White, Richard G, additional, Erasmus, Mzwandile, additional, Jaxa, Lungisa, additional, Raphela, Rodney, additional, Innes, Craig, additional, Brumskine, William, additional, Hiemstra, Andriëtte, additional, Malherbe, Stephanus T, additional, Hassan-Moosa, Razia, additional, Tameris, Michèle, additional, Walzl, Gerhard, additional, Naidoo, Kogieleum, additional, Churchyard, Gavin, additional, Hatherill, Mark, additional, Baepanye, Kesenogile, additional, Baepanye, Tshepiso, additional, Clarke, Ken, additional, Collignon, Marelize, additional, Dlamini, Audrey, additional, Eyre, Candice, additional, Feni, Tebogo, additional, Fikizolo, Moogo, additional, Galane, Phinda, additional, Goliath, Thelma, additional, Gangat, Alia, additional, Malefo-Grootboom, Shirley, additional, Janse van Rensburg, Elba, additional, Janse van Rensburg, Bonita, additional, Kekana, Sophy, additional, Zietsman, Marietjie, additional, Kock, Adrianne, additional, Kunene, Israel, additional, Lakhi, Aneessa, additional, Langa, Nondumiso, additional, Ledwaba, Hilda, additional, Luphoko, Marillyn, additional, Mabasa, Immaculate, additional, Mabe, Dorah, additional, Mabuza, Nkosinathi, additional, Majola, Molly, additional, Makhetha, Mantai, additional, Makoanyane, Mpho, additional, Makhubalo, Blossom, additional, Malay, Vernon, additional, Market, Juanita, additional, Matshego, Selvy, additional, Mbipa, Nontsikelelo, additional, Mmotsa, Tsiamo, additional, Modipa, Sylvester, additional, Mopati, Samuel, additional, Moswegu, Palesa, additional, Mothaga, Primrose, additional, Muller, Dorothy, additional, Nchwe, Grace, additional, Nel, Maryna, additional, Nhlangulela, Lindiwe, additional, Ntamo, Bantubonke, additional, Ntoahae, Lawerence, additional, Ntshauba, Tedrius, additional, Sanyaka, Nomsa, additional, Seabela, Letlhogonolo, additional, Selepe, Pearl, additional, Senne, Melissa, additional, Serake, MG, additional, Thlapi, Maria, additional, Tshikovhi, Vincent, additional, Tswaile, Lebogang, additional, van Aswegen, Amanda, additional, Mbata, Lungile, additional, Takavamanya, Constance, additional, Pinho, Pedro, additional, Mdlulu, John, additional, Taljaard, Marthinette, additional, Slabbert, Naydene, additional, Sayed, Sharfuddin, additional, Nielson, Tanya, additional, Ni Sein, Ni, additional, Govender, Dhineshree, additional, Chinappa, Tilagavathy, additional, Zulu, Mbali Ignatia, additional, Maphanga, Nonhle Bridgette, additional, Hlathi, Senzo Ralph, additional, Gumede, Goodness Khanyisile, additional, Shezi, Thandiwe Yvonne, additional, Maphanga, Jabulisiwe Lethabo, additional, Jali, Zandile Patrica, additional, Cwele, Thobelani, additional, Gwamanda, Nonhlanhla Zanele Elsie, additional, Dlamini, Celaphiwe, additional, Sing, Zibuyile Phindile Penlee, additional, Ntanjana, Ntombozuko Gloria, additional, Nzimande, Sphelele Simo, additional, Mbatha, Siyabonga, additional, Maharaj, Bhavna, additional, Moosa, Atika, additional, Corris, Cara-Mia, additional, Kafaar, Fazlin, additional, Geldenhuys, Hennie, additional, Luabeya, Angelique Kany Kany, additional, Shenje, Justin, additional, Botes, Natasja, additional, Rossouw, Susan, additional, Africa, Hadn, additional, Diamond, Bongani, additional, Braaf, Samentra, additional, Stryers, Sonia, additional, Carstens, Alida, additional, Jansen, Ruwiyda, additional, Mabwe, Simbarashe, additional, Herling, Roxane, additional, Veldsman, Ashley, additional, Makhete, Lebohgang, additional, Steyn, Marcia, additional, Buhlungu, Sivuyile, additional, Erasmus, Margareth, additional, Davids, Ilse, additional, Plaatjie, Patiswa, additional, Companie, Alessandro, additional, Ratangee, Frances, additional, Veldtsman, Helen, additional, Petersen, Christel, additional, Abrahams, Charmaine, additional, Moses, Miriam, additional, Kelepu, Xoliswa, additional, Gregg, Yolande, additional, Swanepoel, Liticia, additional, Magawu, Nomsitho, additional, Cetywayo, Nompumelelo, additional, Mactavie, Lauren, additional, Valley, Habibullah, additional, Filander, Elizabeth, additional, Nqakala, Nambitha, additional, Maasdorp, Elizna, additional, Khoury, Justine, additional, Kriel, Belinda, additional, Smith, Bronwyn, additional, Muller, Liesel, additional, Tonsing, Susanne, additional, Loxton, Andre, additional, Hiemstra, Andriette, additional, Ahlers, Petri, additional, Flinn, Marika, additional, Chung, Eva, additional, Chung, Michelle, additional, and Sato, Alicia, additional

