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1. Kangaroo mother care prior to clinical stabilisation: Implementation barriers and facilitators reported by caregivers and healthcare providers in Uganda.

Author

Victor S Tumukunde, Joseph Katongole, Stella Namukwaya, Melissa M Medvedev, Moffat Nyirenda, Cally J Tann, Janet Seeley, and Joy E Lawn

Subjects
Public aspects of medicine, RA1-1270
Abstract

Kangaroo mother care (KMC) is an evidence-based method to improve newborn survival. However, scale-up even for stable newborns has been slow, with reported barriers to implementation. We examined facilitators and barriers to initiating KMC before stabilisation amongst neonates recruited to the OMWaNA study in Uganda. The OMWaNA study was a randomised controlled trial that examined the mortality effect of KMC prior to stabilisation amongst newborns weighing ≤2000 grams. At the four trial hospitals, we conducted focus group discussions (FGD) separately with caregivers and healthcare providers, in-depth interviews (IDI) with caregivers and key informant interviews (KII) with hospital administrators and healthcare providers. The World Health Organisation (WHO) Health Systems Building Blocks were used to guide thematic analysis. Eight FGDs (4 caregivers, 4 healthcare providers), 41 caregiver IDIs (26 mothers, 8 grandmothers, 7 fathers), and 23 KIIs were conducted. Key themes based on the building blocks were; family and community support/ involvement, health workforce, medical supplies and commodities, infrastructure and design, financing, and health facility leadership. We found that the presence of a family member in the hospital, adequate provision of healthcare workers knowledgeable in supporting KMC prior to stability, and adequate space for KMC beds where neonatal care is being delivered, can enable implementation of KMC before stability. Implementation barriers included fear of inadvertently causing harm to the newborn, inadequate space to practice KMC in the neonatal unit, and a limited number of trained healthcare workers coupled with insufficient medical supplies.

Published
2024
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2. A reflection on ethical and methodological challenges of using separate interviews with adolescent-older carer dyads in rural South Africa

Author

Dumile Gumede, Nothando B. Ngwenya, Stella Namukwaya, Sarah Bernays, and Janet Seeley

Subjects
Dyads, Adolescents, Older carers, Confidentiality, Ethics, Separate interviews, Medical philosophy. Medical ethics, R723-726
Abstract

Abstract Background This article discusses our reflections on ethical and methodological challenges when conducting separate interviews with individuals in dyads in the uMkhanyakude district, South Africa. Our work is embedded in an ethnographic study exploring care relationships between adolescents and their older carers in the context of a large-donor funded HIV programme. We use these reflections to discuss some of the challenges and present possible management strategies that may be adopted in conducting dyadic health research in resource-poor settings. Methods Drawing from the relational agency, three rounds of separate interviews and participant observation were undertaken with dyads of adolescents aged between 13 and 19 and their older carers aged 50+ from October 2017 to September 2018. A reflexive journal was kept to record the interviewer's experiences of the whole research process. We identified methodological and ethical challenges from these data during the thematic analysis. Results A total of 36 separate interviews were conducted with six pairs of adolescent-older carer dyads (n = 12 participants). Five themes emerged: recruitment of dyads, consenting dyads, confidentiality, conducting separate interviews with adolescents and older carers, and interviewer-dyad interaction. We also illustrated how we dealt with these challenges. Conclusions Results from this study can guide the recruitment, consenting and collecting data for health studies that employ a similar form of enquiry in LMICs. However, ethical and methodological challenges should be recognised as features of the relationships between cross-generation dyads rather than weaknesses of the method.

Published
2019
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3. 'How Do We Start? And How Will They React?' Disclosing to Young People with Perinatally Acquired HIV in Uganda

Author

Stella Namukwaya, Sara Paparini, Janet Seeley, and Sarah Bernays

Subjects
children and adolescents, young people, disclosure, caregivers, HIV, Public aspects of medicine, RA1-1270
Abstract

Despite great advances in pediatric HIV care, rates and the extent of full disclosure of HIV status to infected children remain low especially in resource-constrained setting. The World Health Organisation recommends that, by the age of 10–12 years old, children should be made fully aware of their HIV-positive status. However, this awareness is often delayed until much later in their adolescence. Few studies have been conducted to investigate what influences caregivers’ decision-making process in this regard in low-income settings. In this article, we present an analysis of care dyads of caregivers and HIV-positive young people in Kampala, Uganda, as part of the findings of a longitudinal qualitative study about young people’s adherence to antiretroviral therapy embedded in an international clinical trial (BREATHER). Repeat in-depth interviews were conducted with 26 young people living with HIV throughout the course of the trial, and once-off interviews with 16 of their caregivers were also carried out toward the end of the trial. In this article, we examine why and how caregivers decide to disclose a young person’s HIV status to them and explore their feelings and dilemmas toward disclosure, as well as how young people reacted and the influence it had on their relationships with and attitudes toward their caregivers. Caregivers feared the consequences of disclosing the young person’s positive status to them and disclosure commonly occurred hurriedly in response to a crisis, rather than as part of an anticipated and planned process. A key impediment to disclosure was that caregivers feared that disclosing would damage their relationships with the young people and commonly used this as a reason to continue to postpone disclosure. However, young people did not report prolonged feelings of blame or anger toward their caregivers about their own infection, but they did express frustration at the delay and obfuscation surrounding the disclosure process. Our findings can inform the ways in which mainstream HIV services support caregivers through the disclosure process. This includes providing positive encouragement to disclose fully and to be more confident in initiating and sustaining the timely process of disclosure.

Published
2017
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4. Finding Meaning: HIV Self-Management and Wellbeing among People Taking Antiretroviral Therapy in Uganda.

Author

Steve Russell, Faith Martin, Flavia Zalwango, Stella Namukwaya, Ruth Nalugya, Richard Muhumuza, Joseph Katongole, and Janet Seeley

Subjects
Medicine, Science
Abstract

The health of people living with HIV (PLWH) and the sustained success of antiretroviral therapy (ART) programmes depends on PLWH's motivation and ability to self-manage the condition over the long term, including adherence to drugs on a daily basis. PLWH's self-management of HIV and their wellbeing are likely to be interrelated. Successful self-management sustains wellbeing, and wellbeing is likely to motivate continued self-management. Detailed research is lacking on PLWH's self-management processes on ART in resource-limited settings. This paper presents findings from a study of PLWH's self-management and wellbeing in Wakiso District, Uganda. Thirty-eight PLWH (20 women, 18 men) were purposefully selected at ART facilities run by the government and by The AIDS Support Organisation in and around Entebbe. Two in-depth interviews were completed with each participant over three or four visits. Many were struggling economically, however the recovery of health and hope on ART had enhanced wellbeing and motivated self-management. The majority were managing their condition well across three broad domains of self-management. First, they had mobilised resources, notably through good relationships with health workers. Advice and counselling had helped them to reconceptualise their condition and situation more positively and see hope for the future, motivating their work to self-manage. Many had also developed a new network of support through contacts they had developed at the ART clinic. Second, they had acquired knowledge and skills to manage their health, a useful framework to manage their condition and to live their life. Third, participants were psychologically adjusting to their condition and their new 'self': they saw HIV as a normal disease, were coping with stigma and had regained self-esteem, and were finding meaning in life. Our study demonstrates the centrality of social relationships and other non-medical aspects of wellbeing for self-management which ART programmes might explore further and encourage.

Published
2016
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5. Pregnancy in HIV clinical trials in Sub Saharan Africa: failure of consent or contraception?

