Self-care interventions for women's health and well-being.

The human right to health is universal and non-exclusionary, supporting health in full, and for all. Despite advances in health systems globally, 3.6 billion people lack access to essential health services. Women and girls are disadvantaged when it comes to benefiting from quality health services, owing to social norms, unequal power in relationships, lack of consideration beyond their reproductive roles and poverty. Self-care interventions, including medicines and diagnostics, which offer an additional option to facility-based care, can improve the autonomy and agency of women in managing their own health. However, tackling challenges such as stigma is essential to avoid scenarios in which self-care interventions provide more choice for those who already benefit from access to quality healthcare, and leave behind those with the greatest need. This Perspective explores the opportunities that self-care interventions offer to advance the health and well-being of women with an approach grounded in human rights, gender equality and equity.

Effect and cost-effectiveness of human-centred design-based approaches to increase adolescent uptake of modern contraceptives in Nigeria, Ethiopia and Tanzania: Population-based, quasi-experimental studies.

Around half of adolescent pregnancies in low- and middle-income countries are unintended, contributing to millions of unsafe abortions per year. Adolescents 360 (A360), a girl-centred initiative, aimed to increase voluntary uptake of modern contraceptives among adolescents in Nigeria, Ethiopia and Tanzania. We evaluated the effectiveness and cost-effectiveness of A360 in increasing modern contraceptive use in selected geographies. We used before-and-after cross-sectional studies of adolescent girls in four settings. Two Nigerian settings had purposefully selected comparison areas. Baseline and endline household surveys were conducted. The primary study outcome was modern contraceptive prevalence rate (mCPR). Secondary outcomes mapped onto the A360 Theory of Change. Interpretation was aided by a process evaluation along with secular mCPR trends and self-reported A360 exposure data. Incremental design and implementation costs were calculated from implementer systems, site visits, surveys, and interviews. mCPR change was modelled into maternal disability-adjusted life years (DALY) averted to calculate incremental cost-effectiveness ratios. In Oromia, Ethiopia, mCPR increased by 5% points (95% CI 1-10; n = 1,697). In Nigeria, there was no evidence of an effect of A360 on mCPR in Nasarawa (risk ratio: 0·96, 95% CI: 0·76-1·21; n = 5,414) or in Ogun (risk ratio: 1·08, 95% CI: 0·92-1·26; n = 3,230). In Mwanza, Tanzania, mCPR decreased by 9% points (-17 to -0.3; n = 1,973). Incremental cost per DALY averted were $30,855 in Oromia, $111,416 in Nasarawa, $30,114 in Ogun, and $25,579 in Mwanza. Costs per DALY averted were 14-53 times gross domestic product per capita. A360 did not lead to increased adolescent use of modern contraceptives at a population level, except in Oromia, and was not cost-effective. This novel adolescent-centred design approach showed some promise in addressing the reproductive health needs of adolescents, but must be accompanied by efforts to address the contextual drivers of low modern contraceptive use.

Potential cost-effectiveness of community availability of tenofovir, lamivudine, and dolutegravir for HIV prevention and treatment in east, central, southern, and west Africa: a modelling analysis.