Published
2021
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16. Prospective Validation of a Host Blood Transcriptomic Biomarker for Pulmonary Tuberculosis in People Living with HIV: A Diagnostic and Prognostic Accuracy Study

Author

Mendelsohn, Simon C., primary, Fiore-Gartland, Andrew, additional, Penn-Nicholson, Adam, additional, Mulenga, Humphrey, additional, Mbandi, Stanley Kimbung, additional, Borate, Bhavesh, additional, Hadley, Katie, additional, Hikuam, Chris, additional, Musvosvi, Munyaradzi, additional, Bilek, Nicole, additional, Erasmus, Mzwandile, additional, Jaxa, Lungisa, additional, Raphela, Rodney, additional, Nombida, Onke, additional, Kaskar, Masooda, additional, Sumner, Tom, additional, White, Richard G., additional, Innes, Craig, additional, Brumskine, William, additional, Hiemstra, Andriëtte, additional, Malherbe, Stephanus T., additional, Hassan-Moosa, Razia, additional, Tameris, Michèle, additional, Walzl, Gerhard, additional, Naidoo, Kogieleum, additional, Churchyard, Gavin, additional, Scriba, Thomas J., additional, Hatherill, Mark, additional, and Team, CORTIS-HR Study, additional

Published
2020
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17. A Partially-Randomised Phase 3 Trial of Pretomanid, Moxifloxacin and Pyrazinamide in Combination for the Treatment of Drug-Susceptible and Drug-Resistant Pulmonary Tuberculosis

Author

Tweed, Conor, primary, Wills, Genevieve H, additional, Crook, Angela M, additional, Amukoye, Evans, additional, Balanag, Vincent, additional, Ban, Andrea YL, additional, Bateson, Anna LC, additional, Betteridge, Matthew C, additional, Brumskine, William, additional, Caoili, Janice, additional, Chaisson, Richard E, additional, Cevik, Muge, additional, Conradie, Francesca, additional, Dawson, Rodney, additional, del Parigi, Angelo, additional, Diacon, Andreas, additional, Everitt, Daniel E, additional, Fabiane, Stella M, additional, Hunt, Robert, additional, Ahmad, Ismail, additional, Lalloo, Umesh, additional, Lombard, Leandra, additional, Louw, Cheryl, additional, Malahleha, Mookho, additional, McHugh, Timothy D, additional, Mendel, Carl M, additional, Mhimbira, Francis, additional, Moodliar, Ronellle N, additional, Nduba, Videlis, additional, Nunn, Andrew J, additional, Sabi, Issa, additional, Sebe, Modulakgotla A, additional, Selepe, Raesibe AP, additional, Staples, Suzanne, additional, Swindells, Susan, additional, van Niekerk, Christo H, additional, Variava, Ebrahim, additional, Spigelman, Mel, additional, and Gillespie, Stephen H, additional

Published
2020
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18. HIV incidence and predictors of inconsistent condom use among adult men enrolled into an HIV vaccine preparedness study, Rustenburg, South Africa

Author

Maenetje, Pholo, primary, Lindan, Christina, additional, Makkan, Heeran, additional, Chetty-Makkan, Candice M., additional, Latka, Mary H., additional, Charalambous, Salome, additional, Mlotshwa, Mandla, additional, Malefo, Matshidiso, additional, Brumskine, William, additional, Hills, Nancy K., additional, Price, Matthew A., additional, and Edward, Vinodh, additional

Published
2019
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19. Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women.

