Parent Study design
Lessons learned reflect our team’s experiences in undertaking a larger impact evaluation, which consisted of two components. Component 1: was a baseline prospective assessment conducted prior to implementation of a reproductive health program, and component 2: was a cross-sectional retrospective assessment in a site where the program has ended.
Study sites and population
The program included both prospective and retrospective assessment of separate intervention and control sites in urban settlements of Karachi, Pakistan. Jamshed Town as an intervention site and Yousuf Goth as a control site for prospective assessment; and Korangi Town as an intervention site and PIB colony and Dalmia/Shanti as control sites for retrospective surveys were selected. The program was implemented from April 2013 through September 2015 in Korangi Town (for retrospective assessment), and from June 2017 to March 2020 in Jamshed Town (for prospective assessment). The control sites were selected to match the intervention areas in terms of socio-demographic characteristics, such as type of area (urban or peri-urban), population size, and ethnicity or language. Women were eligible if they were aged 16-44 years for prospective assessment and 16-49 years for retrospective assessment, married, usual members of the household, and spoke at least one of the four commonly used languages (Urdu, Pushto, Sindhi, or English).
Jamshed town is the most populated (0.73 million) municipality in the East district of Karachi with majority of Muslim population. The town is populated by diversified ethnic groups including Muhajirs, Punjabis, Sindhis, Kashmiris, Seraikis, Pakhtuns, Balochis, Memons, Bohras, Ismailis, etc. and is also home to minority groups such as Christians, Parsis, and Hindus. Yousuf Goth with nearly one million inhabitants is a peri-urban setting in the neighborhood of district Malir with majority of Muslim population of various ethnic groups. Jamshed town and Yousuf Goth share similar socio-demographic characteristics and consist of large slum areas with some population belonging to the upper-middle class. Both areas have dynamic working-class population and have public/private schools, malls and shopping plazas. The religious festivals, variability in weather pattern influence seasonal migration within and between districts and provinces. For example, families of slum areas move to interior Sindh districts to harvest crops from April to July each year. Some families live temporarily in rented houses in selected settings and frequently shift between nearby communities.
On the other hand, Korangi town with the population size of 2.4 million is a peri-urban neighborhood in the East of Karachi with multi-ethnic population including Muhajirs, Sindhi, Balochi, Pushtuns, and Gilgiti. This is an industrial area and is home to families from Afghanistan and Bangladesh who migrated for the purpose of employment in the garment and leather factories. Population here belong to low and middle class. PIB and Dalmia/Shanti Nagar with the population size of one million and 0.1 million, respectively, are the peri-urban areas located in Gulshan town with majority of Muslim population. In both areas, children’s enrollment in schools is low and they work as helpers in the factories. Some women work in garment factories, some work as housekeepers, but many have low-paying private school teaching jobs. Due to ethnic diversity, the seasonal mobility varies in each ethnicity.
Sampling strategy and sample size
Both prospective and retrospective surveys followed a three-stage random sampling design. Initially, GIS technology was used to construct the sampling frame with distinct area mapping and cluster demarcation of the intervention and control sites. GIS technology was used because Pakistan lack reliable and updated statistics related to structure and household number in union councils of urban slums. Secondly, it is cost-effective method to in-person visits required to validate cluster boundaries and searching for a reliable statistics and unnecessary delays for developing sampling frames. Based on the geographical demarcation by GIS, 283 clusters were formed in intervention sites and 200 clusters in control site for the prospective assessment, whereas, 548 clusters in the intervention site and 160 in the control sites for the retrospective assessment. Each cluster was created on cadastral scale consisted of 60-100 structures. The second stage involved random selection of clusters in the intervention and comparison sites. A total of 105 clusters from an intervention and 100 from control site for the prospective assessment, and 110 clusters in each site for the retrospective assessment were randomly selected for inclusion in the study.
The second stage involved a complete household listing in selected clusters and random sampling of eligible women. The data management unit of Aga Khan University (AKU) developed an android application program for the household listing activity. All households were included in the listing, and the questionnaire sought to determine which had any eligible women who were between the ages of 16-44 years for the prospective component and 16-49 for the retrospective component. Field teams also collected pertinent details on the household location, including GPS coordinates, addresses, written directions, and the name of the household head. The application was tested multiple times to fix bugs and queries prior to household listing. The household listing enrolled 8,179 households in the intervention and 6,406 households in the control sites for prospective assessment, and 9,010 in the intervention and 8,182 in control sites in retrospective assessment to generate a sampling frame for selection of households (secondary sampling units).
