Browsing by Author "Baleeta, Keith"

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    Correlates of uptake of optimal doses of sulfadoxine‑pyrimethamine for prevention of malaria during pregnancy in East‑Central Uganda
    (Malaria Journal, 2020) Mbonye, K. Martin; Kirwana, B. Venantius; Ndugga, Patricia; Kikaire, Bernard; Baleeta, Keith; Kabagenyi, Allen; Asiimwe, Godfrey; Twesigye, Rogers; Kadengye T., Damazo; Dathan, Byonanebye M.
    In 2012, the World Health Organization recommended that pregnant women in malaria-endemic countries complete at least three (optimal) doses of intermittent preventive treatment (IPTp) using sulfadoxinepyrimethamine (SP) to prevent malaria and related adverse events during pregnancy. Uganda adopted this recommendation, but uptake remains low in East-Central and information to explain this low uptake remains scanty. This analysis determined correlates of uptake of optimal doses of IPTp-SP in East-Central Uganda. Methods: This was a secondary analysis of the 2016 Uganda Demographic Health Survey data on 579 women (15–49 years) who attended at least one antenatal care (ANC) visit and had a live birth within 2 years preceding the survey. Uptake of IPTp-SP was defined as optimal if a woman received at least three doses; partial if they received 1–2 doses or none if they received no dose. Multivariate analysis using multinomial logistic regression was used to determine correlates of IPTp-SP uptake. Results: Overall, 22.3% of women received optimal doses of IPTp-SP, 48.2% partial and 29.5% none. Attending ANC at a lower-level health centre relative to a hospital was associated with reduced likelihood of receiving optimal doses of IPTp-SP. Belonging to other religious faiths relative to Catholic, belonging to a household in the middle relative to poorest wealth index, and age 30 and above years relative to 25–29 years were associated with higher likelihood of receiving optimal doses of IPTp-SP. Conclusions: In East-Central Uganda, uptake of optimal doses of IPTp-SP is very low. Improving institutional delivery and household wealth, involving religious leaders in programmes to improve uptake of IPTp-SP, and strengthening IPTp-SP activities at lower level health centers may improve uptake of IPTp-SP in the East-Central Uganda.
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    Effect of ready-to-use supplementary food on mortality in severely immunocompromised HIV-infected individuals in Africa initiating antiretroviral therapy (REALITY): an open-label, parallel-group, randomised controlled trial
    (The lancet HIV, 2018) Mallewa, Jane; Szubert, Alexander J.; Mugyenyi, Peter; Chepkorir, Priscilla; Abongomera, George; Baleeta, Keith; Etyang, Anthony; Warambwa, Colin; Mudzingwa, Shepherd; Agutu, Clara; Nkomani, Sanele; Musiime, Victor; Lugemwa, Abbas; Bwakura-Dangarembizi, Mutsa; on behalf of the REALITY trial team
    In sub-Saharan Africa, severely immunocompromised HIV-infected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy (ART). We hypothesise that universally providing ready-to-use supplementary food (RUSF) would increase early weight gain, thereby reducing early mortality compared with current guidelines recommending ready-to-use therapeutic food (RUTF) for severely malnourished individuals only.We did a 2 × 2 × 2 factorial, open-label, parallel-group trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe. Eligible participants were ART-naive adults and children aged at least 5 years with confirmed HIV infection and a CD4 cell count of fewer than 100 cells per μL, who were initiating ART at the facilities. We randomly assigned participants (1:1) to initiate ART either with (RUSF) or without (no-RUSF) 12 weeks' of peanut-based RUSF containing 1000 kcal per day and micronutrients, given as two 92 g packets per day for adults and one packet (500 kcal per day) for children aged 5–12 years, regardless of nutritional status. In both groups, individuals received supplementation with RUTF only when severely malnourished (ie, body-mass index [BMI] <16–18 kg/m2 or BMI-for-age Z scores <–3 for children). We did the randomisation with computer-generated, sequentially numbered tables with different block sizes incorporated within an online database. Randomisation was stratified by centre, age, and two other factorial randomisations, to 12 week adjunctive raltegravir and enhanced anti-infection prophylaxis (reported elsewhere). Clinic visits were scheduled at weeks 2, 4, 8, 12, 18, 24, 36, and 48, and included nurse assessment of vital status and symptoms and dispensing of all medication including ART and RUSF. The primary outcome was mortality at week 24, analysed by intention to treat. Secondary outcomes included absolute changes in weight, BMI, and mid-upper-arm circumference (MUAC). Safety was analysed in all randomly assigned participants. Follow-up was 48 weeks. This trial is registered with ClinicalTrials.gov (NCT01825031) and the ISRCTN registry (43622374).Between June 18, 2013, and April 10, 2015, we randomly assigned 1805 participants to treatment: 897 to RUSF and 908 to no-RUSF. 56 (3%) were lost-to-follow-up. 96 (10·9%, 95% CI 9·0–13·1) participants allocated to RUSF and 92 (10·3%, 8·5–12·5) to no-RUSF died within 24 weeks (hazard ratio 1·05, 95% CI 0·79–1·40; log-rank p=0·75), with no evidence of interaction with the other randomisations (both p>0·7). Through 48 weeks, adults and adolescents aged 13 years and older in the RUSF group had significantly greater gains in weight, BMI, and MUAC than the no-RUSF group (p=0·004, 0·004, and 0·03, respectively). The most common type of serious adverse event was specific infections, occurring in 90 (10%) of 897 participants assigned RUSF and 87 (10%) of 908 assigned no-RUSF. By week 48, 205 participants had serious adverse events in both groups (p=0·81), and 181 had grade 4 adverse events in the RUSF group compared with 172 in the non-RUSF group (p=0·45).In severely immunocompromised HIV-infected individuals, providing RUSF universally at ART initiation, compared with providing RUTF to severely malnourished individuals only, improved short-term weight gain but not mortality. A change in policy to provide nutritional supplementation to all severely immunocompromised HIV-infected individuals starting ART is therefore not warranted at present.
