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Background: As utilization of individual antenatal care (I-ANC) has increased throughout sub-Saharan Africa, questions have arisen about whether individual versus group-based care might yield better outcomes. We implemented a trial of group-based antenatal care (G-ANC) to determine its impact on birth preparedness and complication readiness (BPCR) among pregnant women in Ghana. Methods: We conducted a cluster randomized controlled trial comparing G-ANC to routine antenatal care in 14 health facilities in the Eastern Region of Ghana. We recruited women in their first trimester to participate in eight two-hour interactive group sessions throughout their pregnancies. Meetings were facilitated by midwives trained in G-ANC methods, and clinical assessments were conducted in addition to group discussions and activities. Data were collected at five timepoints, and results are presented comparing baseline (T0) to 34 weeks' gestation to 3 weeks post-delivery (T1) for danger sign recognition, an 11-point additive scale of BPCR, as well as individual items comprising the scale. Results: 1285 participants completed T0 and T1 assessments (N = 668 I-ANC, N = 617, G-ANC). At T1, G-ANC participants were able to identify significantly more pregnancy danger signs than I-ANC participants (mean increase from 1.8 to 3.4 in G-ANC vs. 1.7 to 2.2 in I-ANC, p < 0.0001). Overall BPCR scores were significantly greater in the G-ANC group than the I-ANC group. The elements of BPCR that showed the greatest increases included arranging for emergency transport (I-ANC increased from 1.5 to 11.5% vs. G-ANC increasing from 2 to 41% (p < 0.0001)) and saving money for transportation (19–32% in the I-ANC group vs. 19–73% in the G-ANC group (p < 0.0001)). Identifying someone to accompany the woman to the facility rose from 1 to 3% in the I-ANC group vs. 2–20% in the G-ANC group (p < 0.001). Conclusions: G-ANC significantly increased BPCR among women in rural Eastern Region of Ghana when compared to routine antenatal care. Given the success of this intervention, future efforts that prioritize the implementation of G-ANC are warranted. Trial registration: ClinicalTrials.gov Identifier: NCT04033003 (25/07/2019). Protocol available: Protocol Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9508671/. [ABSTRACT FROM AUTHOR]

Background: Although AIDS-related deaths have reduced with increased access to antiretroviral care, cardiovascular disease-related morbidities among persons living with HIV are rising. Contributing to this is the higher incidence of Hypertension among Persons Living with HIV. The duration of exposure to the virus and antiretroviral drugs plays a vital role in the pathogenesis, putting perinatally infected children and adolescents at higher risk than behaviorally-infected ones, supporting the calls for increased surveillance of Hypertension among them. Despite the availability of guidelines to support this surveillance, the blood pressure (BP) of adolescents living with HIV (ADLHIV) is not checked during clinical visits. This study aims to assess the effect of a theory-based intervention on healthcare workers' adherence to the guidelines for hypertension screening among adolescents. Methods: A multi-facility cluster-randomized study will be conducted. The clusters will be 20 antiretroviral therapy sites in the Greater Accra Region of Ghana with the highest adolescent caseload. Data will be extracted from the folders of adolescents (10–17 years) who received care in these facilities six months before the study. The ART staff of intervention facilities will receive a multicomponent theory of planned behaviour-based intervention. This will include orientation on hypertension risk among ADLHIV, provision of job aids and pediatric sphygmomanometers. Six months after the intervention, the outcome measure will be the change from baseline in the proportion of ADLHIV whose BP was checked during clinical visits. The calculated sample size is 400 folders. Implications of findings: This study will generate evidence on the effectiveness of a multicomponent theory-based intervention for improving the implementation of clinical practice guidelines. Trial registration: PACTR202205641023383. [ABSTRACT FROM AUTHOR]

Background: We sought to determine the achievement of key performance indicators (KPIs) of initial trauma care at district (first‐level) and regional (second‐level) hospitals in Ghana and to assess the effectiveness of a standardized trauma intake form (TIF) to improve care. Methods: A stepped‐wedge cluster randomized trial was performed with direct observations of trauma management before and after introducing the TIF at emergency units of eight hospitals for 17.5 months. Differences in KPIs were assessed using multivariable logistic regression and generalized linear mixed regression. Results: Management of 4077 patients was observed; 30% at regional and 70% at district hospitals. Eight of 20 KPIs were performed significantly more often at regional hospitals. TIF improved care at both levels. Fourteen KPIs improved significantly at district and eight KPIs improved significantly at regional hospitals. After TIF, regional hospitals still performed better with 18 KPIs being performed significantly more often than district hospitals. After TIF, all KPIs were performed in >90% of patients at regional hospitals. Examples of KPIs for which regional performed better than district hospitals after TIF included: assessment for oxygen saturation (83% vs. 98%) and evaluation for intra‐abdominal bleeding (82% vs. 99%, all p < 0.001). Mortality decreased among seriously injured patients (injury severity score ≥9) at both district (15% before vs. 8% after, p = 0.04) and regional (23% vs. 7%, p = 0.004) hospitals. Conclusions: TIF improved care and lowered mortality at both hospital levels, but KPIs remained lower at district hospitals. Further measures are needed to improve initial trauma care at this level. Clinical trials registration: Clinicaltrials.gov (NCT04547192). [ABSTRACT FROM AUTHOR]

