Understanding the contexts in which female sex workers sell sex in Kampala, Uganda: a qualitative study.

BACKGROUND: Structural, interpersonal and individual level factors can present barriers for HIV prevention behaviour among people at high risk of HIV acquisition, including women who sell sex. In this paper we document the contexts in which women selling sex in Kampala meet and provide services to their clients. METHODS: We collected qualitative data using semi-structured interviews. Women were eligible to participate if they were 18 years or older, self-identified as sex workers or offered sex for money and spoke Luganda or English. Ten women who met clients in venues and outdoor locations were selected randomly from a clinic for women at high risk of HIV acquisition. Ten other women who met clients online were recruited using snowball sampling. Interviews included demographic data, and themes included reasons for joining and leaving sex work, work locations, nature of relationships with clients and peers, interaction with authorities, regulations on sex work, and reported stigma. We conducted interviews over three months. Data were analysed thematically using a framework analysis approach. The coding framework was based on structural factors identified from literature, but also modified inductively with themes arising from the interviews. RESULTS: Women met clients in physical and virtual spaces. Physical spaces included venues and outdoor locations, and virtual spaces were online platforms like social media applications and websites. Of the 20 women included, 12 used online platforms to meet clients. Generally, women from the clinic sample were less educated and predominantly unmarried, while those from the snowball sample had more education, had professional jobs, or were university students. Women from both samples reported experiences of stigma, violence from clients and authorities, and challenges accessing health care services due to the illegality of sex work. Even though all participants worked in settings where sex work was illegal and consequently endured harsh treatment, those from the snowball sample faced additional threats of cybersecurity attacks, extortion from clients, and high levels of violence from clients. CONCLUSIONS: To reduce risk of HIV acquisition among women who sell sex, researchers and implementers should consider these differences in contexts, challenges, and risks to design innovative interventions and programs that reach and include all women.

Process and costs for readiness to safely implement immediate kangaroo mother care: a mixed methods evaluation from the OMWaNA trial at five hospitals in Uganda.

BACKGROUND: Preterm birth complications result in > 1 million child deaths annually, mostly in low- and middle-income countries. A World Health Organisation (WHO)-led trial in hospitals with intensive care reported reduced mortality within 28 days among newborns weighing 1000-1799 g who received immediate kangaroo mother care (iKMC) compared to those who received standard care. Evidence is needed regarding the process and costs of implementing iKMC, particularly in non-intensive care settings. METHODS: We describe actions undertaken to implement iKMC, estimate financial and economic costs of essential resources and infrastructure improvements, and assess readiness for newborn care after these improvements at five Ugandan hospitals participating in the OMWaNA trial. We estimated costs from a health service provider perspective and explored cost drivers and cost variation across hospitals. We assessed readiness to deliver small and sick newborn care (WHO level-2) using a tool developed by Newborn Essential Solutions and Technologies and the United Nations Children's Fund. RESULTS: Following the addition of space to accommodate beds for iKMC, floor space in the neonatal units ranged from 58 m2 to 212 m2. Costs of improvements were lowest at the national referral hospital (financial: $31,354; economic: $45,051; 2020 USD) and varied across the four smaller hospitals (financial: $68,330-$95,796; economic: $99,430-$113,881). In a standardised 20-bed neonatal unit offering a level of care comparable to the four smaller hospitals, the total financial cost could be in the range of $70,000 to $80,000 if an existing space could be repurposed or remodelled, or $95,000 if a new unit needed to be constructed. Even after improvements, the facility assessments demonstrated broad variability in laboratory and pharmacy capacity as well as the availability of essential equipment and supplies. CONCLUSIONS: These five Ugandan hospitals required substantial resource inputs to allow safe implementation of iKMC. Before widespread scale-up of iKMC, the affordability and efficiency of this investment must be assessed, considering variation in costs across hospitals and levels of care. These findings should help inform planning and budgeting as well as decisions about if, where, and how to implement iKMC, particularly in settings where space, devices, and specialised staff for newborn care are unavailable. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02811432 . Registered: 23 June 2016.

The economic burden incurred by families caring for a young child with developmental disability in Uganda.