Author

Bekker LG, Das M, Abdool Karim Q, Ahmed K, Batting J, Brumskine W, Gill K, Harkoo I, Jaggernath M, Kigozi G, Kiwanuka N, Kotze P, Lebina L, Louw CE, Malahleha M, Manentsa M, Mansoor LE, Moodley D, Naicker V, Naidoo L, Naidoo M, Nair G, Ndlovu N, Palanee-Phillips T, Panchia R, Pillay S, Potloane D, Selepe P, Singh N, Singh Y, Spooner E, Ward AM, Zwane Z, Ebrahimi R, Zhao Y, Kintu A, Deaton C, Carter CC, Baeten JM, and Matovu Kiweewa F

Abstract

Background: There are gaps in uptake of, adherence to, and persistence in the use of preexposure prophylaxis for human immunodeficiency virus (HIV) prevention among cisgender women., Methods: We conducted a phase 3, double-blind, randomized, controlled trial involving adolescent girls and young women in South Africa and Uganda. Participants were assigned in a 2:2:1 ratio to receive subcutaneous lenacapavir every 26 weeks, daily oral emtricitabine-tenofovir alafenamide (F/TAF), or daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF; active control); all participants also received the alternate subcutaneous or oral placebo. We assessed the efficacy of lenacapavir and F/TAF by comparing the incidence of HIV infection with the estimated background incidence in the screened population and evaluated relative efficacy as compared with F/TDF., Results: Among 5338 participants who were initially HIV-negative, 55 incident HIV infections were observed: 0 infections among 2134 participants in the lenacapavir group (0 per 100 person-years; 95% confidence interval [CI], 0.00 to 0.19), 39 infections among 2136 participants in the F/TAF group (2.02 per 100 person-years; 95% CI, 1.44 to 2.76), and 16 infections among 1068 participants in the F/TDF group (1.69 per 100 person-years; 95% CI, 0.96 to 2.74). Background HIV incidence in the screened population (8094 participants) was 2.41 per 100 person-years (95% CI, 1.82 to 3.19). HIV incidence with lenacapavir was significantly lower than background HIV incidence (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.04; P<0.001) and than HIV incidence with F/TDF (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.10; P<0.001). HIV incidence with F/TAF did not differ significantly from background HIV incidence (incidence rate ratio, 0.84; 95% CI, 0.55 to 1.28; P = 0.21), and no evidence of a meaningful difference in HIV incidence was observed between F/TAF and F/TDF (incidence rate ratio, 1.20; 95% CI, 0.67 to 2.14). Adherence to F/TAF and F/TDF was low. No safety concerns were found. Injection-site reactions were more common in the lenacapavir group (68.8%) than in the placebo injection group (F/TAF and F/TDF combined) (34.9%); 4 participants in the lenacapavir group (0.2%) discontinued the trial regimen owing to injection-site reactions., Conclusions: No participants receiving twice-yearly lenacapavir acquired HIV infection. HIV incidence with lenacapavir was significantly lower than background HIV incidence and HIV incidence with F/TDF. (Funded by Gilead Sciences; PURPOSE 1 ClinicalTrials.gov number, NCT04994509.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2024
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20. Longitudinal Dynamics of a Blood Transcriptomic Signature of Tuberculosis.

Author

Mulenga H, Musvosvi M, Mendelsohn SC, Penn-Nicholson A, Kimbung Mbandi S, Fiore-Gartland A, Tameris M, Mabwe S, Africa H, Bilek N, Kafaar F, Khader SA, Carstens B, Hadley K, Hikuam C, Erasmus M, Jaxa L, Raphela R, Nombida O, Kaskar M, Nicol MP, Mbhele S, Van Heerden J, Innes C, Brumskine W, Hiemstra A, Malherbe ST, Hassan-Moosa R, Walzl G, Naidoo K, Churchyard G, Hatherill M, and Scriba TJ

