Administrative information
Title {1} | Improving access to family planning for women with disabilities in Kaduna, Nigeria: study protocol for a pragmatic cluster-randomized controlled trial with integrated process evaluation. |
Trial registration {2a and 2b}. | ISRCTN registry, ISRCTN12671153. Retrospectively registered on 17/04/2023, https://www.isrctn.com/ISRCTN12671153. |
Protocol version {3} | Version 3 (1st November 2022) |
Funding {4} | The study is funded by the United Kingdom Foreign, Commonwealth and Development Office under the Programme for Evidence to Inform Disability Action (PENDA) (IATI Identifier: GB-EDU-133903-PENDA). The intervention is designed and implemented under a separate project implemented by a consortium of organizations led by international non-governmental organization (iNGO) Sightsavers and funded by the United Kingdom Foreign, Commonwealth and Development Office under the Disability Inclusive Development programme, as part of Inclusive Futures. |
Author details {5a} | Sarah Marks[1]* ✉ & Ekundayo Arogundade[2]* (joint first), Mark T. Carew[1], Shanquan Chen[1], Lena Morgon Banks[1], Hannah Kuper[1], Femi Adegoke[2]* (joint last) & Calum Davey[1, 3]* * These authors contributed equally to this work ✉Corresponding author [1] International Centre for Evidence in Disability, London School of Hygiene & Tropical Medicine, London, United Kingdom [2] Oxford Policy Management, Abuja, Nigeria [3] Centre for Evaluation, London School of Hygiene & Tropical Medicine, London, United Kingdom |
Name and contact information for the trial sponsor {5b} | Not applicable. This is an observational evaluation study that aims to evaluate to what extent the intervention has achieved its goals. The researchers are not involved in the design, allocation or implementation of the intervention—this is being led by Sightsavers. |
Role of sponsor {5c} | Not applicable. See above {5b}. |
Introduction
Background and rationale {6a}
Objectives {7}
Population | Women aged 18a–49 years that report at least ‘a lot’ of difficulty on one of the six questions in the Washington Group short set or ‘daily’ and ‘a lot’ to additional questions on depression or anxiety; women in the same neighbourhood and age range without disabilities, in order to determine whether the intervention has a specific effect amongst women with disabilities |
Intervention | Components of the IFPLAN project delivered at the health facility and community levels, in the context of state-wide and national broadcast media and advocacy |
Control | ‘Standard’ provision of family planning services in the state, in the context of state-wide and national broadcast media and advocacy |
Outcome | Primary: Access to family planning Secondary: Knowledge, unmet need, and use of family planning |
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Outcome name | Measure | |
---|---|---|
Primary outcome | Access to family planning | Survey: binary (yes / no), based on composite of questions: • Know of at least three modern contraceptive methods that are available; & • Know where to access modern family-planning; & name the location; & list the available family planning services; & • Believe that they could use services if they needed them |
Secondary outcome | Knowledge of family planning | Survey: binary (yes / no), based on composite of questions: • Know of at least three modern contraceptive methods that are available |
Intention to use | Survey: binary (yes / no), based on: • Will use contraceptive method in the future | |
Use of family planning (modern method) | Survey: binary (yes / no), based on composite of questions: • Participant or participant’s partner currently doing something or using any method to delay or avoid getting pregnant; & • (Using a modern contraceptive method) | |
Unmet need for family planning | Survey: binary (yes / no), based on composite of questions: • Would prefer to delay or not to have another child & • Not using contraception | |
Perceived attitudes towards women with disabilities | • Score based on inclusion and participation module of survey |
Participant timeline {13}
Intervention implementation (Planned start April 2023 with implementation lasting for at least 1 year) | |||
---|---|---|---|
Visit | Visit 1: Baseline survey | Visit 2: Process evaluation | Visit 3: Endline survey |
Visit time point | Prior to intervention implementation | During/post intervention implementation | After intervention implementation |
Visit conducted by | OPM Nigeria Data collection team | OPM Nigeria Data collection team | OPM Nigeria Data collection team |
ENROLMENT: | |||
Eligibility screen | X | X | X |
Informed consent of respondent | X | X | X |
Resident, Household listing of women 18–49 years | X | X | |
Women 18–49 years, Washington Group Questions | X | X | |
ASSESSMENTS: | |||
Women 18–49 years, Respondent’s Background | X | X | |
Women 18–49 years, Husband’s background | X | X | |
Women 18–49 years, Marriage and sexual activity | X | X | |
Women 18–49 years, Fertility preferences | X | X | |
Women 18–49 years, Reproductive history | X | X | |
Women 18–49 years, Knowledge of contraceptive methods | X | X | |
Women 18–49 years, Contraceptive use | X | X | |
Women 18–49 years with disabilities, Inclusion and participation | X | X | |
Women 18–49 years with disabilities, Attitudes | X | X | |
Women 18–49 years, HIV knowledge | X | X | |
Women 18–49 years, Experience of gender-based violence | X | X | |
Programme monitoring data on key intervention components | X | ||
Women 18–49 years, Participant response to family planning services | X | ||
Women 18–49 years, Unintended consequences of family planning services | X | ||
Women 18–49 years, Contextual factors affecting use of family planning services | X | ||
Health facility staff, intervention set-up and delivery | X | ||
Health facility staff, perceived impact and operation of the intervention | X | ||
Intervention implementers, intervention set-up and delivery | X | ||
Intervention implementers, perceived impact and operation of the intervention | X |
Sample size {14}
Assumptions: | |
Proportion of women aged 18–49 years | 20.0% |
Proportion of women 18–49 years who are disabled based on Washington Group Questionsa | 0.7% |
Proportion of women 18–49 years with depression or anxietyb | 6.0% |
Estimated overlap between the above | 30% |
Number of people in each cluster | 10,000 |
Proportion of women who have ‘access’ to family planning | 25% |
Derived values: | |
Number of women aged 18–49 years (10,000 × 20%) | 2000 |
Proportion of women 18–49 years who are disabled overall (6% + (0.7% × (100–30%))) | 6.49% |
Number of women 18–49 years who are disabled (2000 × 6.49%) | 130 |
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: Blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Interim analyses {21b}
Methods for additional analyses (e.g. subgroup analyses) {20b}
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Plans to give access to the full protocol, participant-level data and statistical code {31c}
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
Composition of the data monitoring committee, its role and reporting structure {21a}
Adverse event reporting and harms {22}
Frequency and plans for auditing trial conduct {23}
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Dissemination plans {31a}
Discussion
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All women should know about available services if they are to have ‘access’;
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Women who want to delay or reduce future pregnancies should be able to realize ‘access’ through use of services;
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Women who do not want to delay or reduce future pregnancies, or are not in sexually active relationships, are not expected to have realized their ‘access’ to services through service use; instead, understanding access is a composite of their beliefs about using services if they needed them (hypothetically) and their impressions of the barriers or facilitators that we expect should determine use.