Each year, nearly 30 million children globally are at risk of developmental difficulties and disability as a result of newborn health conditions, with the majority living in resource-constrained countries. This study estimates the annual cost to families related to caring for a young child with developmental disability in Uganda. Nested within a feasibility trial of early care and support for young children with developmental disabilities, this sub-study estimated the cost of illness, the cost of paternal abandonment of the caregiver and the affordability of care by household. Seventy-three caregivers took part in this sub-study. The average annual cost of illness to families was USD 949. The main cost drivers were the cost of seeking care and income lost due to loss of employment. Households caring for a child with a disability spent more than the national average household expenditure, and the annual cost of illness for all households was more than 100% of the national GDP per capita. In addition, 84% of caregivers faced economic consequences and resorted to wealth-reducing coping strategies. Families caring for a child with severe impairment incurred USD 358 more on average than those with mild or moderate impairment. Paternal abandonment was common (31%) with affected mothers losing an average of USD 430 in financial support. Caring for a young child with developmental disability was unaffordable to all the study households. Programmes of early care and support have the potential to reduce these financial impacts. National efforts to curb this catastrophic health expenditure are necessary.

Early care and support for young children with developmental disabilities and their caregivers in Uganda: The Baby Ubuntu feasibility trial.

Background: Early care and support provision for young children with developmental disabilities is frequently lacking, yet has potential to improve child and family outcomes, and is crucial for promoting access to healthcare and early education. We evaluated the feasibility, acceptability, early evidence of impact and provider costs of the Baby Ubuntu participatory, peer-facilitated, group program for young children with developmental disabilities and their caregivers in Uganda. Materials and methods: A feasibility trial, with two parallel groups, compared Baby Ubuntu with standard care. Caregivers and children, aged 6-11 months with moderate-severe neurodevelopmental impairment, were recruited and followed for 12 months. Quantitative and qualitative methods captured information on feasibility (ability to recruit), acceptability (satisfactory attendance), preliminary evidence of impact (family quality of life) and provider costs. Results: One hundred twenty-six infants (median developmental quotient, 28.7) were recruited and randomized (63 per arm) over 9 months, demonstrating feasibility; 101 (80%) completed the 12-month follow-up assessment (9 died, 12 were lost to follow up, 4 withdrew). Of 63 randomized to the intervention, 59 survived (93%); of these, 51 (86%) attended ≥6 modules meeting acceptability criteria, and 49 (83%) completed the 12 month follow-up assessment. Qualitatively, Baby Ubuntu was feasible and acceptable to caregivers and facilitators. Enabling factors included community sensitization by local champions, positive and caring attitudes of facilitators toward children with disability, peer support, and the participatory approach to learning. Among 101 (86%) surviving children seen at 12 months, mixed methods evaluation provided qualitative evidence of impact on family knowledge, skills, and attitudes, however impact on a scored family quality of life tool was inconclusive. Barriers included stigma and exclusion, poverty, and the need to manage expectations around the child's progress. Total provider cost for delivering the program per participant was USD 232. Conclusion: A pilot feasibility trial of the Baby Ubuntu program found it to be feasible and acceptable to children, caregivers and healthcare workers in Uganda. A mixed methods evaluation provided rich programmatic learning including qualitative, but not quantitative, evidence of impact. The cost estimate represents a feasible intervention for this vulnerable group, encouraging financial sustainability at scale. Clinical trial registration: [https://doi.org/10.1186/ISRCTN44380971], identifier [ISRCTN44380971].

Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.

INTRODUCTION: Combination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs for people living with HIV (PLHIV).Pharmacovigilance-monitoring the effects of medicines-is essential for understanding real-world drug safety. In Uganda, pharmacovigilance systems have only recently been developed, and rates of ADR reporting for cART are very low. Thus, the safety profile of medicines currently used to treat HIV and tuberculosis in our population is poorly understood.The Med Safety mobile application has been developed through the European Union's Innovative Medicines Initiative WEB-Recognising Adverse Drug Reactions project to promote digital pharmacovigilance. This mobile application has been approved for ADR-reporting by Uganda's National Drug Authority. However, the barriers and facilitators to Med Safety uptake, and its effectiveness in improving pharmacovigilance, are as yet unknown. METHODS AND ANALYSIS: A pragmatic cluster-randomised controlled trial will be implemented over 30 months at 191 intervention and 191 comparison cART sites to evaluate Med Safety. Using a randomisation sequence generated by the sealed envelope software, we shall randomly assign the 382 prescreened cART sites to the intervention and comparison arms. Each cART site is a cluster that consists of healthcare professionals and PLHIV receiving dolutegravir-based cART and/or isoniazid preventive therapy. Healthcare professionals enrolled in the intervention arm will be trained in the use of mobile-based, paper-based and web-based reporting, while those in the comparison arm will be trained in paper-based and web-based reporting only. ETHICS AND DISSEMINATION: Ethical approval was given by the School of Biomedical Sciences Research and Ethics Committee at Makerere University (SBS-REC-720), and administrative clearance was obtained from Uganda National Council for Science and Technology (HS1366ES). Study results will be shared with healthcare professionals, policymakers, the public and academia. TRIAL REGISTRATION NUMBER: PACTR202009822379650.