Subjects
Adolescent, Adult, Anti-HIV Agents therapeutic use, Antitubercular Agents therapeutic use, Biomarkers blood, Coinfection blood, Coinfection diagnosis, Coinfection genetics, Coinfection therapy, Cross-Sectional Studies, Female, HIV Infections blood, HIV Infections diagnosis, HIV Infections drug therapy, HIV Infections genetics, Humans, Linear Models, Longitudinal Studies, Male, Middle Aged, Respiratory Tract Infections blood, Respiratory Tract Infections diagnosis, Respiratory Tract Infections genetics, Respiratory Tract Infections therapy, Risk Assessment, Sensitivity and Specificity, Treatment Outcome, Tuberculosis blood, Tuberculosis prevention & control, Young Adult, Clinical Decision Rules, Gene Expression Profiling, Transcriptome, Tuberculosis diagnosis, Tuberculosis genetics
Abstract

Rationale: Performance of blood transcriptomic tuberculosis (TB) signatures in longitudinal studies and effects of TB-preventive therapy and coinfection with HIV or respiratory organisms on transcriptomic signatures has not been systematically studied. Objectives: We evaluated longitudinal kinetics of an 11-gene blood transcriptomic TB signature, RISK11, and effects of TB-preventive therapy (TPT) and respiratory organisms on RISK11 signature score, in HIV-uninfected and HIV-infected individuals. Methods: RISK11 was measured in a longitudinal study of RISK11-guided TPT in HIV-uninfected adults, a cross-sectional respiratory organisms cohort, or a longitudinal study in people living with HIV (PLHIV). HIV-uninfected RISK11 +  participants were randomized to TPT or no TPT; RISK11 - participants received no TPT. PLHIV received standard-of-care antiretroviral therapy and TPT. In the cross-sectional respiratory organisms cohort, viruses and bacteria in nasopharyngeal and oropharyngeal swabs were quantified by real-time quantitative PCR. Measurements and Main Results: RISK11 +  status was transient in most of the 128 HIV-negative participants with longitudinal samples; more than 70% of RISK11 +  participants reverted to RISK11 - by 3 months, irrespective of TPT. By comparison, reversion from a RISK11 + state was less common in 645 PLHIV (42.1%). Non-HIV viral and nontuberculous bacterial organisms were detected in 7.2% and 38.9% of the 1,000 respiratory organisms cohort participants, respectively, and among those investigated for TB, 3.8% had prevalent disease. Median RISK11 scores (%) were higher in participants with viral organisms alone (46.7%), viral and bacterial organisms (42.8%), or prevalent TB (85.7%) than those with bacterial organisms other than TB (13.4%) or no organisms (14.2%). RISK11 could not discriminate between prevalent TB and viral organisms. Conclusions: Positive RISK11 signature status is often transient, possibly due to intercurrent viral infection, highlighting potentially important challenges for implementation of these biomarkers as new tools for TB control.

Published
2021
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21. HIV Incidence Among Pregnant and Nonpregnant Women in the FACTS-001 Trial: Implications for HIV Prevention, Especially PrEP Use.

Author

Rees H, Chersich MF, Munthali RJ, Brumskine W, Palanee-Phillips T, Nkala B, Ahmed K, Sebe M, Mabude Z, Nchabeleng M, Bekker LG, Kotze P, Mogodiri T, Naidoo I, Panchia R, Myer L, Lombard C, Doncel GF, Gray G, and Delany-Moretlwe S

Subjects
Adolescent, Adult, Female, HIV Infections transmission, Humans, Incidence, Pregnancy, Pregnancy Complications, Infectious epidemiology, Pregnant Women, Risk Factors, Sexual Behavior, South Africa epidemiology, Tenofovir therapeutic use, Young Adult, HIV Infections epidemiology, HIV Infections prevention & control, Infectious Disease Transmission, Vertical prevention & control, Pre-Exposure Prophylaxis statistics & numerical data, Pregnancy Complications, Infectious prevention & control, Tenofovir administration & dosage
Abstract

