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4. Lessons from enriching Tanzania’s clinical research ethics clinical trials oversight and pharmacovigilance through the ASCEND project

Author

Fimbo, Adam, Mwalwisi, Yona H., Matiko, Damas, Mlugu, Eulambius M., Gedi, Emmanuel Masunga, Oriyo, Ndekya M., Mmbaga, Blandina T., Ntinginya, Nyanda E., Sabiiti, Wilber, Mcharo, Ruby, Masemo, Ame, Chambiri, Sunzy M., Lichanda, Bora, Ally, Mayassa, Simai, Burhani, Kaale, Eliangiringa, Mnkugwe, Rajabu Hussein, Kunambi, Peter P., Munishi, Castory, Gotora, Goodluck B., and Mwamwitwa, Kissa

Published
2024
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8. An international report on bacterial communities in esophageal squamous cell carcinoma

Author

Nomburg, Jason, Bullman, Susan, Nasrollahzadeh, Dariush, Collisson, Eric A, Abedi‐Ardekani, Behnoush, Akoko, Larry O, Atkins, Joshua R, Buckle, Geoffrey C, Gopal, Satish, Hu, Nan, Kaimila, Bongani, Khoshnia, Masoud, Malekzadeh, Reza, Menya, Diana, Mmbaga, Blandina T, Moody, Sarah, Mulima, Gift, Mushi, Beatrice P, Mwaiselage, Julius, Mwanga, Ally, Newton, Yulia, Ng, Dianna L, Radenbaugh, Amie, Rwakatema, Deogratias S, Selekwa, Msiba, Schüz, Joachim, Taylor, Philip R, Vaske, Charles, Goldstein, Alisa, Stratton, Michael R, McCormack, Valerie, Brennan, Paul, DeCaprio, James A, Meyerson, Matthew, Mmbaga, Elia J, and Van Loon, Katherine

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Human Genome, Esophageal Cancer, Microbiome, Rare Diseases, Cancer Genomics, Clinical Research, Dental/Oral and Craniofacial Disease, Genetics, Prevention, Digestive Diseases, Infectious Diseases, Cancer, Infection, Bacteria, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Humans, Kenya, Microbiota, Africa, esophageal cancer, esophageal squamous cell carcinoma, Fusobacterium, microbiome, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

The incidence of esophageal squamous cell carcinoma (ESCC) is disproportionately high in the eastern corridor of Africa and parts of Asia. Emerging research has identified a potential association between poor oral health and ESCC. One possible link between poor oral health and ESCC involves the alteration of the microbiome. We performed an integrated analysis of four independent sequencing efforts of ESCC tumors from patients from high- and low-incidence regions of the world. Using whole genome sequencing (WGS) and RNA sequencing (RNAseq) of ESCC tumors from 61 patients in Tanzania, we identified a community of bacteria, including members of the genera Fusobacterium, Selenomonas, Prevotella, Streptococcus, Porphyromonas, Veillonella and Campylobacter, present at high abundance in ESCC tumors. We then characterized the microbiome of 238 ESCC tumor specimens collected in two additional independent sequencing efforts consisting of patients from other high-ESCC incidence regions (Tanzania, Malawi, Kenya, Iran, China). This analysis revealed similar ESCC-associated bacterial communities in these cancers. Because these genera are traditionally considered members of the oral microbiota, we next explored whether there was a relationship between the synchronous saliva and tumor microbiomes of ESCC patients in Tanzania. Comparative analyses revealed that paired saliva and tumor microbiomes were significantly similar with a specific enrichment of Fusobacterium and Prevotella in the tumor microbiome. Together, these data indicate that cancer-associated oral bacteria are associated with ESCC tumors at the time of diagnosis and support a model in which oral bacteria are present in high abundance in both saliva and tumors of some ESCC patients.

Published
2022

9. Treatment outcomes of esophageal cancer in Eastern Africa: protocol of a multi-center, prospective, observational, open cohort study

Author

Buckle, Geoffrey C, Mrema, Alita, Mwachiro, Michael, Ringo, Yona, Selekwa, Msiba, Mulima, Gift, Some, Fatma F, Mmbaga, Blandina T, Mody, Gita N, Zhang, Li, Paciorek, Alan, Akoko, Larry, Ayuo, Paul, Burgert, Stephen, Bukusi, Elizabeth, Charles, Anthony, Chepkemoi, Winnie, Chesumbai, Gladys, Kaimila, Bongani, Kenseko, Aida, Kibwana, Kitembo Salum, Koech, David, Macharia, Caren, Moirana, Ezekiel N, Mushi, Beatrice Paul, Mremi, Alex, Mwaiselage, Julius, Mwanga, Ally, Ndumbalo, Jerry, Nvakunga, Gissela, Ngoma, Mamsau, Oduor, Margaret, Oloo, Mark, Opakas, Jesse, Parker, Robert, Seno, Saruni, Salima, Ande, Servent, Furaha, Wandera, Andrew, Westmoreland, Kate D, White, Russell E, Williams, Brittney, Mmbaga, Elia J, and Van Loon, Katherine

