4 results on '"Ngorima, N"'
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2. Routine versus clinically driven laboratory monitoring of HIV antiretroviral therapy in Africa (DART): a randomised non-inferiority trial
- Author
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DART Trial Team, Mugyenyi, P, Walker, AS, Hakim, J, Munderi, P, Gibb, DM, Kityo, C, Reid, A, Grosskurth, H, Darbyshire, JH, Ssali, F, Bray, D, Katabira, E, Babiker, AG, Gilks, CF, Kabuye, G, Nsibambi, D, Kasirye, R, Zalwango, E, Nakazibwe, M, Kikaire, B, Nassuna, G, Massa, R, Fadhiru, K, Namyalo, M, Zalwango, A, Generous, L, Khauka, P, Rutikarayo, N, Nakahima, W, Mugisha, A, Todd, J, Levin, J, Muyingo, S, Ruberantwari, A, Kaleebu, P, Yirrell, D, Ndembi, N, Lyagoba, F, Hughes, P, Aber, M, Lara, A Medina, Foster, S, Amurwon, J, Wakholi, B Nyanzi, Whitworth, J, Wangati, K, Amuron, B, Kajungu, D, Nakiyingi, J, Omony, W, Tumukunde, D, Otim, T, Kabanda, J, Musana, H, Akao, J, Kyomugisha, H, Byamukama, A, Sabiiti, J, Komugyena, J, Wavamunno, P, Mukiibi, S, Drasiku, A, Byaruhanga, R, Labeja, O, Katundu, P, Tugume, S, Awio, P, Namazzi, A, Bakeinyaga, GT, Katabira, H, Abaine, D, Tukamushaba, J, Anywar, W, Ojiambo, W, Angweng, E, Murungi, S, Haguma, W, Atwiine, S, Kigozi, J, Namale, L, Mukose, A, Mulindwa, G, Atwiine, D, Muhwezi, A, Nimwesiga, E, Barungi, G, Takubwa, J, Mwebesa, D, Kagina, G, Mulindwa, M, Ahimbisibwe, F, Mwesigwa, P, Akuma, S, Zawedde, C, Nyiraguhirwa, D, Tumusiime, C, Bagaya, L, Namara, W, Karungi, J, Kankunda, R, Enzama, R, Latif, A, Robertson, V, Chidziva, E, Bulaya-Tembo, R, Musoro, G, Taziwa, F, Chimbetete, C, Chakonza, L, Mawora, A, Muvirimi, C, Tinago, G, Svovanapasis, P, Simango, M, Chirema, O, Machingura, J, Mutsai, S, Phiri, M, Bafana, T, Chirara, M, Muchabaiwa, L, Muzambi, M, Mutowo, J, Chivhunga, T, Chigwedere, E, Pascoe, M, Warambwa, C, Zengeza, E, Mapinge, F, Makota, S, Jamu, A, Ngorima, N, Chirairo, H, Chitsungo, S, Chimanzi, J, Maweni, C, Warara, R, Matongo, M, Mudzingwa, S, Jangano, M, Moyo, K, Vere, L, Mdege, N, Machingura, I, Ronald, A, Kambungu, A, Lutwama, F, Mambule, I, Nanfuka, A, Walusimbi, J, Nabankema, E, Nalumenya, R, Namuli, T, Kulume, R, Namata, I, Nyachwo, L, Florence, A, Kusiima, A, Lubwama, E, Nairuba, R, Oketta, F, Buluma, E, Waita, R, Ojiambo, H, Sadik, F, Wanyama, J, Nabongo, P, Oyugi, J, Sematala, F, Muganzi, A, Twijukye, C, Byakwaga, H, Ochai, R, Muhweezi, D, Coutinho, A, Etukoit, B, Gilks, C, Boocock, K, Puddephatt, C, Grundy, C, Bohannon, J, Winogron, D, Burke, A, Babiker, A, Wilkes, H, Rauchenberger, M, Sheehan, S, Spencer-Drake, C, Taylor, K, Spyer, M, Ferrier, A, Naidoo, B, Dunn, D, Goodall, R, Peto, L, Nanfuka, R, Mufuka-Kapuya, C, Pillay, D, McCormick, A, Weller, I, Bahendeka, S, Bassett, M, Wapakhabulo, A Chogo, Gazzard, B, Mapuchere, C, Mugurungi, O, Burke, C, Jones, S, Newland, C, Pearce, G, Rahim, S, Rooney, J, Smith, M, Snowden, W, Steens, J-M, Breckenridge, A, McLaren, A, Hill, C, Matenga, J, Pozniak, A, Serwadda, D, Peto, T, Palfreeman, A, and Borok, M
- Subjects
Male ,Neutrophils ,HIV Infections ,law.invention ,Hemoglobins ,Randomized controlled trial ,law ,Medicine ,Urea ,HIV-Associated Lipodystrophy Syndrome ,Hazard ratio ,Lamivudine ,Anemia ,General Medicine ,Middle Aged ,Viral Load ,Anti-Retroviral Agents ,Creatinine ,Disease Progression ,RNA, Viral ,Female ,Drug Monitoring ,Zidovudine ,medicine.drug ,Glomerular Filtration Rate ,Adult ,medicine.medical_specialty ,Neutropenia ,Adolescent ,Organophosphonates ,Acquired immunodeficiency syndrome (AIDS) ,Internal medicine ,Fast track — Articles ,Humans ,Nevirapine ,Adverse effect ,Tenofovir ,Aged ,Intention-to-treat analysis ,business.industry ,Adenine ,medicine.disease ,Dideoxynucleosides ,CD4 Lymphocyte Count ,Clinical trial ,Clinical research ,Immunology ,Africa ,HIV-1 ,business - Abstract
