Cluster-randomized Intervention Research Articles

The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial

BackgroundThe risk of breast cancer patients for long-term side effects of therapy such as neurotoxicity and cardiotoxicity as well as late effects regarding comorbidities varies from individual to individual. Personalised follow-up care concepts that are tailored to individual needs and the risk of recurrences, side effects and late effects are lacking in routine care in Germany.MethodsWe describe the methodology of BETTER-CARE, a parallel-arm cluster-randomised controlled trial conducted at 15 intervention and 15 control centres, aiming to recruit 1140 patients, and the results of the pilot phase. The needs- and risk-adapted complex intervention, based on existing development frameworks, includes a multidisciplinary network and digital platforms for symptom and need documentation and just-in-time adaptive interventions. The control group comprises usual care according to clinical guidelines. The primary outcome is health-related quality of life (EORTC QLQ-C30 global health), and secondary outcomes include treatment adherence.ResultsThe 2-month pilot phase comprising 16 patients in one intervention and one control pilot centre demonstrated the feasibility of the BETTER-CARE approach.DiscussionBETTER-CARE is a feasible intervention and study concept, investigating individualised needs- and risk-adapted breast cancer follow-up care in Germany. If successful, the approach could be implemented in German routine care.Trial registrationGerman Clinical Trial Register DRKS00028840. Registered on April 2022.

Parental norms and attitudes in Relation to Children’s sugar consumption − A mediation analysis of the “Are You Too Sweet?” intervention study

Parental influence on children’s dietary behaviour makes parents an obvious target for prevention strategies with nutritional foci. Mediation analysis is considered a valuable tool for understanding the underlying mechanisms of influence in intervention studies aimed at implementing behaviour change strategies.The present study used data from the multi-component cluster-randomised intervention “Are You Too Sweet?” with 153 Danish children (5–7 years) to explore mediating effects and role of parental determinants on added sugar intake in children.A pre-and post-intervention questionnaire evaluated parental knowledge, practices, self-efficacy, norms, and attitudes. Children’s dietary intake was estimated from a seven-day dietary record. Associations between children’s added sugar intake and parental responses and changes in responses following the intervention were evaluated using linear mixed models. Exploring potential behaviour change pathways of the intervention was done using mediation analyses.Children’s reduction in added sugar consumption was partly mediated by changes in parental norms and attitudes regarding limiting sugar-rich foods and drinks to special occasions. Parental knowledge of guidelines on the intake of sugar-rich discretionary foods and drinks increased as an intervention effect but did not demonstrate a mediating effect. No significant changes or mediating effects were found in parental self-efficacy or practices.The findings highlight parental norms and attitudes regarding restricting sugar-rich foods and drinks to special occasions as modifiable and a mediator for reducing added sugar intake in the “Are You Too Sweet?” intervention study.Trial registration: Retrospectively registered at ISRCTN: ISRCTN10409779.

Understanding menstrual factors associated with poor mental health among female secondary school students in Uganda: a cross-sectional analysis