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Digestive Diseases, Health Services, Rare Diseases, Comparative Effectiveness Research, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adult, Africa, Eastern, Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Female, Health Resources, Humans, Longitudinal Studies, Male, Observational Studies as Topic, Palliative Care, Prospective Studies, Treatment Outcome, Esophageal squamous cell carcinoma, Esophageal cancer, Survival, Quality of life, Comparative, effectiveness, Africa, Eastern Africa, of the African Esophageal Cancer Consortium, Comparative effectiveness, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Epidemiology
Abstract

BackgroundEsophageal squamous cell carcinoma (ESCC) is a major cause of cancer morbidity and mortality in Eastern Africa. The majority of patients with ESCC in Eastern Africa present with advanced disease at the time of diagnosis. Several palliative interventions for ESCC are currently in use within the region, including chemotherapy, radiation therapy with and without chemotherapy, and esophageal stenting with self-expandable metallic stents; however, the comparative effectiveness of these interventions in a low resource setting has yet to be examined.MethodsThis prospective, observational, multi-center, open cohort study aims to describe the therapeutic landscape of ESCC in Eastern Africa and investigate the outcomes of different treatment strategies within the region. The 4.5-year study will recruit at a total of six sites in Kenya, Malawi and Tanzania (Ocean Road Cancer Institute and Muhimbili National Hospital in Dar es Salaam, Tanzania; Kilimanjaro Christian Medical Center in Moshi, Tanzania; Tenwek Hospital in Bomet, Kenya; Moi Teaching and Referral Hospital in Eldoret, Kenya; and Kamuzu Central Hospital in Lilongwe, Malawi). Treatment outcomes that will be evaluated include overall survival, quality of life (QOL) and safety. All patients (≥18 years old) who present to participating sites with a histopathologically-confirmed or presumptive clinical diagnosis of ESCC based on endoscopy or barium swallow will be recruited to participate. Key clinical and treatment-related data including standardized QOL metrics will be collected at study enrollment, 1 month following treatment, 3 months following treatment, and thereafter at 3-month intervals until death. Vital status and QOL data will be collected through mobile phone outreach.DiscussionThis study will be the first study to prospectively compare ESCC treatment strategies in Eastern Africa, and the first to investigate QOL benefits associated with different treatments in sub-Saharan Africa. Findings from this study will help define optimal management strategies for ESCC in Eastern Africa and other resource-limited settings and will serve as a benchmark for future research.Trial registrationThis study was retrospectively registered with the ClinicalTrials.gov database on December 15, 2021,  NCT05177393 .

Published
2022

11. Neurocysticercosis and cognitive impairment among people with epilepsy in Taenia solium endemic regions of rural southern Tanzania: A hospital-based cross-sectional study in mental health clinics of selected sites in Tanzania

Author

Makasi, Charles E., Ngowi, Bernard, Mahande, Michael J., Welte, Tamara M., Stelzle, Dominik, Guga, Godfrey, Schmidt, Veronika, Rüther, Charlotte, Lema, Yakobo, Fabien Prodjinotho, Ulrich, Kilale, Andrew, Prazeres da Costa, Clarissa, Mmbaga, Blandina T., and Winkler, Andrea S.

Published
2024
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12. Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1–2 trial

Author

Ruel, Theodore D, Acosta, Edward P, Liu, Jessica P, Gray, Kathryn P, George, Kathleen, Montañez, Nicole, Popson, Stephanie, Buchanan, Ann M, Bartlett, Mattie, Dayton, Dale, Anthony, Patricia, Brothers, Cynthia, Vavro, Cynthia, Singh, Rajendra, Koech, Lucy, Vhembo, Tichaona, Mmbaga, Blandina T, Pinto, Jorge A, Dobbels, Els FM, Archary, Moherndran, Chokephaibulkit, Kulkanya, Ounchanum, Pradthana, Deville, Jaime G, Hazra, Rohan, Townley, Ellen, Wiznia, Andrew, team, IMPAACT P1093, Carter, Michele F, Mansky, Hannah, Ferreira, Flavia F, Romeiro, Juliana, D'Angelo, Jessica, Williams, Ruth, Jundi, Fernanda, Cruz, Maria Letícia Santos, Sidi, Claude Leon, Kataike, Hajira, Owor, Maxensia, Ahimbisibwe, Grace Miriam, van Rensburg, Anita Janse, Andrea, Catherine V, Ponatshego, Ponego L, Budu, Marian, Tirelo, Lesedi, Masheto, Gaerolwe R, Raesi, Mpho S, Ramogodiri, Moakanyi, Chanthong, Jiraporn, Khamrong, Chintana, Aurpibul, Linda, Fairlie, Lee, Patel, Faeezah, Soma-Kashiram, Hamisha, Hanley, Sherika, Govender, Vani, Sturzbecher, Fernanda Tomé, Cervi, Maria Célia, Njau, Boniface, Matibe, Petronilla, Mukonowenzou, Ruvimbo, Marozva, Catherine C, Keter, Winnie C, Bii, Priscilla C, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Rungmaitree, Supattra, Pilotto, Jose Henrique, Fernandes, Luis Eduardo, and Gomes, Ivete Martins

