Gender-transformative programmes: a framework for demonstrating evidence of social impact.

Ample evidence has demonstrated that gender inequality and restrictive gender norms wield significant influence over health outcomes. While gender-transformative programmes have grown with the aim of challenging these norms and promoting gender equality, their effectiveness in driving sustainable norm change remains a subject of debate. This paper introduces a comprehensive analytical framework designed to assess the impact of these programmes.Drawing from extensive literature reviews of rigorously evaluated health programmes, this framework identifies four key dimensions that are instrumental in determining a programme's potential for transformative change. These dimensions are multiplicative effect, sustainability, spread and scalability. Multiplicative effect emphasises the interconnected nature of societal systems, positing that altering one element can trigger cascading effects throughout the entire system. Sustainability recognises that change within a system is less likely to revert once the structure has shifted. Programmes that facilitate norm change are more likely to sustain the changes brought about by their interventions. Spread acknowledges the importance of engaging entire networks that share the targeted norms. Successful programmes should demonstrate evidence of gender-related outcomes extending beyond the immediate beneficiaries, progressively diffusing through the broader population. Finally, scalability emphasises the need to bring gender-transformative initiatives to a larger scale to effect broader norm change.By aligning programme design and evaluation with these four dimensions, the proposed framework provides a standardised approach for assessing gender-transformative programmes. It shifts the focus from individual-level change to systemic transformation, bridging the gap between programmatic aspirations and the ability to measure genuine progress.

Frontiers of household water insecurity metrics: severity, adaptation and resilience.

The measurement of household-level and individual-level water insecurity has accelerated over the past 5 years through innovation and dissemination of new survey-based experiential psychometric scales modelled after food insecurity scales. These measures offer needed insight into the relative frequency of various dimensions of water problems experienced by households or individuals. But they currently tell us nothing about the severity of these experiences, mitigating behaviours (ie, adaptation) or the effectiveness of water-related behaviours (ie, resilience). Given the magnitude of the global challenge to provide water security for all, we propose a low-cost, theoretically grounded modification to common water insecurity metrics in order to capture information about severity, adaptation and resilience. We also discuss ongoing challenges in cost-effective measurement related to multidimensionality, water affordability and perception of water quality for maximising the impact and sustainability of water supply interventions. The next generation of water insecurity metrics promises better monitoring and evaluation tools-particularly in the context of rapid global environmental change-once scale reliability across diverse contexts is better characterised.

Is there a role for RDTs as we live with COVID-19? An assessment of different strategies.

INTRODUCTION: By 2022, high levels of past COVID-19 infections, combined with substantial levels of vaccination and the development of Omicron, have shifted country strategies towards burden reduction policies. SARS-CoV-2 rapid antigen tests (rapid diagnostic tests (RDTs)) could contribute to these policies by helping rapidly detect, isolate and/or treat infections in different settings. However, the evidence to inform RDT policy choices in low and middle-income countries (LMICs) is limited. METHOD: We provide an overview of the potential impact of several RDT use cases (surveillance; testing, tracing and isolation without and with surveillance; hospital-based screening to reduce nosocomial COVID-19; and testing to enable earlier/expanded treatment) for a range of country settings. We use conceptual models and literature review to identify which use cases are likely to bring benefits and how these may change with outbreak characteristics. Impacts are measured through multiple outcomes related to gaining time, reducing the burden on the health system and reducing deaths. RESULTS: In an optimal scenario in terms of resources and capacity and with baseline parameters, we find marginal time gains of 4 days or more through surveillance and testing tracing and isolation with surveillance, a reduction in peak intensive care unit (ICU) or ICU admissions by 5% or more (hospital-based screening; testing, tracing and isolation) and reductions in COVID-19 deaths by over 6% (hospital-based screening; test and treat). Time gains may be used to strengthen ICU capacity and/or boost vulnerable individuals, though only a small minority of at-risk individuals could be reached in the time available. The impact of RDTs declines with lower country resources and capacity, more transmissible or immune-escaping variants and reduced test sensitivity. CONCLUSION: RDTs alone are unlikely to dramatically reduce the burden of COVID-19 in LMICs, though they may have an important role alongside other interventions such as vaccination, therapeutic drugs, improved healthcare capacity and non-pharmaceutical measures.

The impact of pulse oximetry on diagnosis, management and outcomes of acute febrile illness in low-income and middle-income countries: a systematic review.