BackgroundThere is growing global concern about poor mental health among adolescents in sub-Saharan Africa. In particular, adolescent girls face multiple challenges in managing menstruation which can impact both their health and wellbeing. In this study we address an evidence gap on the association of a broad range of menstrual-related factors with mental health problems amongst secondary school female adolescents in Uganda.MethodsWe used baseline data from a cluster-randomised menstrual health intervention trial conducted in 60 secondary schools in two districts in Uganda. Baseline data were collected between March and July 2022, including socio-demographic characteristics, menstrual knowledge and attitudes, menstrual practices and self-efficacy, and mental health problems measured using the Strengths and Difficulties Questionnaire Total Difficulties score (SDQ-25). We used random-effects linear regression to estimate the adjusted mean difference (aMD) for the association between mental health problems (SDQ Total Difficulties Score) and menstrual-related factors, including the Menstrual Practice Needs Scale (MPNS) and the Self-Efficacy in Addressing Menstrual Needs scale (SAMNS)), accounting for school-level clustering and adjusting for prior confounders.ResultsAmong the 3841 female participants, there was strong and consistent evidence of associations between mental health problems and menstrual-related factors. Mental health problems were associated with poor knowledge about menstruation (aMD = 1.17, 95%CI 0.50, 1.84 <0.001), using disposable and reusable menstrual products compared to using just disposable products (aMD = 1.42, 95%CI 0.92, 1.92, p <0.001), and experiencing menstrual pain even when using an effective management method at last menstrual period (LMP) compared to those experiencing no pain (aMD = 1.60, 95%CI 1.19, 2.01, p <0.001). Mental health problems were also associated with greater unmet menstrual needs according to the MPNS (aMD = 4.40 95%CI 3.96, 4.84, p <0.001), and with lower menstrual self-efficacy measured by the SAMNS (aMD = 0.94 95% CI 0.51, 1.37, p <0.001).ConclusionThis study shows strong evidence that mental health problems reported by adolescent girls in Uganda are associated with poor menstrual health. The association between menstrual health and mental health provides evidence as to why menstrual health should be a public health priority.Trial registrationTrial registration: ISRCTN 45461276. Registered on 16 September 2021.

Family-centered Health Education Intervention for Improving Iron-folic Acid Adherence and Anemia Reduction among Antenatal Mothers in Rural Jodhpur: A Quasi-experimental Study.

Anemia is one of the global public health concerns. Despite the availability of effective treatment options, reducing its prevalence remains challenging. The objectives of this study were to investigate family-centered health education intervention in improving iron - folic acid adherence and anemia status, knowledge, attitude, and practices. A quasi-experimental community interventional trial was conducted. Employing a multistage cluster-randomized sampling technique, intervention and control areas were identified. All pregnant women of gestational age 14-16 weeks with mild and moderate anemia were included and interviewed along with hemoglobin and ferritin estimation. Change in adherence, knowledge, attitude, practice, and anemia status was assessed after the follow-up period for both groups. The results revealed significant improvements in knowledge, attitude, practice, adherence to iron supplements, and anemia status within the intervention group. The participants with moderate anemia decreased from an initial value of 38.66% to 7.25%, whereas mild anemia reduced from 61.33% to 21.74%. Moreover, the mean hemoglobin level showed a significant difference from 9.8 ± 1.3 g/dL at baseline to 10.8 ± 0.5 g/dL at the end line, whereas the serum ferritin level increased from 12.5 ± 8.7 μg/dL to 19.0 ± 7.6 μg/dL. The difference-in-difference analysis revealed 0.78 g/dL hemoglobin and 4.72 μg/dL ferritin improvement in the intervention group is due to family-centered health education. Family-centered health education in multiple modes of intervention improved the adherence to iron supplements and anemia status and increased the knowledge, attitude, and practices toward the same, among pregnant women along with their family members.

Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial

BackgroundAlthough the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physical activity, the educational system in Bavaria, Germany, has recently integrated the promotion of physical activity-related health competence (PAHCO) into the nursing curriculum. However, it cannot be assumed that PAHCO has sufficiently permeated the educational practices and routines of the nursing schools. Therefore, the goal of the present study is to examine and compare the effectiveness as well as implementation of different intervention approaches to address PAHCO in the Bavarian nursing school system.MethodsWe randomly assign 16 nursing schools (cluster-based) to four study arms (bottom-up, top-down led by teachers, top down led by external physical activity experts, control group). Schools in intervention group 1 (IG-1) develop multicomponent inventions to target PAHCO via cooperative planning (preparation, planning, and implementation phase). Intervention groups 2 and 3 (IG-2, IG-3) receive both an expert-based intervention (developed through intervention mapping) via trained mediators to address PAHCO. External physical activity experts deliver the structured PAHCO intervention in IG-2, while teachers from the nursing schools themselves conduct the PAHCO intervention in IG-3. In line with a hybrid effectiveness implementation trial, we apply questionnaire-based pre-post measurements across all conditions (sample size calculation: nfinal = 636) to examine the effectiveness of the intervention approaches and, simultaneously, draw on questionnaires, interview, and protocol data to examine their implementation. We analyze quantitative effectiveness data via linear models (times-group interaction), and implementation data using descriptive distributions and content analyses.ConclusionThe study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system.Trial registrationClinical trials NCT05817396. Registered on April 18, 2023.