Author

Agnes Ssali, Stella Namukwaya, Leonard Bufumbo, Janet Seeley, David G Lalloo, Anatoli Kamali, and Rosalind Parkes-Ratanshi

Subjects
Medicine, Science
Abstract

Higher than expected pregnancy rates have been observed in HIV related clinical trials in Sub-Saharan Africa. We designed a qualitative study to explore the factors contributing to high pregnancy rates among participants in two HIV clinical trials in Sub-Saharan Africa.Female and male participants enrolled in one of two clinical HIV trials in south-west Uganda were approached. The trials were a phase III microbicide efficacy trial among HIV negative women using vaginal gel (MDP); and a trial of primary prevention prophylaxis for invasive cryptococcal disease using fluconazole among HIV infected men and women in Uganda (CRYPTOPRO). 14 focus group discussions and 8 in-depth interviews were conducted with HIV positive and negative women and their male partners over a six month period. Areas explored were their experiences about why and when one should get pregnant, factors affecting use of contraceptives, HIV status disclosure and trial product use.All respondents acknowledged being advised of the importance of avoiding pregnancy during the trial. Factors reported to contribute to pregnancy included; trust that the investigational product (oral capsules/vaginal gel) would not harm the baby, need for children, side effects that led to inconsistent contraceptive use, low acceptance of condom use among male partners. Attitudes towards getting pregnant are fluid within couples over time and the trials often last for more than a year. Researchers need to account for high pregnancy rates in their sample size calculations, and consider lesser used female initiated contraceptive options e.g. diaphragm or female condoms. In long clinical trials where there is a high fetal or maternal risk due to investigational product, researchers and ethics committees should consider a review of participants contraceptive needs/pregnancy desire review after a fixed period, as need for children, partners and health status of participants may alter over time.

Published
2013
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6. Once-daily dolutegravir-based antiretroviral therapy in infants and children living with HIV from age 4 weeks: results from the below 14 kg cohort in the randomised ODYSSEY trial

