Overlooking the contraceptive needs of postpartum women constitutes missed opportunities in health system. Inter-birth interval of at least three years can prevent poor maternal, perinatal and neonatal outcomes and afford women socio-economic benefits of family planning (FP). The unmet need for FP in the postpartum period remains unacceptably high and far exceeds the FP unmet need of other women. The Kenya Demographic and Health Survey (KDHS) estimate the unmet need for postpartum FP to be 74%. Maternal and Child Health (MCH) continuum provides a great opportunity for postpartum FP (PPFP) interventions integration especially antenatal targeted FP information giving and gauging of fertility intentions. However, there is no protocol for structured, targeted antenatal FP information giving and behavioural contracting to influence postpartum fertility intentions of mothers before delivery. Knowledge gap regarding fertility intentions and best antenatal strategies for postpartum FP still exists. The available evidence differs across settings and demography. Equally, there has been inadequate exploration of operationally-feasible ways to integrate FP counselling into existing ANC services with limited number of methodologically rigorous trials. The current protocol will therefore examine the effectiveness of targeted antenatal family planning information provision on early postpartum FP uptake using a randomized control trial in Kisumu County, Kenya. The protocol will assess socio-cultural beliefs towards PPFP and perceived individual control of PPFP choice, analyze knowledge and intention for PPFP, and finally compare and examine the determinants of PPFP uptake between study groups. Through simple sampling, a group of 246 antenatal mothers will be randomly assigned to control, community and facility intervention groups as per eligibility criteria in the study facilities. After at least 3 months of intervention and postpartum follow-up, clinical superiority will be used to gauge which intervention was effective and the model superiority. Questionnaire and Case Report Forms will be the main source of data. The participant will form the unit of analysis which will be by intention to treat. Bivariate analysis will be applied as the selection criteria for inclusion of predictors of intention and uptake in the final logistic regression model. Odds Ratios and 95% confidence interval (CI) will be used to demonstrate significance and the strength of association between selected variables. Dissemination will be through conference presentations and peer reviewed journals. The trial has been registered with the Pan African Clinical Trials Registry PACTR202109586388973 on the 28th September 2021.
This will be a prospective interventional study, a Randomised Control Trial (RCT) conducted in Kisumu East Sub-County within Kisumu County. The randomly sampled facilities are Migosi and Gita Health Centres for intervention in urban and rural areas, respectively. The Community Units (CU) for community-based intervention are Kuoyo CU and Nyalunya CU in an urban and rural areas, respectively. The control facility and CUs are Kowino and Chiga Health Centres and their link CUs in urban and rural areas, respectively. The study will have three arms: facility intervention arm, community intervention arm and a control arm. The study will have three interacting phases (Figs (Figs11 and and2):2): The pre-intervention phase, intervention phase and post-intervention phase. The proposed methods in each phase are not complex thus the overall design can be classified as simple interventional design. The pre-intervention phase will be for establishing sampling frame, intervention package and research tools formulation. The aim of the intervention phase is to determine the effect of the targeted antenatal PPFP information package on the uptake of contraceptive methods during the postpartum period, in comparison with the standard of care. The intervention phase will also integrate qualitative research that is aimed at identifying operational barriers and enablers of the intervention outcomes. Randomization to control and intervention arms is at individual level within randomly selected control, community and the primary level health centres. Participants allocated to the experimental group will receive the targeted antenatal PPFP information package and those allocated to the control group will receive usual antenatal care. The intervention will be provision of antenatal information on PPFP using a standardized PPFP counselling tool (S1 Video) and postpartum appointment setting. The control group will be under the routine standard antenatal care. There will be antenatal PPFP information provision training for the service providers at the facility and Community Health Voluntees (CHV) for the community arm to standardize the intervention. This study will be among pregnant mothers in their second trimester, irrespective of age, attending ANC clinic in the intervention facilities or who are within the respective CUs followed up to 3 months postpartum. Excluded will be those who meet the eligibility criteria but are in another similar study, have latex sensitivity, not anticipating male partner in the next 12 months or the only male partner has had a vasectomy. The study will be conducted in 2 primary health centres and 1 community in each of the two sub-counties. The health centres eligibility depended on if: they offer the continuum of ANC, delivery, and Postnatal Care (PNC); they provide a selection of at least three modern contraceptive methods that are rated 2 or 1 on the Medical Eligibility Criteria (MEC) for postpartum contraceptives and there were no stock-outs of contraceptives during the preceding six months. Multistage sampling will