Incorporating Concern for Health Equity Into Resource Allocation Decisions: Development of a Tool and Population-Based Valuation for Uganda.

OBJECTIVES: Health economic analyses that simultaneously address the concerns of increasing population health and reducing health inequalities require information on public preferences for using healthcare resources to reduce health inequalities and how this is valued relative to improving total population health. Previous research has quantified this preference in the form of an inequality aversion parameter in a specified social welfare function. This study aimed to elicit general population's views on health inequality and to estimate an inequality aversion parameter in Uganda. METHODS: Adult respondents from the general population were recruited and interviewed using survey adapted from an existing questionnaire, including trade-off questions between 2 hypothetical healthcare programs. Data on participants' demographic and socioeconomic characteristics and health-related quality of life measured by 5-level version of EQ-5D were collected. RESULTS: A nationally representative sample of 165 participants were included, with mean age of 37.1 years and mean 5-level version of EQ-5D at 0.836. Most respondents indicated willingness to trade-off some total population health to reduce health inequality. Translating the preferences into an Atkinson inequality aversion parameter (14.70) implies that health gain to the poorest 20% of people should be given approximately 6 times the weight of health gains to the richest 20%. CONCLUSIONS: Our study suggests it is feasible to adapt questionnaires of this type for a Ugandan population and this approach could be used to measure public aversion to health inequality in other settings. The elicited inequality aversion parameter can be used to support the assessment of health inequality impact in economic evaluation in Uganda.

Developing the EQ-5D-5L Value Set for Uganda Using the 'Lite' Protocol.

OBJECTIVE: A 'lite' version of the EQ-5D-5L valuation protocol, which requires a smaller sample by collecting more data from each participant, was proposed and used to develop an EQ-5D-5L value set for Uganda. METHODS: Adult respondents from the general Ugandan population were quota sampled based on age and sex. Eligible participants were asked to complete 20 composite time trade-off tasks in the tablet-assisted personal interviews using the offline EuroQol Portable Valuation Technology software under routine quality control. No discrete choice experiment task was administered. The composite time trade-off data were modelled using four additive and two multiplicative regression models. Model performance was evaluated based on face validity, prediction accuracy in cross-validation and in predicting mild health states. The final value set was generated using the best-performing model. RESULTS: A representative sample (N = 545) participated in this study. Responses to composite time trade-off tasks from 492 participants were included in the primary analysis. All models showed face validity and generated comparable prediction accuracy. The Tobit model with constrained intercepts and corrected for heteroscedasticity was considered the preferred model for the value set on the basis of better performance. The value set ranges from - 1.116 (state 55555) to 1 (state 11111) with 'pain/discomfort' as the most important dimension. CONCLUSIONS: This is the first EQ-5D-5L valuation study using a 'lite' protocol involving composite time trade-off data only. Our results suggest its feasibility in resource-constrained settings. The established EQ-5D-5L value set for Uganda is expected to be used for economic evaluations and decision making in Uganda and the East Africa region.

Incorporating health inequality impact into economic evaluation in low- and middle-income countries: a systematic review.

INTRODUCTION: As well as improving population health, promoting equity in health is one of the key goals of health policy in low- and middle-income countries (LMICs). However, it is less clear how equity is defined, or how it may impact on resource allocation decisions. We investigated the degree to which health inequalities have been considered in economic evaluation of health interventions in LMICs, and what demographic or socioeconomic characteristics were used to define equity relevant subgroups. AREAS COVERED: We reviewed publications since 2010 from three main databases following the search strategy developed by including the key terms 'health inequalities/health disparities/health equity,' 'economics' and 'low- and middle-income countries' in the title or abstract. Twelve studies were identified, mainly focusing on interventions for the more vulnerable groups such as children and women. EXPERT OPINION: Some attempts have been made to assess interventions' impact on health inequality and there is increasing interest in evaluating it, although research in this area is lacking. Population subgroups highlighted in the included studies were those differing in socioeconomic status. Most studies reported the results across subgroups to illustrate inequality impact, and the newly developed methods, extended cost-effectiveness analysis and distributional cost-effectiveness analysis, have also been applied.