BACKGROUND: Post-exposure prophylaxis (PEP) offers protection from HIV after condomless sex, but is not widely available in a timely manner in east, central, southern, and west Africa. To inform the potential pilot implementation of such an approach, we modelled the effect and cost-effectiveness of making PEP consisting of tenofovir, lamivudine, and dolutegravir (TLD) freely and locally available in communities without prescription, with the aim of enabling PEP use within 24 h of condomless sex. Free community availability of TLD (referred to as community TLD) might also result in some use of TLD as pre-exposure prophylaxis (PrEP) and as antiretroviral therapy for people living with HIV. METHODS: Using an existing individual-based model (HIV Synthesis), we explicitly modelled the potential positive and negative effects of community TLD. Through the sampling of parameter values we created 1000 setting-scenarios, reflecting the uncertainty in assumptions and a range of settings similar to those seen in east, central, southern, and west Africa (with a median HIV prevalence of 14·8% in women and 8·1% in men). For each setting scenario, we considered the effects of community TLD. TLD PEP was assumed to have at least 90% efficacy in preventing HIV infection after condomless sex with a person living with HIV. FINDINGS: The modelled effects of community TLD availability based on an assumed high uptake of TLD resulted in a mean reduction in incidence of 31% (90% range over setting scenarios, 6% increase to 57% decrease) over 20 years, with an HIV incidence reduction over 50 years in 91% of the 1000 setting scenarios, deaths averted in 55% of scenarios, reduction in costs in 92% of scenarios, and disability-adjusted life-years averted in 64% of scenarios with community TLD. Community TLD was cost-effective in 90% of setting scenarios and cost-saving (with disability-adjusted life-years averted) in 58% of scenarios. When only examining setting scenarios in which there was lower uptake of community TLD, community TLD is cost-effective in 92% of setting scenarios. INTERPRETATION: The introduction of community TLD, enabling greater PEP access, is a promising approach to consider further in pilot implementation projects. FUNDING: Bill & Melinda Gates Foundation to the HIV Modelling Consortium.

Does increased provider effort improve quality of care? Evidence from a standardised patient study on correct and unnecessary treatment.

BACKGROUND: Poor quality of care, including overprovision (unnecessary care) is a global health concern. Greater provider effort has been shown to increase the likelihood of correct treatment, but its relationship with overprovision is less clear. Providers who make more effort may give more treatment overall, both correct and unnecessary, or may have lower rates of overprovision; we test which is true in the Tanzanian private health sector. METHODS: Standardised patients visited 227 private-for-profit and faith-based facilities in Tanzania, presenting with symptoms of asthma and TB. They recorded history questions asked and physical examinations carried out by the provider, as well as laboratory tests ordered, treatments prescribed, and fees paid. A measure of provider effort was constructed on the basis of a checklist of recommended history taking questions and physical exams. RESULTS: 15% of SPs received the correct care for their condition and 74% received unnecessary care. Increased provider effort was associated with increased likelihood of correct care, and decreased likelihood of giving unnecessary care. Providers who made more effort charged higher fees, through the mechanism of higher consultation fees, rather than increased fees for lab tests and drugs. CONCLUSION: Providers who made more effort were more likely to treat patients correctly. A novel finding of this study is that they were also less likely to provide unnecessary care, suggesting it is not simply a case of some providers doing "more of everything", but that those who do more in the consultation give more targeted care.

Large-scale survey of parental antibiotic use for paediatric upper respiratory tract infections in China: implications for stewardship programmes and national policy.

BACKGROUND: Inappropriate use of antibiotics for upper respiratory tract infections (URTIs) in Chinese children is rampant. Parents' decision-making processes with respect to treatment choices and antibiotic use for paediatric URTIs were investigated to identify key constructs for effective interventions that target the public. METHODS: Data were collected between June 2017 and April 2018 from a random cluster sample of 3188 parents of children aged 0-13 years across three Chinese provinces, representing different stages of economic development. Risk factors of parents' treatment choices and antibiotic use for paediatric URTIs were assessed using binary and multinomial logistic regressions, adjusting for socio-demographic characteristics. RESULTS: A total of 1465 (46.0%) children of the 3188 parents who self-diagnosed their children with a URTI were given antibiotics, with or without prescription. Among these children, 40.5% were self-medicated with antibiotics by their parents and 56.1% obtained further antibiotic prescriptions at healthcare facilities. About 70% of children (n=2197) with URTI symptoms sought care; of these, 54.8% obtained antibiotic prescriptions and 7.7% asked for antibiotic prescriptions, with 79.4% successfully obtaining them. Those perceiving antibiotics as effective for treating the common cold and fever (adjusted odds ratio [aOR]=1.82[95% confidence interval, 1.51-2.19] and 1.77[1.47-2.13], respectively), who had access to non-prescription antibiotics (aOR=5.08[4.03-6.39]), and with greater perceived severity of infection (aOR=2.01[1.58-2.56]), were more likely to use antibiotics. CONCLUSIONS: Multifaceted, context-appropriate interventions are vital to untangle the perpetual problem of self-medication, over-prescription and ill-informed demands for antibiotics. The findings in this study emphasise the need to prioritise interventions that enhance clinical training, neutralise the pressure from patients for antibiotics, educate on appropriate home care, discourage antibiotic self-medication and improve antibiotic dispensing.