be applied involving purposive sampling for the sub counties, purposive sampling for the intervention and control facilities and community and simple random sampling for the subjects. One sub-county will be purposively sampled by the researchers; one with a rural and an urban set up and should be within easy reach by the team. The facilities will be matched based on (1) the average number of deliveries per month and (2) the operational level. The intervention CU would be linked to a facility meeting the basic criteria for intervention facility. Each client meeting the criteria will then be randomly assigned to the study i.e. to the intervention and to the control arms using simple random sampling by picking folded paper labelled “yes” or “no”. There will be no blinding as the intervention facilities and controls are already known. The sample size is estimated based on the following assumptions: among women at three months postpartum, KDHS data report 27% of use of any method (modern or traditional) in Kenya while the Contraceptive Prevalence Rate (CPR) in the general population is 53% [18]. These figures allow the assumption of a desired 26% difference between control and the intervention groups (26% increase in adopting a modern contraceptive by three months postpartum). Therefore, the sample size was calculated pairwise for two separate RCT for community—control arm and the facility—control arm [19–22]. Rosner, 2015 proposed the sample size determination formula for difference in proportions with consideration of type I and II errors and power [22, 23], to be: N1={z(1−α/2)*√(p¯*q¯*(1+1/k))+z1−β*√(p1*q1+(p2*q2)/k)}2/Δ2. Where q1 = 1-p1, q2 = 1-p2, p¯=(p1+kp2)/(1+K), p1, p2 = proportion (incidence) of groups #1 (27%) and #2 (53%), Δ = |p2-p1| = absolute difference between two proportions (0.26), n1 = sample size for group #1, n2 = sample size for group #2, α = probability of type I error (is set at 0.05), β = probability of type II error (is set at 0.1 i.e. 90% power), z = critical Z value for a given α or β(1.96) and K = ratio of sample size for group #2 to group #1(1). Thus for practical equal sample distribution, the actual sample size shall be 246. As such, each facility shall have 41 clients. The study will have 3 phases; pre-intervention (-t for enrolment and t0 for allocation), intervention (t1-t2 for post-allocation) and post-intervention (tx1-tx2 for close out). SPIRIT schedule of the study and a flow diagram of the study are shown in Figs Figs11 and and22 respectively. The estimated starting date of the study will be 20th February, 2022 and the estimated ending date will be in August, 2022. The intervention will be; provision of antenatal information on PPFP using a standardized PPFP counselling tool and postpartum appointment setting. The intervention will be administered once. This will be within the second and third trimesters of pregnancy. The service providers at the facility and CHVs for the community arm will be trained on antenatal PPFP information provision prior to recruitment. To standardize the training to all, pre and post-test will be administered and the data collectors will be expected to get at least 60% in post-test for them to be brought on board as study implementers. Their post-test score will be included in the analysis to rule it out as a confounder. The study nurses in all the arms will do the recruitment of clients through history-taking and carrying out physical assessment. The nurse will then fill the case report form. The control group will be under the routine antenatal care after recruitment. The study nurse or CHV will use a standardized tool of Medical Eligibility Criteria that has been embedded in the teaching tool to deliver the intervention. Each session will be standardized to at least 20 minutes for it to be considered adequate information provision. All the clients will then be undertaken through the exit interview and informed about the last follow-up interview which is between 14 to 16 weeks postpartum. Client exit interviews entries to the data base and the dashboard will be reviewed by the data management team to give feedback to the study steering committee for appropriate corrective actions to improve adherence to intervention protocols. There is no concomitant care or intervention that is recommended or prohibited during the trial that has not been contemplated in the exclusion criteria. Client will be discontinued if they lose their only sexual partner or the only sexual partner undergoes vasectomy in the course of pregnancy, and if the client develops postpartum psychosis, or is hospitalized for more than 14 weeks postpartum. Five tools will be used for data collection, namely; client exit interview guide, case report form, appointment card, site appraisal form and questionnaire. All the tools will be used to collect quantitative data except site appraisal form or some questions in the questionnaire that need brief explanation. The theory of planned behaviour (Fig 3) was applied to design quantitative process and outcome indicators and thus the same tools will be applied [24]. Client exit interview guide and site appraisal form will be developed based on the procedures set out in the counselling guide. Appointment card will be the source of information on client details, proposed date for PPFP initiation and vital PPFP information summary. Each health centre and community unit will have a trained research assistant. The assistant is to ensure adherence to the study manual and standard operating procedures for data management. The primary outcomes will be PPFP knowledge, the intent for use of PPFP (behavioural contracting) and the actual uptake of modern contraceptive methods at three months postpartum. The outcome will largely be assessed