Background: Although the majority of Ghanaian women receive antenatal care (ANC), many exhibit low health literacy by misinterpreting and incorrectly operationalizing ANC messages, leading to poor maternal and newborn health outcomes. Prior research in low-resource settings has found group antenatal care (G-ANC) feasible for women and providers. This study aims to determine the effect of G-ANC on increasing maternal health literacy. We hypothesized that pregnant women randomized into G-ANC would exhibit a greater increase in maternal health literacy than women in routine, individual ANC. Methods: A 5-year cluster randomized controlled trial was conducted in 14 rural and peri-urban health facilities in the Eastern Region of Ghana. Facilities were paired based on patient volume and average gestational age at ANC enrollment and then randomized into intervention (G-ANC) vs. control (routine, individual ANC); 1761 pregnant women were recruited. Data collection occurred at baseline (T0) and post-birth (T2) using the Maternal Health Literacy scale, a 12-item composite scale to assess maternal health literacy. Logistic regression compared changes in health literacy from T0 to T2. Results: Overall, women in both the intervention and control groups improved their health literacy scores over time (p < 0.0001). Women in the intervention group scored significantly higher on 3 individual items and on overall composite scores (p < 0.0001) and were more likely to attend 8 or more ANC visits. Conclusion: While health literacy scores improved for all women attending ANC, women randomized into G-ANC exhibited greater improvement in overall health literacy post-birth compared to those receiving routine individual care. Life-saving information provided during ANC must be presented in an understandable format to prevent women and newborns from dying of preventable causes. Trial Registry: Ethical approval for the study was obtained from the Institutional Review Boards of the University of Michigan (HUM#00161464) and the Ghana Health Service (GHS-ERC: 016/04/19). [ABSTRACT FROM AUTHOR]

Background: The WHO Trauma Care Checklist improved key performance indicators (KPIs) of trauma care at tertiary hospitals. A standardized trauma intake form (TIF) with real-time clinical decision support prompts was developed by adapting the WHO Trauma Care Checklist for use in smaller low- and middle-income country hospitals, where care is delivered by non-specialized providers and without trauma teams. This study aimed to determine the effectiveness of the TIF for improving KPIs in initial trauma care and reducing mortality at non-tertiary hospitals in Ghana. Methods: A stepped-wedge cluster randomized trial was conducted by stationing research assistants at emergency units of eight non- tertiary hospitals for 17.5 months to observe management of injured patients before and after introduction of the TIF. Differences in performance of KPIs in trauma care (primary outcomes) and mortality (secondary outcome) were estimated using generalized linear mixed regression models. Results: Management of 4077 injured patients was observed (2067 before TIF introduction, 2010 after). There was improvement in 14 of 16 primary survey and initial care KPIs after TIF introduction. Airway assessment increased from 72.9 to 98.4 per cent (adjusted OR 25.27, 95 per cent c.i. 2.47 to 258.94; P = 0.006) and breathing assessment from 62.1 to 96.8 per cent (adjusted OR 38.38, 4.84 to 304.69; P = 0.001). Documentation of important clinical data improved from 52.4 to 76.7 per cent (adjusted OR 2.14, 1.17 to 3.89; P = 0.013). The mortality rate decreased from 17.7 to 12.1 per cent among 302 patients (186 before, 116 after) with impaired physiology on arrival (hypotension or decreased level of consciousness) (adjusted OR 0.10, 0.02 to 0.56; P = 0.009). Conclusion: The TIF improved overall initial trauma care and reduced mortality for more seriously injured patients. [ABSTRACT FROM AUTHOR]

Background: Prompt diagnosis and treatment of malaria prevents a mild case from developing into severe disease and death. Unfortunately, parasitological testing of febrile children is greater in the public and formal private sector than in the informal private sector where many patients with malaria-like symptoms first seek treatment. This study was aimed at improving implementation of the T3 policy among OTCMS using some interventions that could be scaled-up easily at the national level. Methods: Interventions were evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts of Ghana. A total of 7 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities participated in the study. Five interventions were implemented in the intervention arm only. These were acquisition of subsidized malaria rapid diagnostic test (RDT) kits, training of OTCMS, supportive visits to OTCMS, community sensitization on malaria, and introduction of malaria surveillance tool. The primary outcome was the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and getting tested (using RDT) before treatment. Secondary outcomes included OTCMS adherence to national malaria treatment guidelines and the recommended RDT retail price. Outcomes were measured using mystery client (an adult who pretends to be a real patient) surveys supplemented by a household survey. Proportions were compared using chi-square test or Fisher exact test. Results: Following deployment of interventions, mystery client survey showed that OTCMS' adherence to malaria protocol in the intervention arm increased significantly (p < 0.05) compared to the control arm. Household surveys in the intervention arm showed that caregivers self-treating their children or visiting drug vendors significantly decreased in favour of visits to OTCMS shops for treatment (p < 0.001). End-line malaria testing rate was higher compared with the baseline rate, though not statistically significant (30.8% vs 10.5%; p = 0.1238). OTCMS in the intervention arm also adhered to the subsidized RDT retail price of GHc2.40. Conclusion: Interventions targeting OTCMS in rural communities have the potential of improving adherence to the T3 malaria policy and subsequently improving management of uncomplicated malaria in Ghana. Trial registration: ISRCTN registry ISRCTN77836926. Registered on 4 November 2019. [ABSTRACT FROM AUTHOR]

Aquaculture in Ghana is experiencing tremendous growth, led mainly by large‐scale commercial cage operators. A major objective of the government and its partners is to ensure that this rapid growth is sustainable and includes small‐scale farmers and poor rural producers. This paper evaluates the aquaculture trainings implemented in six main tilapia‐producing regions in Ghana as part of the Ghana Tilapia Seed Project. The impact evaluation is designed as a cluster randomized controlled trial, with half of the producing districts randomly‐assigned as the treatment and the rest as the control, complemented by qualitative interviews. One year after the trainings, results show positive impacts on the adoption of good record‐keeping, water management, and some biosecurity practices, and on productivity and incomes. In terms of mechanism, improved management practices resulted from reducing overstocking, reducing inbreeding, maintaining water level for fish ponds, regular pond clearing and establishing physical barriers, following advice and recommendations on feeding practices, and complementing feeding practices with farmers' own feed formulation. Half of the trained farmers experienced lower fish mortality, faster growth, and heavier fish at harvest. Marketing and processing advice through the trainings and complementary FishConnect WhatsApp platform likely contributed to higher incomes, although the platform's coverage and regular updating can be improved. [ABSTRACT FROM AUTHOR]

An editorial focuses on assessing lung function measures in preschool-aged children from Ghana, Africa particularly examining the impact of household air pollution from cooking on lung development. It discusses the use of respiratory oscillometry as a feasible method for lung function testing in young children and highlights findings from a study within the Ghana Randomized Air Pollution and Health Study (GRAPHS).