Author

Pauline Amuge, Abbas Lugemwa, Ben Wynne, Hilda A Mujuru, Avy Violari, Cissy M Kityo, Moherndran Archary, Ebrahim Variava, Ellen White, Rebecca M Turner, Clare Shakeshaft, Shabinah Ali, Kusum J Nathoo, Lorna Atwine, Afaaf Liberty, Dickson Bbuye, Elizabeth Kaudha, Rosie Mngqibisa, Modehei Mosala, Vivian Mumbiro, Annet Nanduudu, Rogers Ankunda, Lindiwe Maseko, Adeodata R Kekitiinwa, Carlo Giaquinto, Pablo Rojo, Diana M Gibb, Anna Turkova, Deborah Ford, Amina Farhana Mehar (nee Abdulla), Pattamukkil Abraham, Elaine Abrams, Judith Acero, Gerald Muzorah Agaba, Grace Ahimbisibwe, Barbara Ainebyoona, Winnie Akobye, Yasmeen Akhalwaya, Nazim Akoojee, Shabinah S. Ali, Catherine Andrea, Maria Angeles Muñoz Fernandez, Diana Antonia Rutebarika, Suvaporn Anugulruengkitt, Tsitsi Apollo, Ronelle Arendze, Juliet Ategeka, Eunice Atim, Abdel Babiker, Sarah Babirye, Enock Babu, Edward Bagirigomwa, Angella Baita, David Balamusani, Patsy Baliram, David Baliruno, Colin Ball, Henry Balwa, Alasdair Bamford, Srini Bandi, Dominique Barker, Linda Barlow-Mosha, Shazia Begum, Osee Behuhuma, Sarah Bernays, Rogers Besigye, Maria Bester, Joyline Bhiri, Davide Bilardi, Kristien Bird, Pauline Bollen, Chiara Borg, Anne-Marie Borges Da Silva, Jackie Brown, Elena Bruno, Torsak Bunupuradah, David Burger, Nomzamo Buthelezi, Mutsa Bwakura-Dangarembizi, Africanus Byaruhanga, Joanna Calvert, Petronelle Casey, Haseena Cassim, Sphiwee Cebekhulu, Sanuphong Chailert, Suwalai Chalermpantmetagul, Wanna Chamjamrat, Man Chan, Precious Chandiwana, Thannapat Chankun, Sararut Chanthaburanun, Nuttawut Chanto, Ennie Chidziva, Minenhle Chikowore, Joy Chimanzi, Dujrudee Chinwong, Stuart Chitongo, Moses Chitsamatanga, Joshua Choga, Duangrat Chutima, Polly Clayden, Alexandra Coelho, Angela Colbers, Alexandra Compagnucci, Ana Constança Mendes, Magda Conway, Mark F. Cotton, Jane Crawley, Tim R. Cressey, Jacky Crisp, Ana Cristina Matos, Sumaya Dadan, Jacqui Daglish, Siva Danaviah, Tseleng Daniel, Anita De Rossi, Sukanda Denjanta, Els Dobbels, Maria Dowie, Prosper Dube, Benedictor Dube, Nimisha Dudakia, Alice Elwana, Cristina Epalza, David Eram, Juan Erasmus, Peter Erim, Luis Escosa Garcia, Zaakirah Essack, Carolina Estepa, Monica Etima, Alexandre Fernandes, Maite Fernandez, Felicity Fitzgerald, Jacquie Flynn, Claudia Fortuny Guasch, Caroline Foster, George Fourie, Yolandie Fourie, Sophie Foxall, Derusha Frank, Kate Gandhi, India Garcia, Kathleen Gartner, Joshua Gasa, Gugu Gasa, Diana M. Gibb, Coral Gomez Rico, Daniel Gomez-Pena, Secrecy Gondo, Anna Goodman, Maria Gorreti Nakalema, Winnie Gozhora, Pisut Greetanukroh, Biobanco Gregorio Maranon, Tiziana Grossele, Shamiso Gwande, Tapiwa Gwaze, Tsitsi Gwenzi, James Hakim, Emmanuel Hakiza, Abdul Hamid Kaka, Ashley Harley, Mornay Isaacs, Richard Isabirye, Wilber Ishemunyoro, Tom Jacobs, Lungile Jafta, Nasir Jamil, Anita Janse Janse van Rensburg, Vinesh Jeaven, Maria José Mellado Peña, Gonzague Jourdain, Katabalwa Juliet, Thidarat Jumpimai, Raungwit Junkaew, Thidarat Jupimai, Winfred Kaahwa, Mildred Kabasonga, Olivia Kaboggoza, Rose Jacqueline Kadhuba, Ampika Kaewbundit, Kanyanee Kaewmamueng, Bosco Kafufu, Brenda Kakayi, Phakamas Kamboua, Suparat Kanjanavanit, Gladys Kasangaki, Naruporn Kasipong, Miriam Kasozi, Hajira Kataike, Chrispus Katemba, Nkata Kekane, Adeodata R. Kekitiinwa, Edridah Keminyeto, Woottichai Khamduang, Warunee Khamjakkaew, Jiraporn Khamkon, Sasipass Khannak, Orapin Khatngam, Tassawan Khayanchoomnoom, Busi Khumalo, Mirriam Khunene, Suwimon Khusuwan, Phionah Kibalama, Robinah Kibenge, Anthony Kirabira, Cissy M. Kityo, Lameck Kiyimba, Nigel Klein, Soraya Klinprung, Robin Kobbe, Olivia Kobusingye, Josephine Kobusungye, Areerat Kongponoi, Christoph Königs, Olivier Koole, Christelle Kouakam, Nitinart Krueduangkam, Namthip Kruenual, Nuananong Kunjaroenrut, Raymonds Kyambadde, Priscilla Kyobutungi, Flavia Kyomuhendo, Erinah Kyomukama, Reshma Lakha, Cleopatra Langa, Laddawan Laomanit, Emily Lebotsa, Prattana Leenasirimakul, Lawrence Lekku, Sarah Lensen, Valériane Leroy, Jin Li, Juthamas Limplertjareanwanich, Emma Little, Ezra Lutalo, Jose Luis Jimenez, Hermione Lyall, Candice MacDonald, Gladness Machache, Penelope Madlala, Tryphina Madonsela, Nomfundo Maduna, Joel Maena, Apicha Mahanontharit, Collin Makanga, Candice Makola, Shafic Makumbi, Lucille Malgraaf, Angelous Mamiane, Felicia Mantkowski, Wendy Mapfumo, Laura Marques, Agnes Mary Mugagga, Tshepiso Masienyane, Ruth Mathiba, Farai Matimba, Sajeeda Mawlana, Emmanuel Mayanja, Fatima Mayat, Ritah Mbabazi, Nokuthula Mbadaliga, Faith Mbasani, Kathleen McClaughlin, Helen McIlleron, Watchara Meethaisong, Patricia Mendez Garcia, Annet Miwanda, Carlota Miranda, Siphiwe Mkhize, Kgosimang Mmolawa, Fatima Mohamed, Tumelo Moloantoa, Maletsatsi Monametsi, Samuel Montero, Cecilia L. Moore, Rejoice Mosia, Columbus Moyo, Mumsy Mthethwa, Shepherd Mudzingwa, Tawona Mudzviti, Hilda Mujuru, Emmanuel Mujyambere, Trust Mukanganiki, Cynthia Mukisa Williams, Mark Mulder, Disan Mulima, Alice Mulindwa, Zivai Mupambireyi, Alba Murciano Cabeza, Herbert Murungi, Dorothy Murungu, Sandra Musarurwa, Victor Musiime, Alex V. Musiime, Maria Musisi, Philippa Musoke, Barbara Musoke Nakirya, Godfrey Musoro, Sharif Musumba, Sobia Mustafa, Shirley Mutsai, Phyllis Mwesigwa Rubondo, Mariam Naabalamba, Immaculate Nagawa, Allemah Naidoo, Shamim Nakabuye, Sarah Nakabuye, Sarah Nakalanzi, Justine Nalubwama, Annet Nalugo, Stella Nalusiba, Clementine Namajja, Sylvia Namanda, Paula Namayanja, Esther Nambi, Rachael Kikabi Namuddu, Stella Namukwaya, Florence Namuli, Josephine Namusanje, Rosemary Namwanje, Anusha Nanan-kanjee, Charity Nankunda, Joanita Nankya Baddokwaya, Maria Nannungi, Winnie Nansamba, Kesdao Nanthapisal, Juliet Nanyonjo, Sathaporn Na-Rajsima, Claire Nasaazi, Helena Nascimento, Eleni Nastouli, Wipaporn Natalie Songtaweesin, Kusum Nathoo, Ian Natuhurira, Rashidah Nazzinda, Thabisa Ncgaba, Milly Ndigendawani, Makhosonke Ndlovu, Georgina Nentsa, Chaiwat Ngampiyaskul, Ntombenhle Ngcobo, Nicole Ngo Giang Huong, Pia Ngwaru, Ruth Nhema, Emily Ninsiima, Gloria Ninsiima, Misheck Nkalo Phiri, Antoni Noguera Julian, Monica Nolan, Thornthun Noppakaorattanamanee, Muzamil Nsibuka Kisekka, Eniola Nsirim, Rashina Nundlal, Rosita Nunes, Lungile Nyantsa, Mandisa Nyati, Sean O'Riordan, Paul Ocitti Labeja, Denis Odoch, Rachel Oguntimehin, Martin Ojok, Geoffrey Onen, Wilma Orange, Pradthana Ounchanum, Benson Ouma, Andreia Padrao, Deborah Pako, Anna Parker, Malgorzata Pasko-Szcech, Reena Patel, Rukchanok Peongjakta, Turian Petpranee, Tasmin Phillips, Jackie Philps, Laura Picault, Sonja Pieterse, Helena Pinheiro, Supawadee Pongprapass, Anton Pozniak, Andrew Prendergast, Luis Prieto Tato, Patcharee Puangmalai, Thanyawee Puthanakit, Modiehi Rakgokong, Helena Ramos, Nastassja Ramsagar, Cornelius Rau, Yoann Riault, Pablo Rojo Conejo, Basiimwa Roy Clark, Eddie Rubanga, Baker Rubinga, Chutima Ruklao, Pattira Runarassamee, Chalermpong Saenjum, Chayakorn Saewtrakool, Yacine Saidi, Talia Sainz Costa, Chutima Saisaengjan, Rebecca Sakwa, Tatiana Sarfati, Noshalaza Sbisi, Dihedile Scheppers, Stephan Schultze-Strasser, Ulf Schulze-Sturm, Karen Scott, Janet Seeley, Robert Serunjogi, Leora Sewnarain, Subashinie Sidhoo, Mercy Shibemba, Delane Shingadia, Sheleika Singh, Wasna Sirirungsi, Sibongile Sithebe, Theresa Smit, Kurt Smith, Marlize Smuts, Moira Spyer, Worathip Sripaoraya, Ussanee Srirompotong, Warunee Srisuk, Mark Ssenyonga, Patamawadee Sudsaard, Praornsuda Sukrakanchana, Pathanee Tearsansern, Carla Teixeira, Kanchana Than-in-at, Thitiwat Thapwai, Yupawan Thaweesombat, Jutarat Thewsoongnoen, Rodolphe Thiébaut, Margaret Thomason, Laura Thrasyvoulou, Khanungnit Thungkham, Judith Tikabibamu, Gloria Tinago, Ketmookda Trairat, Gareth Tudor-Williams, Mercy Tukamushaba, Deogratiuos Tukwasibwe, Julius Tumusiime, Joana Tuna, Rebecca Turner, Arttasid Udomvised, Aasia Vadee, Hesti Van Huyssteen, Nadine Van Looy, Yvonne Vaughan-Gordon, Giulio Vecchia, Richard Vowden, Hylke Waalewijn, Rebecca Wampamba, Steve Welch, Ian Weller, Sibusisiwe Weza, Ian White, Kaja Widuch, Helen Wilkes, Sookpanee Wimonklang, Pacharaporn Yingyong, Zaam Zinda Nakawungu, and Peter Zuidewind

Subjects
Adult, Epidemiology, Pyridones, Anti-HIV Agents, Immunology, HIV Infections, 3-Ring, Piperazines, Heterocyclic Compounds, Virology, Oxazines, Humans, Protease Inhibitors, Child, Preschool, Infant, Newborn, Infant, Bayes Theorem, Viral Load, Newborn, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Infectious Diseases, Child, Preschool, Heterocyclic Compounds, 3-Ring, Treatment Outcome
Abstract

Contains fulltext : 283099.pdf (Publisher’s version ) (Open Access) BACKGROUND: Young children living with HIV have few treatment options. We aimed to assess the efficacy and safety of dolutegravir-based antiretroviral therapy (ART) in children weighing between 3 kg and less than 14 kg. METHODS: ODYSSEY is an open-label, randomised, non-inferiority trial (10% margin) comparing dolutegravir-based ART with standard of care and comprises two cohorts (children weighing ≥14 kg and