A cost study for mobile phone health surveys using interactive voice response for assessing risk factors of noncommunicable diseases.

BACKGROUND: This is the first study to examine the costs of conducting a mobile phone survey (MPS) through interactive voice response (IVR) to collect information on risk factors for noncommunicable diseases (NCD) in three low- and middle-income countries (LMIC); Bangladesh, Colombia, and Uganda. METHODS: This is a micro-costing study conducted from the perspective of the payer/funder with a 1-year horizon. The study evaluates the fixed costs and variable costs of implementing one nationally representative MPS for NCD risk factors of the adult population. In this costing study, we estimated the sample size of calls required to achieve a population-representative survey and associated incentives. Cost inputs were obtained from direct economic costs incurred by a central study team, from country-specific collaborators, and from platform developers who participated in the deployment of these MPS during 2017. Costs were reported in US dollars (USD). A sensitivity analysis was conducted assessing different scenarios of pricing and incentive strategies. Also, costs were calculated for a survey deployed targeting only adults younger than 45 years. RESULTS: We estimated the fixed costs ranging between $47,000 USD and $74,000 USD. Variable costs were found to be between $32,000 USD and $129,000 USD per nationally representative survey. The main cost driver was the number of calls required to meet the sample size, and its variability largely depends on the extent of mobile phone coverage and access in the country. Therefore, a larger number of calls were estimated to survey specific harder-to-reach sub-populations. CONCLUSION: Mobile phone surveys have the potential to be a relatively less expensive and timely method of collecting survey information than face-to-face surveys, allowing decision-makers to deploy survey-based monitoring or evaluation programs more frequently than it would be possible having only face-to-face contact. The main driver of variable costs is survey time, and most of the variability across countries is attributable to the sampling differences associated to reaching out to population subgroups with low mobile phone ownership or access.

Effectiveness and cost-effectiveness of integrating the management of depression into routine HIV Care in Uganda (the HIV + D trial): A protocol for a cluster-randomised trial.

BACKGROUND: An estimated 8-30 % of people living with HIV (PLWH) have depressive disorders (DD) in sub-Saharan Africa. Of these, the majority are untreated in most of HIV care services. There is evidence from low- and middle- income countries of the effectiveness of both psychological treatments and antidepressant medication for the treatment of DD among PLWH, but no evidence on how these can be integrated into routine HIV care. This protocol describes a cluster-randomised trial to evaluate the effectiveness and cost-effectiveness of the HIV + D model for the integration of a collaborative stepped care intervention for DD into routine HIV care, which we have developed and piloted in Uganda. METHODS: Forty public health care facilities that provide HIV care in Kalungu, Masaka and Wakiso Districts will be randomly selected to participate in the trial. Each facility will recruit 10-30 eligible PLWH with DD and the total sample size will be 1200. The clusters will be randomised 1:1 to receive Enhanced Usual Care alone (EUC, i.e. HIV clinicians trained in Mental Health Gap Action Programme including guidelines on when and where to refer patients for psychiatric care) or EUC plus HIV + D (psychoeducation, Behavioural Activation, antidepressant medication and referral to a supervising mental health worker, delivered in a collaborative care stepwise approach). Eligibility criteria are PLWH attending the clinic, aged ≥ 18 years who screen positive on a depression screening questionnaire (Patient Health Questionnaire, PHQ-9 ≥ 10). The primary outcome is the mean depressive disorder symptom severity scores (assessed using the PHQ-9) at 3 months' post-randomisation, with secondary mental health, disability, HIV and economic outcomes measured at 3 and 12 months. The cost-effectiveness of EUC with HIV + D will be assessed from both the health system and the societal perspectives by collecting health system, patient and productivity costs and mean DD severity scores at 3 months, additional to health and non-health related quality of life measures (EQ-5D-5 L and OxCAP-MH). DISCUSSION: The study findings will inform policy makers and practitioners on the cost-effectiveness of a stepped care approach to integrate depression management in routine care for PLWH in low-resource settings. TRIAL REGISTRATION: ISRCTN, ISRCTN86760765. Registered 07 September 2017, https://doi.org/10.1186/ISRCTN86760765 .