Background Understanding the influence of participatory video-making on the nutrition-related behavior of video creators may help shape nutrition education interventions. Objectives This study assessed the perceived value and influence of a participatory video intervention among participants and stakeholders. Methods A 2018–2019 cluster randomized controlled trial (registered at clinicaltrials.gov as NCT03704649) selected 20 schools (10 intervention, n  = 181; 10 control, n  = 170) in 1 Ghanaian rural district, enrolled adolescent girls aged 13–16 y, and provided a nutrition curriculum. Each intervention school also participated in 2 series of activities designed to help adolescents plan, film, and screen 2 nutrition-related videos. The Most Significant Change method involved intervention participants and local stakeholders to assess the value and influence of the intervention – a secondary outcome of the trial. Project staff collected 116 stories of change from the adolescents. Stories described shifts in 4 domains: participant, peer, and family behavior, and structural changes in the school. The project team used a selection rubric to identify 14 stories that reflected heightened nutrition literacy. Staff conducted interviews with the 14 adolescents whose stories were selected to elaborate on details and perceived resonance. Finally, local stakeholders assessed the stories to identify the 4 most significant changes of the intervention – 1 per domain. A separate thematic analysis identified emerging patterns of motivation and action across the 14 interviews. Results The chosen Most Significant Change stories revealed how adolescents found creative solutions to acquire iron-rich foods, encouraged neighbors to eat iron-rich foods, taught their family new agricultural practices, and promoted change in their school canteen. Local stakeholders valued stories that addressed common community nutrition issues in a creative and sustainable way, whereas adolescents prioritized stories that showed a change in health outcomes. Conclusion Stories of change revealed that the intervention promoted a transformative influence; participants modified their eating habits, lifestyle, and their environment. [ABSTRACT FROM AUTHOR]

Anaemia in children under five years remains a significant cause of mortality and morbidity in low-middle income countries. Globally, 27% of the world's population is anaemic, of which developing countries account for more than 89%. The global prevalence is worse in Africa and Asia. Anaemia has the potential of maintaining the cycle of poverty, as it prevents children from attaining their full development potential. An important part of anaemia in children under-five years are preventable. Locally available dietary (LAD) interventions may be the sustainable interventions to address the high prevalence of anaemia in our communities. The aim of the study is to determine the effect of counselling on Locally Available Diet, on anaemia among children aged 6–59 months in the Kumbungu District of the Northern Region, Ghana. This study will be a community-based cluster randomized, controlled trial, with two parallel arms; Iron + Folic Acid (IFA arm) hereby referred to as the Standard care arm and Iron + Folic Acid + Counselling on Locally available dietary intervention (IFA+LAD arm) referred to as the Standard Plus arm. Study participants are children between the ages of 6 to 56 months. All study participants would receive iron plus folic acid. The minimum number of children per arm is 330 and the number of community clusters is 10 (5 per study arm). Also, considering this study proposes two parallel arms, the total minimum study sample size of children under five years is 496, the minimum total number of community clusters is 10 and a minimum of 25 households per community cluster, 124 households per study arm and 248 households for the study. Randomization is at the level of the clusters (selected communities). The intervention group receives counselling on LAD at a household level aimed at promoting the intake of locally available iron, folate and vitamin B12 rich foods. Also encourage the intake of food rich in enhancers of iron absorption and discouraging the intake of food rich in inhibitors of iron absorption. The primary outcome is mean haemoglobin levels in study arms. Secondary outcomes would include measurement of weight, height/length, mid upper arm circumference, dietary record, serum iron, ferritin, and other parameters of full blood count. Ethical clearance has been obtained and trial registered with Pan African Trial Registry (www.pactr.org) PACTR201906918438423. [ABSTRACT FROM AUTHOR]

Background Little is known about how the level of program participation affects child nutrition in rural interventions. Objectives This study examined the association between participation level in a nutrition-sensitive agriculture intervention and children's diet and anthropometric outcomes in rural Ghana. Methods Nutrition Links was a cluster randomized controlled trial (clinicaltrials.gov NCT01985243), which enrolled caregivers with children (aged less than 2 mo in 2014–2015 and less than 18 mo in 2016–2017). Of the 287 caregivers in 19 intervention communities who enrolled, 233 adopted the intervention and received layer poultry, garden inputs, and weekly child feeding education. The egg production and repayment of poultry were monitored, and feed was sold at the weekly meetings. After endline, the nutrition educators rated each woman who adopted the intervention on a scale [very poor (1) to excellent (5)] for: 1) meeting attendance, 2) egg productivity, 3) feed and poultry loan payment, 4) contributions during meetings, and 5) attentiveness towards group members. Participation level was classified as high, medium, and low by dividing the sum of these 5 items into tertiles; 54 women who did not adopt the intervention were classified as "no participation." Generalized mixed linear models tested the difference in changes in children's diet and anthropometric indices between the participation levels and the control category – 213 caregiver-child dyads in 20 communities who received standard-of-care health and agricultural services. Results Compared with the control category, only high participation was associated with egg consumption [adjusted OR (aOR) = 3.03; 95% CI: 1.15, 7.94]. Both medium and high participation levels were associated with length‐for‐age z ‐scores (LAZ)/height‐for‐age z ‐scores (HAZ) [adjusted β-coefficients (aβ) = 0.44; 95% CI: 0.16, 0.72 and 0.40; 95% CI: 0.12, 0.67, respectively]. Conclusion These results highlight the importance of promoting and monitoring the level of beneficiary participation to estimate the full potential of nutrition-sensitive agriculture interventions to improve nutritional outcomes. [ABSTRACT FROM AUTHOR]