Subjects
Prevention, Pediatric AIDS, Clinical Research, HIV/AIDS, Clinical Trials and Supportive Activities, Infectious Diseases, Pediatric, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Infection, Good Health and Well Being, Adolescent, Adult, Antiviral Agents, Child, Child, Preschool, Female, HIV Infections, HIV Integrase Inhibitors, HIV Seropositivity, HIV-1, Heterocyclic Compounds, 3-Ring, Humans, Infant, Male, Oxazines, Piperazines, Pyridones, RNA, Tablets, IMPAACT P1093 team, Medical and Health Sciences
Abstract

BackgroundSafe and potent antiretroviral medications in child-friendly formulations are needed to treat young children living with HIV-1. We aimed to select dosing for a dispersible tablet formulation of dolutegravir that achieved pharmacokinetic exposures similar to those in adults, and was safe and well tolerated in young children.MethodsInternational Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) P1093 is a phase 1-2 ongoing multicentre, open-label, non-comparative study of dolutegravir. A 5 mg dispersible tablet formulation of dolutegravir was studied in children aged 4 weeks to less than 6 years old, weighing at least 3 kg, with HIV RNA of greater than 1000 copies per mL and no previous treatment with integrase strand transfer inhibitor recruited from IMPAACT clinical research sites in Africa, the Americas, and Asia. Doses were selected on the basis of intensive pharmacokinetic evaluation on days 5-10, with safety and tolerability assessed up to 48 weeks. The primary objectives of this study are to evaluate the pharmacokinetics of dolutegravir in combination with optimised background therapy and to establish the dose of dolutegravir that achieves the targeted 24-h trough concentration and 24-h area under the curve for infants, children, and adolescents with HIV-1, to establish the safety and tolerability of dolutegravir at 24 and 48 weeks, and to select a dose that achieves similar exposure to the dolutegravir 50 mg once daily dose in adults. This analysis included participants treated with the proposed dose of dolutegravir dispersible tablets in two stages for each of three age cohorts. This trial is registered at ClinicalTrials.gov (NCT01302847) and is ongoing.FindingsWe recruited 181 participants from April 20, 2011, to Feb 19, 2020; of these, 96 received dolutegravir dispersible tablets. This analysis included 73 (35, 48% female) participants who received the final proposed dose with median (range) age of 1 year (0·1 to 6·0), weight (minimum-maximum) of 8·5 kg (3·7 to 18·5), plasma HIV-1 RNA concentration of 4·2 log10 copies per mL (2·1 to 7·0), and CD4% of 24·0% (0·3 to 49·0); 64 (87·7%) were treatment-experienced. The selected dose within each age cohort (≥2 years to

Published
2022

16. Unravelling patient pathways in the context of antibacterial resistance in East Africa

Author

Keenan, Katherine, Fredricks, Kathryn J., Al Ahad, Mary Abed, Neema, Stella, Mwanga, Joseph R., Kesby, Mike, Mushi, Martha F., Aduda, Annette, Green, Dominique L., Lynch, Andy G., Huque, Sarah I., Mmbaga, Blandina T., Worthington, Hannah, Kansiime, Catherine, Olamijuwon, Emmanuel, Ntinginya, Nyanda E., Loza, Olga, Bazira, Joel, Maldonado-Barragán, Antonio, Smith, VAnne, Decano, Arun Gonzales, Njeru, John Mwaniki, Sandeman, Alison, Stelling, John, Elliott, Alison, Aanensen, David, Gillespie, Stephen H., Kibiki, Gibson, Sabiiti, Wilber, Sloan, Derek J., Asiimwe, Benon B., Kiiru, John, Mshana, Stephen E., and Holden, Matthew T. G.

Published
2023
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22. Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial

Author

Lockman, Shahin, Brummel, Sean S, Ziemba, Lauren, Stranix-Chibanda, Lynda, McCarthy, Katie, Coletti, Anne, Jean-Philippe, Patrick, Johnston, Ben, Krotje, Chelsea, Fairlie, Lee, Hoffman, Risa M, Sax, Paul E, Moyo, Sikhulile, Chakhtoura, Nahida, Stringer, Jeffrey SA, Masheto, Gaerolwe, Korutaro, Violet, Cassim, Haseena, Mmbaga, Blandina T, João, Esau, Hanley, Sherika, Purdue, Lynette, Holmes, Lewis B, Momper, Jeremiah D, Shapiro, Roger L, Thoofer, Navdeep K, Rooney, James F, Frenkel, Lisa M, Amico, K Rivet, Chinula, Lameck, Currier, Judith, Team and Investigators, IMPAACT 2010 VESTED Study, Best, Brookie M, Blanchette, Cheryl, Browning, Renee, Cheng, Yao, Fox, Andee, Jaliaah, Nagawa, Knowles, Kevin, Mirochnick, Mark, Murtaugh, William A, Patras, Emmanuel, Pinilla, Mauricio, van Wyk, Jean, and Whalen, Frances

