Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: study protocol for a randomized controlled trial

Vitamin A supplementation of 6-59 month old children is currently recommended by the World Health Organization based on evidence that it reduces mortality. There has been considerable interest in determining the benefits of neonatal vitamin A supplementation, but the results of existing trials are conflicting. A technical consultation convened by WHO pointed to the need for larger scale studies in Asia and Africa to inform global policy on the use of neonatal vitamin A supplementation. Three trials were therefore initiated in Ghana, India and Tanzania to determine if vitamin A supplementation (50,000 IU) given to neonates once orally on the day of birth or within the next two days will reduce mortality in the period from supplementation to 6 months of age compared to placebo. The trials are individually randomized, double masked, and placebo controlled. The required sample size is 40,200 in India and 32,000 each in Ghana and Tanzania. The study participants are neonates who fulfil age eligibility, whose families are likely to stay in the study area for the next 6 months, who are able to feed orally, and whose parent(s) provide informed written consent to participate in the study. Neonates randomized to the intervention group receive 50,000 IU vitamin A and the ones randomized to the control group receive placebo at the time of enrollment. Mortality and morbidity information are collected through periodic home visits by a study worker during infancy. The primary outcome of the study is mortality from supplementation to 6 months of age. The secondary outcome of the study is mortality from supplementation to 12 months of age. The three studies will be analysed independent of each other. Subgroup analysis will be carried out to determine the effect by birth weight, sex, and timing of DTP vaccine, socioeconomic groups and maternal large-dose vitamin A supplementation. The three ongoing studies are the largest studies evaluating the efficacy of vitamin A supplementation to neonates. Policy formulation will be based on the results of efficacy of the intervention from the ongoing randomized controlled trials combined with results of previous studies

Management of HIV and AIDS at lower primary health care facility in Chalinze, eastern Tanzania

Implementation of Antiretroviral Therapy (ART) services at health centres in Tanzania were delayed due to several reasons including shortage of qualified staff, inadequate infrastructure and logistics problems. However, patients from peripheral areas experienced difficulties in accessing ART services due to long distances from clinics. National AIDS Control Programme (NACP) and Non-Governmental Organizations (NGOs) embarked on ART services scale-up programme aimed at improved ART availability and accessibility. Through this programme ART services were established at health centres and selected dispensaries. However, no previous documented experiences existed at country level to guide provision of services. Therefore, this study was designed to gather experiences and share lessons learnt with other health care providers and programme implementing partners. This was a descriptive cross-sectional study involved patients enrolled to ART services between May 2007 and April 2009. Data collection involved observation of health providers’ performance and retrospective ART and care patients’ registers review. During the study period, 611 care and 284 ART patients were attended.Majority of patients (85.1%; 762/895) were adults aged 25-45 years. In total 61.5% (550/895) of the patients had CD4+T lymphocytes ≤350/μl the cut-off point for initiating ART. The frequency of symptoms was noted to significantly decrease with increasing CD4 counts (P>0.001). Numbness, parotid enlargement and genital discharge were not related to patient level of CD4+T-lymphocytes counts. Papular pruritic eruptions 98/282 (34.8%), tuberculosis 86/282 (30.5%) and oesophageal candidiasis 37/282 (13.1) were the most diagnosed AIDS defining illnesses. Sixteen patients on care died and 30 were lost to follow up. Overall the clinical management was poorly performed. ART services can successively be provided at health centre level and encourages HIV-infected persons to seek care. However, clinicians need regular clinical mentorship and supportive supervision

HIV and parasitic co-infections among patients seeking care at health facilities in Tanzania

Untreated tropical parasitic co-infections appear to speed the progression of HIV-1 disease. However, to date, there have been few studies conducted in resource limited settings to ascertain the interaction of parasitic co-infection where HIV/AIDS management largely depends on CD4+ T lymphocyte cells counts and WHO clinical staging. This study aimed to determine the prevalence of parasites, their association with CD4+ T lymphocyte cells changes and clinical manifestation of HIV-infection in patients attending HIV/AIDS management clinics in Tanzania. Adult HIV-infected patients registering for the first time at HIV/AIDS management clinics were recruited; with physical examination and laboratory tests performed at baseline and after 6 months. Patients were assigned a clinical stage and screened for helminths and Plasmodium sp. co-infection, CD4+ T lymphocyte cells, haemoglobin and HIV-1 p24 antigen. Of the 421 HIV-1 infected patients studied, 198 (47.0%) were co-infected with one or more parasites. Of those studied, 93/421(22.1%) had helminth only co-infection, and 50/421(12.9%) had Plasmodium sp only co-infection. Mixed Plasmodium sp and helminth co-infection was diagnosed in 55/421(13.0%) patients. Helminths frequently diagnosed included: hookworm 65/421(15.4%), Schistosomiasis 49/421(11.6%), Strongyloides stercoralis 57/421(13.5%), and Ascaris lumbricoides 54/421(12.8%). No statistical association was found between CD4+ T lymphocyte cells <200/µl, or WHO clinical stage III/IV with parasite co-infections (AOR 1.2, 95%CI 0.8-1.8). Anaemia was common in parasite co-infected patients (32.8% vs 18.8%). Parasite co-infection was associated with risk of anaemia (AOR 2.1, 95%CI 1.3-3.2). In multivariable logistic regression analysis, baseline CD4+ T lymphocyte cells <200/µl was significantly associated with CD4+ T lymphocyte cells <200/µl (AOR 2.4, 95%CI 1.3-4.7) at six months. HIV-1 P24 antigen mean concentration was higher in parasite co-infected patients (ranges 47.6 to 56.9) as compared to patients without parasite co-infection (5.5). We have looked at one set of parasites and found high prevalence of malaria and helminth co-infection in HIV-infected individuals. Given the available reports on health impacts of helminth co-infection in HIV/AIDS patients and the anecdotal reports of helminth’s health effects in HIV-uninfected persons, helminths and other prevalent parasites should not be ignored in HIV/AIDS programs. Based on local helminth epidemiology and HIV-infected cohort specific helminths co-infection prevalence data, mass treatment of soil transmitted helminths can be incorporated into HIV/AIDS management programmes