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10 results on '"Vaneshree Govender"'

1. Hen egg white bovine colostrum supplement reduces symptoms of mild/moderate COVID-19: a randomized control trial

Author

Jaclyn Kelly Mann, Tarylee Reddy, Mary van der Stok, Ayanda Ngubane, Takalani Mulaudzi, Nobuhle Mchunu, Portia Nevhungoni, Nithendra Manickchund, Pariva Manickchund, Chelline Helena Louise Cairns, Vaneshree Govender, Thumbi Ndung'u, Mahomed Yunus Suleman Moosa, and Bernadett Isabel Gosnell

Subjects
colostrum, coronavirus, COVID-19, delta, egg white, lactoferrin, Medicine, Medicine (General), R5-920
Abstract

Aim: The ability of a hen egg white bovine colostrum supplement to prevent severe COVID-19 was tested in a double-blind randomized control study. Methods: Adults with mild/moderate COVID-19, risk factors for severe disease, and within 5 days of symptom onset were assigned to the intervention (n = 77) or placebo (n = 79) arms. Symptoms were documented until day 42 post-enrollment and viral clearance was assessed at 11–13 days post-symptom onset. Results: One participant developed severe COVID-19. The severe-type symptom score was lower in the active arm at 11–13 days post-symptom onset (p = 0.049). Chest pain, fever/chills, joint pain/malaise, and sore throat were significantly less frequent in the active arm. No differences in viral clearance were observed. Conclusion: The intervention reduced symptoms of mild/moderate COVID-19. Clinical Trial Registration: DOH-27-062021-9191 (South African National Clinical Trials Register)

Published
2023
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2. Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.

Author

Thesla Palanee-Phillips, Katie Schwartz, Elizabeth R Brown, Vaneshree Govender, Nyaradzo Mgodi, Flavia Matovu Kiweewa, Gonasagrie Nair, Felix Mhlanga, Samantha Siva, Linda-Gail Bekker, Nitesha Jeenarain, Zakir Gaffoor, Francis Martinson, Bonus Makanani, Sarita Naidoo, Arendevi Pather, Jessica Phillip, Marla J Husnik, Ariane van der Straten, Lydia Soto-Torres, and Jared Baeten

Subjects
Medicine, Science
Abstract

Women in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication over a month or longer, may reduce these adherence challenges.ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) is a phase III, randomized, double-blind, placebo-controlled trial testing the safety and effectiveness of a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine for prevention of HIV-1 infection. We describe the baseline characteristics of African women enrolled in the ASPIRE trial.Between August 2012 and June 2014, 5516 women were screened and 2629 HIV-1 seronegative women between 18-45 years of age were enrolled from 15 research sites in Malawi, South Africa, Uganda, and Zimbabwe. The median age was 26 years (IQR 22-31) and the majority (59%) were unmarried. Nearly 100% of participants reported having a primary sex partner in the prior three months but 43% did not know the HIV-1 status of their primary partner; 17% reported additional concurrent partners. Nearly two-thirds (64%) reported having disclosed to primary partners about planned vaginal ring use in the trial. Sexually transmitted infections were prevalent: 12% had Chlamydia trachomatis, 7% Trichomonas vaginalis, 4% Neisseria gonorrhoeae, and 1% syphilis.African HIV-1 seronegative women at risk of HIV -1 infection were successfully enrolled into a phase III trial of dapivirine vaginal ring for HIV-1 prevention.

Published
2015
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3. Ethical considerations in implementing a biometric coenrolment prevention system in clinical trials in South Africa

Author

Jayajothi Moodley, Sarita Naidoo, Neetha Morar, Vaneshree Govender, Patrick Charls, and Gita Ramjee

Subjects
Medical legislation, K3601-3611, Medicine, Medical philosophy. Medical ethics, R723-726
Abstract

Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks, a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council’s (SAMRC) Information Technology Services Division. The use of this web-based system to capture participant’s identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their names, SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion. This information was verified at all study visits. If a participant attempted to screen or co-enrol at multiple CRSs, the system flagged this as a potential coenrolment.By addressing the ethical concerns around participant consent and rights, participant confidentiality and privacy, data securityand access, and data management and storage, we were able to successfully implement BCEPS within the clinical trials conducted at HPRU,while adhering to the principles of good clinical practice (GCP), including respect for persons, beneficence and justice.