Background: Men with have sex with men (MSM) in Africa face high levels of stigma due to elevated HIV exposure (actual or perceived), same-sex practices, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. Most stigma-reduction interventions have focused on single-level targets (e.g., health care facility level [HCF]) and addressed one type of stigma (e.g., HIV), without engaging the multiple intersecting stigmas that MSM encounter. Determining the feasibility and acceptability of multi-level intervention of reducing intersectional stigma and estimating its efficacy on increasing HIV testing are needed. Methods: We proposed a mixed method study among MSM in Ghana. First, we will develop the intervention protocol using the Convergence Framework, which combines three interventions that were previously implemented separately in Ghana for reducing stigma at the HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Then, we will conduct a cluster randomized controlled trial with four pairs of HCFs matched on staff size. HCFs within each pair are randomized to the HCF-level stigma-reduction intervention or control arm. MSM (n = 216) will be randomized to receive the group-level and individual-level interventions or standard of care control arm. MSM will be assigned to receive HIV testing at one of the HCFs that match their study assignment (intervention or control facility). The frequency of HIV testing between MSM in the study arms at 3 and 6 months will be compared, and the predictors of HIV testing uptake at the HCF, peer group and individual-levels will be assessed using multi-level regression models. Discussion: These findings from this study will provide important evidence to inform a hybrid implementation-effectiveness trial of a public health intervention strategy for increasing HIV case detection among key populations in sub-Saharan African communities. Accurate information on HIV prevalence can facilitate epidemic control through more precise deployment of public health measures aimed at HIV treatment and viral load suppression, which eliminates risk of transmission. Trial registration: This study was prospectively registered on ClinicalTrials.gov, Identifier: NCT04108078, on September 27, 2019. [ABSTRACT FROM AUTHOR]

Background: In cluster randomized trials (CRTs) of interventions against malaria, mosquito movement between households ultimately leads to contamination between intervention and control arms, unless they are separated by wide buffer zones.Methods: This paper proposes a method for adjusting estimates of intervention effectiveness for contamination and for estimating a contamination range between intervention arms, the distance over which contamination measurably biases the estimate of effectiveness. A sigmoid function is fitted to malaria prevalence or incidence data as a function of the distance of households to the intervention boundary, stratified by intervention status and including a random effect for the clustering. The method is evaluated in a simulation study, corresponding to a range of rural settings with varying intervention effectiveness and contamination range, and applied to a CRT of insecticide treated nets in Ghana.Results: The simulations indicate that the method leads to approximately unbiased estimates of effectiveness. Precision decreases with increasing mosquito movement, but the contamination range is much smaller than the maximum distance traveled by mosquitoes. For the method to provide precise and approximately unbiased estimates, at least 50% of the households should be at distances greater than the estimated contamination range from the discordant intervention arm.Conclusions: A sigmoid approach provides an appropriate analysis for a CRT in the presence of contamination. Outcome data from boundary zones should not be discarded but used to provide estimates of the contamination range. This gives an alternative to "fried egg" designs, which use large clusters (increasing costs) and exclude buffer zones to avoid bias. [ABSTRACT FROM AUTHOR]

Background: We aimed to determine the incidence of childhood burn injuries in rural Ghana and describe modifiable household risk factors to inform prevention initiatives.Methods: We performed a cluster-randomized, population-based survey of caregivers of children in a rural district in Ghana, representing 2713 households and 14,032 children. Caregivers were interviewed regarding childhood burn injuries within the past 6 months and household risk factors.Results: 357 households were sampled. Most used an open fire with biomass fuel for cooking (85.8%). Households rarely cooked in a separate kitchen (10%). Stove height was commonly within reach of children under five years (<1 m; 96.0%). The weighted annualized incidence of CBI was 63 per 1000 child-years (6.4% of children per year); reported mean age was 4.4 years (SD 4.0). The most common etiology was flame burn. Older age (OR 0.89, 95% CI 0.8-1.0) and households with an older sibling ≥12 years (OR 0.58, 95% CI 0.3-1.3) seemed to be associated with lower odds of CBI.Conclusions: Childhood burn injury is common in rural Ghana. Opportunities exist to reduce the risk of childhood burn injury childhood burns in rural settings by supporting the transition to safer cooking arrangements, child barrier apparatuses in homes without older children, and/or development of formal childcare programs. [ABSTRACT FROM AUTHOR]

Background: Despite progress in vaccination coverage, timeliness of childhood vaccination remains a challenge in many settings. We aimed to assess if mobile phone-based reminders and incentives to health workers and caregivers could increase timely neonatal vaccination in a rural, low-resource setting. Methods: We conducted an open-label cluster randomized controlled 1:1:1 trial with three arms in 15 communities in Northern Ghana. Communities were randomized to 1) a voice call reminder intervention; 2) a community health volunteer (CHV) intervention with incentivized rewards; 3) control. In the voice call reminder arm, a study staff member made voice calls to mothers shortly after birth to encourage vaccination and provide personalized information about available vaccination services. In the incentive arm, CHVs promoted infant vaccination and informed women with recent births about available vaccination opportunities. Both CHVs and women were provided small monetary incentives for on-time early infant vaccination in this arm, delivered using mobile phone-based banking applications. No study activities were conducted in control communities. A population-based survey compared vaccination coverage across arms in the pre-intervention and intervention periods. The primary endpoint was completion of at least one dose of Polio vaccine within 14 days of life and BCG vaccination within 28 days of life. Results: Six-hundred ninety births were identified; 106, 88, and 88 from pre-intervention and 150, 135, and 123 in the intervention period, in the control, voice call reminder and CHV incentive arms, respectively. In adjusted intent-to-treat analysis, voice call reminders were associated with 10.5 percentage point (95% CI: 4.0, 17.1) higher coverage of on-time vaccination, while mobile phone-based incentives were associated with 49.5 percentage point (95% CI: 26.4, 72.5) higher coverage. Conclusion: Community-based interventions using mobile phone technologies can improve timely early vaccination coverage. A CHV approach with incentives to community workers and caregivers was a more effective strategy than voice call reminders. The impact of vaccination "nudges" via voice calls may be constrained in settings where network coverage and phone ownership are limited. Trial registration: This trial was registered at ClinicalTrials.gov; NCT03797950. [ABSTRACT FROM AUTHOR]