Testing the Moderating Effect of Anti-Prejudice Motivation and Peer Attitudes on the Effectiveness of a School-Based Vicarious Contact Intervention

Vicarious contact has often been used for studying prejudice-reduction in school contexts due to its relatively accessible application through written or audiovisual portrayals of positive intergroup contact. However, these interventions may sometimes prove ineffective, thus restricting their ecological validity and independent use in education. To contribute to the understanding of factors that might facilitate or mitigate the efficacy of vicarious contact in reducing ethnic prejudice among adolescents, the present study tested for the moderating effect of anti-prejudice motivation and friends’ outgroup attitudes. Participants were Finnish secondary school students (N = 334; M = 13.38 years, SD = 0.53; 48% female; 19% ethnic minority) allocated into cluster-randomized intervention (N = 149) and control (N = 185) groups. Participants in the intervention group took part in 4 × 45-min teacher-led intervention sessions. A pretest-posttest design was employed to assess the outgroup attitudes three weeks before the intervention and the follow-up two weeks after. The results showed that adolescents’ intrinsic, but not extrinsic, anti-prejudice motivation and the pre-intervention attitudes of their reciprocal classroom friends positively predicted post-intervention attitudes towards people from different ethnic and cultural groups. However, only extrinsic motivation moderated the intervention effect as the results indicated the intervention to have a detrimental effect on outgroup attitudes among adolescents with less motivation to be non-prejudiced in order to gain social acceptance. This attitudinal backlash among adolescents less susceptible to the social influence of others implies that motivational aspects should not be overlooked when developing school-based intervention programs, especially when social norms are used as a mechanism of attitude change.

Longitudinal associations between food parenting practices and dietary intake in preschool children: The ToyBox Study

IntroductionFood Parenting Practices (FPPs) include the practices parents use in the act of feeding their children, which may further influence their health. ObjectivesTo assess associations between changes in FPPs (permissiveness, food availability, guided choices, water encouragement, rules and limits and the use of food as reward) over 1 year and dietary intake (water, energy-dense/nutrient-poor and nutrient-dense foods) at follow-up in 4- to 6-year-old preschool-aged children. MethodsLongitudinal data from the control group of the ToyBox study, a cluster-randomized controlled intervention study, was used (NCT02116296). Multilevel ordinal logistic regression analyses including FPP as the independent variables and dietary intake as outcome. ResultsNine hundred sixty-four parent-child dyads (50.5% boys and 95.0% mothers) were included. Limited changes on the use of FPPs were observed over time. Nevertheless, in boys, often having F&V at home was associated with higher F&V consumption (OR = 6.92 [1.58; 30.38]), and increasing home availability of F&V was directly associated with higher water consumption (OR = 7.62 [1.63; 35.62]). Also, not having sweets or salty snacks available at home was associated with lower consumption of desserts (OR = 4.34 [1.75; 10.75]). In girls, having F&V availability was associated with higher F&V consumption (OR = 6.72 [1.52; 29.70]) and lower salty snack consumption (OR = 3.26 [1.50; 7.10]) and never having soft drinks at home was associated with lower consumption of sweets (OR = 7.89 [6.32; 9.86]). Also, never being permissive about soft drink consumption was associated with lower soft drink consumption (OR = 4.09 [2.44; 6.85]). ConclusionUsing favorable FPPs and avoiding the negative ones is prospectively associated with healthier dietary intake, especially of F&V, and less intake of soft drinks, desserts, and salty snacks.

