Evaluation of the Friendship Bench' Circle Kubatana Tose (CKT): an add-on support group intervention - a mixed-methods pilot interventional cohort study protocol.

INTRODUCTION: Mental disorders are endemic. However, the mental health treatment gap remains high, especially in low-resource settings. Task-shifting is a universally recommended strategy to mitigate the care gap. The Friendship Bench (FB), a task-shifting, low-intensity psychotherapy programme founded in Zimbabwe, is effective in managing anxiety and depression. The FB programme offers clients the choice of joining add-on mental health support groups known as Circle Kubatana Tose (CKT). These groups offer an opportunity for continued psychoeducation, social support and economic strengthening. However, the evidence base for the effectiveness of add-on support groups is sparse. We hypothesise that participation in CKT is associated with increased adherence to treatment regimens, social support and well-being. This mixed-methods prospective cohort study seeks to evaluate the intermediate effects (6-month follow-up) of CKT groups, including process outcome evaluation. METHODS AND ANALYSIS: We will recruit participants (N=178) receiving mental healthcare from the FB in Harare primary care clinics. Follow-up assessments will occur at enrolment, 6 weeks, 3 months and 6 months, assessing changes in common mental disorders (depression and anxiety), social support, positive psychological indices (hope and resilience), health-related quality of life, working alliance, economic outcomes (net income) and implementation outcome (feasibility, acceptability/satisfaction and uptake of services). Quantitative data will be analysed using descriptive analysis, bivariate statistics, Cox proportional hazard models and generalised mixed models (maximum likelihood estimation). Qualitative data will be analysed using thematic analysis. DISSEMINATION AND ETHICS: Ethical approval was granted by the Medical Research Council of Zimbabwe (MRCZ/A/2427). The findings will inform the potential utility of add-on support groups in the management of anxiety and depression using task-shifting. Dissemination study outcomes will be disseminated in academic journals, social media, conferences and policy briefs.

Fractional dose compared with standard dose inactivated poliovirus vaccine in children: a systematic review and meta-analysis.

BACKGROUND: Since WHO recommended introduction of at least a single dose of inactivated poliovirus vaccine (IPV) in routine immunisation schedules, there have been global IPV shortages. Fractional-dose IPV (fIPV) administration is one of the strategies to ensure IPV availability. We reviewed studies comparing the effects of fractional with full-dose IPV vaccination to determine when seroconversion proportions with each strategy become similar in children aged 5 years and younger. METHOD: In this systematic review and meta-analysis, we searched 16 databases in July, 2019, for trials and observational studies, including ongoing studies that compare immunogenicity and adverse events of fractional-dose (0·1 mL) to full-dose (0·5 mL) IPV in healthy children aged 5 years or younger regardless of study design, number of doses, and route of administration. Screening, selection of articles, data extraction, and risk of bias assessment were done in duplicate, and conflicts were resolved by discussion or arbitration by a third author. We assessed immunogenicity, the main outcome, as proportion of seroconverted participants and changes in geometric mean titres of anti-poliovirus antibodies. Timepoints were eligible for analysis if measurements were done at least 4 weeks after vaccination. Summary estimates were pooled by use of random-effects meta-analysis. Analysis was stratified by study design, type of outcome measure, type of poliovirus, and number of doses given. We assessed heterogeneity using the χ2 test of homogeneity and quantified it using the I2 statistic. We assessed risk of bias using the Cochrane risk of bias tool, and the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. The study is registered with PROSPERO, CRD42018092647. FINDINGS: 860 records were screened for eligibility, of which 36 potentially eligible full-text articles were assessed and 14 articles were included in the final analysis: two ongoing trials and 12 articles reporting on ten completed studies. For poliovirus type 2, there were no significant differences in the proportions of seroconversions between fractional and full doses of IPV for two or three doses: the risk ratio for serconversion at one dose was 0·61 (95% CI 0·51-0·72), at two doses was 0·90 (0·82-1·00), and at three doses was 0·95 (0·91-1·00). Geometric mean titres (GMTs) for poliovirus type 2 were lower for fIPV than for full-dose IPV: -0·51 (95% CI -0·87 to -0·14) at one dose, -0·49 (-0·70 to -0·28) at two doses, and -0·98 (-1·46 to -0·51) at three doses. The seroconversion meta-analysis for the three-dose comparison was homogeneous (p=0·45; I2=0%), whereas heterogeneity was observed in the two-dose (p<0·00001; I2=88%) and one-dose (p=0·0004; I2=74%) comparisons. Heterogeneity was observed in meta-analyses of GMTs for one-dose (p<0·00001; I2=92%), two-dose (p=0·002; I2=80%), and three-dose (p<0·00001; I2=93%) comparisons. Findings for types 1 and 3 were similar to those for type 2. The certainty of the evidence was high for the three-dose comparisons and moderate for the rest of the comparisons. INTERPRETATION: There is no substantial difference in seroconversion between three doses of fIPV and three doses of full-dose IPV, although the full dose gives higher titres of antibodies for poliovirus type 1, 2, and 3. Use of fractional IPV instead of the full dose can stretch supplies and possibly lower the cost of vaccination. FUNDING: South African Medical Research Council and the National Research Foundation of South Africa.

Incomplete vaccination and associated factors among children aged 12-23 months in South Africa: an analysis of the South African demographic and health survey 2016.