BACKGROUND: Acute fever is a common presenting symptom in low/middle-income countries (LMICs) and is strongly associated with sepsis. Hypoxaemia predicts disease severity in such patients but is poorly detected by clinical examination. Therefore, including pulse oximetry in the assessment of acutely febrile patients may improve clinical outcomes in LMIC settings. METHODS: We systematically reviewed studies of any design comparing one group where pulse oximetry was used and at least one group where it was not. The target population was patients of any age presenting with acute febrile illness or associated syndromes in LMICs. Studies were obtained from searching PubMed, EMBASE, CABI Global Health, Global Index Medicus, CINAHL, Cochrane CENTRAL, Web of Science and DARE. Further studies were identified through searches of non-governmental organisation websites, snowballing and input from a Technical Advisory Panel. Outcomes of interest were diagnosis, management and patient outcomes. Study quality was assessed using the Cochrane Risk of Bias 2 tool for Cluster Randomised Trials and Risk of Bias in Non-randomized Studies of Interventions tools, as appropriate. RESULTS: Ten of 4898 studies were eligible for inclusion. Their small number and heterogeneity prevented formal meta-analysis. All studies were in children, eight only recruited patients with pneumonia, and nine were conducted in Africa or Australasia. Six were at serious risk of bias. There was moderately strong evidence for the utility of pulse oximetry in diagnosing pneumonia and identifying severe disease requiring hospital referral. Pulse oximetry used as part of a quality-assured facility-wide package of interventions may reduce pneumonia mortality, but studies assessing this endpoint were at serious risk of bias. CONCLUSIONS: Very few studies addressed this important question. In LMICs, pulse oximetry may assist clinicians in diagnosing and managing paediatric pneumonia, but for the greatest impact on patient outcomes should be implemented as part of a health systems approach. The evidence for these conclusions is not widely generalisable and is of poor quality.

Effect of mobile application user interface improvements on minimum expected home visit coverage by community health workers in Mali: a randomised controlled trial.

BACKGROUND: Proactive community case management (ProCCM) has shown promise to advance goals of universal health coverage (UHC). ProCCM community health workers (CHWs) face operational challenges when pursuing their goal of visiting every household in their service area at least twice monthly to proactively find sick patients. We developed a software extension (UHC Mode) to an existing CHW mobile application featuring user interface design improvements to support CHWs in planning daily home visits. We evaluated the effect of UHC Mode on minimum expected home visit coverage. METHODS: We conducted a parallel-group, two-arm randomised controlled trial of ProCCM CHWs in two separate regions in Mali. CHWs were randomly assigned to UHC Mode or the standard mobile application (control) with a 1:1 allocation. Randomisation was stratified by health catchment area. CHWs and other programme personnel were not masked to arm allocation. CHWs used their assigned intervention for 4 months. Using a difference-in-differences analysis, we estimated the mean change in minimum expected home visit coverage from preintervention to postintervention between arms. RESULTS: Enrolment occurred in January 2019. Of 199 eligible CHWs randomised to the intervention or control arm, 196 were enrolled and 195 were included in the analysis. Households whose CHW used UHC Mode had 2.41 times higher odds of minimum expected home visit coverage compared with households whose CHW used the control (95% CI 1.68 to 3.47; p<0.0005). Minimum expected home visit coverage in the UHC Mode arm increased 13.6 percentage points (95% CI 8.1 to 19.0) compared with the control arm. CONCLUSION: Our findings suggest UHC Mode is an effective tool that can improve home visit coverage and promote progress towards UHC when implemented in the ProCCM context. User interface design of health information systems that supports health workers' daily practices and meets their requirements can have a positive impact on health worker performance and home visit coverage. TRIAL REGISTRATION NUMBER: NCT04106921.

ASHA Kirana: when digital technology empowered front-line health workers.

This practice paper describes our experience of implementing accredited social health activists (ASHA) Kirana, a digital technology-enabled Maternal Clinical Assessment Tool (M-CAT) and how the ASHAs felt empowered in the process. M-CAT aimed to train ASHAs to collect data that assists doctors in identifying maternal risks, in Karnataka, India. Systematic clinical assessment is not common in rural public health institutions. High caseloads, a tendency to 'normalise' maternal risks, varied competence of doctors and task shifting to insufficiently trained cadres may be some contributing factors. M-CAT was a response to this challenge. ASHAs asked a set symptom-cluster-based questions during home visits that were analysed by software algorithms to generate reports for doctors. M-CAT was implemented in one primary health centre with a group of 14 ASHAs, 2 auxiliary nurse midwives and 349 pregnant and postpartum women over 4 months. Our team worked with the ASHAs to refine the tool and supported them with training, hands-on assistance and regular debrief meetings. By learning how to collect individual-level data that they could interpret and act on, the ASHAs felt empowered with new knowledge on maternal risks. Their perfunctory data collection at home visits changed to substantive interactions with women and families, during which they captured pertinent qualitative information. The information asymmetry between doctors and ASHAs reduced. ASHAs started taking proactive steps on early indications of maternal risks. They changed from being mere transmitters of information to active users of it. Thus, technology-driven initiatives that include empowerment as an objective can strengthen the role of front-line workers in health systems.