Ethical acceptability of telemedicine: Nursing home resident's perspective on telemedical consultations.

The use of telemedicine in health care has recently expanded, and with it the need to evaluate its use from an ethical perspective. Studies investigating the ethical acceptability of telemedical consultations (TC) in nursing homes are lacking, and in particular, the perspectives and experiences of older adults with TC are underrepresented. The objective of this study is to identify ethically relevant parameters in the acute care of nursing home residents using TC and to derive recommendations. A combination of qualitative research methods was employed to gain a comprehensive understanding of the research topic. These included semi-structured face-to-face interviews and participant observations. Due to the phased design of the cluster-randomized controlled intervention trial in the overarching study project, our investigations were carried out in phases before and after the implementation of the telemedical systems in the nursing homes. We identified various ethical challenges associated with the use of TC, including those related to autonomy, participation, privacy, self-conception, beneficence, security and justice. Our analysis indicates that the use of TC for nursing home residents is ethically acceptable, provided that several recommendations to promote acceptability are considered. Our findings provide insights into the variety of ethical challenges that can arise when using TC in nursing homes to provide care for older adults while also providing information on how these challenges can be addressed. Furthermore, these findings provide guidance for further research to improve the care of residents in nursing homes from an ethical perspective.

Enhancing Time Reading and Recording Skills in First-Grade Children with Learning Difficulties Using the "Clock Motor Game".

This study aimed to explore the effect of the motor game, "Clock Motor Games", on the improvement of "Reading and Recording of Time" (RRT) in children with Grade 1 mathematical learning difficulties (MLDs). A within-school cluster-randomized intervention study was conducted with 232 children (aged 6-7 years) with limited physical education experience (0.7 ± 0.3 years). The participants were divided into two groups: a control group, which received conventional teaching on time without any additional motor activities, and an experimental group, which incorporated the concept of time with the "Clock Motor Game", for 3 weeks. The Clock-Reading Test was administered before the intervention (T0), immediately after each session (T1), and five weeks after the intervention (T2) in both groups. The results demonstrated that the experimental group exhibited significantly greater improvements in RRT performance compared to the control group (U = 4416.5; p < 0.001; r = 0.3; medium effect). Additionally, the experimental group was more likely to show progress and less likely to experience regression or stagnation compared to the control group (25% vs. 38.4%). The findings suggest that practicing "Clock Motor Games" can positively contribute to the RRT ability in children with Grade 1 MLD.

Process evaluation of The Breastfeeding Trial. What factors impact the intervention delivery?

Abstract Background Breastmilk is the ideal nutrition for infants, and breastfeeding is an important health promoting behaviour. In Denmark, most mothers initiate breastfeeding but many cease within the first months resulting in just 14% reaching the World Health Organization recommendation of six months exclusive breastfeeding. A large-scaled, cluster-randomized intervention study implemented in the Danish health visiting programme aimed to extent the duration of breastfeeding and reduce social inequality. To elucidate how the intervention was implemented, a process evaluation of the intervention was conducted. Methods Following the MRC guidelines for process evaluation, we used a mixed methods approach to assess the delivery of the intervention, and facilitators and barriers in the context that affected the implementation. Data from questionnaires distributed to the health visiting managers of 21 Danish municipalities and 242 health visitors employed there, and data from three focus groups with health visitors and eight individual interviews with mothers in the intervention informed the process evaluation. Results Preliminary findings from questionnaires imply that the training program slightly enhanced health visitors’ breastfeeding support competencies. However, health visitors explained in the focus groups that they provided support as usual. A contextual factor hindering the implementation was change of personnel. Having had favourable experiences with the intervention acted as facilitator. Findings from interviews with mothers indicated a high fidelity in the distribution of intervention materials and partner involvement. Conclusions Preliminary findings of this study show variability in how the intervention was implemented throughout the intervention sites. This evaluation will assist in the interpretation of the results of the effectiveness study and inform policy makers about if and how this intervention could be scaled up. Key messages • Health visitors in intervention clusters seemed to have gained competencies in breastfeeding support; however, expressed that they provided support ‘as usual’. • Change of personnel acted as a barrier, while having had positive experiences with the intervention acted as a facilitator.

