Factors associated with major structural birth defects among newborns delivered at Muhimbili National Hospital and Municipal Hospitals in Dar Es Salaam, Tanzania 2011 – 2012

Introduction: ninety-four percent of all birth defects and 95% of deaths due to the birth defects occur in low and middle income countries,Tanzania among them. In Tanzania there are currently limited birth defects prevention strategies in place due to limited information on factorsassociated with the occurrence of birth defects.Methods: we conducted a case control study that included newborns born from October, 2011through February, 2012 at 4 participating hospitals. A case was defined as any newborn of a Dar es salaam resident with a neural tube defect,orofacial clefts, limb reduction defects or musculo-skeletal defects (SBD) born during the study period. A control was defined as the next threenewborns (delivered after the case) without birth defects. Univariate, bivariate and multivariate analysis were done using Epi Info version 3.5.1.Results: a total of 400 newborns participated in the study, 100 cases and 300 controls. Factors associated with higher odds of a SBD includedmaternal fever (adjusted odds ratio (AOR) = 1.99; 95% confidence interval (CI): 1.14-3.52), maternal hypertension (AOR=3.99; 95% CI: 1.67-9.54), and low birth weight (AOR=3.48; 95% CI: 1.77-6.85). Antimalarial use during pregnancy was protective (AOR=0.48; 95% CI: 0.28-0.84).Folic acid supplementation was protective only in bivariate analysis (OR=0.56; 95% CI: 0.32-0.96). Conclusion: maternal fever, hypertension, and low birth weight are associated with higher odds of SBD. Antimalarial use during pregnancy was associated with lower odds of SBD. Early screening of pregnant mothers for hypertension and other causes of low birth weight may reduce SBD in Dar Es Salaam

Evaluation of HIV antigen /antibody combination ELISAs for diagnosis of HIV infection in Dar Es Salaam, Tanzania

Introduction: the aim of this study was to evaluate the performance of Enzygnost HIV Integral II antigen/antibody combination ELISAs in orderto formulate HIV ELISA testing algorithms for the Ministry of Health and Social Welfare, Tanzania. Methods: this was a laboratory-based evaluation of Enzygnost HIV Integral II Antibody/ Antigen, Murex HIV antigen/antibody and Vironostika HIV Uniform II antigen/antibody conducted between October 2011 and May 2012. Results: a total of 600 blood samples were included in the evaluation. A total of 209/596 (35.1%) serum samples were confirmed HIV positive. Of these, the prevalence of HIV infection was 2.3% (3/130), 2.3% (3/127), 2.2% (3/139) and 100% (200/200) for VCT clients, ANC attendees, blood donors and CTC patients, respectively. Three hundred and eighty seven (64.9%) were HIV negative samples. Sensitivity was 100% (95% CI; 98.3-100%) for all the three HIV ELISAs. The specificity for the Enzygnost HIV Integral II and Murex was 100% (95% CI; 99.1-100%). The final specificity at repeat testing was 99.5% (95% CI; 98.2-99.9%) for  Vironostika. Enzygnost HIV Integral II detected HIV infection seven days since first bleed.Conclusion: initial testing using either Vironostika or Murex HIV   antigen/antibody combination ELISA followed by testing of reactive samples on the Enzygnost HIV Integral II gave a sensitivity and specificity of 100% with reduced window period. Combination of two HIV antigen/antibody  combination ELISAs can be used as an alternative confirmatory testing  strategy for screening of donated blood at the National and Zonal blood transfusion centres and in lab diagnosis of HIV infection

Adherence to Antiretroviral Therapy among HIV Infected Children Measured by Caretaker Report, Medication Return, and Drug Level in Dar Es Salaam, Tanzania.

Adherence to antiretroviral drugs in the treatment of paediatric HIV infection is complicated because of many factors including stigma and drug intake logistics. It is therefore important to identify children with non-adherence in order to intervene before they become at risk of developing treatment failure or drug resistance. The aim of this study was to determine the level of adherence to antiretroviral therapy (ART), measured by caretaker report, medication return and nevirapine plasma concentration. In addition, the association between level of adherence and patient's immune status was compared across the three methods of measuring adherence. This was a descriptive cross-sectional study involving HIV infected children aged 2-14 years, on nevirapine- based antiretroviral treatment for at least six months, attending care and treatment clinic in three municipal hospitals in Dar- Es- Salaam City. Eligible patients and their accompanying caretakers were consecutively enrolled after obtaining written informed consent. Structured questionnaires were administered to caretakers to assess patient's adherence by caretaker report and medication return whereas a single blood sample for CD4 cell count/percent and determination of nevirapine plasma concentration was taken from patients on the day of assessment. A total of 300 patients and accompanying caretakers were enrolled and the mean patient age (SD) was 8 (3) years. Caretakers' report and medication return showed good adherence (98% and 97%) respectively. However, the level of adherence assessed by nevirapine plasma concentration (85%) was significantly lower than caretaker report and medication return (p < 0.001). The agreement between nevirapine plasma concentration and medication return and between nevirapine plasma concentration and caretaker report was weak (k = 0. 131) (k = 0. 09) respectively. Nevirapine plasma concentration below 3 μg/ml was associated with immunosuppression (p = 0. 021) whereas medication return (>5% of prescribed doses) and caretaker reported missing more than one dose within 72 hours prior to interview were not associated with immunosuppression (p = 0. 474), (p = 0. 569) respectively. Lower adherence level observed using nevirapine plasma concentration and its association with immunological response supports the validity of the method and indicates that adherence data obtained from caretaker report and medication return may overestimate the true adherence in paediatric antiretroviral therapy

