- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527364
Evaluation of Changing the Scripts Intervention in Nigeria
Study Overview
Status
Conditions
Detailed Description
Background: Modern contraception use to space or limit births is an important aspect of reproductive health because it has the potential to improve maternal health and child outcomes, reduce poverty, and promote gender equality. Despite their benefits, modern contraceptive use remains low in many developing countries, including Nigeria. Nigeria has the largest population and one of the lowest modern contraceptive use rates in sub-Saharan Africa. The 2023-2024 Nigerian Demographic and Health Survey (NDHS) found that the prevalence of modern contraceptives among married women was 15.3%, a 3-percentage point increase from the 2018 NDHS. Rates in Kano and Kaduna continue to remain lower than the national average. In Kano, about 10.6% of married women were using a modern method, roughly double the level recorded in the 2018 NDHS, while in Kaduna, a slight decrease was observed (0.6%) over the years and by 2023-2024 survey about 13.1% were using a modern contraceptive method.
Mass media interventions have been used over the years to address low family planning uptake because they can simultaneously influence individuals, families, peer networks and communities. Evidence across these different ecological levels have found that mass media approaches can influence family planning behaviors, knowledge, perceptions, attitudes and expectations . However, despite the large body of evidence documenting the impact of mass media, there's a need for rigorous evaluations that measure multiple outcomes along the behavioral pathway as well as assessments that capture the cost implications.
Objective: The objective of this study is to evaluate a multimedia intervention to be implemented by BBC Media Action in Kano and Kaduna. This evaluation will estimate the intervention's impact on family planning/child spacing method use, examine behavioral mechanisms of change, estimate cost-efficiency, and generate insights into its sustainability.
Methodology: Using a quasi-experimental design, the evaluation will be conducted in Kano, Kaduna, and Nasarawa (comparison) States. It is a three-year (2026 - 2028), mixed-methods, longitudinal evaluation of the BBC Media Action multimedia SBC intervention. Data collected will include a longitudinal cohort survey with women of reproductive age who meet our inclusion criteria at baseline. The baseline survey will be collected before the intervention begins and a follow-up survey will be conducted two years after the start of intervention implementation. In addition, in-depth interviews will be conducted with a subset of the cohort women and their partners, and program monitoring interviews with intervention women, intervention men, and program implementers. Key informant interviews and an online survey will be conducted with key implementing partners to gather insights into sustainability. To inform the cost efficiency analysis, costs associated with implementation will be collected from the financial management systems of partners along with semi-structured interviews with partners.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francine E Wood, PhD, MPH
- Phone Number: +1-424-209-9188
- Email: fwood@health.ucsd.edu
Study Contact Backup
- Name: Erin Pearson, PhD, MPH
- Phone Number: 1-254-624-6937
- Email: eepearson@health.ucsd.edu
Study Locations
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Kaduna, Nigeria
- Recruiting
- Household survey
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Contact:
- OPM Nigeria
- Phone Number: +2348030000603
- Email: info.nigeriaoffice@opml.co.uk
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Kano, Nigeria
- Recruiting
- Household survey
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Contact:
- OPM Nigeria
- Phone Number: +2348030000603
- Email: info.nigeriaoffice@opml.co.uk
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Nasarawa, Nigeria
- Recruiting
- Household survey
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Contact:
- OPM Nigeria
- Phone Number: +2348030000603
- Email: info.nigeriaoffice@opml.co.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All eligibility criteria based on self-report:
- Aged 15-44 years old at baseline
- Female
- Sexually active (based on self-report; i.e., in union)
- Able to provide informed consent
- Current residence in the selected intervention or comparison area
Exclusion Criteria:
- Are not considered sexually active (i.e. not in union)
- Are unable to provide consent
- Are younger than 15 years and older than 44 years at baseline
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Multimedia (BBC MA) + Supply Side Interventions (MSI)
Arm 1 includes local government areas (LGAs) in Kano and Kaduna that will receive the multimedia intervention led by BBC Media Action (BBC MA) and have existing Marie Stopes International (MSI) supply-side interventions
|
Led BBC Media Action (BBC MA) and implemented in collaboration with multiple partners, the intervention will create an integrated "story world" designed to shift knowledge, attitudes, and beliefs, spark conversations, and reshape social norms around family planning or child spacing.
The aim is to empower women and couples to make and act on informed family planning/child spacing decisions, ultimately increasing uptake and continuation of contraception.
This will be achieved through a range of multimedia channels and formats, including TV drama, radio drama, radio discussion and call-in shows, public service announcements, social media, mobile IVR drama, and community engagement.
Family planning services in the public sector in Nigeria supported by supply-side interventions implemented by Marie Stopes International (MSI) Nigeria.