Effect of peer-distributed HIV self-test kits on demand for biomedical HIV prevention in rural KwaZulu-Natal, South Africa: a three-armed cluster-randomised trial comparing social networks versus direct delivery.

STUDY OBJECTIVE: We investigated two peer distribution models of HIV self-testing (HIVST) in HIV prevention demand creation compared with trained young community members (peer navigators). METHODS: We used restricted randomisation to allocate 24 peer navigator pairs (clusters) in KwaZulu-Natal 1:1:1: (1) standard of care (SOC): peer navigators distributed clinic referrals, pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) information to 18-30 year olds. (2) peer navigator direct distribution (PND): Peer navigators distributed HIVST packs (SOC plus two OraQuick HIVST kits) (3) incentivised peer networks (IPN): peer navigators recruited young community members (seeds) to distribute up to five HIVST packs to 18-30 year olds within their social networks. Seeds received 20 Rand (US$1.5) for each recipient who distributed further packs. The primary outcome was PrEP/ART linkage, defined as screening for PrEP/ART eligibility within 90 days of pack distribution per peer navigator month (pnm) of outreach, in women aged 18-24 (a priority for HIV prevention). Investigators and statisticians were blinded to allocation. Analysis was intention to treat. Total and unit costs were collected prospectively. RESULTS: Between March and December 2019, 4163 packs (1098 SOC, 1480 PND, 1585 IPN) were distributed across 24 clusters. During 144 pnm, 272 18-30 year olds linked to PrEP/ART (1.9/pnm). Linkage rates for 18-24-year-old women were lower for IPN (n=26, 0.54/pnm) than PND (n=45, 0.80/pnm; SOC n=49, 0.85/pnm). Rate ratios were 0.68 (95% CI 0.28 to 1.66) for IPN versus PND, 0.64 (95% CI 0.26 to 1.62) for IPN versus SOC and 0.95 (95% CI 0.38 to 2.36) for PND versus SOC. In 18-30 year olds, PND had significantly more linkages than IPN (2.11 vs 0.88/pnm, RR 0.42, 95% CI 0.18 to 0.98). Cost per pack distributed was cheapest for IPN (US$36) c.f. SOC (US$64). Cost per person linked to PrEP/ART was cheaper in both peer navigator arms compared with IPN. DISCUSSION: HIVST did not increase demand for PrEP/ART. Incentivised social network distribution reached large numbers with HIVST but resulted in fewer linkages compared with PrEP/ART promotion by peer navigators. TRIAL REGISTRATION NUMBER: NCT03751826.

Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi.

INTRODUCTION: Reaching high coverage of HIV testing remains essential for HIV diagnosis, treatment and prevention. We evaluated the effectiveness and safety of door-to-door distribution of HIV self-testing (HIVST) kits in rural Malawi. METHODS: This cluster randomised trial, conducted between September 2016 and January 2018, used restricted 1:1 randomisation to allocate 22 health facilities and their defined areas to door-to-door HIVST alongside the standard of care (SOC) or the SOC alone. The study population included residents (≥16 years). HIVST kits were provided door-to-door by community-based distribution agents (CBDAs) for at least 12 months. The primary outcome was recent HIV testing (in the last 12 months) measured through an endline survey. Secondary outcomes were lifetime HIV testing and cumulative 16-month antiretroviral therapy (ART) initiations, which were captured at health facilities. Social harms were reported through community reporting systems. Analysis compared cluster-level outcomes by arm. RESULTS: Overall, 203 CBDAs distributed 273 729 HIVST kits. The endline survey included 2582 participants in 11 HIVST clusters and 2908 participants in 11 SOC clusters. Recent testing was higher in the HIVST arm (68.5%, 1768/2582) than the SOC arm (48.9%, 1422/2908), with adjusted risk difference (RD) of 16.1% (95% CI 6.5% to 25.7%). Lifetime testing was also higher in the HIVST arm (86.9%, 2243/2582) compared with the SOC arm (78.5%, 2283/2908; adjusted RD 6.3%, 95% CI 2.3% to 10.3%). Differences were most pronounced for adolescents aged 16-19 years (adjusted RD 18.6%, 95% CI 7.3% to 29.9%) and men (adjusted RD 10.2%, 95% CI 3.1% to 17.2%). Cumulative incidence of ART initiation was 1187.2 and 909.0 per 100 000 population in the HIVST and SOC arms, respectively (adjusted RD 309.1, 95% CI -95.5 to 713.7). Self-reported HIVST use was 42.5% (1097/2582), with minimal social harms reported. CONCLUSION: Door-to-door HIVST increased recent and lifetime testing at population level and showed high safety, underscoring potential for HIVST to contribute to HIV elimination goals in priority settings. TRIAL REGISTRATION NUMBER: NCT02718274.