Rationale and design of the GOLDEN BRIDGE II: a cluster-randomised multifaceted intervention trial of an artificial intelligence-based cerebrovascular disease clinical decision support system to improve stroke outcomes and care quality in China

BackgroundGiven the swift advancements in artificial intelligence (AI), the utilisation of AI-based clinical decision support systems (AI-CDSSs) has become increasingly prevalent in the medical domain, particularly in the management of...

Effectiveness of a nutrition and physical activity intervention among adolescent

Unhealthy food intake, physical inactivity, and body image (BI) dissatisfaction could potentially lead to obesity and health problems. This cluster-randomized intervention study aimed to investigate the effectiveness of a nutrition and physical activity (PA) intervention on related knowledge, attitudes, and practices among Saudi adolescent girls (aged 13–14) living in Arar City. One hundred thirty-eight girls were selected and recruited randomly from two schools. The respondents in the intervention group (IG; n=68) received a three-month intervention program that consisted of six 90- minute sessions. The participants in the control group (CG; n=70) received only their traditional education and did not receive the intervention program. The groups’ total pre-test scores for practices were significantly different; therefore, the pre-test scores were used as covariates. The IG demonstrated significant improvements in knowledge, attitudes, and practices (p&amp;lt;0.001 for all), and improvement in the IG was greater than that in the CG at the post- test and three-month follow-up time points (p&amp;lt;0.001 for both). These findings provide evidence of the significant influence of a nutrition, PA, and positive BI intervention on related knowledge, attitudes, and practices among Saudi adolescent girls.

The role of qualification and quality management in the prescription of antipsychotics and potentially inappropriate medication (PIM) in nursing home residents in Germany: results of the HIOPP-3-iTBX study.

Nursing home residents (NHR) show high rates of polypharmacy. The HIOPP-3-iTBX study is the first cRCT on medication optimization in nursing homes (NH) in Germany. The intervention did not result in a reduction of PIM and/or antipsychotics. This analysis looks at structure quality in the HIOPP-3-iTBX study participants. Evaluation of structure quality as part of a cluster-randomized controlled intervention study. Structure quality in multiprofessional teams from n = 44 NH (n = 44 NH directors, n = 91 family doctors (FD), and n = 52 pharmacies with n = 62 pharmacists) was assessed using self-designed questionnaires at baseline. Main aspects of the questionnaires related to the qualification of participants, quality management, the medication process and size of the facilities. All completed questionnaires were included. number of PIM/antipsychotics was drawn from the baseline medication analysis in 692 NHR. Data were analyzed by descriptive statistics and mixed model logistic regression. The presence of a nurse with one of the additional qualifications pain nurse or Zertifiziertes Curriculum (Zercur) Geriatrie in the participating NH was associated with a lower risk for the prescription of PIM/antipsychotics. No association between any characteristic in the other participants at baseline was observed. The results support the known role of nursing qualification in the quality and safety of care. Further studies need to look more closely at how use is made of the additional qualifications within the multiprofessional teams. Perspectively, the results can contribute to the development of quality standards in NH in Germany.