Lifting lockdown policies: A critical moment for COVID-19 stigma.

COVID-19 'lockdown' policies may have unintended consequences for individuals, households and country economies. Hence lockdown may be unsustainable despite the risk of a resurgence of new COVID-19 infections. The repeal and alteration of lockdown policies mark a symbolic transfer of responsibility for epidemic control from state to individual. This has the potential to catalyse fear, blame and judgement within and between populations. We draw on experience from the HIV pandemic to show that this will worsen during later phases of the pandemic if COVID-19 stigma increases, as we fear it could. We suggest policy recommendations for 'lockdown lifting' to limit COVID-19 stigma. We suggest three policy priorities to minimise potential increases in COVID-19 stigma: limit fear by strengthening risk communication, engage communities to reduce the emergence of blaming, and emphasise social justice to reduce judgement. 'Lockdown' policies cannot continue uninterrupted. However, lifting lockdown without unintended consequences may prove harder than establishing it. This period has the potential to see the emergence of fear, blame and judgement, intersecting with existing inequalities, as governments seek to share responsibility for preventing further Sars-Cov-2 transmission. As we have learned from HIV, it is critical that a wave of COVID-19 stigma is prevented from flourishing.

Treatment as Prevention: Concepts and Challenges for Reducing HIV Incidence.

BACKGROUND: Four of the largest HIV prevention trials have been conducted in sub-Saharan Africa, enrolling hundreds of thousands of participants in catchment areas of millions of people. The trials have focused on community-level interventions to increase diagnosis and initiation of antiretroviral therapy (ART) to improve health and reduce HIV transmission. Universal test-and-treat strategies are deployed to achieve viral suppression thereby reducing risk to uninfected persons, known as treatment as prevention (TasP). PURPOSE: We review the work that found HIV plasma load to correlate with transmission risk, demonstrated that ART could reduce genital tract viral expression, and showed early treatment to be beneficial for persons living with HIV, and that HIV-uninfected sexual partners were protected from infection. We review the seemingly inconsistent findings of the major TasP trials: the TasP [National Agency for AIDS Research (ANRS) 12249] study in South Africa, the SEARCH trial in Kenya and Uganda, the Botswana Combination Prevention Project Ya Tsie study, and the HIV Prevention Trials Network 071 (PopART) trial in Zambia and South Africa. FINDINGS: All the trials reinforce the critical need to identify approaches to optimize programs and incentivize uptake and engagement in HIV testing and ART-based care in ways that consistently reduce HIV transmission. That other chronic conditions can be screened for and treated in the same infrastructures suggests added value of HIV investments. CONCLUSIONS: Implementation challenges are a principal frontier in the global struggle to reduce HIV transmission and mortality using TasP, complementing efforts to find a cure for HIV and an effective, deployable vaccine.

Sexuality, fertility and family planning characteristics of married women aged 15 to 19 years in Ethiopia, Nigeria and Tanzania: a comparative analysis of cross-sectional data.