Subjects
Perinatal Period - Conditions Originating in Perinatal Period, Clinical Trials and Supportive Activities, Prevention, Infectious Diseases, Clinical Research, Pediatric, HIV/AIDS, Infant Mortality, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Reproductive health and childbirth, Good Health and Well Being, Adenine, Adult, Alanine, Anti-HIV Agents, Drug Therapy, Combination, Emtricitabine, Female, Gestational Age, HIV Infections, Heterocyclic Compounds, 3-Ring, Humans, Infant, Newborn, Infectious Disease Transmission, Vertical, Oxazines, Piperazines, Pregnancy, Pregnancy Complications, Infectious, Pregnancy Outcome, Pyridones, Tenofovir, Ultrasonography, Prenatal, IMPAACT 2010/VESTED Study Team and Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundAntiretroviral therapy (ART) during pregnancy is important for both maternal health and prevention of perinatal HIV-1 transmission; however adequate data on the safety and efficacy of different ART regimens that are likely to be used by pregnant women are scarce. In this trial we compared the safety and efficacy of three antiretroviral regimens started in pregnancy: dolutegravir, emtricitabine, and tenofovir alafenamide fumarate; dolutegravir, emtricitabine, and tenofovir disoproxil fumarate; and efavirenz, emtricitabine, and tenofovir disoproxil fumarate.MethodsThis multicentre, open-label, randomised controlled, phase 3 trial was done at 22 clinical research sites in nine countries (Botswana, Brazil, India, South Africa, Tanzania, Thailand, Uganda, the USA, and Zimbabwe). Pregnant women (aged ≥18 years) with confirmed HIV-1 infection and at 14-28 weeks' gestation were eligible. Women who had previously taken antiretrovirals in the past were excluded (up to 14 days of ART during the current pregnancy was permitted), as were women known to be pregnant with multiple fetuses, or those with known fetal anomaly or a history of psychiatric illness. Participants were randomly assigned (1:1:1) using a central computerised randomisation system. Randomisation was done using permuted blocks (size six) stratified by gestational age (14-18, 19-23, and 24-28 weeks' gestation) and country. Participants were randomly assigned to receive either once-daily oral dolutegravir 50 mg, and once-daily oral fixed-dose combination emtricitabine 200 mg and tenofovir alafenamide fumarate 25 mg; once-daily oral dolutegravir 50 mg, and once-daily oral fixed-dose combination emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; or once-daily oral fixed-dose combination of efavirenz 600 mg, emtricitabine 200 mg, and tenofovir disoproxil fumarate 300 mg. The primary efficacy outcome was the proportion of participants with viral suppression, defined as an HIV-1 RNA concentration of less than 200 copies per mL, at or within 14 days of delivery, assessed in all participants with an HIV-1 RNA result available from the delivery visit, with a prespecified non-inferiority margin of -10% in the combined dolutegravir-containing groups versus the efavirenz-containing group (superiority was tested in a pre-planned secondary analysis). Primary safety outcomes, compared pairwise among treatment groups, were the occurrence of a composite adverse pregnancy outcome (ie, either preterm delivery, the infant being born small for gestational age, stillbirth, or spontaneous abortion) in all participants with a pregnancy outcome, and the occurrence of grade 3 or higher maternal and infant adverse events in all randomised participants. This trial was registered with ClinicalTrials.gov, NCT03048422.FindingsBetween Jan 19, 2018, and Feb 8, 2019, we enrolled and randomly assigned 643 pregnant women: 217 to the dolutegravir, emtricitabine, and tenofovir alafenamide fumarate group, 215 to the dolutegravir, emtricitabine, and tenofovir disoproxil fumarate group, and 211 to the efavirenz, emtricitabine, and tenofovir disoproxil fumarate group. At enrolment, median gestational age was 21·9 weeks (IQR 18·3-25·3), the median HIV-1 RNA concentration among participants was 902·5 copies per mL (152·0-5182·5; 181 [28%] of 643 participants had HIV-1 RNA concentrations of

Published
2021

23. Effect of seven anti-tuberculosis treatment regimens on sputum microbiome: a retrospective analysis of the HIGHRIF study 2 and PanACEA MAMS-TB clinical trials