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    Effect of ready-to-use supplementary food on mortality in severely immunocompromised HIV-infected individuals in Africa initiating antiretroviral therapy (REALITY): an open-label, parallel-group, randomised controlled trial
    (Elsevier Ltd., 2018) Mallewa, Jane.; Berkley, James A; Szubert, Alexander J.; Mugyenyi, Peter; Chidziva, Ennie; Thomason, Margaret J; Walker, Sarah A.; Chepkorir, Priscilla; Abongomera, George; Baleeta, Keith; Etyang, Anthony; Warambwa, Colin; Melly, Betty; Gibb, Diana M; Prendergast, Andrew J; Mudzingwa, Shepherd; Kelly, Christine; Agutu, Clara; Wilkes, Helen; Nkomani, Sanele; Musiime, Victor; Lugemwa, Abbas; Pett, Sarah L; Bwakura-Dangarembizi, Mutsa
    In sub-Saharan Africa, severely immunocompromised HIV-infected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy (ART). We hypothesise that universally providing readyto- use supplementary food (RUSF) would increase early weight gain, thereby reducing early mortality compared with current guidelines recommending ready-to-use therapeutic food (RUTF) for severely malnourished individuals only. Methods We did a 2 × 2 × 2 factorial, open-label, parallel-group trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe. Eligible participants were ART-naive adults and children aged at least 5 years with confirmed HIV infection and a CD4 cell count of fewer than 100 cells per μL, who were initiating ART at the facilities. We randomly assigned participants (1:1) to initiate ART either with (RUSF) or without (no-RUSF) 12 weeks’ of peanut-based RUSF containing 1000 kcal per day and micronutrients, given as two 92 g packets per day for adults and one packet (500 kcal per day) for children aged 5–12 years, regardless of nutritional status. In both groups, individuals received supplementation with RUTF only when severely malnourished (ie, body-mass index [BMI] <16–18 kg/m² or BMI-for-age Z scores <–3 for children). We did the randomisation with computer-generated, sequentially numbered tables with different block sizes incorporated within an online database. Randomisation was stratified by centre, age, and two other factorial randomisations, to 12 week adjunctive raltegravir and enhanced anti-infection prophylaxis (reported elsewhere). Clinic visits were scheduled at weeks 2, 4, 8, 12, 18, 24, 36, and 48, and included nurse assessment of vital status and symptoms and dispensing of all medication including ART and RUSF. The primary outcome was mortality at week 24, analysed by intention to treat. Secondary outcomes included absolute changes in weight, BMI, and mid-upper-arm circumference (MUAC). Safety was analysed in all randomly assigned participants. Follow-up was 48 weeks. This trial is registered with ClinicalTrials.gov (NCT01825031) and the ISRCTN registry (43622374). Findings Between June 18, 2013, and April 10, 2015, we randomly assigned 1805 participants to treatment: 897 to RUSF and 908 to no-RUSF. 56 (3%) were lost-to-follow-up. 96 (10·9%, 95% CI 9·0–13·1) participants allocated to RUSF and 92 (10·3%, 8·5–12·5) to no-RUSF died within 24 weeks (hazard ratio 1·05, 95% CI 0·79–1·40; log-rank p=0·75), with no evidence of interaction with the other randomisations (both p>0·7). Through 48 weeks, adults and adolescents aged 13 years and older in the RUSF group had significantly greater gains in weight, BMI, and MUAC than the no-RUSF group (p=0·004, 0·004, and 0·03, respectively). The most common type of serious adverse event was specific infections, occurring in 90 (10%) of 897 participants assigned RUSF and 87 (10%) of 908 assigned no-RUSF. By week 48, 205 participants had serious adverse events in both groups (p=0·81), and 181 had grade 4 adverse events in the RUSF group compared with 172 in the non-RUSF group (p=0·45). Interpretation In severely immunocompromised HIV-infected individuals, providing RUSF universally at ART initiation, compared with providing RUTF to severely malnourished individuals only, improved short-term weight gain but not mortality. A change in policy to provide nutritional supplementation to all severely immunocompromised HIV-infected individuals starting ART is therefore not warranted at present. Funding Joint Global Health Trials Scheme (UK Medical Research Council, UK Department for International Development, and Wellcome Trust).