BACKGROUND: Adolescents 360 (A360) is an initiative being rolled out across Ethiopia, Nigeria and Tanzania with the aim of increasing uptake of voluntary modern contraception among sexually active women aged 15 to 19 years. Using evaluation baseline survey data, we described key sexuality, fertility and contraceptive use characteristics of married women aged 15 to 19 years living in three sub-national settings. METHODS: Cross-sectional baseline surveys of married women aged 15 to 19 years were conducted in Oromia (Ethiopia), Nasarawa (Northern Nigeria), and Mwanza (Tanzania) between August 2017 and February 2018. We also interviewed the husbands of a sub-group of married respondents to measure spousal acceptance and support for adolescent women to use modern contraception. A clustered sampling design was used in all three countries. We produced descriptive statistics on the socio-demographic and sexual and reproductive health characteristics of married women aged 15 to 19 years by study setting. RESULTS: In Oromia, Nasarawa and Mwanza, 31.4% (327/1198), 27.4% (1321/4816) and 7.5% (15/201) of married women surveyed had no education, and 68.3, 81.3 and 83.1% had ever been pregnant, respectively. Unmet need for modern contraception was 20.5, 21.9 and 32.0% in married women in Oromia, Nasarawa and Mwanza, made up almost entirely of unmet need for spacing. The vast majority of married women surveyed in Oromia (89.1%) and Mwanza (90.1%) had seen or heard about contraception in the last 12 months, compared to 30.1% of those surveyed in Nasarawa. Modern contraceptive prevalence (mCPR) was highest in married women aged 15 to 19 years in Oromia (47.2%), followed by Mwanza (19.4%) and Nasarawa (8.7%). Of those using a modern method of contraception in Oromia, 93.4% were using injectables or long-acting methods, compared to 49.4% in Nasarawa and 69.6% in Mwanza. CONCLUSIONS: Overall, unmet need for modern contraception is high among married women aged 15 to 19 years across the three settings. mCPR for married women aged 15 to 19 years is low in Nasarawa and Mwanza. Ultimately, no single intervention will suit all situations, but improving the quality, analyses and utilisation of subnational data can help decision-makers design more context specific interventions.

Translating DREAMS into practice: Early lessons from implementation in six settings.

BACKGROUND: The 'DREAMS Partnership' promotes a multi-sectoral approach to reduce adolescent girls and young women's (AGYW) vulnerability through a core package of interventions targeting multiple sources of HIV risk-to promote Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) lives. Implementation of such multi-sectoral programmes is complex and requires adaptation to national and local contexts. We describe the early implementation of DREAMS in diverse settings, to identify lessons for the scale-up and replication of combination programmes for young people. METHODS: As part of evaluations underway in six DREAMS sites in three countries (Kenya, South Africa and Zimbabwe), we draw on process evaluation data collected from focus group discussions, key informant interviews, and in-depth interviews with beneficiaries, parents/caregivers, programme managers and opinion leaders. Additionally, structured observations were conducted and Gantt charts completed upon consultation with implementers. We concurrently reviewed documentation available on DREAMS and held cross-site discussions to interpret findings. FINDINGS: All sites sought to implement all components of the DREAMS core package, but how and when they were implemented varied by context. Models of delivery differed, with either multiple or single partners responsible for some or all interventions. Key challenges included the urgent and ambitious expectations of DREAMS; 'layering' multiple interventions across different sectors (health, education, social welfare); supporting individuals' journeys between services to improve uptake and retention; engaging communities beyond direct beneficiaries; avoiding perceived/actual exclusivity; and ensuring continuity of commitment and funding for DREAMS. Despite significant challenges, DREAMS was well-received in the communities and perceived by both beneficiaries and implementers to empower AGYW to remain HIV negative. Structures, protocols and tools were introduced to strengthen referrals and deliver services targeted to the age and circumstances of young people. CONCLUSIONS: The benefits of combinations or integrated 'packages' of interventions are increasingly recognised. Early implementation of DREAMS provides useful lessons for improving coordination across multiple partners using a phased, systematic approach, regular adaptions to each unique context, and ensuring community ownership.

Targeted combination prevention to support female sex workers in Zimbabwe accessing and adhering to antiretrovirals for treatment and prevention of HIV (SAPPH-IRe): a cluster-randomised trial.