Published
2022

7. Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial

Author

Anna Turkova, Hylke Waalewijn, Man K Chan, Pauline D J Bollen, Mutsa F Bwakura-Dangarembizi, Adeodata R Kekitiinwa, Mark F Cotton, Abbas Lugemwa, Ebrahim Variava, Grace Miriam Ahimbisibwe, Ussanee Srirompotong, Vivian Mumbiro, Pauline Amuge, Peter Zuidewind, Shabinah Ali, Cissy M Kityo, Moherndran Archary, Rashida A Ferrand, Avy Violari, Diana M Gibb, David M Burger, Deborah Ford, Angela Colbers, Amina Farhana Mehar (nee Abdulla), Pattamukkil Abraham, Elaine Abrams, Judith Acero, Gerald Muzorah Agaba, Grace Ahimbisibwe, Barbara Ainebyoona, Winnie Akobye, Yasmeen Akhalwaya, Nazim Akoojee, Shabinah S. Ali, Catherine Andrea, Maria Angeles Muñoz Fernandez, Rogers Ankunda, Diana Antonia Rutebarika, Suvaporn Anugulruengkitt, Tsitsi Apollo, Ronelle Arendze, Juliet Ategeka, Eunice Atim, Lorna Atwine, Abdel Babiker, Sarah Babirye, Enock Babu, Edward Bagirigomwa, Angella Baita, David Balamusani, Patsy Baliram, David Baliruno, Colin Ball, Henry Balwa, Alasdair Bamford, Srini Bandi, Dominique Barker, Linda Barlow-Mosha, Dickson Bbuye, Shazia Begum, Osee Behuhuma, Sarah Bernays, Rogers Besigye, Maria Bester, Joyline Bhiri, Davide Bilardi, Kristien Bird, Pauline Bollen, Chiara Borg, Anne-Marie Borges Da Silva, Jackie Brown, Elena Bruno, Torsak Bunupuradah, David Burger, Nomzamo Buthelezi, Mutsa Bwakura-Dangarembizi, Africanus Byaruhanga, Joanna Calvert, Petronelle Casey, Haseena Cassim, Sphiwee Cebekhulu, Sanuphong Chailert, Suwalai Chalermpantmetagul, Wanna Chamjamrat, Man Chan, Precious Chandiwana, Thannapat Chankun, Sararut Chanthaburanun, Nuttawut Chanto, Ennie Chidziva, Minenhle Chikowore, Joy Chimanzi, Dujrudee Chinwong, Stuart Chitongo, Moses Chitsamatanga, Joshua Choga, Duangrat Chutima, Polly Clayden, Alexandra Coelho, Alexandra Compagnucci, Ana Constança Mendes, Magda Conway, Mark F. Cotton, Jane Crawley, Tim R. Cressey, Jacky Crisp, Ana Cristina Matos, Sumaya Dadan, Jacqui Daglish, Siva Danaviah, Tseleng Daniel, Anita De Rossi, Sukanda Denjanta, Els Dobbels, Maria Dowie, Prosper Dube, Benedictor Dube, Nimisha Dudakia, Alice Elwana, Cristina Epalza, David Eram, Juan Erasmus, Peter Erim, Luis Escosa Garcia, Zaakirah Essack, Carolina Estepa, Monica Etima, Alexandre Fernandes, Maite Fernandez, Felicity Fitzgerald, Jacquie Flynn, Claudia Fortuny Guasch, Caroline Foster, George Fourie, Yolandie Fourie, Sophie Foxall, Derusha Frank, Kate Gandhi, India Garcia, Kathleen Gartner, Joshua Gasa, Gugu Gasa, Carlo Giaquinto, Diana M. Gibb, Coral Gomez Rico, Daniel Gomez-Pena, Secrecy Gondo, Anna Goodman, Maria Gorreti Nakalema, Winnie Gozhora, Pisut Greetanukroh, Biobanco Gregorio Maranon, Tiziana Grossele, Shamiso Gwande, Tapiwa Gwaze, Tsitsi Gwenzi, James Hakim, Emmanuel Hakiza, Abdul Hamid Kaka, Ashley Harley, Mornay Isaacs, Richard Isabirye, Wilber Ishemunyoro, Tom Jacobs, Lungile Jafta, Nasir Jamil, Anita Janse Janse van Rensburg, Vinesh Jeaven, Maria José Mellado Peña, Gonzague Jourdain, Katabalwa Juliet, Thidarat Jumpimai, Raungwit Junkaew, Thidarat Jupimai, Winfred Kaahwa, Mildred Kabasonga, Olivia Kaboggoza, Rose Jacqueline Kadhuba, Ampika Kaewbundit, Kanyanee Kaewmamueng, Bosco Kafufu, Brenda Kakayi, Phakamas Kamboua, Suparat Kanjanavanit, Gladys Kasangaki, Naruporn Kasipong, Miriam Kasozi, Hajira Kataike, Chrispus Katemba, Elizabeth Kaudha, Nkata Kekane, Adeodata R. Kekitiinwa, Edridah Keminyeto, Woottichai Khamduang, Warunee Khamjakkaew, Jiraporn Khamkon, Sasipass Khannak, Orapin Khatngam, Tassawan Khayanchoomnoom, Busi Khumalo, Mirriam Khunene, Suwimon Khusuwan, Phionah Kibalama, Robinah Kibenge, Anthony Kirabira, Cissy M. Kityo, Lameck Kiyimba, Nigel Klein, Soraya Klinprung, Robin Kobbe, Olivia Kobusingye, Josephine Kobusungye, Areerat Kongponoi, Christoph Königs, Olivier Koole, Christelle Kouakam, Nitinart Krueduangkam, Namthip Kruenual, Nuananong Kunjaroenrut, Raymonds Kyambadde, Priscilla Kyobutungi, Flavia Kyomuhendo, Erinah Kyomukama, Reshma Lakha, Cleopatra Langa, Laddawan Laomanit, Emily Lebotsa, Prattana Leenasirimakul, Lawrence Lekku, Sarah Lensen, Valériane Leroy, Jin Li, Afaaf Liberty, Juthamas Limplertjareanwanich, Emma Little, Ezra Lutalo, Jose Luis Jimenez, Hermione Lyall, Candice MacDonald, Gladness Machache, Penelope Madlala, Tryphina Madonsela, Nomfundo Maduna, Joel Maena, Apicha Mahanontharit, Collin Makanga, Candice Makola, Shafic Makumbi, Lucille Malgraaf, Angelous Mamiane, Felicia Mantkowski, Wendy Mapfumo, Laura Marques, Agnes Mary Mugagga, Lindiwe Maseko, Tshepiso Masienyane, Ruth Mathiba, Farai Matimba, Sajeeda Mawlana, Emmanuel Mayanja, Fatima Mayat, Ritah Mbabazi, Nokuthula Mbadaliga, Faith Mbasani, Kathleen McClaughlin, Helen McIlleron, Watchara Meethaisong, Patricia Mendez Garcia, Annet Miwanda, Carlota Miranda, Siphiwe Mkhize, Kgosimang Mmolawa, Rosie Mngqibisa, Fatima Mohamed, Tumelo Moloantoa, Maletsatsi Monametsi, Samuel Montero, Cecilia L. Moore, Rejoice Mosia, Columbus Moyo, Mumsy Mthethwa, Shepherd Mudzingwa, Tawona Mudzviti, Hilda Mujuru, Emmanuel Mujyambere, Trust Mukanganiki, Cynthia Mukisa Williams, Mark Mulder, Disan Mulima, Alice Mulindwa, Zivai Mupambireyi, Alba Murciano Cabeza, Herbert Murungi, Dorothy Murungu, Sandra Musarurwa, Victor Musiime, Alex V. Musiime, Maria Musisi, Philippa Musoke, Barbara Musoke Nakirya, Godfrey Musoro, Sharif Musumba, Sobia Mustafa, Shirley Mutsai, Phyllis Mwesigwa Rubondo, Mariam Naabalamba, Immaculate Nagawa, Allemah Naidoo, Shamim Nakabuye, Sarah Nakabuye, Sarah Nakalanzi, Justine Nalubwama, Annet Nalugo, Stella Nalusiba, Clementine Namajja, Sylvia Namanda, Paula Namayanja, Esther Nambi, Rachael Kikabi Namuddu, Stella Namukwaya, Florence Namuli, Josephine Namusanje, Rosemary Namwanje, Anusha Nanan-kanjee, Annet Nanduudu, Charity Nankunda, Joanita Nankya Baddokwaya, Maria Nannungi, Winnie Nansamba, Kesdao Nanthapisal, Juliet Nanyonjo, Sathaporn Na-Rajsima, Claire Nasaazi, Helena Nascimento, Eleni Nastouli, Wipaporn Natalie Songtaweesin, Kusum Nathoo, Ian Natuhurira, Rashidah Nazzinda, Thabisa Ncgaba, Milly Ndigendawani, Makhosonke Ndlovu, Georgina Nentsa, Chaiwat Ngampiyaskul, Ntombenhle Ngcobo, Nicole Ngo Giang Huong, Pia Ngwaru, Ruth Nhema, Emily Ninsiima, Gloria Ninsiima, Misheck Nkalo Phiri, Antoni Noguera Julian, Monica Nolan, Thornthun Noppakaorattanamanee, Muzamil Nsibuka Kisekka, Eniola Nsirim, Rashina Nundlal, Rosita Nunes, Lungile Nyantsa, Mandisa Nyati, Sean O'Riordan, Paul Ocitti Labeja, Denis Odoch, Rachel Oguntimehin, Martin Ojok, Geoffrey Onen, Wilma Orange, Pradthana Ounchanum, Benson Ouma, Andreia Padrao, Deborah Pako, Anna Parker, Malgorzata Pasko-Szcech, Reena Patel, Rukchanok Peongjakta, Turian Petpranee, Tasmin Phillips, Jackie Philps, Laura Picault, Sonja Pieterse, Helena Pinheiro, Supawadee Pongprapass, Anton Pozniak, Andrew Prendergast, Luis Prieto Tato, Patcharee Puangmalai, Thanyawee Puthanakit, Modiehi Rakgokong, Helena Ramos, Nastassja Ramsagar, Cornelius Rau, Yoann Riault, Pablo Rojo Conejo, Basiimwa Roy Clark, Eddie Rubanga, Baker Rubinga, Chutima Ruklao, Pattira Runarassamee, Chalermpong Saenjum, Chayakorn Saewtrakool, Yacine Saidi, Talia Sainz Costa, Chutima Saisaengjan, Rebecca Sakwa, Tatiana Sarfati, Noshalaza Sbisi, Dihedile Scheppers, Stephan Schultze-Strasser, Ulf Schulze-Sturm, Karen Scott, Janet Seeley, Robert Serunjogi, Leora Sewnarain, Clare Shakeshaft, Subashinie Sidhoo, Mercy Shibemba, Delane Shingadia, Sheleika Singh, Wasna Sirirungsi, Sibongile Sithebe, Theresa Smit, Kurt Smith, Marlize Smuts, Moira Spyer, Worathip Sripaoraya, Warunee Srisuk, Mark Ssenyonga, Patamawadee Sudsaard, Praornsuda Sukrakanchana, Pathanee Tearsansern, Carla Teixeira, Kanchana Than-in-at, Thitiwat Thapwai, Yupawan Thaweesombat, Jutarat Thewsoongnoen, Rodolphe Thiébaut, Margaret Thomason, Laura Thrasyvoulou, Khanungnit Thungkham, Judith Tikabibamu, Gloria Tinago, Ketmookda Trairat, Gareth Tudor-Williams, Mercy Tukamushaba, Deogratiuos Tukwasibwe, Julius Tumusiime, Joana Tuna, Rebecca Turner, Arttasid Udomvised, Aasia Vadee, Hesti Van Huyssteen, Nadine Van Looy, Yvonne Vaughan-Gordon, Giulio Vecchia, Richard Vowden, Rebecca Wampamba, Steve Welch, Ian Weller, Sibusisiwe Weza, Ellen White, Ian White, Kaja Widuch, Helen Wilkes, Sookpanee Wimonklang, Ben Wynne, Pacharaporn Yingyong, and Zaam Zinda Nakawungu