The final stage involved random selection of women from these sites. A sample size of 1836 (~2000) women from each site was required to the retrospective and prospective survey. The study team used household listing and identified 2,019 eligible women in intervention and 2,147 eligible women in control sites for prospective survey; and 2,750 eligible women each from intervention and control sites for the retrospective assessments using a computerized process. The calculated sample size was powered to test even at least a 5% (percentage point) difference in critical value of CPR in intervention sites compared to control sites at 0.05 significance with 90% probability of exceeding the critical value on a two-sided test. This process was carried out in STATA using a uniform [0, 1] random number generator with a fixed seed. Women were ranked by the number drawn. The lowest random draws from eligible women in the household were selected to participate in the survey. The randomly selected women were uploaded to the CommCare application for interview by the enumerators assigned to each cluster. The CommCare application randomly selected one if there were more than one eligible woman in a selected household.
Survey questionnaires (additional file 1 & 2)
We finalized the questionnaire for the retrospective and prospective assessments using country-specific standard data collection instruments such as demographics and health surveys. The survey questionnaire covered a range of topics on women’s reproductive health, including marital status, contraceptive knowledge and use, childbearing, and abortion and access to safe abortion services. It sought insights on issues related to implementation, uptake, and continuation of a modern method. The assessments used to describe month-by-month history of certain key events i.e. births, pregnancies, termination of pregnancies, and family planning use of the respondents for the five years calendar period (January 2013 to 2018) preceding the date of interview. It also captured the information on change in contraceptive methods, and reasons of discontinuation [4]. The survey questionnaire, originally devised in English, was translated into Urdu (the national language) and was then back translated into English. We used digital data collection process which is useful for on-time data entry and checking, however requires resources such accessories, power bank, and internet connectivity for uploading data from fields. We conducted two pilot-testing exercises prior to data collection and modified the questionnaire based on feedbacks. In the initial week, enumerator was asked to complete one questionnaire a day, which was increased to two completed questionnaires a day in the second week, and after wards three completed questionnaires a day for the rest of the survey period.
Data quality assurance
The study team implemented a number of strategies to ensure quality fieldwork. These included regular quality checks in CommCare application to identify inconsistencies and outliers in the data. The CommCare is a software developed by Dimagi that allows non-programmers to design and use mobile application for android devices. This is used across multiple sectors with the need to collect data digitally. The application had built-in quality checks to minimize errors and ensure proper skip patterns. The enumerators were trained to sync completed forms for review by the team leader. This means that completed forms on the enumerators’ tablet were uploaded to a central server so that the team leader could access them on her tablet before leaving the field so as to clarify any mistakes. The syncing process was done on completion of each form. Each team leader reviewed the collected information on her tablet during and after the field visits. Team leaders also visited randomly selected 5% of the households to verify collected information, however, no such discrepancies were found. We hired all female enumerators and team leaders based upon the local norms where a female is allowed to enter the household and talk to woman. We developed a protocol for re-visiting cases with major errors such as when an enumerator skipped collecting information on pregnancy even when the respondent had a birth in the last 30 months. The data management unit documented the data cleaning notes and ran rounds of STATA cleaning codes to fix case specific errors on discussions with field manager, then re-ran to confirm all issues were resolved. In addition, enumerator refresher trainings were conducted weekly to discuss issues with data and fieldwork and to discuss updated field protocols where appropriate. In order to minimize loss to follow up between the household listing and re-visits for the survey, when a selected woman could not be found at their household, the enumerator made three attempts to contact her on different days. After each interview or attempt to make contact with a selected woman, enumerators completed an ‘interviewer contacts’ form in CommCare, which documented the status of each case (e.g. completed, not eligible, moved away, re-scheduled, etc.). To improve response rates, enumerators also scheduled interviews for days/times most convenient for participants (for example, on weekends or evenings, outside of working hours).
Ethical Approval
The Ethical Review Committee of the Aga Khan University (4964-Ped-ERC-17) and the National Bioethics Committee of Pakistan approved the study. The enumerator read aloud the consent form before asking survey questions to eligible women and signed the consent form on their behalf. The enumerator also provided a hard copy of consent form to the respondent.