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McCormack S.,MRC Clinical Trials Unit | Ramjee G.,MRC HIV Prevention Research Unit | Kamali A.,MRC UVRI Uganda Research Unit | Rees H.,University of Witwatersrand | And 19 more authors.
The Lancet | Year: 2010

Background Innovative prevention strategies for HIV-1 transmission are urgently needed. PRO2000 vaginal gel was efficacious against HIV-1 transmission in studies in macaques; we aimed to assess efficacy and safety of 2 and 0·5 PRO2000 gels against vaginal HIV-1 transmission in women in sub-Saharan Africa. Methods Microbicides Development Programme 301 was a phase 3, randomised, double-blind, parallel-group trial, undertaken at 13 clinics in South Africa, Tanzania, Uganda, and Zambia. We randomly assigned sexually active women, aged 18 years or older (≥16 years in Tanzania and Uganda) without HIV-1 infection in a 1:1:1 ratio to 2 PRO2000, 0·5 PRO2000, or placebo gel groups for 52 weeks (up to 104 weeks in Uganda). Randomisation was done by computerised random number generator. Investigators and participants were masked to group assignment. The primary efficacy outcome was incidence of HIV-1 infection before week 52, which was censored for pregnancy and excluded participants without HIV-1 follow-up data or with HIV-1 infection at enrolment. HIV-1 status was established by rapid tests or ELISA at screening at 12 weeks, 24 weeks, 40 weeks, and 52 weeks, and confirmed in a central reference laboratory. The primary safety endpoint was an adverse event of grade 3 or worse. Use of 2 PRO2000 gel was discontinued on Feb 14, 2008, on the recommendation of the Independent Data Monitoring Committee because of low probability of benefit. This trial is registered at http://isrctn.org, number ISRCTN 64716212. Findings We enrolled 9385 of 15 818 women screened. 2591 (95) of 2734 participants enrolled to the 2 PRO2000 group, 3156 (95) of 3326 in the 0·5 PRO2000 group, and 3112 (94) of 3325 in the placebo group were included in the primary efficacy analysis. Mean reported gel use at last sex act was 89 (95 CI 86-91). HIV-1 incidence was much the same between groups at study end (incidence per 100 woman-years was 4·5 [95 CI 3·8-5·4] for 0·5 PRO2000 vs 4·3 [3·6-5·2] for placebo, hazard ratio 1·05 [0·82-1·34], p=0·71), and at discontinuation (4·7 [3·8-5·8] for 2 PRO2000 gel, 3·9 [3·0-4·9] for 0·5 PRO2000 gel, and 3·9 [3·1-5·0] for placebo gel). Incidence of the primary safety endpoint at study end was 4·6 per 100 woman-years (95 CI 3·9-5·4) in the 0·5 PRO2000 group and 3·9 (3·2-4·6) in the placebo group; and was 4·5 (3·7-5·5) in the 2 PRO2000 group at discontinuation. Interpretation Although safe, 0·5 PRO2000 and 2 PRO2000 are not efficacious against vaginal HIV-1 transmission and are not indicated for this use. Funding UK Department for International Development, UK Medical Research Council, European and Developing Countries Clinical Trials Partnership, International Partnership for Microbicides, and Endo Pharmaceuticals Solutions. © 2010 Elsevier Ltd All rights reserved.


PubMed | MRC Uganda Research Unit on AIDS, Mwanza Intervention Trials Unit, Tanzanian Ministry of Health and Social Welfare and London School of Hygiene and Tropical Medicine
Type: Journal Article | Journal: Tropical medicine & international health : TM & IH | Year: 2016

Data on renal dysfunction in sub-Saharan Africa, comparing urban and rural areas, have not yet been reported. Therefore, we aimed to determine the distribution of low estimated glomerular filtration rates (eGFRs) in urban and rural Tanzania, to describe factors associated with low eGFR and to quantify fractions attributable to common risk factors.We conducted a community-based survey of 1095 randomly selected Tanzanian adults (18 years). A structured questionnaire and examinations were used to document sociodemographic characteristics, diet, physical activity, anthropomorphic measurements and blood pressure. Blood tests were performed for HIV infection, diabetes mellitus and creatinine. eGFR was calculated using two equations recommended for African adults.Serum creatinine was available for 1043 participants: 170 in Mwanza city, 326 in district towns and 547 in rural areas. Mean age was 35.5 years and 54% were females. The prevalence of eGFR < 60 ml/min/1.73 m(2) in these 3 strata was 2.3% (95% CI = 0.8-6.6%), 7.5% (4.7-11.8%) and 7.4% (5.1-10.6%), respectively. When age standardised to the WHO world population, prevalences were 3.8%, 10.1% and 8.1%. Factors associated with low eGFR included district town residence, older age, greater wealth, less physical activity and hypertension. Only 21% of cases with eGFR < 60 ml/min/1.73 m(2) were attributable to HIV, hypertension or diabetes.Decreased renal function is common in Tanzania, particularly in district towns, and unique risk factors for kidney disease may exist in this population. Population-specific strategies for prevention, early diagnosis and treatment of kidney disease are needed for Africa.