Published
2016
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4. Social harms in female-initiated HIV prevention method research

Author

Sarah T. Roberts, Sharon A. Riddler, Jayajothi Moodley, Kusbashni Woeber, Annalene Nel, Katherine E. Bunge, Devika Singh, Vaneshree Govender, Thesla Palanee-Phillips, Elizabeth T. Montgomery, Gonasagrie Nair, Richard H. Beigi, Logashvari Naidoo, Zakir Gaffour, Kristine Torjesen, Samantha Siva, Jeanne M. Marrazzo, Leila E. Mansoor, Samuel Kabwigu, Jared M. Baeten, Krishnaveni Reddy, Nitesha Jeenarain, Mariëtte Malherbe, and Z. Mike Chirenje

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Anti-HIV Agents, Immunology, Human immunodeficiency virus (HIV), MEDLINE, Intimate Partner Violence, HIV Infections, medicine.disease_cause, Article, Ethics, Research, law.invention, 03 medical and health sciences, Monitoring in clinical trials, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, medicine, Humans, Immunology and Allergy, Prospective Studies, 030212 general & internal medicine, Patient participation, Prospective cohort study, Africa South of the Sahara, business.industry, Vaginal creams, 030104 developmental biology, Infectious Diseases, Family medicine, Vaginal Creams, Foams, and Jellies, Domestic violence, Female, Patient Participation, Safety, business
Abstract

Assessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.Secondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.Social harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.Measurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (4% per 100 person-years), and the majority have been partner-related events. However, any incidence of social harm within the context of HIV prevention is important to capture and understand for the safety of individuals, and for the successful impact of prevention methods in a real-world context.

Published
2019
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5. Impact of Male Partner Involvement on Women’s Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial

Author

Gonasagrie Nair, Jared M. Baeten, Thesla Palanee-Philips, Kalendri Naidoo, Nishanta Singh, Sarah T. Roberts, Elizabeth T. Montgomery, Zakir Gaffoor, Vaneshree Govender, Samuel Kabwigu, Katie Schwartz, Krishnaveni Reddy, Aspire Study Team, Flavia Matovu Kiweewa, and Samantha Siva

Subjects
Adult, Male, Zimbabwe, Malawi, medicine.medical_specialty, Adolescent, Social Psychology, Anti-HIV Agents, Dapivirine, Psychological intervention, HIV Infections, Article, South Africa, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Humans, Medicine, Uganda, 030212 general & internal medicine, 030505 public health, business.industry, Vaginal microbicide, Public health, Public Health, Environmental and Occupational Health, Attendance, Contraceptive Devices, Female, Vaginal ring, Microbicides for sexually transmitted diseases, Health psychology, Pyrimidines, Infectious Diseases, Family medicine, Female, 0305 other medical science, business
Abstract

Although vaginal microbicides for HIV prevention are designed to be female-initiated, male partner influence has been identified as one of the most significant factors impacting women's willingness and ability to use them. As a result, research teams have sought to increase male partner involvement by encouraging disclosure of product use to male partners, promoting male partner engagement in the study through attendance at the study clinic, and helping women to garner male partner support for product use. This paper aims to assess the impact of these three elements of male partner involvement on women's adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized placebo-controlled clinical trial involving 2629 women in Malawi, South Africa, Uganda, and Zimbabwe. During the study, 64-80% of participants reported disclosure of ring use at each quarterly visit, and 13% reported that their partners had attended the study clinic at some point during the study. At study exit, 66% reported that their partner was supportive, 18% unsupportive, and 17% were unsure. After adjusting for age, site and time in study, women were more likely to have low ring adherence if they had an unsupportive male partner (aRR 1.29, 95% CI 1.03-1.62). Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38-35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70-6.24), relative to an unknown level of partner support. Women were also more likely to have a supportive partner if their partner had attended the clinic (aRRR 3.77, 95% CI 1.36-10.42). This study suggests that although the vaginal ring is relatively discreet, lack of support from male partners remains a relevant barrier to use. Though both disclosure and clinic attendance may increase partner support, disclosure may also increase partner opposition. Interventions to reduce male partner opposition are needed to maximize the potential impact of the ring and other PrEP products for HIV prevention.