BACKGROUND: Strengthening engagement of female sex workers with health services is needed to eliminate HIV. We assessed the efficacy of a targeted combination intervention for female sex workers in Zimbabwe. METHODS: We did a cluster-randomised trial from 2014 to 2016. Clusters were areas surrounding female sex worker clinics and were enrolled in matched pairs. Sites were randomly assigned (1:1) to receive usual care (free sexual-health services supported by peer educators, including HIV testing on demand, referral for antiretroviral therapy [ART], and health education) or an intervention that supported additional regular HIV testing, on-site initiation of ART, pre-exposure prophylaxis, adherence, and intensified community mobilisation. The primary outcome was the proportion of all female sex workers with HIV viral load 1000 copies per mL or greater, assessed through respondent-driven sampling surveys. We used an adapted cluster-summary approach to estimate risk differences. This trial is registered with Pan African Clinical Trials Registry, number PACTR201312000722390. RESULTS: We randomly assigned 14 clusters to usual care or the intervention (seven in each group). 3612 female sex workers attended clinics in the usual-care clusters and 4619 in the intervention clusters during the study. Half as many were tested (1151 vs 2606) and diagnosed as being HIV positive (546 vs 1052) in the usual-care clusters. The proportion of all female sex workers with viral loads of 1000 copies per mL or greater fell in both study groups (from 421 [30%] of 1363 to 279 [19%] of 1443 in the usual-care group and from 399 [30%] of 1303 to 240 [16%] of 1439 in the intervention group), but with a risk difference at the end of the assessment period of only -2·8% (95% CI -8·1 to 2·5, p=0·23). Among HIV-positive women, the proportions with viral loads less than 1000 copies per mL were 590 (68%) of 869 in the usual-care group and 588 (72%) of 828 in the intervention group at the end of the assessment period, adjusted risk difference of 5·3% (95% CI -4·0 to 14·6, p=0·20). There were no adverse events. INTERPRETATION: Our intervention of a dedicated programme for female sex workers led to high levels of HIV diagnosis and treatment. Further research is needed to optimise programme content and intensity for the broader population. FUNDING: UN Population Fund (through Zimbabwe's Integrated Support Fund funded by UK Department for International Development, Irish Aid, and Swedish International Development Cooperation Agency).

Evaluating the impact of an intervention to increase uptake of modern contraceptives among adolescent girls (15-19 years) in Nigeria, Ethiopia and Tanzania: the Adolescents 360 quasi-experimental study protocol.

INTRODUCTION: Nigeria, Ethiopia and Tanzania have some of the highest teenage pregnancy rates and lowest rates of modern contraceptive use among adolescents. The transdisciplinary Adolescents 360 (A360) initiative being rolled out across these three countries uses human-centred design to create context-specific multicomponent interventions with the aim of increasing voluntary modern contraceptive use among girls aged 15-19 years. METHODS: The primary objective of the outcome evaluation is to assess the impact of A360 on the modern contraceptive prevalence rate (mCPR) among sexually active girls aged 15-19 years. A360 targets different subpopulations of adolescent girls in the three countries. In Northern Nigeria and Ethiopia, the study population is married girls aged 15-19 years. In Southern Nigeria, the study population is unmarried girls aged 15-19 years. In Tanzania, both married and unmarried girls aged 15-19 years will be included in the study. In all settings, we will use a prepopulation and postpopulation-based cross-sectional survey design. In Nigeria, the study design will also include a comparison group. A one-stage sampling design will be used in Nigeria and Ethiopia. A two-stage sampling design will be used in Tanzania. Questionnaires will be administered face-to-face by female interviewers aged between 18 and 26 years. Study outcomes will be assessed before the start of A360 implementation in late 2017 and approximately 24 months after implementation in late 2019. ETHICS AND DISSEMINATION: Findings of this study will be widely disseminated through workshops, conference presentations, reports, briefings, factsheets and academic publications.

Trials and tribulations: cross-learning from the practices of epidemiologists and economists in the evaluation of public health interventions.