Balira R.,National Institute for Medical Research NIMR | Mabey D.,London School of Hygiene and Tropical Medicine | Weiss H.,London School of Hygiene and Tropical Medicine | Ross D.A.,London School of Hygiene and Tropical Medicine | And 3 more authors.
International Journal of Gynecology and Obstetrics | Year: 2015

Abstract Objective To assess the operational integration of maternal HIV testing and syphilis screening in Mwanza, Tanzania. Methods Interviews were conducted with 76 health workers (HW) from three antenatal clinics (ANC) and three maternity wards in 2008-2009 and 1137 consecutive women admitted for delivery. Nine ANC health education sessions and client flow observations were observed. Results Only 25.0% of HWs reported they had received training in both prevention of mother-to-child transmission (PMTCT) and syphilis screening. HIV and syphilis tests were sometimes performed in different rooms and results recorded in separate registers with different formats and the results were not always given by the same person. At delivery, most women had been tested for both HIV (79.4%) and syphilis (88.1%) during pregnancy. Of those not tested antenatally for each infection, 70.1% were tested for HIV at delivery but none for syphilis. Conclusion Integration of maternal HIV and syphilis screening was limited. Integrated care guidelines and related health worker training should address this gap. © 2015 International Federation of Gynecology and Obstetrics.


Settumba S.N.,Medical Research Council Uganda Virus Research Institute | Sweeney S.,London School of Hygiene and Tropical Medicine | Seeley J.,Medical Research Council Uganda Virus Research Institute | Seeley J.,London School of Hygiene and Tropical Medicine | And 6 more authors.
Tropical Medicine and International Health | Year: 2015

Objective: To explore the chronic disease services in Uganda: their level of utilisation, the total service costs and unit costs per visit. Methods: Full financial and economic cost data were collected from 12 facilities in two districts, from the provider's perspective. A combination of ingredients-based and step-down allocation costing approaches was used. The diseases under study were diabetes, hypertension, chronic obstructive pulmonary disease (COPD), epilepsy and HIV infection. Data were collected through a review of facility records, direct observation and structured interviews with health workers. Results: Provision of chronic care services was concentrated at higher-level facilities. Excluding drugs, the total costs for NCD care fell below 2% of total facility costs. Unit costs per visit varied widely, both across different levels of the health system, and between facilities of the same level. This variability was driven by differences in clinical and drug prescribing practices. Conclusion: Most patients reported directly to higher-level facilities, bypassing nearby peripheral facilities. NCD services in Uganda are underfunded particularly at peripheral facilities. There is a need to estimate the budget impact of improving NCD care and to standardise treatment guidelines. © 2015 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.


Francis J.M.,London School of Hygiene and Tropical Medicine | Francis J.M.,National Institute for Medical Research | Grosskurth H.,London School of Hygiene and Tropical Medicine | Grosskurth H.,National Institute for Medical Research | And 6 more authors.
Tropical Medicine and International Health | Year: 2014