Anaemia in young sub-Saharan African children may be due to the double burden of malaria and iron deficiency. Primary analysis of a double-blind, cluster randomized trial of iron containing micronutrient powder supplementation in Ghanaian children aged 6 to 35 months found no difference in malaria risk between intervention and placebo groups. Here, we performed a secondary analysis of the trial data to assess the impact of long-term prophylactic iron fortificant on the risk of iron deficiency and anaemia in trial subjects. This population-based randomized-cluster trial involved 1958 children aged between 6 to 35 months, identified at home and able to eat semi-solid foods. The intervention group (n = 967) received a daily dose containing 12.5 mg elemental iron (as ferrous fumarate), vitamin A (400 μg), ascorbic acid (30 mg) and zinc (5 mg). The placebo group (n = 991) received a similar micronutrient powder but without iron. Micronutrient powder was provided daily to both groups for 5 months. At baseline and endline, health assessment questionnaires were administered and blood samples collected for analysis. The two groups had similar baseline anthropometry, anaemia, iron status, demographic characteristics, and dietary intakes (p > 0.05). Of the 1904 (97.2%) children who remained at the end of the intervention, the intervention group had significantly higher haemoglobin (p = 0.0001) and serum ferritin (p = 0.0002) levels than the placebo group. Soluble transferrin receptor levels were more saturated among children from the iron group compared to non-iron group (p = 0.012). Anaemia status in the iron group improved compared to the placebo group (p = 0.03). Continued long-term routine use of micronutrient powder containing prophylactic iron reduced anaemia, iron deficiency and iron deficiency anaemia among pre-school children living in rural Ghana's malaria endemic area. [ABSTRACT FROM AUTHOR]

Introduction: falls contribute to almost one-fifth of injury-related deaths. The majority of these occur in low- and middle-income countries. The impact of fall injury in low- and middle-income countries is greater in younger individuals. We aimed to determine the epidemiology of falls among rural Ghanaian children. Methods: from March to May, 2018, we conducted a cluster-randomized household survey of caregivers in a rural Ghanaian sub-district, regarding household child falls and their severity. We utilized a previously validated survey tool for household child injury. Associations between household child falls and previously described predictors of household child injury were examined with multivariable logistic regression. These included age and gender of the child, household socioeconomic status, caregiver education, employment status, and their beliefs on why household child injuries occur. Results: three hundred and fifty-seven caregivers of 1,016 children were surveyed. One hundred and sixty-four children under 18 years had sustained a household fall within the past six months, giving a household child fall prevalence of 16% (95% C.I, 14%-19%). Mean age was 4.4 years; 59% were males. Ground level falls were more common (80%). Severity was mostly moderate (86%). Most caregivers believed household child injuries occurred due to lack of supervision (85%) or unsafe environment (75%); only 2% believed it occurred because of fate. Girls had reduced odds of household falls (adjusted O.R 0.6; 95% C.I 0.4-0.9). Five to nine year-old and 15- 17 year-old children had reduced odds of household falls (adjusted O.R 0.4; 95% C.I 0.2-0.7 and 0.1; 95% C.I 0.02-0.3, respectively) compared to 1-4 year- olds. Caregiver engagement in non-salary paying work was associated with increased odds of household child falls (adjusted O.R 2.2; 95% C.I 1.0- 4.7) compared to unemployed caregivers. There was no association between household child falls and caregiver education, socioeconomic status and beliefs about why household child injuries occurred. Conclusion: the prevalence of household child falls in rural Ghana was 16%. This study confirms the need to improve supervision of all children to reduce household falls, especially younger children and particularly boys. Majority of caregivers also acknowledge the role of improper child supervision and unsafe environments in household child falls. These beliefs should be reinforced and emphasized in campaigns to prevent household child falls in rural communities. [ABSTRACT FROM AUTHOR]

Background: The International Labor Organization (ILO) estimates that 11% of children (ages 5 to 17) worldwide are child laborers. ILO recently drew attention to migrant child laborers as an underreported, but more vulnerable group to adverse outcomes relative to children working locally. Sub-Saharan Africa (SSA) continues to be the continent with the highest rates of child labor, with Ghana registering one of the highest incidence rates at 22%, including unaccompanied child migrants engaged in labor. Adolescent girls make up the majority of unaccompanied rural-to-urban migrants in search of better economic opportunities. Studies document the myriad of serious threats to health and emotional well-being experienced by adolescent girls who migrate to engage in child labor. These threats underline the urgent need for theoretically informed preventive interventions, specifically tailored to address the root causes of female child migrant labor and the needs of girls from economically insecure families and communities. Methods: A two-arm cluster randomized control trial will be conducted to assess the feasibility, acceptability, and preliminary impact of ANZANSI (family economic empowerment + multiple family groups) among 100 adolescent girls and their caregivers in the Northern Region of Ghana. Ten schools will be randomly selected from a list of eligible schools, and randomized to one of two study arms: (1) control arm (n = 5 schools, n = 50 adolescent-caregiver dyads); (2) treatment arm (n = 5 schools, n = 50 adolescent-caregiver dyads) receiving ANZANSI over a 9-month period. Adolescents (ages 11 to 14) in the same school will be assigned to the same study condition to avoid contamination. Discussion: The primary aim of the study is to address the urgent need for theoretically and empirically informed interventions that prevent adolescent girls' unaccompanied rural-to-urban migration for child labor. Existing programs are not preventive and primarily target children who already migrated to the city and are living and working on the streets. This study is one of the first studies to pilot test a combination intervention, integrating family economic empowerment targeting household poverty with multiple family groups addressing family cohesion and perceptions on gender norms, child education/labor, all of which are factors, when combined, force girls to drop out of school and migrate. Trial registration: ClinicalTrials.gov; NCT04231669; Registered January 18, 2020; [ABSTRACT FROM AUTHOR]