Subjects
Male, Adolescent, Pyridones, Epidemiology, Immunology, Infant, HIV Infections, 3-Ring, Piperazines, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Infectious Diseases, Child, Child, Preschool, Female, Heterocyclic Compounds, 3-Ring, Humans, Oxazines, Rifampin, Uganda, HIV-1, Tuberculosis, Heterocyclic Compounds, Virology, Preschool
Abstract

Contains fulltext : 282959.pdf (Publisher’s version ) (Open Access) BACKGROUND: Children with HIV-associated tuberculosis (TB) have few antiretroviral therapy (ART) options. We aimed to evaluate the safety and pharmacokinetics of dolutegravir twice-daily dosing in children receiving rifampicin for HIV-associated TB. METHODS: We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. Children (aged 4 weeks to

Published
2022

8. 'Because we all have to grow up': supporting adolescents in Uganda to develop core competencies to transition towards managing their HIV more independently

Author

Christine Matama, Helen Nakyambadde, Chloe Lanyon, Anna Turkova, Stella Namukwaya, Victor Musiime, Sarah Bernays, Janet Seeley, and Sara Paparini

Subjects
Male, viral suppression, paediatric, psychosocial support, Adolescent, Anti-HIV Agents, media_common.quotation_subject, Adolescent Health, Human immunodeficiency virus (HIV), HIV Infections, Context (language use), Disclosure, medicine.disease_cause, Literacy, Medication Adherence, 03 medical and health sciences, 0302 clinical medicine, Nursing, Situated, medicine, Humans, Uganda, adolescents, adherence, 030212 general & internal medicine, Child, Research Articles, media_common, Core Knowledge, 030505 public health, business.industry, Public Health, Environmental and Occupational Health, Core competency, transition, HIV, Disease Management, Caregiver burden, Self Care, Clinical trial, Infectious Diseases, Caregivers, Female, Self Report, 0305 other medical science, business, Research Article
Abstract

Introduction Sustaining optimal adherence is the major challenge facing adolescents living with HIV (ALHIV), particularly in low‐resource settings, where “second‐line” is often the last accessible treatment option. We explored the knowledge and skills adolescents need in order to maintain improved adherence behaviours, and the specific ways clinicians and caregivers may support young people to do so more independently. Methods We conducted individual, in‐depth interviews with 20 ALHIV aged 10 to 18 years in Uganda in 2017 to 2018. All participants had recently commenced second‐line treatment as part of a clinical trial. We used thematic qualitative analysis to examine adherence experiences and challenges while on first‐line therapy, as well as specific supports necessary to optimise treatment‐taking longer‐term. Results Adherence difficulties are exacerbated by relatively rapid shifts from caregiver‐led approaches during childhood, to an expectation of autonomous treatment‐taking with onset of adolescence. For many participants this shift compounded their ongoing struggles managing physical side effects and poor treatment literacy. Switching to second‐line typically prompted reversion back to supervised adherence, with positive impacts on self‐reported adherence in the immediate term. However, this measure is unlikely to be sustainable for caregivers due to significant caregiver burden (as on first line), and provided little opportunity for clinicians to guide and develop young people’s capacity to successfully adopt responsibility for their own treatment‐taking. Conclusions As ALHIV in sub‐Saharan Africa are attributed increasing responsibility for treatment adherence and HIV management, they must be equipped with the core knowledge and skills required for successful, self‐directed care. Young people need to be relationally supported to develop necessary “adherence competencies” within the supportive framework of a gradual “transition” period. Clinic conversations during this period should be adolescent‐focussed and collaborative, and treatment‐taking strategies situated within the context of their lived environments and support networks, to facilitate sustained adherence. The disclosure of adherence difficulties must be encouraged so that issues can be identified and addressed prior to treatment failure.