Cultural and linguistic adaptation of the multi-dimensional OXCAP-MH for outcome measurement of mental health among people living with HIV/AIDS in Uganda: the Luganda version.

BACKGROUND: It is rare to find HIV/AIDS care providers in sub-Saharan Africa routinely providing mental health services, yet 8-30% of the people living with HIV have depression. In an ongoing trial to assess integration of collaborative care of depression into routine HIV services in Uganda, we will assess quality of life using the standard EQ-5D-5L, and the capability-based OxCAP-MH which has never been adapted nor used in a low-income setting. We present the results of the translation and validation process for cultural and linguistic appropriateness of the OxCAP-MH tool for people living with HIV/AIDS and depression in Uganda. METHODS: The translation process used the Concept Elaboration document, the source English version of OxCAP-MH, and the Back-Translation Review template as provided during the user registration process of the OxCAP-MH, and adhered to the Translation and Linguistic Validation process of the OxCAP-MH, which was developed following the international principles of good practice for translation as per the International Society for Pharmacoeconomics and Outcomes Research's standards. RESULTS: The final official Luganda version of the OxCAP-MH was obtained following a systematic iterative process, and is equivalent to the English version in content, but key concepts were translated to ensure cultural acceptability, feasibility and comprehension by Luganda-speaking people. CONCLUSION: The newly developed Luganda version of the OxCAP-MH can be used both as an alternative or as an addition to health-related quality of life patient-reported outcome measures in research about people living with HIV with comorbid depression, as well as more broadly for mental health research.

Quality of life and associated factors among HIV positive patients after completion of treatment for Cryptococcal meningitis.

BACKGROUND: Cryptococcal meningitis (CCM) remains one of the leading causes of mortality among HIV infected patients. Due to factors such as the severity of CCM pathology, the quality of life (QOL) of patients post-treatment is likely to be poor. Few studies have reported on QOL of CCM patients post treatment completion. We used data collected among patients in the CryptoDex trial (ISRCTN59144167) to determine QOL and associated factors at week 10 and six months from treatment initiation. METHODOLOGY: CryptoDex was a double-blind placebo-controlled trial of adjunctive dexamethasone in HIV infected adults with CCM, conducted between 2013 and 2015 in six countries in Asia and Africa. QOL was determined using the descriptive and Visual Analog Scales (VAS) of the EuroQol Five-Dimension-Three-Level (EQ-5D-3L) tool. We derived index scores, and described these and the VAS scores at 10 weeks and 6 months; and used linear regression to determine the relationship between various characteristics and VAS scores at both time points. VAS scores were interpreted as very good (81-100), good (51-80), normal (31-50) and bad/very bad (0-30). RESULTS: Of 451 patients enrolled in the trial, 238 had QOL evaluations at week 10. At baseline, their mean age (SD) was 35.2(8.5) years. The mean index scores (SD) were 0.785(0.2) and 0.619(0.4) among African and Asian patients respectively at week 10, and 0.879(0.2) and 0.731(0.4) among African and Asian patients respectively at month six. The overall mean VAS score (SD) at 10 weeks was 57.2 (29.7), increasing significantly to 72(27.4) at month six (p<0.001). At week 10, higher VAS score was associated with greater weight (p = 0.007) and being African (p<0.001), while lower VAS score was associated with positive yeast culture at day 14 (p = 0.026). At month six, higher VAS score remained associated with African origin (p = 0.006) while lower VAS score was associated with positive yeast culture (p = 0.006). Lower VAS scores were associated with higher number of inpatient days at 10 weeks and 6 months (p = 0.003 and 0.002 respectively). CONCLUSION: QOL was good among patients that had completed therapy for CCM, but below perfect. Strategies to improve QOL among CCM survivors are required.

Hepatitis B virus seroepidemiology data for Africa: Modelling intervention strategies based on a systematic review and meta-analysis.