The randomized controlled trial is commonly used by both epidemiologists and economists to test the effectiveness of public health interventions. Yet we have noticed differences in practice between the two disciplines. In this article, we propose that there are some underlying differences between the disciplines in the way trials are used, how they are conducted and how results from trials are reported and disseminated. We hypothesize that evidence-based public health could be strengthened by understanding these differences, harvesting best-practice across the disciplines and breaking down communication barriers between economists and epidemiologists who conduct trials of public health interventions.

Evaluating the impact of DREAMS on HIV incidence among young women who sell sex: protocol for a non-randomised study in Zimbabwe.

BACKGROUND: "Determined, Resilient, AIDS-free, Mentored and Safe" (DREAMS) is a package of biomedical, social and economic interventions offered to adolescent girls and young women aged 10-24 years with the aim of reducing HIV incidence. In four of the six DREAMS districts in Zimbabwe, DREAMS includes an offer of oral pre-exposure prophylaxis (DREAMS+PrEP), alongside interventions to support demand and adherence, to women aged 18-24 who are at highest risk of HIV infection, including young women who sell sex (YWSS). This evaluation study addresses the question: does the delivery of DREAMS+PrEP through various providers reduce HIV incidence among YWSS Zimbabwe? We describe our approach to designing a rigorous study to assess whether DREAMS+PrEP had an impact on HIV incidence. METHODS: The study design needed to account for the fact that: 1) DREAMS+PrEP was non-randomly allocated; 2) there is no sampling frame for the target population for the evaluation; 3) there are a small number of DREAMS districts (N = 6), and 4) DREAMS+PrEP is being implemented by various providers. The study will use a cohort analysis approach to compare HIV incidence among YWSS in two DREAMS+PrEP districts to HIV incidence among YWSS in non-DREAMS comparison sites. YWSS will be referred to services and recruited into the cohort through a network-based (respondent-driven) recruitment strategy, and followed-up 12- and 24-months after enrolment. Women will be asked to complete a questionnaire and offered HIV testing. Additional complications of this study include identifying comparable populations of YWSS in the DREAMS+PrEP and non-DREAMS comparison sites, and retention of YWSS over the 24-month period. The primary outcome is HIV incidence among YWSS HIV-negative at study enrolment measured by repeat, rapid HIV testing over 24-months. Inference will be based on plausibility that DREAMS+PrEP had an impact on HIV incidence. A process evaluation will be conducted to understand intervention implementation, and document any contextual factors determining the success or failure of intervention delivery. DISCUSSION: HIV prevention products of known efficacy are available. Innovative studies are needed to provide evidence of how to optimise product use through combination interventions to achieve population impact within different contexts. We describe the design of such a study.

The HIV Care Cascade Among Female Sex Workers in Zimbabwe: Results of a Population-Based Survey From the Sisters Antiretroviral Therapy Programme for Prevention of HIV, an Integrated Response (SAPPH-IRe) Trial.

INTRODUCTION: Female sex workers (FSW) in sub-Saharan Africa have a higher prevalence of HIV than other women of reproductive age. Social, legal, and structural barriers influence their access to care. Little is known about the HIV diagnosis and care cascade in most countries in Southern Africa. We aimed to describe the HIV diagnosis and care cascade among FSW in Zimbabwe. METHODS: We conducted cross-sectional respondent driven sampling (RDS) surveys of FSW in 14 sites across Zimbabwe as the baseline for a cluster-randomised controlled trial investigating a combination HIV prevention and care package. We administered a questionnaire, tested women for HIV and measured viral load. We report the mean, minimum, and maximum respondent-driven sampling-2 weighted site values. RESULTS: The survey included 2722 women, approximately 200 per site. The mean HIV prevalence was 57.5% (42.8-79.2 site minimum and maximum). Of HIV-positive women, 64.0% (51.6-73.7) were aware of their status, 67.7% (53.4-84.1) of these reported taking antiretroviral therapy, and 77.8% (64.4-90.8) of these had a suppressed HIV viral load (<1000 copies/mL). Among all HIV-positive women, 49.5% had a viral load < 1000 copies/mL. CONCLUSIONS: Although most HIV-positive women aware of their status are accessing antiretroviral therapy, 36.0% of HIV-positive women are unaware of their status and 29.3% of all FSW have an unsuppressed HIV viral load. Investigation and investment into models of testing, treatment, and care are necessary to reach UNAIDS targets for HIV elimination.