A Qualitative Study of Nursing Home Staff Lived Experience With Advance Care Planning

ObjectiveAdvance care planning (ACP) within nursing homes (NHs) is an integral component of resident-centered care yet remains an ongoing area for improvement. This study explored health care providers’ experiences when facilitating ACP discussions with residents and their families. DesignInterpretive description was used to explore meanings and generate knowledge that is applicable for clinical contexts. Setting and ParticipantsA purposive sample of 27 staff members (2 directors of care, 3 assistant directors of care, 1 nurse practitioner, 11 registered nurses, 3 registered practical nurses, and 7 social workers) from 29 NHs located across 3 Canadian provinces that participated in cluster-randomized intervention study to improve ACP. MethodsSemistructured interviews were conducted between January and July 2020. Interpretive description methods were used for analysis. ResultsThree themes were identified. “Navigating Relational Tensions During ACP with Families” captures the relational tensions that participants experienced while navigating ACP processes with residents and their families. The second theme, “Where’s the Doctor?” highlights the general lack of physician involvement in ACP discussions and the subsequent pressures faced by participants when supporting residents and families. The last theme, “Crises Change the Best Laid Plans,” illustrates the challenges participants face when trying to adhere to existing care plans during residents' medical crises. Conclusion and ImplicationsParticipants’ experiences indicate that current ACP processes in NHs do not meet the needs of residents, families, or care teams. Additional support from physicians and changes to structural processes are needed to support resident-centered end-of-life planning within this care context.

Outcomes and process evaluation of a cluster-randomised participatory organisational intervention among German healthcare workers

BackgroundIn the present investigation the results of the outcome and process evaluation of a participatory workplace intervention are reported. The intervention aimed to increase the workers’ self-assessed physical and mental work ability.MethodsThe intervention was a two-arm, cluster-randomised trial with healthcare workers in 10 hospitals and one elderly care centre in Germany. Outcome data on workers were collected in questionnaires at baseline, and two follow-ups between 2019 and 2021. The intervention consisted of interviews and workshops, in which employees proposed measures for reducing the physical and psychosocial load and strengthening resources at work. Outcome data were analysed with linear-mixed regression models. The process evaluation was based on the thematic criteria proposed in previous literature and the collection of the type of intervention measures and their implementation status.ResultsThe regression analysis did not provide evidence of treatment differences or reductions of psychosocial load in the intervention wards. The process evaluation suggested that the measures did not address specifically the self-assessed work ability. In addition, there was no indication that the intervention measures were causally related to the intended goals.ConclusionsThe planning and implementation of organisational interventions require a careful consideration of the definition of intervention goals, the theoretical rationale of the intervention and a project-oriented action plan during the delivery phase.

Improving cardiovascular health in rural China and beyond

In 2021, high blood pressure claimed 11·3 million lives globally. 1 Vaduganathan M Mensah GA Turco JV Fuster V Roth GA The global burden of cardiovascular diseases and risk: a compass for future health. J Am Coll Cardiol. 2022; 80: 2361-2371 Crossref PubMed Scopus (4) Google Scholar High blood pressure has ranked consistently as the top modifiable risk factor globally for over 20 years. Although its prevalence is universally high, awareness, management, and control of high blood pressure are particularly poor in low-income and middle-income countries. 2 Geldsetzer P Manne-Goehler J Marcus ME et al. The state of hypertension care in 44 low-income and middle-income countries: a cross-sectional study of nationally representative individual-level data from 1·1 million adults. Lancet. 2019; 394: 652-662 Summary Full Text Full Text PDF PubMed Scopus (199) Google Scholar Several cluster randomised controlled trials have shown that community health worker-led interventions were effective in significantly reducing blood pressure in Argentina (the HCPIA trial), 3 He J Irazola V Mills KT et al. Effect of a community health worker-led multicomponent intervention on blood pressure control in low-income patients in Argentina: a randomized clinical trial. JAMA. 2017; 318: 1016-1025 Crossref PubMed Scopus (98) Google Scholar Malaysia and Colombia (the HOPE 4 trial), 4 Schwalm JD McCready T Lopez-Jaramillo P et al. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster randomised controlled trial. Lancet. 2019; 394: 1231-1242 Summary Full Text Full Text PDF PubMed Scopus (92) Google Scholar and Bangladesh, Pakistan, and Sri Lanka (the COBRA-BPS trial). 5 Jafar TH Gandhi M de Silva HA et al. A community-based intervention for managing hypertension in rural South Asia. N Engl J Med. 2020; 382: 717-726 Crossref PubMed Scopus (68) Google Scholar More recently, in 2022, Sun and colleagues 6 Sun Y Mu J Wang DW et al. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022; 399: 1964-1975 Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar showed that in the China Rural Hypertension Control Project (the CRHCP trial), a village doctor-led intensive hypertension intervention increased hypertension control by 37% compared with usual care. The 18-month net reduction in systolic blood pressure was as large as 14·5 mm Hg. Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trialThe non-physician community health-care provider-led intensive blood pressure intervention is effective in reducing cardiovascular disease and death. Full-Text PDF