Background: Physician shortage is a major barrier to hypertension (HTN) control in Ghana, with only one physician to 10,000 patients in 2015, thus limiting its capacity for HTN control at the primary care level such as the Community Health Planning and Services (CHPS) compounds, where most Ghanaians receive care. A Task-Shifting Strategy for HTN control (TASSH) based on the WHO Cardiovascular (CV) Risk Package is an evidence-based strategy for mitigating provider- and systems-level barriers to optimal HTN control. Despite its effectiveness, TASSH remains untested in CHPS zones. Additionally, primary care practices in low- and middle-income countries (LMICs) lack resources and expertise needed to coordinate multilevel system changes without assistance. The proposed study will evaluate the effectiveness of practice facilitation (PF) as a quality improvement strategy for implementing TASSH within CHPS zones in Ghana.Methods: Guided by the Consolidated Framework for Implementation Research and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, we will evaluate, in a hybrid clinical effectiveness-implementation design, the effect of PF on the uptake of an evidence-based TASSH, among 700 adults who present to 70 CHPS zones with uncontrolled HTN. Components of the PF strategy include (a) an advisory board that provides leadership support for implementing the intervention within the CHPS zones and (b) trained task-strengthening facilitators (TSFs) who serve as practice coaches to provide training, and performance feedback to community health officers (CHOs) who will deliver TASSH at the CHPS zones. For this purpose, the TSFs are trained to identify, counsel, and refer adults with uncontrolled HTN to community health centers in Bono East Region of Ghana.Discussion: Uptake of community-based evidence-supported interventions for hypertension control in Ghana is urgently needed to address the CVD epidemic and its associated morbidity, mortality, and societal costs. Findings from this study will provide policymakers and other stakeholders the "how to do it" empirical literature on the uptake of evidence-based task-strengthening interventions for HTN control in Ghana and will serve as a model for similar action in other low, middle-income countries.Trial Registration: ClinicalTrials.gov, NCT03490695 . Registered on 6 April 2018.Protocol Version and Date: Version 1, date: 21 August, 2019. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization initiated test, treat, and track (T3) malaria strategy to support malaria-endemic countries in their efforts to achieve universal coverage with diagnostic testing, antimalarial treatment, and strengthening surveillance systems. Unfortunately, T3 is not adopted by over-the-counter medicine sellers (OTCMS) where many patients with malaria-like symptoms first seek treatment. Sub-Saharan African countries are considering introducing and scaling up RDTs in these outlets to reduce malaria burden. In this context, this study is aimed at improving implementation of the T3 among OTCMS using a number of intervention tools that could be scaled-up easily at the national level.Methods/design: The interventions will be evaluated using a two-arm, cluster randomized trial across 8 rural communities (4 clusters per arm), in two adjacent districts (Fanteakwa North and Fanteakwa South districts) of Ghana. A total of 8 OTCMS in the intervention arm and 5 OTCMS in the control arm in the selected communities will participate in the study. In the intervention arm only, subsidized malaria rapid diagnostic test (mRDT) kits will be introduced after the OTCMS have been trained on how to use the kit appropriately. Supervision, technical assistance, feedbacks, and collection of data will be provided on a regular basis at the participating medicine stores. The primary outcome is the proportion of children under 10 years with fever or suspected to have malaria visiting OTCMS and tested (using mRDT) before treatment. Secondary outcomes will include adherence to national malaria treatment guidelines and recommended mRDT retail price. Outcomes will be measured using mainly a household survey supplemented by mystery client survey and a surveillance register on malaria tests conducted by the OTCMS during patient consultations. Data collected will be double entered and verified using Microsoft Access 2010 (Microsoft Inc., Redmond, Washington) and analyzed using STATA version 11.0.Discussion: The trial will provide evidence on the combined effectiveness of provider and community interventions in improving adherence to the T3 initiative among OTCMS in rural Ghana.Ethical Clearance: NMIMR-IRB CPN 086/18-19 TRIAL REGISTRATION: ISRCTN registry ISRCTN77836926 . Registered on 4 November 2019. [ABSTRACT FROM AUTHOR]

In this paper, we explore gender norms held by men and women that might contribute to male perpetration of intimate partner violence (IPV) in Ghana. This qualitative research was conducted at the pre-intervention stage of a cluster randomized controlled trial. Our intervention uses community-based action teams to change social norms on gender and violence. Focus group discussions and in-depth interviews were conducted within communities. We found that male perpetrated IPV is a common phenomenon within the study communities, yet it is complex and experienced differently depending on the context. A woman's non-compliance with gender norms provided context for the male partner to enforce societal conformity through IPV. Also, male partners' misbehavior (e.g. alcohol abuse) may exacerbate IPV. Whereas the former is socially acceptable, the latter may be contested. Victims may challenge/counteract IPV using varying tactics (e.g. threats), which were mainly directed toward male partners' immoral behavior. We conclude that there is a need to assess IPV with key considerations for female agency, as some victims may respond with violence. Moreover, some communities have the tendency to demonstrate more gender-equitable attitudes regarding male perpetration of IPV, as indicated by laws instituted by some traditional leaders to deter perpetrators. These are key learnings that can inform the design and delivery of various interventions that seek to address IPV. [ABSTRACT FROM AUTHOR]

Background: The potential of mobile-health (mHealth) technology for the management of hypertension among stroke survivors in Africa remains unexplored. We assessed whether an mHealth technology-enabled, nurse-guided intervention initiated among stroke patients within one month of symptom onset is effective in improving their blood pressure (BP) control. Methods: A two-arm pilot cluster randomized controlled trial involving 60 stroke survivors, ≥18 years, with BP ≥140/90 mmHg at screening/enrollment visit at a medical center in Ghana. Participants in the intervention arm (n = 30) received a Blue-toothed BP device and smartphone with an App for monitoring BP measurements and medication intake under nurse guidance for three months after which intervention was withdrawn. Control arm (n = 30) received usual care. Primary outcome measure was proportion with clinic BP < 140/90 mmHg at month 9; secondary outcomes included medication adherence. Findings: Mean ± SD age was 55 ± 13 years, 65% males. Two participants on intervention and three in control group were lost to follow-up. At month 9, proportion on the intervention versus controls with BP < 140/90 mmHg was 14/30 (46.7%) versus 12/30 (40.0%), p = 0.79 by intention-to-treat; systolic BP < 140 mmHg was 22/30 (73.3%) versus 13/30 (43.3%), p = 0.035. Mean ± SD medication possession ratio was 0.95 ± 0.16 on intervention versus 0.98 ± 0.24 in the control arm, p = 0.56. Interpretation: We demonstrate feasibility and signal of improvement in BP control among stroke survivors in a resource-limited setting via an mHealth intervention. Larger scale studies are warranted. Trial registration: NCT02568137. Registered on 13 July 2015 at ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]