Author

Musisi, Emmanuel, Mtafya, Bariki, Ntinginya, Nyanda E., Heinrich, Norbert, Kibiki, Gibson S., Hoelscher, Michael, Boeree, Martin, Gillespie, Stephen, Sabiiti, Wilber, Sloan, Derek, Hoffmann, Larissa, Noreña, Ivan, Lutchmun, Wandini, Dreisbach, Julia, Demel, Petra Gross, Kelly, Andrea, Brake, Lindsey te, Svensson, Elin, Aarnoutse, Rob, Honeyborne, Isobella, Wildner, Leticia Muraro, Hunt, Robert, McHugh, Timothy D., Nunn, Andrew J, Phillips, Patrick P.J., Gong, Xue, Dawson, Rodney, Narunsky, Kim, Diacon, Andreas, de Jager, Veronique, Friedrich, Sven, Sanne, Ian, Rassool, Mohammed, Mangu, Chacha, Manyama, Christina, Sabi, Issa, Minja, Lilian T., Mhimbira, Francis, Mbeya, Benno, Sasamalo, Mohamed, Reither, Klaus, Jugheli, Levan, Sam, Noel, Semvua, Hadija, Mpagama, Stellah, Liyoyo, Alphonce, Mmbaga, Blandina T., Adegbite, Bayode Romeo, Adegnika, Ayola Akim, Grobusch, Martin Peter, Grobusch, Martin P., Kirenga, Bruce, Ssengooba, Willy, Joloba, Moses, Khosa, Celso, Massango, Isabel, Azam, Khalide, Jani, Ilesh, Nliwasa, Mariott, Twabi, Hussein Hassan, Mukoka, Madalo, Msefula, Chisomo L., Wyness, Adam, Eldirdiri, Sahar, Dombay, Evelin, Ntinginya, Nyanda E, Kibiki, Gibson S, and Gillespie, Stephen H

Published
2023
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24. Mortality associated with third-generation cephalosporin resistance in Enterobacterales bloodstream infections at eight sub-Saharan African hospitals (MBIRA): a prospective cohort study

Author

Aliye, Jabir, Assefa, Nega, Edessa, Dumessa, Oundo, Joseph, Berihun, Mulu, Dankwah, Thomas, Osei, Mary M, Fandoh, Maud, Gakpo, Margaret, Mulunda, Caroline, Mvera, Benedict, Chimenya, Mabvuto, Feasey, Nicholas, Mallewa, Jane, Abdulraheem, Khadija, Akujobi, Tobechi A, Okonkwo, Chinelo H, Britz, Luzell, Bulbula, André N H, Fataar, Aaqilah, Mmbaga, Blandina T, Ng'unda, Neema, Chirwa, Uchizi, Kakula, Nyambe, Mutemba, Charles, Nakazwe, Ruth, Aiken, Alexander M, Rehman, Andrea M, de Kraker, Marlieke E A, Madrid, Lola, Kebede, Meron, Labi, Appiah-Korang, Obeng-Nkrumah, Noah, Nyamwaya, Brian, Kagucia, Eunice, Cocker, Derek, Kawaza, Kondwani, Lester, Rebecca, Iregbu, Kenneth C, Medugu, Nubwa, Nwajiobi-Princewill, Philip I, Dramowski, Angela, Sonda, Tolbert, Hemed, Asia, Fwoloshi, Sombo, Ojok, David, Scott, J Anthony G, and Whitelaw, Andrew

Published
2023
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27. Effect of pregnancy versus postpartum maternal isoniazid preventive therapy on infant growth in HIV-exposed uninfected infants: a post-hoc analysis of the TB APPRISE trial

Author

Sterling, Timothy R., Browning, Renee, McCarthy, Katie, Aaron, Lisa, Shin, Katherine, Golner, Amanda, Zimmer, Bonnie, Mathad, Jyoti S., Pahwa, Savita, Kulkarni, Vandana, Costello, Diane, Rexroad, Vivian, Gandhi, Monica, Du Plessis, Joan, James Loftis, Amy, Cherkos, Ashenafi S., LaCourse, Sylvia M., Enquobahrie, Daniel A., Richardson, Barbra A., Bradford, Sarah, Montepiedra, Grace, Mmbaga, Blandina T., Mbengeranwa, Tapiwa, Masheto, Gaerolwe, Jean–Phillippe, Patrick, Chakhtoura, Nahida, Theron, Gerhard, Weinberg, Adriana, Cassim, Haseena, Raesi, Mpho S., Jean, Elsie, Wabwire, Deo, Nematadzira, Teacler, Stranix-Chibanda, Lynda, Hesseling, Anneke C., Aurpibul, Linda, Gupta, Amita, and John-Stewart, Grace

Published
2023
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28. Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial

Author

João, Esaú C, Morrison, R Leavitt, Shapiro, David E, Chakhtoura, Nahida, Gouvèa, Maria Isabel S, de Lourdes B Teixeira, Maria, Fuller, Trevon L, Mmbaga, Blandina T, Ngocho, James S, Njau, Boniface N, Violari, Avy, Mathiba, Ruth, Essack, Zaynab, Pilotto, Jose Henrique S, Moreira, Luis Felipe, Rolon, Maria Jose, Cahn, Pedro, Prommas, Sinart, Cressey, Timothy R, Chokephaibulkit, Kulkanya, Werarak, Peerawong, Laimon, Lauren, Hennessy, Roslyn, Frenkel, Lisa M, Anthony, Patricia, Best, Brookie M, Siberry, George K, and Mirochnick, Mark