Pragmatic economic evaluation of community-led delivery of HIV self-testing in Malawi.

INTRODUCTION: Community-based strategies can extend coverage of HIV testing and diagnose HIV at earlier stages of infection but can be costly to implement. We evaluated the costs and effects of community-led delivery of HIV self-testing (HIVST) in Mangochi District, Malawi. METHODS: This economic evaluation was based within a pragmatic cluster-randomised trial of 30 group village heads and their catchment areas comparing the community-led HIVST intervention in addition to the standard of care (SOC) versus the SOC alone. The intervention involved mobilising community health groups to lead 7-day HIVST campaigns including distribution of HIVST kits. The SOC included facility-based HIV testing services. Primary costings estimated economic costs of the intervention and SOC from the provider perspective, with costs annualised and measured in 2018 US$. A postintervention survey captured individual-level data on HIV testing events, which were combined with unit costs from primary costings, and outcomes. The incremental cost per person tested HIV-positive and associated uncertainty were estimated. RESULTS: Overall, the community-led HIVST intervention costed $138 624 or $5.70 per HIVST kit distributed, with test kits and personnel the main contributing costs. The SOC costed $263 400 or $4.57 per person tested. Individual-level provider costs were higher in the community-led HIVST arm than the SOC arm (adjusted mean difference $3.77, 95% CI $2.44 to $5.10; p<0.001), while the intervention effect on HIV positivity varied based on adjustment for previous diagnosis. The incremental cost per person tested HIV positive was $324 but increased to $1312 and $985 when adjusting for previously diagnosed self-testers or self-testers on treatment, respectively. Community-led HIVST demonstrated low probability of being cost-effective against plausible willingness-to-pay values, with HIV positivity a key determinant. CONCLUSION: Community-led HIVST can provide HIV testing at a low additional unit cost. However, adding community-led HIVST to the SOC was not likely to be cost-effective, especially in contexts with low prevalence of undiagnosed HIV. TRIAL REGISTRATION NUMBER: NCT03541382.

The Structural and Intercultural Competence for Epidemiological Studies (SICES) guidelines: a 22-item checklist.

Structural and intercultural competence approaches have been widely applied to fields such as medical training, healthcare practice, healthcare policies and health promotion. Nevertheless, their systematic implementation in epidemiological research is absent. Based on a scoping review and a qualitative analysis, in this article we propose a checklist to assess cultural and structural competence in epidemiological research: the Structural and Intercultural Competence for Epidemiological Studies guidelines. These guidelines are organised as a checklist of 22 items and consider four dimensions of competence (awareness and reflexivity, cultural and structural validation, cultural and structural sensitivity, and cultural and structural representativeness), which are applied to the different stages of epidemiological research: (1) research team building and research questions; (2) study design, participant recruitment, data collection and data analysis; and (3) dissemination. These are the first guidelines addressing structural and cultural competence in epidemiological inquiry.

Leapfrogging laboratories: the promise and pitfalls of high-tech solutions for antimicrobial resistance surveillance in low-income settings.

The scope and trajectory of today's escalating antimicrobial resistance (AMR) crisis is inadequately captured by existing surveillance systems, particularly those of lower income settings. AMR surveillance systems typically collate data from routine culture and susceptibility testing performed in diagnostic bacteriology laboratories to support healthcare. Limited access to high quality culture and susceptibility testing results in the dearth of AMR surveillance data, typical of many parts of the world where the infectious disease burden and antimicrobial need are high. Culture and susceptibility testing by traditional techniques is also slow, which limits its value in infection management. Here, we outline hurdles to effective resistance surveillance in many low-income settings and encourage an open attitude towards new and evolving technologies that, if adopted, could close resistance surveillance gaps. Emerging advancements in point-of-care testing, laboratory detection of resistance through or without culture, and in data handling, have the potential to generate resistance data from previously unrepresented locales while simultaneously supporting healthcare. Among them are microfluidic, nucleic acid amplification technology and next-generation sequencing approaches. Other low tech or as yet unidentified innovations could also rapidly accelerate AMR surveillance. Parallel advances in data handling further promise to significantly improve AMR surveillance, and new frameworks that can capture, collate and use alternate data formats may need to be developed. We outline the promise and limitations of such technologies, their potential to leapfrog surveillance over currently available, conventional technologies in use today and early steps that health systems could take towards preparing to adopt them.