Fostering Resilience in Adolescents at Risk: Study protocol for a cluster randomized controlled trial within the resilience school-based intervention.

Resilience is considered of high relevance when developing interventions to cope with stressful situations. Schools are one of the key settings to promote resilience among adolescents. The purpose of this cluster randomized controlled trial is to assess the effectiveness of an intervention in adolescents at risk, aged 12-to-15 years old, to increase resilience and emotional regulation strategies. The recruitment period started in January 2022. Schools will be randomly allocated to control and intervention groups by an external researcher using computer-generated random numbers. The minimum sample size was estimated to be 70 participants per group. Primary health care nurses will carry out the intervention during the school period (January to June 2022). Students will follow a specific training consisting of six 55-min sessions, for 6 weeks. Each session will consist of 5 min of mindfulness, followed by 45 min of the corresponding activity: introducing resilience, self-esteem, emotional regulation strategies, social skills, problem-solving, community resources, social and peer support, and 5 min to explain the activity to do at home. Data will be collected at baseline, 6 weeks, and 24 weeks after the intervention. The child youth resilience measure-32 (CYRM-32) scale will be used to assess the effectiveness of the intervention. This study received a grant in June 2021. The intervention is intended to improve mental health through resilience. Different factors related to resilience will be promoted, such as self-esteem, emotional regulation, social and communication skills, problem-solving and peer support, among others. As it has been designed as a cluster-randomized school-based intervention, we will directly ameliorate the participation and engagement of the target population. With the present intervention, we expect to improve coping skills in adolescents by enhancing resilience capacities.

Potential drivers for schistosomiasis persistence: Population genetic analyses from a cluster-randomized urogenital schistosomiasis elimination trial across the Zanzibar islands.

The World Health Organization's revised NTD Roadmap and the newly launched Guidelines target elimination of schistosomiasis as a public health problem in all endemic areas by 2030. Key to meeting this goal is elucidating how selective pressures imposed by interventions shape parasite populations. Our aim was to identify any differential impact of a unique cluster-randomized tri-armed elimination intervention (biannual mass drug administration (MDA) applied alone or in association with either mollusciciding (snail control) or behavioural change interventions) across two Zanzibarian islands (Pemba and Unguja) on the population genetic composition of Schistosoma haematobium over space and time. Fifteen microsatellite loci were used to analyse individual miracidia collected from infected individuals across islands and intervention arms at the start (2012 baseline: 1,522 miracidia from 176 children; 303 from 43 adults; age-range 6-75, mean 12.7 years) and at year 5 (2016: 1,486 miracidia from 146 children; 214 from 25 adults; age-range 9-46, mean 12.4 years). Measures of genetic diversity included allelic richness (Ar), Expected (He) and Observed heterozygosity (Ho), inbreeding coefficient (FST), parentage analysis, estimated worm burden, worm fecundity, and genetic sub-structuring. There was little evidence of differential selective pressures on population genetic diversity, inbreeding or estimated worm burdens by treatment arm, with only the MDA+snail control arm within Unguja showing trends towards reduced diversity and altered inbreeding over time. The greatest differences overall, both in terms of parasite fecundity and genetic sub-structuring, were observed between the islands, consistent with Pemba's persistently higher mean infection intensities compared to neighbouring Unguja, and within islands in terms of infection hotspots (across three definitions). These findings highlight the important contribution of population genetic analyses to elucidate extensive genetic diversity and biological drivers, including potential gene-environmental factors, that may override short term selective pressures imposed by differential disease control strategies. Trial Registration: ClinicalTrials.gov ISRCTN48837681.