Subjects
Reproductive Medicine, Medical Microbiology, Biomedical and Clinical Sciences, HIV/AIDS, Clinical Trials and Supportive Activities, Infectious Diseases, Prevention, Pediatric, Clinical Research, Mental Health, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Reproductive health and childbirth, Infection, Good Health and Well Being, Adult, Alkynes, Anti-HIV Agents, Benzoxazines, Cyclopropanes, Drug Therapy, Combination, Female, HIV Infections, HIV Integrase Inhibitors, Humans, Infant, Newborn, Infectious Disease Transmission, Vertical, Lamivudine, Outcome Assessment, Health Care, Pregnancy, Pregnancy Complications, Infectious, Raltegravir Potassium, Viral Load, Young Adult, Zidovudine, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAlthough antiretroviral regimens containing integrase inhibitors rapidly suppress HIV viral load in non-pregnant adults, few published data from randomised controlled trials have compared the safety and efficacy of any integrase inhibitor to efavirenz when initiated during pregnancy. We compared safety and efficacy of antiretroviral therapy with either raltegravir or efavirenz in late pregnancy.MethodsAn open-label, randomised controlled trial was done at 19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA. Antiretroviral-naive pregnant women (20-

Published
2020

29. The role of multidimensional poverty in antibiotic misuse: a mixed-methods study of self-medication and non-adherence in Kenya, Tanzania, and Uganda

Author

Green, Dominique L, Keenan, Katherine, Fredricks, Kathryn J, Huque, Sarah I, Mushi, Martha F, Kansiime, Catherine, Asiimwe, Benon, Kiiru, John, Mshana, Stephen E, Neema, Stella, Mwanga, Joseph R, Kesby, Mike, Lynch, Andy G, Worthington, Hannah, Olamijuwon, Emmanuel, Abed Al Ahad, Mary, Aduda, Annette, Njeru, John Mwaniki, Mmbaga, Blandina T, Bazira, Joel, Sandeman, Alison, Stelling, John, Gillespie, Stephen H, Kibiki, Gibson, Sabiiti, Wilber, Sloan, Derek J, Holden, Matthew T G, Smith, V Anne, Decano, Arun Gonzales, Maldonado-Barragán, Antonio, Aanensen, David, Ntinginya, Nyanda E, Elliott, Alison, and Clarkson, Madeleine

Published
2023
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33. Mentoring the Mentors: Implementation and Evaluation of Four Fogarty-Sponsored Mentoring Training Workshops in Low-and Middle-Income Countries

Author

Gandhi, Monica, Raj, Tony, Fernandez, Ryan, Rispel, Laetitia, Nxumalo, Nonhlanhla, Lescano, Andrés G, Bukusi, Elizabeth A, Mmbaga, Blandina T, Heimburger, Douglas C, and Cohen, Craig R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Africa, Asia, Biomedical Research, Cross-Cultural Comparison, Developing Countries, Education, Global Health, Guidelines as Topic, Humans, Income, Mentoring, Mentors, Professional Competence, Program Evaluation, South America, Teaching, United States, Medical and Health Sciences, Tropical Medicine, Biomedical and clinical sciences, Health sciences
Abstract

A growing body of evidence highlights the importance of competent mentoring in academic research. We describe the development, implementation, and evaluation of four regional 2-day intensive workshops to train mid- and senior-level investigators conducting public health, clinical, and basic science research across multiple academic institutions in low- and middle-income countries (LMICs) on tools and techniques of effective mentoring. Sponsored by the Fogarty International Center, workshops included didactic presentations, interactive discussions, and small-group problem-based learning and were conducted in Lima, Peru; Mombasa, Kenya; Bangalore, India; and Johannesburg, South Africa, from 2013 to 2016. Mid- or senior-level faculty from multiple academic institutions within each region applied and were selected. Thirty faculty from 12 South America-based institutions, 29 faculty from eight East Africa-based institutions, 37 faculty from 14 South Asia-based institutions, and 36 faculty from 13 Africa-based institutions participated, with diverse representation across disciplines, gender, and academic rank. Discussions and evaluations revealed important comparisons and contrasts in the practice of mentoring, and specific barriers and facilitators to mentoring within each cultural and regional context. Specific regional issues related to hierarchy, the post-colonial legacy, and diversity arose as challenges to mentoring in different parts of the world. Common barriers included a lack of a culture of mentoring, time constraints, lack of formal training, and a lack of recognition for mentoring. These workshops provided valuable training, were among the first of their kind, were well-attended, rated highly, and provided concepts and a structure for the development and strengthening of formal mentoring programs across LMIC institutions.