Objective: Systematic review and meta-analysis of published studies of alcohol use among young people (age 15-24 years) in eastern Africa to estimate prevalence of alcohol use and determine the extent of use of standardised screening questionnaires in alcohol studies. Methods: Five databases (MEDLINE, EMBASE, Global Health, Africa-wide, and PsycINFO) were searched for publications until 30th June 2013. Results were summarised using the guidelines on preferred reporting items for systematic reviews and meta-analyses (PRISMA) and on quality assessment using the modified quality assessment tool for systematic reviews of observational studies (QATSO). Heterogeneity was assessed using the I2 statistic (DerSimonian-Laird). Results: We identified 2785 potentially relevant studies, of which 56 were eligible for inclusion. Only two studies (4%) used the standardised Alcohol Use Disorder Identification Test (AUDIT) questionnaire, and six studies (13%) used the Cut down, Annoyed, Guilt, Eye opener (CAGE) questionnaire. The reported median prevalence of alcohol use was ever-use 52% [interquartile range (IQR): 20-58%], use in the last month 28% (IQR: 17-37%), use in the last year 26% (IQR: 22-32%), and problem drinking as defined by CAGE or AUDIT 15% (IQR: 3-36%). We observed high heterogeneity between studies, with the highest prevalence of ever use of alcohol among university students (82%; 95%CI: 79-85%) and female sex workers (66%; 95%CI: 58-74%). Current use was most prevalent among male sex workers (69%; 95%CI: 63-75%). Conclusions: Reported alcohol use and problem drinking were common among diverse groups of young people in eastern Africa, indicating the urgent need for alcohol-focused interventions in this population. Few studies have used standardised alcohol screening questionnaires. Epidemiological research to investigate alcohol-focused interventions in young people should aim to apply such questionnaires that should be validated for use in this population. © 2014 The Authors.


PubMed | MRC UVRI Uganda Research Unit on AIDS, National Institute for Medical Research, Mwanza Intervention Trials Unit and London School of Hygiene and Tropical Medicine
Type: Journal Article | Journal: PloS one | Year: 2015

Research has shown that health system utilization is low for chronic diseases (CDs) other than HIV. We describe the knowledge and perceptions of CDs identified from rural and urban communities in north-west Tanzania and southern Uganda.Data were collected through a quantitative population survey, a quantitative health facility survey and focus group discussions (FGDs) and in-depth interviews (IDIs) in subgroups of population survey participants. The main focus of this paper is the findings from the FGDs and IDIs.We conducted 24 FGDs, involving approximately 180 adult participants and IDIs with 116 participants (18 years). CDs studied included: asthma/chronic obstructive lung disease (COPD), diabetes, epilepsy, hypertension, cardiac failure and HIV- related disease. The understanding of most chronic conditions involved a combination of biomedical information, gleaned from health facility visits, local people who had suffered from a complaint or knew others who had and beliefs drawn from information shared in the community. The biomedical contribution shows some understanding of the aetiology of a condition and the management of that condition. However, local beliefs for certain conditions (such as epilepsy) suggest that biomedical treatment may be futile and therefore work counter to biomedical prescriptions for management.Current perceptions of selected CDs may represent a barrier that prevents people from adopting efficacious health and treatment seeking behaviours. Interventions to improve this situation must include efforts to improve the quality of existing health services, so that people can access relevant, reliable and trustworthy services.


PubMed | National Institute for Medical Research, Mwanza Intervention Trials Unit and London School of Hygiene and Tropical Medicine
Type: Journal Article | Journal: BMC infectious diseases | Year: 2017

Data on the burden of dysglycemia among HIV-infected patients on antiretroviral therapy (ART) in Africa are limited. We determined the prevalence of pre-diabetes and diabetes among HIV-infected patients who started ART when malnourished 2 to 3years previously and investigated the association of dysglycemia with body composition.Malnourished (body mass index (BMI)<18.5kg/mTwo hundred seventy-three (57%) of 478 patients who were alive at trial conclusion were followed-up. The mean age was 41.5 (SD 9.8) years and 65.2% (178) were females. The mean follow-up BMI was 19.9 (SD 2.8) kg/mLow rather than high measures of adipose tissue were associated with increased risk of pre-diabetes and diabetes. Additional studies are needed to further investigate the role of body composition and control of glucose metabolism in the pathogenesis of diabetes among persons living with HIV in Africa.


Hargreaves J.R.,London School of Hygiene and Tropical Medicine | Delany-Moretlwe S.,University of Witwatersrand | Hallett T.B.,Imperial College London | Johnson S.,Genesis Analytics | And 4 more authors.
The Lancet HIV | Year: 2016

Theories of epidemiology, health behaviour, and social science have changed the understanding of HIV prevention in the past three decades. The HIV prevention cascade is emerging as a new approach to guide the design and monitoring of HIV prevention programmes in a way that integrates these multiple perspectives. This approach recognises that translating the efficacy of direct mechanisms that mediate HIV prevention (including prevention products, procedures, and risk-reduction behaviours) into population-level effects requires interventions that increase coverage. An HIV prevention cascade approach suggests that high coverage can be achieved by targeting three key components: demand-side interventions that improve risk perception and awareness and acceptability of prevention approaches; supply-side interventions that make prevention products and procedures more accessible and available; and adherence interventions that support ongoing adoption of prevention behaviours, including those that do and do not involve prevention products. Programmes need to develop delivery platforms that ensure these interventions reach target populations, to shape the policy environment so that it facilitates implementation at scale with high quality and intensity, and to monitor the programme with indicators along the cascade. © 2016 Elsevier Ltd