BACKGROUND: Socioeconomic and health inequalities remain a huge problem in post-apartheid South Africa. Despite substantial efforts at ensuring universal access to vaccines, many children remain under-vaccinated in the country. This study aimed to assess the prevalence and factors associated with incomplete vaccination in the first year of life, among children aged 12-23 months in South Africa. METHODS: The study is a secondary analysis of the 2016 South African Demographic and Health Survey. A multivariable logistic regression model was applied to the data on 708 children aged 12-23 months. The study outcome, vaccination completeness, was assessed using a composite assessment of nine doses of four vaccines; Bacillus Calmette-Guérin (BCG) (one dose), Polio (four doses), diphtheria-tetanus-pertussis containing vaccines (DTP) (three doses) and measles-containing vaccines (MCV) (one dose). Children who received all the nine doses were categorized as completely vaccinated. Independent variables included child, maternal, and demographic characteristics. Variables were included in the model based on literature findings. Bivariate analyses were used to examine the crude association between each independent variable and incomplete vaccination, while the multivariable logistic regression model was used to examine the adjusted association after controlling for other variables. Measures of association were presented as odds ratios (OR) with their 95% confidence intervals (CI). RESULTS: About two-fifths (40.8%) of the children were incompletely vaccinated. The prevalence of incomplete vaccination was significantly high among children whose mothers did not receive antenatal care (ANC) during pregnancy (57.5%), and children living in Gauteng Province (52.2%). From the bivariate analyses, the odds of being incompletely vaccinated were three times higher in children whose mothers did not attend ANC compared with children whose mothers attended ANC (crude OR = 2.93; 95% CI 1.42-6.03). The odds were about three times higher in children living in Mpumalanga province (OR = 2.58; 95% CI 1.27-5.25) and in those living in Gauteng province (OR = 2.76; 95% CI 1.30-5.91), compared with those living in Free State province. Conversely, the odds were 32% lower in children from rich households, compared with those from poor households (OR = 0.68; 95% CI 0.47-0.98). In the adjusted model, the higher odds of incomplete vaccination in children whose mothers did not attend ANC were maintained in both magnitude and direction (adjusted OR [aOR] = 2.87; 95% CI 1.31-6.25). Similarly, compared with children living in Free State province, the higher odds of a child being incompletely vaccinated in Mpumalanga (aOR = 2.30; 95% CI 1.03-5.14) and in Gauteng (aOR = 3.10; 95% CI 1.35-7.15) provinces were maintained in both magnitude and direction. CONCLUSIONS: There is a substantial burden of incomplete childhood vaccination in South Africa. Maternal ANC attendance during pregnancy and area of residence significantly influences this burden. Interventions that promote broader health service utilization, such as ANC attendance, can help improve the awareness and uptake of routine childhood vaccination. It is also imperative to take into consideration the provincial disparities in childhood vaccination completeness, in planning and implementing interventions to improve vaccination coverage in the country.

Country-Level Assessment of Missed Opportunities for Vaccination in South Africa: Protocol for Multilevel Analysis.

BACKGROUND: Vaccination is one of the greatest public health interventions of all time. Vaccination coverage in South Africa has shown a steady improvement in reaching the national target. However, while there is progress nationally, there are districts within the country that are below the set target for vaccination coverage. One of the main drivers of suboptimal vaccination coverage is thought to be missed opportunities for vaccination. OBJECTIVE: This study aims to understand the magnitude and determinants of missed opportunities for vaccination in South Africa. METHODS: The 2016 South African Demographic and Health Survey will be used to conduct multilevel regression analyses to determine individual and contextual factors associated with missed opportunities for vaccination in South Africa. The perspectives of parents attending health care facilities in South Africa will be explored through exit interviews and focus group discussions. Similarly, perspectives of the health care providers will be sought to understand enablers and barriers to vaccination coverage at the facility level. Insights to such factors will aid in designing tailor-made interventions to improve vaccination coverage in South Africa. RESULTS: Ethical review submission is planned for October 2020. Data collection is expected to be underway in January 2021. CONCLUSIONS: The extent of missed opportunities in South Africa coupled with the associated factors presents an opportunity for efforts to increase uptake in districts where vaccination coverage is below the national target. Population-level data such as those from the 2016 South African Demographic Health Survey will provide an idea of the magnitude of missed opportunities for vaccination in South Africa at the national and subnational levels. The findings of the study will inform national and subnational policy implementation on vaccinations and help to find context-specific interventions to improve vaccination coverage. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16672.

Protocol for a systematic review and meta-analysis of fractional dose compared with standard dose inactivated polio vaccination in children.

INTRODUCTION: WHO recommends the introduction of at least one single dose of inactivated polio vaccine (IPV) in routine immunisation schedules. Thus, there has been an increased demand and concurrent supply shortages of IPV worldwide. One of the strategies to improve access is the use of fractional instead of full doses of IPV. We aim to compare the effects of fractional with standard doses of IPV. METHODS AND ANALYSIS: We will include randomised trials, non-randomised trials, case-control studies and cohort studies that compared fractional with full doses of IPV among children aged 5 years or younger. We will search for eligible studies among published and grey literature. Two authors will independently screen the results of the search, select studies, extract data and assess risk of bias. We will stratify analyses by study design, type of poliovirus, type of outcome measure and number of IPV doses given. For each type of poliovirus, we will pool the outcome data from studies using random-effects meta-analyses. Statistical heterogeneity will be assessed using the χ2 test of homogeneity and quantified using the I2 statistic. To investigate statistical heterogeneity, subgroup analyses will be performed based on the timing of the first fractional dose, age of administration, immunisation schedules and country income status. Sensitivity analyses will be used to assess if the effect of IPV fractional dosing is affected by study design, risk of bias and methods of meta-analysis. ETHICS AND DISSEMINATION: We obtained approval from the University of Cape Town Human Research Ethics Committee (HREC REF: 412/2018). The findings of this review will provide evidence for decision-making with regards to IPV dosage, eventually improving access to the vaccine by stretching vaccine supplies. The results will be published in the University of Cape Town online library and in a peer reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42018092647.