Qualitative Examination of the Role and Influence of Mothers-in-Law on Young Married Couples' Family Planning in Rural Maharashtra, India.

Unmet need for family planning (FP) continues to be high in India, especially among young and newly married women. Mothers-in-law (MILs) often exert pressure on couples for fertility and control decision making and behaviors around fertility and FP, yet there is a paucity of literature to understand their perspectives. Ten focus group discussions (FGDs) were carried out with MILs of young married women (aged 18-29 years) participating in a couple-focused FP intervention as a part of a cluster-randomized intervention evaluation trial (the CHARM2 study) in rural Maharashtra, India. FGDs included questions on their roles, attitudes, and decision making around fertility and FP. Audio-recorded data were translated/transcribed into English and analyzed for key themes using a deductive coding method. MILs reported having social norms of early fertility and son preference. They understood that family size norms are lower among daughters-in-law and that spacing can be beneficial but were not supportive of short-term contraceptives, especially before the first child. They preferred female sterilization, opposed abortion, had apprehensions around side effects from contraceptive use, and had misconceptions about the intrauterine device, with particular concerns around its coercive insertion. MILs mostly believed that decision making should be done jointly by a husband and wife, but that as elders, they should be consulted and involved in the decision-making process. These findings highlight the need for engagement of MILs for FP promotion in rural India and the potential utility of social norms interventions.

Depression management and antiretroviral treatment outcome among people living with HIV in Northwest and East regions of Cameroon

BackgroundSeveral interventions have shown benefits in improving mental health problems such as depression which is common in people living with HIV. However, there is a paucity of evidence on the effect of these interventions in improving HIV treatment outcomes. This study aimed at bridging this evidence gap and guiding the integration of depression and HIV management, particularly in rural health settings of Cameroon.Materials and methodsWe carried out a cluster-randomized intervention study targeting persons aged 13 years and above who had been on antiretroviral treatment for 6–9 months. Participants were followed up for 12 months during which those in the intervention group underwent routine screening and management of depression. Comparisons were done using the two-way ANOVA and Chi-squared test with significance set at 5%.ResultsOverall, 370 participants with a median age of 39 years (IQR: 30–49) were enrolled in this study. Of these, 42 (11.3%) were screened with moderate to severe depressive symptoms and 41 (11.1%) had poor treatment adherence. There was a significant drop in depression scores in the intervention group from 3.88 (± 3.76) to 2.29 (± 2.39) versus 4.35 (± 4.64) to 3.39 (± 3.0) in controls (p < 0.001) which was accompanied by a drop in the prevalence of moderate to severe depressive symptoms in the intervention group from 9% to 0.8% (p = 0.046). Decreased depression scores were correlated with better adherence scores with correlation coefficients of − 0.191, − 0.555, and − 0.513 at baseline, 6 months, and 12 months of follow-up respectively (p < 0.001) but there was no significant difference in adherence levels (p = 0.255) and viral suppression rates (p = 0.811) between groups.ConclusionThe results of this study suggest that considering routine screening and management of depression as an integral component of HIV care could positively impact HIV treatment outcomes. However, there is a need for more research to identify the best combinations of context-specific and cost-effective strategies that can impactfully be integrated with HIV management.Trial registration Trial registration Number: DRKS00027440. Name of Registry: German Clinical Trials Register. Date registration: December 10, 2021 (‘retrospectively registered’). Date of enrolment of the first participant: 05/08/2019