Ethical issues in intervention studies on the prevention and management of diabetes and hypertension in sub-Saharan Africa

Conducting intervention studies in Africa, where medicines supply for chronic conditions is inequitable and patchy, raises major ethical issues. Here we discuss what should the ethical approach be for a research programme in terms of provision of a steady and sustainable supply of medicines for patients with diabetes and hypertension

Patient and health provider costs of integrated HIV, diabetes and hypertension ambulatory health services in low-income settings — an empirical socio-economic cohort study in Tanzania and Uganda

Background: Integration of health services might be an efficient strategy for managing multiple chronic conditions in sub-Saharan Africa, considering the scope of treatments and synergies in service delivery. Proven to promote compliance, integration may lead to increased economies-of-scale. However, evidence on the socio-economic consequences of integration for providers and patients is lacking. We assessed the clinical resource use, staff time, relative service efficiency and overall societal costs associated with integrating HIV, diabetes and hypertension services in single one-stop clinics where persons with one or more of these conditions were managed. Methods: 2273 participants living with HIV infection, diabetes, or hypertension or combinations of these conditions were enrolled in 10 primary health facilities in Tanzania and Uganda and followed-up for up to 12 months. We collected data on resources used from all participants and on out-of-pocket costs in a sub-sample of 1531 participants, while a facility-level costing study was conducted at each facility. Health worker time per participant was assessed in a time-motion morbidity-stratified study among 228 participants. The mean health service cost per month and out-of-pocket costs per participant visit were calculated in 2020 US$prices. Nested bootstrapping from these samples accounted for uncertainties. A data envelopment approach was used to benchmark the efficiency of the integrated services. Last, we estimated the budgetary consequences of integration, based on prevalence-based projections until 2025, for both country populations. Results: Their average retention after 1 year service follow-up was 1911/2273 (84.1$39.11 (95% CI 33.99, 44.33), $32.18 (95$22.65 (95% CI 21.86, 23.43) for the combinations of HIV and diabetes and of HIV and hypertension, diabetes and hypertension, respectively. These costs were 34.4% (95% CI 17.9%, 41.9%) lower as compared to managing any two conditions separately in two different participants. The cost of managing an individual with all three conditions was 48.8% (95% CI 42.1%, 55.3%) lower as compared to managing these conditions separately. Out-of-pocket healthcare expenditure per participant per visit was $7.33 (95% CI 3.70, 15.86). This constituted 23.4% (95% CI 9.9, 54.3) of the total monthly service expenditure per patient and 11.7% (95% CI 7.3, 22.1) of their individual total household income. The integrated clinics’ mean efficiency benchmark score was 0.86 (range 0.30–1.00) suggesting undercapacity that could serve more participants without compromising quality of care. The estimated budgetary consequences of managing multi-morbidity in these types of integrated clinics is likely to increase by 21.5% (range 19.2–23.4%) in the next 5 years, including substantial savings of 21.6% on the provision of integrated care for vulnerable patients with multi-morbidities. Conclusion: Integration of HIV services with diabetes and hypertension control reduces both health service and household costs, substantially. It is likely an efficient and equitable way to address the increasing burden of financially vulnerable households among Africa’s ageing populations. Additional economic evidence is needed from longer-term larger-scale implementation studies to compare extended integrated care packages directly simultaneously with evidence on sustained clinical outcomes

Integrating health services for HIV infection, diabetes and hypertension in sub-Saharan Africa: a cohort study

Background HIV, diabetes and hypertension have a high disease burden in sub-Saharan Africa. Healthcare is organised in separate clinics, which may be inefficient. In a cohort study, we evaluated integrated management of these conditions from a single chronic care clinic.ObjectivesTo determined the feasibility and acceptability of integrated management of chronic conditions in terms of retention in care and clinical indicators. Design and setting Prospective cohort study comprising patients attending 10 health facilities offering primary care in Dar es Salaam and Kampala. Intervention Clinics within health facilities were set up to provide integrated care. Patients with either HIV, diabetes or hypertension had the same waiting areas, the same pharmacy, were seen by the same clinical staff, had similar provision of adherence counselling and tracking if they failed to attend appointments. Primary outcome measures Retention in care, plasma viral load. Findings Between 5 August 2018 and 21 May 2019, 2640 patients were screened of whom 2273 (86%) were enrolled into integrated care (832 with HIV infection, 313 with diabetes, 546 with hypertension and 582 with multiple conditions). They were followed up to 30 January 2020. Overall, 1615 (71.1%)/2273 were female and 1689 (74.5%)/2266 had been in care for 6 months or more. The proportions of people retained in care were 686/832 (82.5%, 95% CI: 79.9% to 85.1%) among those with HIV infection, 266/313 (85.0%, 95% CI: 81.1% to 89.0%) among those with diabetes, 430/546 (78.8%, 95% CI: 75.4% to 82.3%) among those with hypertension and 529/582 (90.9%, 95% CI: 88.6 to 93.3) among those with multimorbidity. Among those with HIV infection, the proportion with plasma viral load <100 copies/mL was 423(88.5%)/478. Conclusion Integrated management of chronic diseases is a feasible strategy for the control of HIV, diabetes and hypertension in Africa and needs evaluation in a comparative study