BACKGROUND: International Sustainable Development Goals (SDGs) for elimination of hepatitis B virus (HBV) infection set ambitious targets for 2030. In African populations, infant immunisation has been fundamental to reducing incident infections in children, but overall population prevalence of chronic hepatitis B (CHB) infection remains high. In high-prevalence populations, adult catch-up vaccination has sometimes been deployed, but an alternative Test and Treat (T&T) approach could be used as an intervention to interrupt transmission. Universal T&T has not been previously evaluated as a population intervention for HBV infection, despite high-profile data supporting its success with human immunodeficiency virus (HIV). METHODS AND FINDINGS: We set out to investigate the relationship between prevalence of HBV infection and exposure in Africa, undertaking a systematic literature review in November 2019. We identified published seroepidemiology data representing the period 1995-2019 from PubMed and Web of Science, including studies of adults that reported prevalence of both hepatitis B surface antigen (HBsAg; prevalence of HBV infection) and antibody to hepatitis B core antigen (anti-HBc; prevalence of HBV exposure). We identified 96 studies representing 39 African countries, with a median cohort size of 370 participants and a median participant age of 34 years. Using weighted linear regression analysis, we found a strong relationship between the prevalence of infection (HBsAg) and exposure (anti-HBc) (R2 = 0.45, p < 0.001). Region-specific differences were present, with estimated CHB prevalence in Northern Africa typically 30% to 40% lower (p = 0.007) than in Southern Africa for statistically similar exposure rates, demonstrating the need for intervention strategies to be tailored to individual settings. We applied a previously published mathematical model to investigate the effect of interventions in a high-prevalence setting. The most marked and sustained impact was projected with a T&T strategy, with a predicted reduction of 33% prevalence by 20 years (95% CI 30%-37%) and 62% at 50 years (95% CI 57%-68%), followed by routine neonatal vaccination and prevention of mother to child transmission (PMTCT; at 100% coverage). In contrast, the impact of catch-up vaccination in adults had a negligible and transient effect on population prevalence. The study is constrained by gaps in the published data, such that we could not model the impact of antiviral therapy based on stratification by specific clinical criteria and our model framework does not include explicit age-specific or risk-group assumptions regarding force of transmission. CONCLUSIONS: The unique data set collected in this study highlights how regional epidemiology data for HBV can provide insights into patterns of transmission, and it provides an evidence base for future quantitative research into the most effective local interventions. In combination with robust neonatal immunisation programmes, ongoing PMTCT efforts, and the vaccination of high-risk groups, diagnosing and treating HBV infection is likely to be of most impact in driving advances towards elimination targets at a population level.

Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda.

BACKGROUND: There are 2.5 million neonatal deaths each year; the majority occur within 48 h of birth, before stabilisation. Evidence from 11 trials shows that kangaroo mother care (KMC) significantly reduces mortality in stabilised neonates; however, data on its effect among neonates before stabilisation are lacking. The OMWaNA trial aims to determine the effect of initiating KMC before stabilisation on mortality within seven days relative to standard care. Secondary objectives include exploring pathways for the intervention's effects and assessing incremental costs and cost-effectiveness between arms. METHODS: We will conduct a four-centre, open-label, individually randomised, superiority trial in Uganda with two parallel groups: an intervention arm allocated to receive KMC and a control arm receiving standard care. We will enrol 2188 neonates (1094 per arm) for whom the indication for KMC is 'uncertain', defined as receiving ≥ 1 therapy (e.g. oxygen). Admitted singleton, twin and triplet neonates (triplet if demise before admission of ≥ 1 baby) weighing ≥ 700-≤ 2000 g and aged ≥ 1-< 48 h are eligible. Treatment allocation is random in a 1:1 ratio between groups, stratified by weight and recruitment site. The primary outcome is mortality within seven days. Secondary outcomes include mortality within 28 days, hypothermia prevalence at 24 h, time from randomisation to stabilisation or death, admission duration, time from randomisation to exclusive breastmilk feeding, readmission frequency, daily weight gain, infant-caregiver attachment and women's wellbeing at 28 days. Primary analyses will be by intention-to-treat. Quantitative and qualitative data will be integrated in a process evaluation. Cost data will be collected and used in economic modelling. DISCUSSION: The OMWaNA trial aims to assess the effectiveness of KMC in reducing mortality among neonates before stabilisation, a vulnerable population for whom its benefits are uncertain. The trial will improve understanding of pathways underlying the intervention's effects and will be among the first to rigorously compare the incremental cost and cost-effectiveness of KMC relative to standard care. The findings are expected to have broad applicability to hospitals in sub-Saharan Africa and southern Asia, where three-quarters of global newborn deaths occur, as well as important policy and programme implications. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02811432. Registered on 23 June 2016.

Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol.

INTRODUCTION: Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the 'ABAaNA EIP', for young children with neurodevelopmental impairment in Uganda. METHODS AND ANALYSIS: We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6-11 completed months) with neurodevelopmental impairment (defined as a developmental quotient <70 on Griffiths Scales of Mental Development, and, or Hammersmith Infant Neurological Examination score <60) will be recruited and randomised to the intervention or standard care arm. Intervention arm families will receive the 10-modular, peer-facilitated, participatory, community-based programme over 6 months. Recruited families will be followed up at 6 and 12 months after recruitment, and assessors will be blinded to the trial allocation. The primary hypothesis is that the ABAaNA EIP is feasible and acceptable when compared with standard care. Primary outcomes of interest are feasibility (number recruited and randomised at baseline) and acceptability (protocol violation of arm allocation and number of sessions attended) and family and child quality of life. Guided by the study aim, the qualitative data analysis will use a data-led thematic framework approach. The findings will inform scalability and sustainability of the programme. ETHICS AND DISSEMINATION: The trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement. TRIAL REGISTRATION NUMBER: ISRCTN44380971; protocol version 3.0, 19th February 2018.

Acceptability and Predictors of Uptake of Anti-retroviral Pre-exposure Prophylaxis (PrEP) Among Fishing Communities in Uganda: A Cross-Sectional Discrete Choice Experiment Survey.

We used a discrete choice experiment to assess the acceptability and potential uptake of HIV pre-exposure prophylaxis (PrEP) among 713 HIV-negative members of fishing communities in Uganda. Participants were asked to choose between oral pill, injection, implant, condoms, vaginal ring (women), and men circumcision. Product attributes were HIV prevention effectiveness, sexually transmitted infection (STI) prevention, contraception, waiting time, and secrecy of use. Data were analysed using mixed multinomial logit and latent class models. HIV prevention effectiveness was viewed as the most important attribute. Both genders preferred oral PrEP. Women least preferred the vaginal ring and men the implant. Condom use was predicted to decrease by one third among men, and not to change amongst women. Oral PrEP and other new prevention technologies are acceptable among fishing communities and may have substantial demand. Future work should explore utility of multiple product technologies that combine contraception with HIV and other STI prevention.

Public perceptions and behaviours related to the risk of infection with Aedes mosquito-borne diseases: a cross-sectional study in Southeastern France.

OBJECTIVES: To explore public perceptions and behaviours related to the risk of flavivirus and alphavirus infection in Southeastern regions of France following the recent colonisation of the Asian tiger mosquito, Aedes albopictus, and the identification of four autochthonous cases of dengue and chikungunya fever in these regions. DESIGN: Cross-sectional telephone survey using a proportional random digit dialling selection method. SETTING: Interviews were conducted from 28 November 2011 to 29 January 2012 using a computer-assisted telephone interviewing system. PARTICIPANTS: 1506 French speaking adults aged 18 years or older residing in French Mediterranean regions. RESULTS: Protective health behaviours were found to be performed less frequently among men (AOR=0.65, 95% CI 0.52% to 0.80%), residents with lower educational status (AOR=0.61, 95% CI 0.43% to 0.85% for respondents with primary school education; AOR=0.69, 95% CI 0.53% to 0.90% for those with some secondary school education), and those living in regions where the Aedes mosquito is objectively rare (AOR=0.60, 95% CI 0.36% to 0.98% for Aude; AOR=0.63, 95% CI 0.44% to 0.89% for Herault; AOR=0.56, 95% CI 0.34% to 0.93% for Eastern Pyrenees). Empirical results also suggest that behavioural responses to infection risk are greater shaped by the perceived exposure to Aedes, notably the perceived frequency of mosquito bites (AOR=2.07, 95% CI 1.84% to 2.32%) and visual identification of Aedes mosquitoes in one's immediate environment (AOR=1.98, 95% CI 1.45% to 2.71%) rather than by other common predictors of protective behaviours. CONCLUSIONS: These findings may help with the development of innovative instruments designed to make more visible and personal the threat of flavivirus and alphavirus infections induced by the presence of A albopictus in order to promote significant behavioural changes among populations at risk.