Background: Attention to nutrition during all phases of child and adolescent development is necessary to ensure healthy physical growth and to protect investments made earlier in life. Leveraging school meals programs as platforms to scale-up nutrition interventions is relevant as programs function in nearly every country in the world.Objective: The aim of this study was to evaluate the impact of a large-scale school meals program in Ghana on school-age children's anthropometry indicators.Methods: A longitudinal cluster randomized control trial was implemented across the 10 regions of Ghana, covering 2869 school-age children (aged 5-15 y). Communities were randomly assigned to 1) control group without intervention or 2) treatment group providing the reformed national school feeding program, providing 1 hot meal/d in public primary schools. Primary outcomes included height-for-age (HAZ) and BMI-for-age (BAZ) z scores. The analysis followed an intention-to-treat approach as per the published protocol for the study population and subgroup analysis by age (i.e., midchildhood for children 5-8 y and early adolescence for children 9-15 y), gender, poverty, and region of residence. We used single-difference ANCOVA with mixed-effect regression models to assess program impacts.Results: School meals had no effect on HAZ and BAZ in children aged 5-15 y. However, in per-protocol subgroup analysis, the school feeding intervention improved HAZ in 5- to 8-y-old children (effect size: 0.12 SDs), in girls (effect size: 0.12 SDs)-particularly girls aged 5-8 y living in the northern regions, and in children aged 5-8 y in households living below the poverty line (effect size: 0.22 SDs). There was also evidence that the intervention influenced food allocation and sharing at the household level.Conclusion: School meals can provide a platform to scale-up nutrition interventions in the early primary school years, with important benefits accruing for more disadvantaged children. This trial was registered at www.isrctn.com as ISRCTN66918874. [ABSTRACT FROM AUTHOR]

Uncontrolled hypertension is a major risk factor for cardiovascular disease. Evidence-based interventions to improve hypertension control in high-income countries have not been translated equally in sub-Saharan Africa (SSA). The objective of the Addressing Hypertension Care in Africa (ADHINCRA) Study was to test the feasibility and signal of efficacy of a multilevel, nurse-led, mobile health enhanced intervention in improving hypertension control in Ghana. Using a cluster randomized controlled pilot trial design, four hospitals in Kumasi, Ghana, were randomized to the intervention arm (2 hospitals) and enhanced usual care arm (2 hospitals). A total of 240 patients with uncontrolled hypertension defined as systolic blood pressure (BP) ≥140 mmHg on their most recent visit were included (60 patients per hospital). Patients in the intervention arm received an intervention that consisted of nurse-led task-shifting and a mobile health application (Medtronic® Labs' Empower Health), and home BP monitoring. The enhanced usual care arm received usual care as determined by their providers, plus short text messages on health. The intervention was administered for six months, after which it was withdrawn, and patients were followed for six more months to assess outcomes. Feasibility measures included recruitment and dropout rates of study participants, protocol adherence in both arms. Clinical outcomes included changes in BP control status and systolic BP levels from baseline. Secondary outcomes included change in glycemic control, rates of hypertensive urgencies/emergencies, cardiovascular disease events, and medication adherence. Findings from this study will provide critical pilot data to inform the conduct of a larger scale trial and the development of scalable health system and policy interventions to improve hypertension control in low-resource settings. Trial registration NCT04010344. Registered on July 8, 2019 at ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04010344 [ABSTRACT FROM AUTHOR]

• MGCubed provides live interactive satellite-transmitted teaching between Ghana's capital and schools in remote rural areas. • Highly trained and selected studio teachers each teach over 20 classrooms simultaneously supported by local facilitators. • Using an RCT, we find substantive learning gains in math and English. • Impacts are remarkably similar across the six studio teachers, and geographic areas. • In this pilot iteration, the program is less cost-effective than other programs that do not rely on satellite transmitted live teaching. Rural students in lower- and middle-income countries dramatically underperform their urban peers. Through a cluster randomized controlled trial, we explore live, interactive instruction via satellite as a potential solution. The studied program equipped 70 randomly selected schools in two areas of Ghana with technology to connect to a studio in Ghana's capital Accra, where instructors provided math and English lessons simultaneously to 10-12 schools at a time, supported by in-class facilitators. An additional 77 schools served as control. We estimate substantial gains in rural students' numeracy and literacy skills. After one year, we observe an immediate gain of 0.21 standard deviations in numeracy. After two years, we observe a gain of 0.26 standard deviations in numeracy and a gain of 0.33 standard deviations in literacy. These effects are remarkably consistent across different satellite instructors and geographic areas. Much larger gains in foundational literacy and numeracy skills and evidence from quantile regressions suggest that the program was effective in tailoring instruction at the appropriate level and in closing substantial pre-existing gaps in basic skills. The program demonstrates the feasibility of establishing a successful distance instruction model in remote and resource-constrained contexts; however, given large infrastructure and implementation expenses, the program is not (yet) cost-effective. [ABSTRACT FROM AUTHOR]