Integrating HIV, Diabetes, and Hypertension services in Africa: study protocol for a cluster randomized trial in Tanzania and Uganda.

Introduction: HIV programmes in sub-Saharan Africa are well-funded but programmes for diabetes and hypertension are weak with only a small proportion of patients in regular care. Health care provision is organised from stand-alone clinics. In this cluster-randomised trial, we are evaluating a concept of integrated care for people with HIV-infection, diabetes or hypertension from a single point of care. Methods and Analysis: 32 primary care health facilities in Dar es Salaam and Kampala regions were randomised to either integrated or standard vertical care. In the integrated care arm, services are organised from a single clinic where patients with either HIV-infection, diabetes, or hypertension are managed by the same clinical and counselling teams. They use the same pharmacy and laboratory and have the same style of patient records. Standard care involves separate pathways, i.e. separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has 2 primary endpoints: retention in care of people with hypertension or diabetes and plasma viral load suppression. Recruitment is expected to take 6 months and follow-up is for 12 months. With 100 participants enrolled in each facility with diabetes or hypertension, the trial will provide 90% power to detect an absolute difference in retention of 15% between the study arms (at the 5% two-sided significance level). If 100 participants with HIV-infection are also enrolled in each facility, we will have 90% power to show non-inferiority in virological suppression to a delta=10% margin (i.e. that the upper limit of the one-sided 95% confidence interval of the difference between the two arms will not exceed 10%). To allow for loss to follow-up, the trial will enrol over 220 persons per facility. This is the only trial of its kind evaluating the concept of a single integrated clinic for chronic conditions in Africa Ethics and Dissemination: The protocol has been approved by ethics committee of The AIDS Support Organisation, National Institute of Medical Research and the Liverpool School of Tropical Medicine. Dissemination of findings will be done through journal publications and meetings involving study participants, health care providers and other stakeholders. Trial registration: ISRCTN43896688 Strengths of this trial • This is the largest trial of its kind with replication in over 30 health facilities and 2 countries. • It was designed, implemented and is being monitored in partnership with patient representatives, health care providers, policy makers and other stakeholders. • The trial is measuring objective markers of effectiveness and is multidisciplinary. Limitations of this trial • The trial has a relatively short follow-up of 12 months and cannot estimate effect against mortality or other longer-term outcomes. • The trial cannot be blinded – both health care providers and patients know the intervention being delivered at each health facility

Integrating HIV, diabetes and hypertension services in Africa: study protocol for a cluster randomised trial in Tanzania and Uganda

Introduction HIV programmes in sub-Saharan Africa are well funded but programmes for diabetes and hypertension are weak with only a small proportion of patients in regular care. Healthcare provision is organised from stand-alone clinics. In this cluster randomised trial, we are evaluating a concept of integrated care for people with HIV infection, diabetes or hypertension from a single point of care. Methods and analysis 32 primary care health facilities in Dar es Salaam and Kampala regions were randomised to either integrated or standard vertical care. In the integrated care arm, services are organised from a single clinic where patients with either HIV infection, diabetes or hypertension are managed by the same clinical and counselling teams. They use the same pharmacy and laboratory and have the same style of patient records. Standard care involves separate pathways, that is, separate clinics, waiting and counselling areas, a separate pharmacy and separate medical records. The trial has two primary endpoints: retention in care of people with hypertension or diabetes and plasma viral load suppression. Recruitment is expected to take 6 months and follow-up is for 12 months. With 100 participants enrolled in each facility with diabetes or hypertension, the trial will provide 90% power to detect an absolute difference in retention of 15% between the study arms (at the 5% two-sided significance level). If 100 participants with HIV infection are also enrolled in each facility, we will have 90% power to show non-inferiority in virological suppression to a delta=10% margin (ie, that the upper limit of the one-sided 95% CI of the difference between the two arms will not exceed 10%). To allow for lost to follow-up, the trial will enrol over 220 persons per facility. This is the only trial of its kind evaluating the concept of a single integrated clinic for chronic conditions in Africa. Ethics and dissemination The protocol has been approved by ethics committee of The AIDS Support Organisation, National Institute of Medical Research and the Liverpool School of Tropical Medicine. Dissemination of findings will be done through journal publications and meetings involving study participants, healthcare providers and other stakeholders. Trial registration number ISRCTN43896688

Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life.

CAPRISA, 2015.Abstract available in pdf