Published
2019
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6. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author

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

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

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

Published
2020

7. Impact of Partner-Related Social Harms on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III Trial

Author

Flavia Matovu, Arendevi Pather, Jared M. Baeten, Sarah T. Roberts, Elizabeth R. Brown, Samantha Siva, Logashvari Naidoo, Kudzai Hlahla, Lydia Soto-Torres, Vaneshree Govender, Thesla Palanee-Phillips, Kristine Torjesen, Gonasagrie Nair, Zakir Gafoor, Katie Schwartz, Krishnaveni Reddy, Bonus Makanani, and Elizabeth T. Montgomery

Subjects
0301 basic medicine, Adult, Anti-HIV Agents, intimate partner violence, Dapivirine, HIV prevention, Prevention Research, HIV Infections, law.invention, Medication Adherence, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, law, Medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, adherence, Young adult, pre-exposure prophylaxis, social harms, business.industry, Contraceptive Devices, Female, 030112 virology, Vaginal ring, Confidence interval, 3. Good health, Clinical trial, Infectious Diseases, Harm, Pyrimidines, Relative risk, Female, business, Demography
Abstract

Background: Long-acting female-initiated methods such as the dapivirine ring may give women greater agency in HIV-1 prevention. However, social harms, defined as nonmedical adverse consequences of study participation or dapivirine ring use, may reduce product adherence and consequently HIV-1 protection. Methods: We assessed whether experiencing social harms from male partners was associated with lower adherence to the dapivirine ring in the MTN-020/ASPIRE trial. Reports of social harms were solicited quarterly. Low adherence was defined by plasma dapivirine levels ≤95 pg/mL or residual dapivirine levels in returned rings >23.5 mg. Results: Among 2629 women enrolled in ASPIRE, 85 (3.2%) reported 87 social harms during a median follow-up of 1.6 years. Women were significantly more likely to have low adherence, measured by plasma dapivirine levels, at visits with a social harm in the past month than at visits where no social harm was reported (adjusted risk ratio 2.53, 95% confidence interval: 1.37 to 4.66, P = 0.003). There was no association for social harms reported ≥1 month prior, suggesting an acute, short-term effect. Women were significantly more likely to not return a ring at visits with a social harm reported (adjusted risk ratio 24.70, 95% confidence interval: 18.57 to 32.85, P < 0.001). In rings that were returned, social harms were not associated with residual dapivirine levels. Conclusions: Although social harms were uncommon (1 year of use), participants reporting social harms by male partners had lower adherence to the dapivirine ring. Strategies to mitigate nonadherence to product use related to social harms should be evaluated in future studies of female-controlled HIV-1 prevention options.

Published
2018

8. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Author

Jared M. Baeten, Thesla Palanee-Phillips, Elizabeth R. Brown, Katie Schwartz, Lydia E. Soto-Torres, Vaneshree Govender, Nyaradzo M. Mgodi, Flavia Matovu Kiweewa, Gonasagrie Nair, Felix Mhlanga, Samantha Siva, Linda-Gail Bekker, Nitesha Jeenarain, Zakir Gaffoor, Francis Martinson, Bonus Makanani, Arendevi Pather, Logashvari Naidoo, Marla Husnik, Barbra A. Richardson, Urvi M. Parikh, John W. Mellors, Mark A. Marzinke, Craig W. Hendrix, Ariane van der Straten, Gita Ramjee, Zvavahera M. Chirenje, Clemensia Nakabiito, Taha E. Taha, Judith Jones, Ashley Mayo, Rachel Scheckter, Jennifer Berthiaume, Edward Livant, Cindy Jacobson, Patrick Ndase, Rhonda White, Karen Patterson, Donna Germuga, Beth Galaska, Katherine Bunge, Devika Singh, Daniel W. Szydlo, Elizabeth T. Montgomery, Barbara S. Mensch, Kristine Torjesen, Cynthia I. Grossman, Nahida Chakhtoura, Annalene Nel, Zeda Rosenberg, Ian McGowan, and Sharon Hillier

Subjects
0301 basic medicine, medicine.medical_specialty, education.field_of_study, Pathology, business.industry, Incidence (epidemiology), Dapivirine, Population, General Medicine, 030112 virology, Vaginal ring, Article, Clinical trial, 03 medical and health sciences, 0302 clinical medicine, medicine.anatomical_structure, Clinical research, Internal medicine, medicine, Vagina, 030212 general & internal medicine, Young adult, education, business
Abstract

BackgroundAntiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. MethodsWe conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe. ResultsAmong the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0....