BACKGROUND: HIV antiretroviral therapy (ART) is often managed without routine laboratory monitoring in Africa; however, the effect of this approach is unknown. This trial investigated whether routine toxicity and efficacy monitoring of HIV-infected patients receiving ART had an important long-term effect on clinical outcomes in Africa. METHODS: In this open, non-inferiority trial in three centres in Uganda and one in Zimbabwe, 3321 symptomatic, ART-naive, HIV-infected adults with CD4 counts less than 200 cells per microL starting ART were randomly assigned to laboratory and clinical monitoring (LCM; n=1659) or clinically driven monitoring (CDM; n=1662) by a computer-generated list. Haematology, biochemistry, and CD4-cell counts were done every 12 weeks. In the LCM group, results were available to clinicians; in the CDM group, results (apart from CD4-cell count) could be requested if clinically indicated and grade 4 toxicities were available. Participants switched to second-line ART after new or recurrent WHO stage 4 events in both groups, or CD4 count less than 100 cells per microL (LCM only). Co-primary endpoints were new WHO stage 4 HIV events or death, and serious adverse events. Non-inferiority was defined as the upper 95% confidence limit for the hazard ratio (HR) for new WHO stage 4 events or death being no greater than 1.18. Analyses were by intention to treat. This study is registered, number ISRCTN13968779. FINDINGS: Two participants assigned to CDM and three to LCM were excluded from analyses. 5-year survival was 87% (95% CI 85-88) in the CDM group and 90% (88-91) in the LCM group, and 122 (7%) and 112 (7%) participants, respectively, were lost to follow-up over median 4.9 years' follow-up. 459 (28%) participants receiving CDM versus 356 (21%) LCM had a new WHO stage 4 event or died (6.94 [95% CI 6.33-7.60] vs 5.24 [4.72-5.81] per 100 person-years; absolute difference 1.70 per 100 person-years [0.87-2.54]; HR 1.31 [1.14-1.51]; p=0.0001). Differences in disease progression occurred from the third year on ART, whereas higher rates of switch to second-line treatment occurred in LCM from the second year. 283 (17%) participants receiving CDM versus 260 (16%) LCM had a new serious adverse event (HR 1.12 [0.94-1.32]; p=0.19), with anaemia the most common (76 vs 61 cases). INTERPRETATION: ART can be delivered safely without routine laboratory monitoring for toxic effects, but differences in disease progression suggest a role for monitoring of CD4-cell count from the second year of ART to guide the switch to second-line treatment. FUNDING: UK Medical Research Council, the UK Department for International Development, the Rockefeller Foundation, GlaxoSmithKline, Gilead Sciences, Boehringer-Ingelheim, and Abbott Laboratories.
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3. Impact of second-line antiretroviral regimens on lipid profiles in an African setting: The DART trial sub-study
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Gomo, Z. A. R., Hakim, J. G., Walker, S. A., Tinago, W., Mandozana, G., Kityo, C., Munderi, P., Katabira, E., Reid, A., Gibb, D. M., Gilks, C. F., Grosskurth, H., Kabuye, G., Nsibambi, D., Kasirye, R., Zalwango, E., Nakazibwe, M., Kikaire, B., Nassuna, G., Massa, R., Fadhiru, K., Namyalo, M., Zalwango, A., Generous, L., Khauka, P., Rutikarayo, N., Nakahima, W., Mugisha, A., Todd, J., Levin, J., Muyingo, S., Ruberantwari, A., Kaleebu, P., Yirrell, D., Ndembi, N., Lyagoba, F., Hughes, P., Aber, M., Lara, A. M., Medina, A., Foster, S., Amurwon, J., Wakholi, B. N., Nyanzi, B., Wangati, K., Amuron, B., Kajungu, D., Nakiyingi, J., Omony, W., Mugyenyi, P., Ssali, F., Tumukunde, D., Otim, T., Kabanda, J., Musana, H., Akao, J., Kyomugisha, H., Byamukama, A., Sabiiti, J., Komugyena, J., Wavamunno, P., Mukiibi, S., Drasiku, A., Byaruhanga, R., Labeja, O., Katundu, P., Tugume, S., Awio, P., Namazzi, A., Bakeinyaga, G. T., Abaine, D., Tukamushaba, J., Anywar, W., Ojiambo, W., Angweng, E., Murungi, S., Haguma, W., Atwiine, S., Kigozi, J., Namale, L., Mukose, A., Mulindwa, G., Atwiine, D., Muhwezi, A., Nimwesiga, E., Barungi, G., Takubwa, J., Mwebesa, D., Kagina, G., Mulindwa, M., Ahimbisibwe, F., Mwesigwa, P., Akuma, S., Zawedde, C., Nyiraguhirwa, D., Tumusiime, C., Bagaya, L., Namara, W., Karungi, J., Kankunda, R., Enzama, R., Latif, A., Robertson, V., Chidziva, E., Bulaya-Tembo, R., Musoro, G., Taziwa, F., Chimbetete, C., Chakonza, L., Mawora, A., Muvirimi, C., Svovanapasis, P., Simango, M., Chirema, O., Machingura, J., Mutsai, S., Phiri, M., Bafana, T., Chirara, M., Muchabaiwa, L., Muzambi, M., Chigwedere, E., Pascoe, M., Warambwa, C., Zengeza, E., Mapinge, F., Makota, S., Jamu, A., Ngorima, N., Chirairo, H., Chitsungo, S., Chimanzi, J., Maweni, C., Warara, R., Matongo, M., Mudzingwa, S., Jangano, M., Moyo, K., Vere, L., Machingura, I., Ronald, A., Kambungu, A., Lutwama, F., Mambule, I., Nanfuka, A., Walusimbi, J., Nabankema, E., Nalumenya, R., Namuli, T., Kulume, R., Namata, I., Nyachwo, L., Florence, A., Kusiima, A., Lubwama, E., Nairuba, R., Oketta, F., Buluma, E., Waita, R., Ojiambo, H., Sadik, F., Wanyama, J., Nabongo, P., Oyugi, J., Sematala, F., Muganzi, A., Twijukye, C., Byakwaga, H., Ochai, R., Muhweezi, D., Coutinho, A., Etukoit, B., Boocock, K., Puddephatt, C., Grundy, C., Bohannon, J., Winogron, D., Darbyshire, J., Burke, A., Bray, D., Babiker, A., Wilkes, H., Rauchenberger, M., Sheehan, S., Spencer-Drake, C., Taylor, K., Spyer, M., Ferrier, A., Naidoo, B., Dunn, D., Ruth Goodall, Nanfuka, R., Mufuka-Kapuya, C., Pillay, D., Goodall, R., Kapaata, A., Katuramur, M., Magala, R., Magambo, B., Mataruka, K., Mccormick, A., Mugarura, L., Musunga, T., Nabankkema, M., Nkalubo, J., Nkurunziza, P., Parry, C., Weller, I., Bahendeka, S., Bassett, M., Chogo Wapakhabulo, A., Gazzard, B., Mapuchere, C., Mugurungi, O., Burke, C., Distel, M., Jones, S., Loeliger, E., Naidoo, P., Newland, C., Pearce, G., Rahim, S., Rooney, J., Smith, M., Snowden, W., Steens, J. -M, Breckenridge, A., Mclaren, A., Hill, C., Matenga, J., Pozniak, A., Serwadda, D., Peto, T., Palfreeman, A., and Borok, M.
4. Economic evaluation of a cluster randomized, non-inferiority trial of differentiated service delivery models of HIV treatment in Zimbabwe.
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Benade M, Nichols BE, Fatti G, Kuchukhidze S, Takarinda K, Mabhena-Ngorima N, Grimwood A, and Rosen S
- Abstract
About 85% of Zimbabwe's >1.4 million people living with HIV are on antiretroviral treatment (ART). Further expansion of its treatment program will require more efficient use of existing resources. Two promising strategies for reducing resource utilization per patient are multi-month medication dispensing and community-based service delivery. We evaluated the costs to providers and patients of community-based, multi-month ART delivery models in Zimbabwe. We used resource and outcome data from a cluster-randomized non-inferiority trial of three differentiated service delivery (DSD) models targeted to patients stable on ART: 3-month facility-based care (3MF), community ART refill groups (CAGs) with 3-month dispensing (3MC), and CAGs with 6-month dispensing (6MC). Using local unit costs, we estimated the annual cost in 2020 USD of providing HIV treatment per patient from the provider and patient perspectives. In the trial, retention at 12 months was 93.0% in the 3MF, 94.8% in the 3MC, and 95.5% in the 6MC arms. The total average annual cost of HIV treatment per patient was $187 (standard deviation $39), $178 ($30), and $167 ($39) in each of the three arms, respectively. The annual cost/patient was dominated by ART medications (79% in 3MF, 87% in 3MC; 92% in 6MC), followed by facility visits (12%, 5%, 5%, respectively) and viral load (8%, 8%, 2%, respectively). When costs were stratified by district, DSD models cost slightly less, with 6MC the least expensive in all districts. Savings were driven by differences in the number of facility visits made/year, as expected, and low uptake of annual viral load tests in the 6-month arm. The total annual cost to patients to obtain HIV care was $10.03 ($2) in the 3MF arm, $5.12 ($0.41) in the 3MC arm, and $4.40 ($0.39) in the 6MF arm. For stable ART patients in Zimbabwe, 3- and 6-month community-based multi-month dispensing models cost less for both providers and patients than 3-month facility-based care and had non-inferior outcomes., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Benade et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2023
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