Peck R.,Mwanza Intervention Trials Unit | Peck R.,New York Medical College | Mghamba J.,Tanzanian Ministry of Health and Social Welfare | Vanobberghen F.,Mwanza Intervention Trials Unit | And 8 more authors.
The Lancet Global Health | Year: 2014

Background: Historically, health facilities in sub-Saharan Africa have mainly managed acute, infectious diseases. Few data exist for the preparedness of African health facilities to handle the growing epidemic of chronic, non-communicable diseases (NCDs). We assessed the burden of NCDs in health facilities in northwestern Tanzania and investigated the strengths of the health system and areas for improvement with regard to primary care management of selected NCDs. Methods: Between November, 2012, and May, 2013, we undertook a cross-sectional survey of a representative sample of 24 public and not-for-profit health facilities in urban and rural Tanzania (four hospitals, eight health centres, and 12 dispensaries). We did structured interviews of facility managers, inspected resources, and administered self-completed questionnaires to 335 health-care workers. We focused on hypertension, diabetes, and HIV (for comparison). Our key study outcomes related to service provision, availability of guidelines and supplies, management and training systems, and preparedness of human resources. Findings: Of adult outpatient visits to hospitals, 58% were for chronic diseases compared with 20% at health centres, and 13% at dispensaries. In many facilities, guidelines, diagnostic equipment, and first-line drug therapy for the primary care of NCDs were inadequate, and management, training, and reporting systems were weak. Services for HIV accounted for most chronic disease visits and seemed stronger than did services for NCDs. Ten (42%) facilities had guidelines for HIV whereas three (13%) facilities did for NCDs. 261 (78%) health workers showed fair knowledge of HIV, whereas 198 (59%) did for hypertension and 187 (56%) did for diabetes. Generally, health systems were weaker in lower-level facilities. Front-line health-care workers (such as non-medical-doctor clinicians and nurses) did not have knowledge and experience of NCDs. For example, only 74 (49%) of 150 nurses had at least fair knowledge of diabetes care compared with 85 (57%) of 150 for hyptertension and 119 (79%) of 150 for HIV, and only 31 (21%) of 150 had seen more than five patients with diabetes in the past 3 months compared with 50 (33%) of 150 for hypertension and 111 (74%) of 150 for HIV. Interpretation: Most outpatient services for NCDs in Tanzania are provided at hospitals, despite present policies stating that health centres and dispensaries should provide such services. We identified crucial weaknesses (and strengths) in health systems that should be considered to improve primary care for NCDs in Africa and identified ways that HIV programmes could serve as a model and structural platform for these improvements. © 2014 Peck et al.


Hayes R.,London School of Hygiene and Tropical Medicine | Kapiga S.,Mwanza Intervention Trials Unit | Padian N.,London School of Hygiene and Tropical Medicine | Padian N.,University of California at Berkeley | And 3 more authors.
AIDS | Year: 2010

Previous papers in this supplement have reviewed the evidence of the effectiveness of alternative HIV prevention methods from randomized controlled trials and other studies. This paper draws together the main conclusions from these reviews. A conceptual framework is presented that maps the proximal and distal determinants of sexual HIV transmission and helps to identify the stages in the causal pathway at which each intervention approach acts. The advances, gaps and challenges emerging from the reviews of individual intervention methods are summarized and cross-cutting themes identified. Approximately 90% of HIV prevention trials have found no effect on HIV incidence and we explore the alternative explanations for the large number of 'flat' trials. We conclude that there is no single explanation for these flat results, which may be due to interventions that are ineffective or inappropriately targeted or implemented, or to factors related to the design or conduct of trials. We examine the lessons from these flat results and provide recommendations on what should be done differently in future trials. HIV prevention remains of critical importance in an era of expanded delivery of antiretroviral therapy. In future HIV prevention research, it is important that resources are used as efficiently as possible to provide rigorous evidence of the effectiveness of a wider array of complementary prevention tools. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.

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