The HIV prevention cascade: integrating theories of epidemiological, behavioural, and social science into programme design and monitoring.

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.

Towards cash transfer interventions for tuberculosis prevention, care and control: key operational challenges and research priorities.

BACKGROUND: Cash transfer interventions are forms of social protection based on the provision of cash to vulnerable households with the aim of reduce risk, vulnerability, chronic poverty and improve human capital. Such interventions are already an integral part of the response to HIV/AIDS in some settings and have recently been identified as a core element of World Health Organization's End TB Strategy. However, limited impact evaluations and operational evidence are currently available to inform this policy transition. DISCUSSION: This paper aims to assist national tuberculosis (TB) programs with this new policy direction by providing them with an overview of concepts and definitions used in the social protection sector and by reviewing some of the most critical operational aspects associated with the implementation of cash transfer interventions. These include: 1) the various implementation models that can be used depending on the context and the public health goal of the intervention; 2) the main challenges associated with the use of conditionalities and how they influence the impact of cash transfer interventions on health-related outcomes; 3) the implication of targeting diseases-affected households and or individuals versus the general population; and 4) the financial sustainability of including health-related objectives within existing cash transfer programmes. We aimed to appraise these issues in the light of TB epidemiology, care and prevention. For our appraisal we draw extensively from the literature on cash transfers and build upon the lessons learnt so far from other health outcomes and mainly HIV/AIDS. CONCLUSIONS: The implementation of cash transfer interventions in the context of TB is still hampered by important knowledge gaps. Initial directions can be certainly derived from the literature on cash transfers schemes and other public health challenges such as HIV/AIDS. However, the development of a solid research agenda to address persisting unknowns on the impact of cash transfers on TB epidemiology and control is vital to inform and support the adoption of the post-2015 End TB strategy.

Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014.

BACKGROUND: In a stepped wedge, cluster randomised trial, clusters receive the intervention at different time points, and the order in which they received it is randomised. Previous systematic reviews of stepped wedge trials have documented a steady rise in their use between 1987 and 2010, which was attributed to the design's perceived logistical and analytical advantages. However, the interventions included in these systematic reviews were often poorly reported and did not adequately describe the analysis and/or methodology used. Since 2010, a number of additional stepped wedge trials have been published. This article aims to update previous systematic reviews, and consider what interventions were tested and the rationale given for using a stepped wedge design. METHODS: We searched PubMed, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Web of Science, the Cochrane Library and the Current Controlled Trials Register for articles published between January 2010 and May 2014. We considered stepped wedge randomised controlled trials in all fields of research. We independently extracted data from retrieved articles and reviewed them. Interventions were then coded using the functions specified by the Behaviour Change Wheel, and for behaviour change techniques using a validated taxonomy. RESULTS: Our review identified 37 stepped wedge trials, reported in 10 articles presenting trial results, one conference abstract, 21 protocol or study design articles and five trial registrations. These were mostly conducted in developed countries (n = 30), and within healthcare organisations (n = 28). A total of 33 of the interventions were educationally based, with the most commonly used behaviour change techniques being 'instruction on how to perform a behaviour' (n = 32) and 'persuasive source' (n = 25). Authors gave a wide range of reasons for the use of the stepped wedge trial design, including ethical considerations, logistical, financial and methodological. The adequacy of reporting varied across studies: many did not provide sufficient detail regarding the methodology or calculation of the required sample size. CONCLUSIONS: The popularity of stepped wedge trials has increased since 2010, predominantly in high-income countries. However, there is a need for further guidance on their reporting and analysis.