Published
2020

9. A Failed Method? Reflections on Using Audio Diaries in Uganda With Young People Growing Up With HIV in the BREATHER Trial

Author

Janet Seeley, Sara Paparini, Sarah Bernays, and Stella Namukwaya

Subjects
Gerontology, Adult, Male, Health Knowledge, Attitudes, Practice, Adolescent, Human immunodeficiency virus (HIV), Participatory action research, HIV Infections, medicine.disease_cause, law.invention, Medication Adherence, Interviews as Topic, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Uganda, 030212 general & internal medicine, Longitudinal Studies, Child, Qualitative Research, Randomized Controlled Trials as Topic, 030504 nursing, Public Health, Environmental and Occupational Health, Diaries as Topic, Tape Recording, Female, 0305 other medical science, Psychology, Confidentiality, Qualitative research
Abstract

In this article, we present a case study in which we consider our use of the audio diary method with young people (aged 10–24) living with HIV in Uganda in a longitudinal qualitative study conducted in a clinical randomized control trial. Despite initial enthusiasm for the method among participants to capture accounts of participants’ experiences outside of the confines of the HIV clinic, the constraints the young people encountered in accessing sufficient privacy to confidently make recordings meant that no one elected to use them again in the study. Despite the insights the use of the method generated, the lack of acceptability led to its relative failure. This demonstrates that despite the call for innovation, there is an unwavering necessity when selecting methods that they align with the needs and preferences of our participants and with an attentive assessment of the local context in which illness narratives are produced.

Published
2018

10. 'How Do We Start? And How Will They React?' Disclosing to Young People with Perinatally Acquired HIV in Uganda

Author

Sarah Bernays, Stella Namukwaya, Janet Seeley, and Sara Paparini

Subjects
caregivers, medicine.medical_specialty, media_common.quotation_subject, Human immunodeficiency virus (HIV), Anger, medicine.disease_cause, young people, Blame, 03 medical and health sciences, 0302 clinical medicine, medicine, Mainstream, 030212 general & internal medicine, Full disclosure, Psychiatry, Original Research, media_common, 030505 public health, lcsh:Public aspects of medicine, Public Health, Environmental and Occupational Health, HIV, lcsh:RA1-1270, Clinical trial, children and adolescents, Feeling, Public Health, disclosure, 0305 other medical science, Psychology, Qualitative research
Abstract

Despite great advances in pediatric HIV care, rates and the extent of full disclosure of HIV status to infected children remain low especially in resource-constrained setting. The World Health Organisation recommends that, by the age of 10-12 years old, children should be made fully aware of their HIV-positive status. However, this awareness is often delayed until much later in their adolescence. Few studies have been conducted to investigate what influences caregivers' decision-making process in this regard in low-income settings. In this article, we present an analysis of care dyads of caregivers and HIV-positive young people in Kampala, Uganda, as part of the findings of a longitudinal qualitative study about young people's adherence to antiretroviral therapy embedded in an international clinical trial (BREATHER). Repeat in-depth interviews were conducted with 26 young people living with HIV throughout the course of the trial, and once-off interviews with 16 of their caregivers were also carried out toward the end of the trial. In this article, we examine why and how caregivers decide to disclose a young person's HIV status to them and explore their feelings and dilemmas toward disclosure, as well as how young people reacted and the influence it had on their relationships with and attitudes toward their caregivers. Caregivers feared the consequences of disclosing the young person's positive status to them and disclosure commonly occurred hurriedly in response to a crisis, rather than as part of an anticipated and planned process. A key impediment to disclosure was that caregivers feared that disclosing would damage their relationships with the young people and commonly used this as a reason to continue to postpone disclosure. However, young people did not report prolonged feelings of blame or anger toward their caregivers about their own infection, but they did express frustration at the delay and obfuscation surrounding the disclosure process. Our findings can inform the ways in which mainstream HIV services support caregivers through the disclosure process. This includes providing positive encouragement to disclose fully and to be more confident in initiating and sustaining the timely process of disclosure.

Published
2017

11. Antiretroviral therapy and changing patterns of HIV stigmatisation in Entebbe, Uganda

Author

Richard Muhumuza, Stella Namukwaya, Joseph Katongole, Janet Seeley, Steve Russell, Ruth Nalugya, and Flavia Zalwango

Subjects
Male, Health (social science), Social stigma, Social Stigma, Psychological intervention, HIV Infections, Human physical appearance, Social group, 0302 clinical medicine, 5. Gender equality, gender, Medicine, Uganda, 030212 general & internal medicine, 10. No inequality, Qualitative Research, media_common, Health Policy, Middle Aged, Anti-Retroviral Agents, Female, Original Article, 0305 other medical science, chronic illness, Clinical psychology, Adult, medicine.medical_specialty, Adolescent, media_common.quotation_subject, doctor–patient communication/interaction, Stigma (botany), Social issues, Interviews as Topic, Young Adult, 03 medical and health sciences, Dignity, Humans, Psychiatry, Stereotyping, 030505 public health, business.industry, Public Health, Environmental and Occupational Health, HIV, Original Articles, developing countries, Self Care, stigma, Chronic Disease, business, Qualitative research
Abstract

Antiretroviral therapy (ART) has the potential to change processes of HIV stigmatisation. In this article, changing processes of stigmatisation among a group of people living with HIV (PLWH) on ART in Wakiso District, Uganda, are analysed using qualitative data from a study of PLWH's self‐management of HIV on ART. There were 38 respondents (20 women, 18 men) who had been taking ART for at least 1 year. They were purposefully selected from government and non‐government ART providers. Two in‐depth interviews were held with each participant. Processes of reduced self‐stigmatisation were clearly evident, caused by the recovery of their physical appearance and support from health workers. However most participants continued to conceal their status because they anticipated stigma; for example, they feared gossip, rejection and their status being used against them. Anticipated stigma was gendered: women expressed greater fear of enacted forms of stigma such as rejection by their partner; in contrast men's fears focused on gossip, loss of dignity and self‐stigmatisation. The evidence indicates that ART has not reduced underlying structural drivers of stigmatisation, notably gender identities and inequalities, and that interventions are still required to mitigate and tackle stigmatisation, such as counselling, peer‐led education and support groups that can help PLWH reconstruct alternative and more positive identities. A video abstract of this article can be found at: https://youtu.be/WtIaZJQ3Y_8

Published
2015

12. Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV?