Background: 'Home-grown' school feeding programmes are complex interventions with the potential to link the increased demand for school feeding goods and services to community-based stakeholders, including smallholder farmers and women's groups. There is limited rigorous evidence, however, that this is the case in practice. This evaluation will examine explicitly, and from a holistic perspective, the simultaneous impact of a national school meals programme on micronutrient status, alongside outcomes in nutrition, education and agriculture domains. The 3-year study involves a cluster-randomised control trial designed around the scale-up of the national school feeding programme, including 116 primary schools in 58 districts in Ghana. The randomly assigned interventions are: 1) a school feeding programme group, including schools and communities where the standard government programme is implemented; 2) 'home-grown' school feeding, including schools and communities where the standard programme is implemented alongside an innovative pilot project aimed at enhancing nutrition and agriculture; and 3) a control group, including schools and households from communities where the intervention will be delayed by at least 3 years, preferably without informing schools and households. Primary outcomes include child health and nutritional status, school participation and learning, and smallholder farmer income. Intermediate outcomes along the agriculture and nutrition pathways will also be measured. The evaluation will follow a mixed-method approach, including child-, household-, school- and community-level surveys as well as focus group discussions with project stakeholders. The baseline survey was completed in August 2013 and the endline survey is planned for November 2015.Results: The tests of balance show significant differences in the means of a number of outcome and control variables across the intervention groups. Important differences across groups include marketed surplus, livestock income, per capita food consumption and intake, school attendance, and anthropometric status in the 2-5 and 5-15 years age groups. In addition, approximately 19 % of children in the target age group received some form of free school meals at baseline.Conclusion: Designing and implementing the evaluation of complex interventions is in itself a complex undertaking, involving a multi-disciplinary research team working in close collaboration with programme- and policy-level stakeholders. Managing the complexity from an analytical and operational perspective is an important challenge. The analysis of the baseline data indicates that the random allocation process did not achieve statistically comparable treatment groups. Differences in outcomes and control variables across groups will be controlled for when estimating treatment effects.Trial Registration Number: ISRCTN66918874 (registered on 5 March 2015). [ABSTRACT FROM AUTHOR]

Typhoid fever remains a significant health problem in sub-Saharan Africa, with incidence rates of >100 cases per 100,000 person-years of observation. Despite the prequalification of safe and effective typhoid conjugate vaccines (TCV), some uncertainties remain around future demand. Real-life effectiveness data, which inform public health programs on the impact of TCVs in reducing typhoid-related mortality and morbidity, from an African setting may help encourage the introduction of TCVs in high-burden settings. Here, we describe a cluster-randomized trial to investigate population-level protection of TYPBAR-TCV®, a Vi-polysaccharide conjugated to a tetanus-toxoid protein carrier (Vi-TT) against blood-culture-confirmed typhoid fever, and the synthesis of health economic evidence to inform policy decisions. A total of 80 geographically distinct clusters are delineated within the Agogo district of the Asante Akim region in Ghana. Clusters are randomized to the intervention arm receiving Vi-TT or a control arm receiving the meningococcal A conjugate vaccine. The primary study endpoint is the total protection of Vi-TT against blood-culture-confirmed typhoid fever. Total, direct, and indirect protection are measured as secondary outcomes. Blood-culture-based enhanced surveillance enables the estimation of incidence rates in the intervention and control clusters. Evaluation of the real-world impact of TCVs and evidence synthesis improve the uptake of prequalified/licensed safe and effective typhoid vaccines in public health programs of high burden settings. This trial is registered at the Pan African Clinical Trial Registry, accessible at Pan African Clinical Trials Registry (ID: PACTR202011804563392). [ABSTRACT FROM AUTHOR]

• CLTS intervention communities were 11 times less likely to practice open defecation at follow-up compared to controls. • Intervention communities with higher average social identification showed lower open defecation rates. • In control communities, higher open defecation rates were connected with higher social identificatio. • The results highlight the need of considering the social context when planning and implementing sanitation campaigns. Unsafe sanitation practices are a major source of environmental pollution and are a leading cause of death in countries of the Global South. One of the most successful campaigns to eradicate open defecation is "Community-Led Total Sanitation" (CLTS). It aims at shifting social norms towards safe sanitation practices. However, the effectiveness of CLTS is heterogeneous. Based on social identity theory, we expect CLTS to be most effective in communities with stronger social identification, because in these communities individuals should rather follow social norms. We conducted a cluster-randomized controlled trial with 3,216 households in 132 communities in Ghana, comparing CLTS to a control arm. Self-reported open defecation rates and social identification were assessed pre-post. Generalized Estimating Equations showed that CLTS achieved lower open defecation rates compared to controls. This effect was significantly stronger for communities with stronger average social identification. The results confirm the assumptions of social identity theory. They imply that pre-existing social identification needs to be considered for planning CLTS, and strengthened beforehand if needed. [ABSTRACT FROM AUTHOR]

Background: Ghana is among African countries not likely to achieve the Sustainable Development Goal (SDG) three (3) target of reducing maternal mortality to 70 per 100,000 live births by the year 2030 if maternal and child health services utilization are not improved. Community engagement in health is therefore advocated to help address this challenge. This study evaluated the impact of a community engagement intervention on maternal and child health services utilization in Ghana.Methods: This study was a cluster randomised trial among primary healthcare facilities (n = 64) in the Greater Accra and Western regions in Ghana. Multivariate multiple regression analysis and paired-ttest were used to determine impact of the community engagement intervention on maternal and child health indicators at baseline and follow-up.Results: Intervention health facilities recorded significant improvements over control facilities in terms of average spontaneous vaginal deliveries per month per health facility (baseline mean = 15, follow-up mean = 30, p = 0.0013); child immunizations (baseline mean = 270, follow-up mean = 455, p = 0.0642) and female condoms distribution (baseline mean = 0, follow-up mean = 2, p = 0.0628). Other improved indicators in intervention facilities were average number of Human Immunodeficiency Virus (HIV) tests for non-pregnant women (baseline mean = 55, follow-up 104, p = 0.0213); HIV tests for pregnant women (baseline mean = 40, follow-up mean = 119, p = 0.0067) and malaria tests (baseline mean = 43, follow-up mean = 380, p = 0.0174). Control facilities however performed better than intervention facilities in terms of general laboratory tests, voluntary counselling and testing, treatment of sexually transmitted infections, male child circumcisions and other minor surgical procedures.Conclusion: Community engagement in health has the potential of improving utilization of maternal and child health services. There is the need for multi-stakeholder dialogues on complementing existing quality improvement interventions with community engagement strategies. [ABSTRACT FROM AUTHOR]