based on the CRFs, appointment card and questionnaire. Actual uptake of modern contraceptive method will be established three months postpartum between the 12th to 14th weeks after birth. The CRFs will be filled on recruitment by the trained ANC service provider. The appointment card will be filled by the health worker after the client has accepted to set postnatal follow up date for PPFP. The questionnaire will be filled at 14 weeks postpartum during the scheduled MCH visit by a trained enumerator. A process evaluation will be undertaken with the objectives of understanding the barriers and enablers related to the delivery of PPFP. This will be evaluated based on client exit interviews and site appraisal forms. The client exit interview guide and site visit appraisal form will be used to assess the process quality indicators which will include: waiting time, time/trimester of start of FP counselling, time after FP counselling, group/ individual session, availability of teaching aid on the table during counselling, gauging FP information level, application of GATHER (Greet, Ask, Tell, Help, Explain and Return/Refer) Model and BRAIDED (Benefits, Risks, Alternatives, Inquiries, Decision, Explanation, Documentation) Model. The models will capture satisfaction with information given, responses to questions, respectful care, confidentiality and privacy. Client exit interviews will be done by trained enumerator immediately after the intervention has been administered to reduce recall bias by the client. Site appraisal form will be filled on site visits by the research team and the enumerator will fill other details to include workload for ANC, number of staff available to offer ANC services, availability of FP counselling bag and flipchart. Internal consistency will be ensured by piloting the tools and refining them to ensure they capture the essence of what they were meant to collect and Cronbach’s alpha of 0.7 will be acceptable. The data will be password-protected: only authorized users will be allowed access to the data. In addition, the collected information will be stored safely; hardcopies will be stored in lockable cabinets and soft copies will be secured by password. Data transmission will be encrypted to ensure data integrity and confidentiality of participants. Data entry will be done in SPSS version 26. Data management team will comprise the PI, site data clerks, the study nurses and Community Health Workers. The main roles of team will include; monitoring acceptance rate (proportion of those who accepted to participate versus those sampled), monitoring retention (percentage of participants proceeding from recruitment, treatment to follow-up including missing outcome data), monthly forecast of recruitment for the trial period remaining, monitoring loss to follow-up as a proportion of the ones not yet reached by 16 weeks postpartum follow-up to those who were recruited, overseeing data management metrics such as the rate of electronic data capture, return dates and rate of returns, number of completed follow-up, withdrawal rate, monitoring intervention fidelity by the study nurse or Community Health Worker (CHW), data quality checks and results dashboard review. The interim analysis will be for monitoring purposes from the Kobo toolbox dashboard. It will be used to determine acceptance and retention rates and forecasting trial period remaining and the proportion of the unreached or dropout rates. This being a behavioural intervention study, the researcher do not envisage a circumstance warranting prior termination of the trial due to internal factors. The participant will form the unit of analysis. All analyses will be by intention to treat. Descriptive statistics will be tabulated for individual characteristics and summarized into frequencies and percentages for categorical variables and means, median, range and standard deviation for continuous variables. Bivariate analysis of effects of sociocultural beliefs on PPFP uptake will be done and presented on two-by-two (2×2) tables with Chi-square being the inferential statistics. P-values will be used to assess the significance of homogeneity of proportions and odds ratio (OR) and 95% confidence interval (95% CI) will demonstrate the strength of the relationship. Binary logistic regression analysis will be done to adjust for confounders of sociocultural beliefs as determinants of PPFP uptake. Fertility intentions for postpartum mothers will be measure by Likert scale [25] and disaggregated based on sociodemographic aspects and other individual characteristics. Intention to use PPFP will be simplified in proportions of the categorical yes or no to appointment for PPFP. Bivariate analysis of determinants of fertility intentions will be done and presented in two-by-two (2×2) tables with Chi-square being the inferential statistics. Binary logistic regression analysis will be done to adjust for confounders of determinants of fertility intentions. Student t-test will be used to analyze perceived individual control of PPFP choice and level of fertility intention to ascertain the significance in differences in means for the determinants of perceived control of FP choice and level of fertility intention and significant determinants will be fitted in multilinear regression analysis to adjust for confounders. Postpartum Family Planning uptake between control and intervention groups will be compared by use of simple clinical superiority in the proportions. Bivariate analysis with Chi-square statistics will be used to analyse the determinants of Postpartum Family Planning uptake between control and intervention groups and this will form the selection criteria for inclusion in the final regression model.
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