Background: During pregnancy and postpartum period, the sexual behaviors of women and their partners change in ways that may either increase or reduce HIV risks. Pregnant women are a priority population for reducing both horizontal and vertical HIV transmission., Setting: Nine sites in 4 South African provinces., Methods: Women aged 18-30 years were randomized to receive pericoital tenofovir 1% gel or placebo gel and required to use reliable modern contraception. We compared HIV incidence in women before, during, and after pregnancy and used multivariate Cox Proportional hazards models to compare HIV incidence by pregnancy status., Results: Rates of pregnancy were 7.1 per 100 woman-years (95% confidence interval [CI]: 6.3 to 8.1) and highest in those who reported oral contraceptive use (25.1 per 100 woman-years; adjusted hazard ratio 22.97 higher than other women; 95% CI: 5.0 to 105.4) or had 2 children. Birth outcomes were similar between trial arms, with 59.8% having full-term live births. No difference was detected in incident HIV during pregnancy compared with nonpregnant women (2.1 versus 4.3%; hazard ratio = 0.56, 95% CI: 0.14 to 2.26). Sexual activity was low in pregnancy and the early postpartum period, as was consistent condom use., Conclusions: Pregnancy incidence was high despite trial participation being contingent on contraceptive use. We found no evidence that rates of HIV acquisition were elevated in pregnancy when compared with those in nonpregnant women. Risks from reductions in condom use may be offset by reduced sexual activity. Nevertheless, high HIV incidence in both pregnant and nonpregnant women supports consideration of introducing antiretroviral-containing pre-exposure prophylaxis for pregnant and nonpregnant women in high HIV prevalence settings., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2021
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22. Annual Tuberculosis Preventive Therapy for Persons With HIV Infection : A Randomized Trial.

Author

Churchyard G, Cárdenas V, Chihota V, Mngadi K, Sebe M, Brumskine W, Martinson N, Yimer G, Wang SH, Garcia-Basteiro AL, Nguenha D, Masilela L, Waggie Z, van den Hof S, Charalambous S, Cobelens F, Chaisson RE, Grant AD, and Fielding KL

Subjects
Adolescent, Adult, Anti-HIV Agents therapeutic use, Antitubercular Agents administration & dosage, Drug Administration Schedule, Drug Therapy, Combination, Ethiopia, Female, HIV Infections drug therapy, Humans, Isoniazid administration & dosage, Male, Mozambique, Rifampin administration & dosage, Rifampin therapeutic use, South Africa, Young Adult, Antitubercular Agents therapeutic use, HIV Infections complications, Isoniazid therapeutic use, Rifampin analogs & derivatives, Tuberculosis, Pulmonary prevention & control
Abstract

Background: Tuberculosis preventive therapy for persons with HIV infection is effective, but its durability is uncertain., Objective: To compare treatment completion rates of weekly isoniazid-rifapentine for 3 months versus daily isoniazid for 6 months as well as the effectiveness of the 3-month rifapentine-isoniazid regimen given annually for 2 years versus once., Design: Randomized trial. (ClinicalTrials.gov: NCT02980016)., Setting: South Africa, Ethiopia, and Mozambique., Participants: Persons with HIV infection who were receiving antiretroviral therapy, were aged 2 years or older, and did not have active tuberculosis., Intervention: Participants were randomly assigned to receive weekly rifapentine-isoniazid for 3 months, given either annually for 2 years or once, or daily isoniazid for 6 months. Participants were screened for tuberculosis symptoms at months 0 to 3 and 12 of each study year and at months 12 and 24 using chest radiography and sputum culture., Measurements: Treatment completion was assessed using pill counts. Tuberculosis incidence was measured over 24 months., Results: Between November 2016 and November 2017, 4027 participants were enrolled; 4014 were included in the analyses (median age, 41 years; 69.5% women; all using antiretroviral therapy). Treatment completion in the first year for the combined rifapentine-isoniazid groups ( n  = 3610) was 90.4% versus 50.5% for the isoniazid group ( n  = 404) (risk ratio, 1.78 [95% CI, 1.61 to 1.95]). Tuberculosis incidence among participants receiving the rifapentine-isoniazid regimen twice ( n  = 1808) or once ( n  = 1802) was similar (hazard ratio, 0.96 [CI, 0.61 to 1.50])., Limitation: If rifapentine-isoniazid is effective in curing subclinical tuberculosis, then the intensive tuberculosis screening at month 12 may have reduced its effectiveness., Conclusion: Treatment completion was higher with rifapentine-isoniazid for 3 months compared with isoniazid for 6 months. In settings with high tuberculosis transmission, a second round of preventive therapy did not provide additional benefit to persons receiving antiretroviral therapy., Primary Funding Source: The U.S. Agency for International Development through the CHALLENGE TB grant to the KNCV Tuberculosis Foundation.

Published
2021
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