Whole-genome sequencing as part of national and international surveillance programmes for antimicrobial resistance: a roadmap.

The global spread of antimicrobial resistance (AMR) and lack of novel alternative treatments have been declared a global public health emergency by WHO. The greatest impact of AMR is experienced in resource-poor settings, because of lack of access to alternative antibiotics and because the prevalence of multidrug-resistant bacterial strains may be higher in low-income and middle-income countries (LMICs). Intelligent surveillance of AMR infections is key to informed policy decisions and public health interventions to counter AMR. Molecular surveillance using whole-genome sequencing (WGS) can be a valuable addition to phenotypic surveillance of AMR. WGS provides insights into the genetic basis of resistance mechanisms, as well as pathogen evolution and population dynamics at different spatial and temporal scales. Due to its high cost and complexity, WGS is currently mainly carried out in high-income countries. However, given its potential to inform national and international action plans against AMR, establishing WGS as a surveillance tool in LMICs will be important in order to produce a truly global picture. Here, we describe a roadmap for incorporating WGS into existing AMR surveillance frameworks, including WHO Global Antimicrobial Resistance Surveillance System, informed by our ongoing, practical experiences developing WGS surveillance systems in national reference laboratories in Colombia, India, Nigeria and the Philippines. Challenges and barriers to WGS in LMICs will be discussed together with a roadmap to possible solutions.

Diagnostic performance of a point-of-care saliva urea nitrogen dipstick to screen for kidney disease in low-resource settings where serum creatinine is unavailable.

BACKGROUND: Kidney disease is prevalent in low-resource settings worldwide, but tests for its diagnosis are often unavailable. The saliva urea nitrogen (SUN) dipstick is a laboratory and electricity independent tool, which may be used for the detection of kidney disease. We investigated the feasibility and performance of its use in diagnosing kidney disease in community settings in Africa. METHODS: Adult patients at increased risk of kidney disease presenting to three community health centres, a rural district hospital and a central hospital in Malawi were recruited between October 2016 and September 2017. Patients underwent concurrent SUN and creatinine testing at enrolment, and at 1 week, 1 month, 3 months and 6 months thereafter. RESULTS: Of 710 patients who presented at increased risk of kidney disease, 655 (92.3%) underwent SUN testing at enrolment, and were included (aged 38 (29-52) years, 367 (56%) female and 333 (50.8%) with HIV). Kidney disease was present in 482 (73.6%) patients and 1479 SUN measurements were made overall. Estimated glomerular filtration rate (eGFR) correlated with SUN (r=-0.39; p<0.0001). The area under the receiver operating characteristics curve was 0.61 for presenting SUN to detect acute or chronic kidney disease, and 0.87 to detect severe (eGFR <15 mL/min/1.73 m2) kidney disease (p<0.0001; sensitivity 82.3%, specificity 81.8%, test accuracy 81.8%). In-hospital mortality was greater if enrolment SUN was elevated (>test pad #1) compared with patients with non-elevated SUN (p<0.0001; HR 3.3 (95% CI 1.7 to 6.1). CONCLUSIONS: SUN, measured by dipstick, is feasible and may be used to screen for kidney disease in low resource settings where creatinine tests are unavailable.

Redefining typhoid diagnosis: what would an improved test need to look like?

INTRODUCTION: Typhoid fever is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases and 116.8 thousand deaths in 2017. Typhoid point-of-care (POC) diagnostic tests are widely used but have poor sensitivity and specificity, resulting in antibiotic overuse that has led to the emergence and spread of multidrug-resistant strains. With recent advances in typhoid surveillance and detection, this is the ideal time to produce a target product profile (TPP) that guides product development and ensure that a next-generation test meets the needs of users in the resource-limited settings where typhoid is endemic. METHODS: A structured literature review was conducted to develop a draft TPP for a next-generation typhoid diagnostic test with minimal and optimal desired characteristics for 36 test parameters. The TPP was refined using feedback collected from a Delphi survey of key stakeholders in clinical medicine, microbiology, diagnostics and public and global health. RESULTS: A next-generation typhoid diagnostic test should improve patient management through the diagnosis and treatment of infection with acute Salmonella enterica serovars Typhi or Paratyphi with a sensitivity ≥90% and specificity ≥95%. The test would ideally be used at the lowest level of the healthcare system in settings without a reliable power or water supply and provide results in <15 min at a cost of