Author

Diana M. Gibb, Stella Namukwaya Kihika, Sarah Bernays, Janet Seeley, Sara Paparini, and Tim Rhodes

Subjects
Cyclopropanes, Male, Pediatrics, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, chemistry.chemical_compound, 0302 clinical medicine, 030212 general & internal medicine, Longitudinal Studies, Young adult, Child, Qualitative Research, education.field_of_study, General Medicine, Viral Load, Alkynes, HIV/AIDS, Drug Therapy, Combination, Female, 0305 other medical science, Viral load, medicine.medical_specialty, Efavirenz, Adolescent, Anti-HIV Agents, Population, antiretroviral therapy, PAEDIATRICS, Truth Disclosure, Drug Administration Schedule, Medication Adherence, 03 medical and health sciences, Young Adult, medicine, Humans, education, 030505 public health, business.industry, Research, HIV, Patient Acceptance of Health Care, Antiretroviral therapy, Benzoxazines, Clinical trial, chemistry, Family medicine, business, Qualitative research
Abstract

OBJECTIVES: A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8-24) living with HIV with viral load

Published
2017

13. Finding Meaning: HIV self-management and wellbeing among people taking antiretroviral therapy in Uganda

Author

Stella Namukwaya, Janet Seeley, Joseph Katongole, Faith Martin, Ruth Nalugya, Steve Russell, Richard Muhumuza, and Flavia Zalwango

Subjects
RNA viruses, Male, Gerontology, Coping (psychology), Social stigma, Social Stigma, lcsh:Medicine, Social Sciences, HIV Infections, Personal Satisfaction, Disease, Pathology and Laboratory Medicine, Geographical Locations, 0302 clinical medicine, Immunodeficiency Viruses, Adaptation, Psychological, Medicine and Health Sciences, Psychology, Public and Occupational Health, Uganda, 030212 general & internal medicine, lcsh:Science, Qualitative Research, Multidisciplinary, Self-management, 1. No poverty, HIV diagnosis and management, Middle Aged, Vaccination and Immunization, Socioeconomic Aspects of Health, Anti-Retroviral Agents, Medical Microbiology, Viral Pathogens, Viruses, Female, Pathogens, 0305 other medical science, Research Article, Adult, Psychological Adjustment, Immunology, Self-concept, Antiretroviral Therapy, Microbiology, Medication Adherence, Interviews as Topic, 03 medical and health sciences, Social support, Antiviral Therapy, Acquired immunodeficiency syndrome (AIDS), Retroviruses, Mental Health and Psychiatry, medicine, Humans, Microbial Pathogens, 030505 public health, business.industry, lcsh:R, Lentivirus, Organisms, Biology and Life Sciences, HIV, Social Support, medicine.disease, Diagnostic medicine, Self Concept, Health Care, Self Care, People and Places, Africa, Quality of Life, lcsh:Q, Preventive Medicine, business, Qualitative research
Abstract

The health of people living with HIV (PLWH) and the sustained success of antiretroviral therapy (ART) programmes depends on PLWH's motivation and ability to self-manage the condition over the long term, including adherence to drugs on a daily basis. PLWH's self-management of HIV and their wellbeing are likely to be interrelated. Successful self-management sustains wellbeing, and wellbeing is likely to motivate continued self-management. Detailed research is lacking on PLWH's self-management processes on ART in resource-limited settings. This paper presents findings from a study of PLWH's self-management and wellbeing in Wakiso District, Uganda. Thirty-eight PLWH (20 women, 18 men) were purposefully selected at ART facilities run by the government and by The AIDS Support Organisation in and around Entebbe. Two in-depth interviews were completed with each participant over three or four visits. Many were struggling economically, however the recovery of health and hope on ART had enhanced wellbeing and motivated self-management. The majority were managing their condition well across three broad domains of self-management. First, they had mobilised resources, notably through good relationships with health workers. Advice and counselling had helped them to reconceptualise their condition and situation more positively and see hope for the future, motivating their work to self-manage. Many had also developed a new network of support through contacts they had developed at the ART clinic. Second, they had acquired knowledge and skills to manage their health, a useful framework to manage their condition and to live their life. Third, participants were psychologically adjusting to their condition and their new 'self': they saw HIV as a normal disease, were coping with stigma and had regained self-esteem, and were finding meaning in life. Our study demonstrates the centrality of social relationships and other non-medical aspects of wellbeing for self-management which ART programmes might explore further and encourage.

Published
2016

14. A randomised placebo-controlled safety and acceptability trial of PRO 2000 vaginal microbicide gel in sexually active women in Uganda

Author

Julie M. Bakobaki, Anatoli Kamali, Romano Byaruhanga, Catherine Muwonge, Clare Rutterford, Andrew J. Nunn, Helen Byomire, Charles J.N. Lacey, Pius Okong, Albert T. Profy, Heiner Grosskurth, Sheena McCormack, and Stella Namukwaya

Subjects
Adult, Sexually transmitted disease, medicine.medical_specialty, Adolescent, Polymers, Population, Sexually Transmitted Diseases, HIV Infections, Dermatology, Placebo, Medication Adherence, law.invention, Condoms, Young Adult, Naphthalenesulfonates, Randomized controlled trial, law, Internal medicine, medicine, Humans, Uganda, education, Gynecology, education.field_of_study, Antiinfective agent, Vaginal microbicide, business.industry, Middle Aged, Microbicides for sexually transmitted diseases, Infectious Diseases, Patient Satisfaction, Chemoprophylaxis, Anti-Infective Agents, Local, Vaginal Creams, Foams, and Jellies, Female, business
Abstract

Objectives To determine the safety of 0.5% and 2% PRO 2000 gel in terms of local and systemic adverse events (AE) and the acceptability of gel use. Design A randomised placebo-controlled trial among healthy, sexually active African women aged 18–45 years. Between June 2003 and September 2004, 180 consenting women were randomly assigned to one of four groups: PRO 2000 gel (0.5% or 2%), placebo gel, or condom use only. Participants were screened for sexually transmitted infections, with HIV counselling and testing. Women randomly assigned to gel used this intravaginally twice a day for 28 days. Follow-up visits were fortnightly up to 6 weeks from enrolment, and comprised a physical examination including colposcopy, laboratory testing and questionnaire interviews. Results Ten women were lost to follow-up, none due to AE. Adherence with total gel doses was 69%. Observed rates of the primary toxicity endpoints, ulceration greater than 2×1 cm and clinically relevant coagulation abnormalities were, for PRO 2000 0.5%: 1.6% (95% CI 0.04% to 8.5%) and 0% (97.5% CI 0% to 5.7%), and for PRO 2000 2%: 0% and 0% (97.5% CI 0% to 5.9%). Women randomly assigned to active gels did not show an increased rate of AE. Gel use had no significant effect on haematology and biochemistry results. Women found gel use highly acceptable. Conclusions Both concentrations of PRO 2000 gel were found to be safe and well tolerated. These data justified testing the gels in large-scale effectiveness trials.

Published
2010

15. The Framing and Fashioning of Therapeutic Citizenship Among People Living With HIV Taking Antiretroviral Therapy in Uganda

Author

Flavia Zalwango, Janet Seeley, Stella Namukwaya, and Steve Russell

Subjects
Adult, Male, media_common.quotation_subject, Human immunodeficiency virus (HIV), HIV Infections, coping and adaptation, medicine.disease_cause, Antiviral Agents, 03 medical and health sciences, 0302 clinical medicine, Nursing, Acquired immunodeficiency syndrome (AIDS), HIV & Sexual Health, Collective identity, Adaptation, Psychological, self-care, medicine, Humans, Uganda, Narrative, 030212 general & internal medicine, Africa, Sub-Saharan, Citizenship, Physical Therapy Modalities, media_common, research, qualitative, 030505 public health, business.industry, adherence / compliance, Public Health, Environmental and Occupational Health, Cognitive reframing, medicine.disease, Antiretroviral therapy, Self Care, Framing (social sciences), HIV/AIDS, health care, users’ experiences, Female, illness and disease, experiences, 0305 other medical science, business
Abstract

In this article, we examine how people living with HIV (PLWH) were able to reconceptualize or “reframe” their understanding of HIV and enhance their capacity to self-manage the condition. Two in-depth interviews were held with 38 PLWH (20 women, 18 men) selected from three government and nongovernment antiretroviral therapy (ART) delivery sites in Wakiso District, and the narratives analyzed. ART providers played an important role in shaping participants’ HIV self-management processes. Health workers helped PLWH realize that they could control their condition, provided useful concepts and language for emotional coping, and gave advice about practical self-management tasks, although this could not always be put into practice. ART providers in this setting were spaces for the development of a collective identity and a particular form of therapeutic citizenship that encouraged self-management, including adherence to ART. Positive framing institutions are important for many PLWH in resource-limited settings and the success of ART programs.