Published
2019

35. Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1–2 trial

Author

Deville, Jaime G, Carter, Michele F, Mansky, Hannah, Pinto, Jorge A, Ferreira, Flavia F, Romeiro, Juliana, D'Angelo, Jessica, Williams, Ruth, Jundi, Fernanda, Cruz, Maria Letícia Santos, Sidi, Claude Leon, Kataike, Hajira, Owor, Maxensia, Ahimbisibwe, Grace Miriam, van Rensburg, Ms Anita Janse, Andrea, Catherine V, Ponatshego, Ponego L, Budu, Marian, Tirelo, Lesedi, Masheto, Gaerolwe R, Raesi, Mpho S., Ramogodiri, Moakanyi, Chanthong, Jiraporn, Khamrong, Chintana, Aurpibul, Linda, Fairlie, Lee, Patel, Faeezah, Soma-Kashiram, Hamisha, Archary, Moherndran, Hanley, Sherika, Govender, Vani, Sturzbecher, Fernanda Tomé, Cervi, Maria Célia, Mmbaga, Blandina T, Njau, Boniface, Matibe, Petronilla, Mukonowenzou, Ruvimbo, Marozva, Catherine C, Keter, Winnie C, Bii, Priscilla C, Ounchanum, Pradthana, Cressey, Tim R, Sukrakanchana, Pra-ornsuda, Chokephaibulkit, Kulkanya, Rungmaitree, Supattra, Pilotto, Jose Henrique, Fernandes, Luis Eduardo, Gomes, Ivete Martins, Ruel, Theodore D, Acosta, Edward P, Liu, Jessica P, Gray, Kathryn P, George, Kathleen, Montañez, Nicole, Popson, Stephanie, Buchanan, Ann M, Bartlett, Mattie, Dayton, Dale, Anthony, Patricia, Brothers, Cynthia, Vavro, Cynthia, Singh, Rajendra, Koech, Lucy, Vhembo, Tichaona, Dobbels, Els F M, Hazra, Rohan, Townley, Ellen, and Wiznia, Andrew

Published
2022
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36. Differences in thrombin and plasmin generation potential between East African and Western European adults: The role of genetic and non‐genetic factors

Author

Temba, Godfrey S., Vadaq, Nadira, Wan, Jun, Kullaya, Vesla, Huskens, Dana, Pecht, Tal, Jaeger, Martin, Boahen, Collins K., Matzaraki, Vasiliki, Broeders, Wieteke, Joosten, Leo A.B., Faradz, Sultana M.H., Kibiki, Gibson, Middeldorp, Saskia, Cavalieri, Duccio, Lionetti, Paolo, de Groot, Philip G., Schultze, Joachim L., Netea, Mihai G., Kumar, Vinod, de Laat, Bas, Mmbaga, Blandina T., van der Ven, Andre J., Roest, Mark, and de Mast, Quirijn

Published
2022
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40. Non-prescribed antibiotic dispensing practices for symptoms of urinary tract infection in community pharmacies and accredited drug dispensing outlets in Tanzania: a simulated clients approach

Author

Ndaki, Pendo M., Mushi, Martha F., Mwanga, Joseph R., Konje, Eveline T., Mugassa, Stella, Manyiri, Msilikale W., Mwita, Stanley M., Ntinginya, Nyanda E., Mmbaga, Blandina T., Keenan, Katherine, Sabiiti, Wilber, Kesby, Mike, Benitez-Paez, Fernando, Sandeman, Alison, Holden, Matthew T. G., and Mshana, Stephen E.

Published
2022
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41. Prospective cohort study reveals unexpected aetiologies of livestock abortion in northern Tanzania

Author

Thomas, Kate M., Kibona, Tito, Claxton, John R., de Glanville, William A., Lankester, Felix, Amani, Nelson, Buza, Joram J., Carter, Ryan W., Chapman, Gail E., Crump, John A., Dagleish, Mark P., Halliday, Jo E. B., Hamilton, Clare M., Innes, Elisabeth A., Katzer, Frank, Livingstone, Morag, Longbottom, David, Millins, Caroline, Mmbaga, Blandina T., Mosha, Victor, Nyarobi, James, Nyasebwa, Obed M., Russell, George C., Sanka, Paul N., Semango, George, Wheelhouse, Nick, Willett, Brian J., Cleaveland, Sarah, and Allan, Kathryn J.

Published
2022
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47. Alcohol consumption and oesophageal squamous cell cancer risk in east Africa: findings from the large multicentre ESCCAPE case-control study in Kenya, Tanzania, and Malawi

Author

Kigen, Nicolas, Oduor, Margaret, Karuru Maina, Stephen, Some, Fatima, Kibosia, Caroline, Mwasamwaja, Amos, Mremi, Alex, Kiwelu, Ireen, Swai, Remigi, Kiwelu, Godwin, Mustapha, Sophia, Mghase, Eliawawomy, Mchome, Amana, Shao, Redfan, Mallya, Evarista, Kilonzo, Kajiru, Kamkwantira, Anstead, Kamdolozi, Mercy, Liomba, George, Chasimpha, Steady, Narh, Clement, Bouaoun, Liacine, Abedi-Ardekani, Behnoush, Mushi, Godfrey, Namwai, Theresia, Suwedi, Mary, Solomon, Thandiwe, Malamba, Rose, Carreira, Christine, Middleton, Daniel R S, Mmbaga, Blandina T, Menya, Diana, Dzamalala, Charles, Nyakunga-Maro, Gissela, Finch, Peter, Mlombe, Yohannie, Schüz, Joachim, and McCormack, Valerie

Published
2022
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48. Financial toxicity and acute injury in the Kilimanjaro region: An application of the Three Delays Model.