Published
2016
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9. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Author

Judith G. Jones, Patrick Ndase, Nahida Chakhtoura, Elizabeth T. Montgomery, Daniel W. Szydlo, Samantha Siva, Katherine E. Bunge, Annalene Nel, Mark A. Marzinke, Cynthia I. Grossman, Nitesha Jeenarain, Urvi M. Parikh, Zeda F. Rosenberg, Flavia Matovu Kiweewa, Taha E. Taha, Marla Husnik, Donna Germuga, Francis Martinson, Ian McGowan, Zvavahera M. Chirenje, Vaneshree Govender, Bonus Makanani, Ariane van der Straten, Katie Schwartz, Elizabeth R. Brown, Sharon L. Hillier, Barbra A. Richardson, John W. Mellors, Felix Mhlanga, Kristine Torjesen, Gita Ramjee, Logashvari Naidoo, Craig W. Hendrix, Rhonda White, Rachel Scheckter, Beth Galaska, Nyaradzo Mgodi, Thesla Palanee-Phillips, Karen Patterson, Jennifer Berthiaume, Arendevi Pather, Jared M. Baeten, Zakir Gaffoor, Ashley J Mayo, Barbara S. Mensch, Devika Singh, Linda-Gail Bekker, Lydia Soto-Torres, Cindy Jacobson, Gonasagrie Nair, Clemensia Nakabiito, and Edward Livant

Subjects
0301 basic medicine, Gynecology, medicine.medical_specialty, business.industry, Incidence (epidemiology), Dapivirine, Human immunodeficiency virus (HIV), Obstetrics and Gynecology, General Medicine, medicine.disease_cause, 030112 virology, Vaginal ring, 03 medical and health sciences, Hiv 1 prevention, Medicine, business
Abstract

(Abstracted from N Engl J Med 2016; DOI: 10.1056/NEJMoa1506110)The objective of this study was to examine the efficacy of dapivirine vaginal rings in providing protection against human immunodeficiency virus type 1 (HIV-1). HIV-1 infection incidence is one of the highest in sub-Saharan Africa.

Published
2016
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10. Ethical Considerations in Implementing a Biometric Co-enrolment Prevention System in Clinical Trials in South Africa

Author

Gita Ramjee, Patrick Charls, Jayajothi Moodley, Sarita Naidoo, Neetha S. Morar, and Vaneshree Govender

Subjects
Biometrics, Data management, Immunology, Medicine (miscellaneous), lcsh:Medicine, lcsh:Medical legislation, lcsh:K3601-3611, Health Professions (miscellaneous), 03 medical and health sciences, 0302 clinical medicine, Informed consent, Environmental protection, Virology, Respect for persons, Medicine, Confidentiality, 030212 general & internal medicine, Justice (ethics), lcsh:R723-726, Medical education, 030505 public health, business.industry, Beneficence, lcsh:R, Public Health, Environmental and Occupational Health, Clinical trial, Infectious Diseases, Good clinical practice, 0305 other medical science, business, lcsh:Medical philosophy. Medical ethics, Psychology, Law
Abstract

Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks, a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council’s (SAMRC) Information Technology Services Division. The use of this web-based system to capture participant’s identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their names, SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion. This information was verified at all study visits. If a participant attempted to screen or co-enrol at multiple CRSs, the system flagged this as a potential coenrolment. By addressing the ethical concerns around participant consent and rights, participant confidentiality and privacy, data security and access, and data management and storage, we were able to successfully implement BCEPS within the clinical trials conducted at HPRU, while adhering to the principles of good clinical practice (GCP), including respect for persons, beneficence and justice.

Published
2014
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