Published
2015

16. Pregnancy in HIV clinical trials in Sub Saharan Africa: failure of consent or contraception?

Author

Leonard Bufumbo, Stella Namukwaya, David G. Lalloo, Anatoli Kamali, Janet Seeley, Rosalind Parkes-Ratanshi, Agnes Ssali, Parkes-Ratanshi, Rosalind [0000-0001-9297-1311], and Apollo - University of Cambridge Repository

Subjects
wc_503_4, Adult, Male, medicine.medical_specialty, Antifungal Agents, Pregnancy Rate, Sexual Behavior, lcsh:Medicine, wc_503, HIV Infections, Spermatocidal Agents, wa_550, law.invention, Condoms, Young Adult, Condom, law, Informed consent, Pregnancy, Medicine, Humans, Uganda, Young adult, Pregnancy Complications, Infectious, Condoms, Female, lcsh:Science, Fluconazole, Africa South of the Sahara, Gynecology, wa_30, Multidisciplinary, business.industry, lcsh:R, Contraceptive Devices, Female, Cryptococcosis, medicine.disease, Clinical trial, Pregnancy rate, Clinical research, Contraception, Family planning, Family medicine, Vaginal Creams, Foams, and Jellies, Female, lcsh:Q, business, Research Article
Abstract

Objective\ud \ud Higher than expected pregnancy rates have been observed in HIV related clinical trials in Sub-Saharan Africa. We designed a qualitative study to explore the factors contributing to high pregnancy rates among participants in two HIV clinical trials in Sub-Saharan Africa.\ud \ud Methods\ud \ud Female and male participants enrolled in one of two clinical HIV trials in south-west Uganda were approached. The trials were a phase III microbicide efficacy trial among HIV negative women using vaginal gel (MDP); and a trial of primary prevention prophylaxis for invasive cryptococcal disease using fluconazole among HIV infected men and women in Uganda (CRYPTOPRO). 14 focus group discussions and 8 in-depth interviews were conducted with HIV positive and negative women and their male partners over a six month period. Areas explored were their experiences about why and when one should get pregnant, factors affecting use of contraceptives, HIV status disclosure and trial product use.\ud \ud Results\ud \ud All respondents acknowledged being advised of the importance of avoiding pregnancy during the trial. Factors reported to contribute to pregnancy included; trust that the investigational product (oral capsules/vaginal gel) would not harm the baby, need for children, side effects that led to inconsistent contraceptive use, low acceptance of condom use among male partners. Attitudes towards getting pregnant are fluid within couples over time and the trials often last for more than a year. Researchers need to account for high pregnancy rates in their sample size calculations, and consider lesser used female initiated contraceptive options e.g. diaphragm or female condoms. In long clinical trials where there is a high fetal or maternal risk due to investigational product, researchers and ethics committees should consider a review of participants contraceptive needs/pregnancy desire review after a fixed period, as need for children, partners and health status of participants may alter over time.

Published
2013

17. A randomized controlled safety and acceptability trial of dextrin sulphate vaginal microbicide gel in sexually active women in Uganda

Author

Charles J.N. Lacey, Andrew J. Nunn, Romano Byaruhanga, Julie M. Bakobaki, Michael I. Bukenya, Stella Namukwaya, Heiner Grosskurth, Pius Okong, James A. G. Whitworth, and Sheena McCormack

Subjects
Sexually transmitted disease, Adult, medicine.medical_specialty, Sexual Behavior, Immunology, Population, Sexually Transmitted Diseases, Placebo, law.invention, Randomized controlled trial, Anti-Infective Agents, law, Internal medicine, Dextrins, medicine, Immunology and Allergy, Humans, Vaginal bleeding, Uganda, education, Gynecology, education.field_of_study, business.industry, Vaginal microbicide, Microbicides for sexually transmitted diseases, Administration, Intravaginal, Infectious Diseases, medicine.anatomical_structure, Patient Satisfaction, Vagina, Vaginal Creams, Foams, and Jellies, Female, medicine.symptom, Safety, business
Abstract

OBJECTIVE: To assess the safety of dextrin sulphate (DS) gel compared to placebo gel in terms of local and systemic adverse events, and to determine the acceptability of dextrin sulphate gel. DESIGN: A 4-week randomized trial of DS intra-vaginal gel, partially blinded, with placebo and observation control arms. Participants were randomized to use DS gel twice daily, placebo gel twice daily, DS gel pre-sex, or into an observation only arm. METHODS: Sexually active women were recruited from post natal and HIV clinics at Nsambya Hospital, Kampala, Uganda. Screening, enrolment and follow-up visits took place every 1 or 2 weeks over an 8-week period and consisted of questionnaire interviews, colposcopy examinations, sexually transmitted infection screen and routine laboratory testing. RESULTS: Out of a total of 172 women screened, 109 were randomized to use DS gel twice daily (65 women), placebo gel twice daily (15 women), DS gel pre-sex (nine women) or into an observation only arm (20 women). Two individuals had abnormal colposcopy findings in the DS twice daily gel use arm. Vaginal bleeding was reported as frequently by participants in the active gel arm as by participants in the placebo and observation only arms. No clinically significant difference was observed between arms in terms of vaginal flora, Candida, haemoglobin, white cell count, platelets, thrombin time, activated partial thromboplastin time, creatinine and aspartate aminotransferase results after 4 weeks of gel use. DS gel appeared to be acceptable to over 95% of the users. CONCLUSIONS: Results show a satisfactory safety and acceptability profile of dextrin sulphate gel.

Published
2005

18. Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV?

Author

Bernays, Sarah, Paparini, Sara, Seeley, Janet, Kihika, Stella Namukwaya, Gibb, Diana, and Rhodes, Tim

Abstract

Objectives: A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8-24) living with HIV with viral load <50 c/mL to examine adaptation, acceptability and experience of SCT to inform intervention development. Setting: Paediatric HIV clinics in the UK (2), Ireland (1), the USA (1) and Uganda (1). Participants: All BREATHER trial participants who were over the age of 10 and aware of their HIV diagnosis were invited to participate. 49 young people from both arms of the BREATHER trial (31 females and 18 males; 40% of the total trial population in the respective sites; age range 11-24) gave additional consent to participate in the qualitative study. Results: Young people from both trial arms had initial concerns about the impact of SCT on their health and adherence, but these decreased over the early months in the trial. Young people randomised to SCT reported preference for SCT compared with CT pre-trial. Attitudes to SCT did not vary greatly by gender or country. Once short-term adaptation challenges were overcome, SCT was positively described as reducing impact of side effects, easing the pressure to carry and remember medication and enabling more weekend social activities. Young people on both arms reported frequent medication side effects and occasional missed doses that they had rarely voiced to clinical staff. Participants liked SCT by trial end but were concerned that peers who had most problems adhering could find SCT disruptive and difficult to manage. Conclusions: To realise the potential of SCT (and mitigate possible risks of longer interruptions), careful dissemination and communication post-trial is needed. SCT should be provided alongside a package of monitoring, support and education over 3 months to allow adaptation. [ABSTRACT FROM AUTHOR]

Published
2017
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