Author

Frankiewicz, Parker, Sawe, Yvonne, Sakita, Francis, Mmbaga, Blandina T., Staton, Catherine, Joiner, Anjni P., and Smith, Emily R.

Abstract

Background: Trauma and injury present a significant global burden–one that is exacerbated in low- and middle-income settings like Tanzania. Our study aimed to describe the landscape of acute injury care and financial toxicity in the Kilimanjaro region by leveraging the Three Delays Model. Methods: This cross-sectional study used an ongoing injury registry and financial questionnaires collected at Kilimanjaro Christian Medical Centre (KCMC) in Moshi, Tanzania from December 2022 until March 2023. Financial toxicity measures included catastrophic expenditure and impoverishment, in accordance with World Health Organization standards. Descriptive analysis was also performed. Findings: Most acute injury patients that presented to the KCMC Emergency Department experienced financial toxicity due to their out-of-pocket (OOP) hospital expenses (catastrophic health expenditure, CHE: 62.8%; impoverishment, IMP: 85.9%). Households within our same which experienced financial toxicity had more dependents (CHE: 18.4%; IMP: 17.9% with ≥6 dependents) and lower median monthly adult-equivalent incomes (CHE: 2.53 times smaller than non-CHE; IMP: 4.27 times smaller than non-IMP). Individuals experiencing financial toxicity also underwent more facility transfers with a higher surgical burden. Interpretation: Delay 1 (decision to seek care) and Delay 2 (reaching appropriate care facility) could be significant factors for those who will experience financial toxicity. In the Tanzanian healthcare system where national health insurance is present, systematic expansions are indicated to target those who are at higher risk for financial toxicity including those who live in rural areas, experience unemployment, and have many dependents. [ABSTRACT FROM AUTHOR]

Published
2024
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49. Study protocol for Sauti ya Vijana (The Voice of Youth): A hybrid-type 1 randomized trial to evaluate effectiveness and implementation of a mental health and life skills intervention to improve health outcomes for Tanzanian youth living with HIV.

Author

Mollel, Getrud J., Ketang'enyi, Eunice, Komba, Lilian, Mmbaga, Blandina T., Shayo, Aisa M., Boshe, Judith, Knettel, Brandon, Gallis, John A., Turner, Elizabeth L., O'Donnell, Karen, Baumgartner, Joy Noel, Ogbuoji, Osondu, and Dow, Dorothy E.

Abstract

Objective: Young people living with HIV (YPLWH) experience increased morbidity and mortality compared to all other age groups. Adolescence brings unique challenges related to sexual reproductive health, the elevated importance of peer groups, and often, emerging symptoms of emotional distress. Failure to address this unique life stage for YPLWH can lead to worse HIV and mental health outcomes. Herein lies the protocol for a hybrid-type-1 effectiveness-implementation trial designed to evaluate a mental health and life skills intervention that aims to address these needs for YPLWH in Tanzania. Methods: This is an individually randomized group-treatment trial designed to evaluate the effectiveness of Sauti ya Vijana (SYV: The Voice of Youth) toward improving viral suppression (HIV RNA <400 copies/mL) and mental health outcomes and to assess implementation including acceptability, feasibility, fidelity, and cost-effectiveness of the manualized intervention. The trial is being conducted across four geographically distinct regions of Tanzania. Peer group leaders (PGL) with lived HIV experience deliver the 10-session group-based intervention and two individual sessions during which participants describe their disclosure narrative (when they learned they live with HIV) and value-based goal setting. Caregiver or chosen supportive adults are encouraged to attend two specific group sessions with their youth. Participants are 10–24 years of age, prescribed antiretroviral therapy for at least 6 months, fully aware of their HIV status, able to commit to session attendance, and able to understand and meaningfully contribute to group sessions. Participant study visits occur at 5 time points for evaluation: baseline, 4-, 6-, 12-, and 18-months post baseline. A single booster session is conducted before the 12-month visit. Study visits evaluate mental health, adverse childhood events, interpersonal violence, resilience, stigma, HIV knowledge, substance use, sexual relationships, ART adherence, and HIV RNA. Implementation outcomes evaluate feasibility and acceptability through attendance, intervention session notes, focus discussion groups and qualitative interviews. Fidelity to the intervention is measured using fidelity checklists by a PGL observer at each group session. Cost effectiveness is calculated using an incremental cost-effectiveness ratio that utilizes a patient cost questionnaire and financial records of study costs. Significance: Few mental health interventions for YPLWH have demonstrated effectiveness. Results from this study will provide information about effectiveness and implementation of a peer-led intervention for delivering a mental health and life skills intervention in low-income settings. Trial identifier: This trial is registered at clinicaltrials.gov NCT05374109. [ABSTRACT FROM AUTHOR]

Published
2024
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