Supply-side interventions include health provider training on family planning service provision, supporting family planning commodity supply, and monitoring family planning service quality.
|
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Experimental: Arm 2: Multimedia intervention (BBC MA) only
Arm 2 includes LGAs in Kano and Kaduna that will only receive the BBC MA multimedia intervention but do NOT have existing MSI supply-side interventions.
|
Led BBC Media Action (BBC MA) and implemented in collaboration with multiple partners, the intervention will create an integrated "story world" designed to shift knowledge, attitudes, and beliefs, spark conversations, and reshape social norms around family planning or child spacing.
The aim is to empower women and couples to make and act on informed family planning/child spacing decisions, ultimately increasing uptake and continuation of contraception.
This will be achieved through a range of multimedia channels and formats, including TV drama, radio drama, radio discussion and call-in shows, public service announcements, social media, mobile IVR drama, and community engagement.
|
|
Active Comparator: Arm 3: Supply Side Interventions (MSI) only
Arm 3 includes LGAs in Nasarawa that have existing MSI supply side interventions but will NOT receive the multimedia (BBC MA) intervention
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Family planning services in the public sector in Nigeria supported by supply-side interventions implemented by Marie Stopes International (MSI) Nigeria.
Supply-side interventions include health provider training on family planning service provision, supporting family planning commodity supply, and monitoring family planning service quality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Current family planning use
Time Frame: Baseline and follow-up (2 years after implementation start)
|
Change in prevalence of women's self-reported FP use (1) any FP method; 2) modern FP method) between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences)
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Baseline and follow-up (2 years after implementation start)
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Intent to use a family planning method
Time Frame: Baseline and follow-up (2 years after implementation start)
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Change in prevalence of women's self-reported intent to use an FP method between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences). This will be a categorical variable measured among all participants, defined as 0=No intent, 1=Intent, 2=FP User. Intent to use FP will be assessed in the following scenarios:
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Baseline and follow-up (2 years after implementation start)
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Favorable attitude towards family planning
Time Frame: Baseline and follow-up (2 years after implementation start)
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Change in prevalence of women reporting that they are in favor of the use of family planning/child spacing methods between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences)
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Baseline and follow-up (2 years after implementation start)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy to discuss family planning/child spacing with partner/husband
Time Frame: Baseline and follow-up (2 years after implementation start)
|
Change in women's mean self-efficacy score (CSESSA Nigeria husband/partner communication sub-scale) between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in differences).
Range: 0-40 with higher values indicating higher levels of self-efficacy.
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Baseline and follow-up (2 years after implementation start)
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Perceived prevalence of family planning use
Time Frame: Baseline and follow-up (2 years after implementation start)
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Change in mean number of married women in the community (out of 10) that participants think use family planning/child spacing methods between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences).
Range: 0-10 with higher values indicating a higher perceived prevalence of FP use among married women in their community.
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Baseline and follow-up (2 years after implementation start)
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Preference-aligned fertility management (PFM)
Time Frame: Baseline and follow-up (2 years after implementation start)
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Change in prevalence of women whose fertility preferences align with their contraceptive behavior between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences). PFM is defined as:
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Baseline and follow-up (2 years after implementation start)
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Family planning intent actualized
Time Frame: Follow-up (2 years after implementation start)
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Change in prevalence of women reporting FP use (1) any FP method or 2) modern FP method) any time within the 2-year follow-up period among those who reported intending to use an FP method at baseline between each intervention group compared to the comparison group at the 2-year follow-up (single time point)
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Follow-up (2 years after implementation start)
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Confidence in ability to use family planning
Time Frame: Baseline and follow-up (2 years after implementation start)
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Change in prevalence of women reporting that they feel confident they could use FP if they wanted to between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences)
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Baseline and follow-up (2 years after implementation start)
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Frequency of communication about family planning/child spacing with husband/partner
Time Frame: Baseline and follow-up (2 years after implementation start)
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Change in prevalence of women reporting that they communicate about family planning/child spacing methods with their husband/partner "often" or "sometimes" between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences)
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Baseline and follow-up (2 years after implementation start)
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Concrete plan to use family planning
Time Frame: Baseline and follow-up (2 years after implementation start)
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Change in prevalence of women reporting that they have a concrete plan to start using an FP method (including having identified a place to access the FP method) between baseline and 2-year follow-up in each intervention group compared to the comparison group (difference-in-differences)
|
Baseline and follow-up (2 years after implementation start)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Erin Pearson, PhD, MPH, University of California, San Diego
Publications and helpful links
General Publications
- National Population Commission - NPC, & ICF. (2019). Nigeria Demographic and Health Survey 2018 - Final Report. http://dhsprogram.com/pubs/pdf/FR359/FR359.pdf
- High Impact Practices in Family Planning (HIPs). (2017). Mass Media: Reaching audiences far and wide with messages to support healthy reproductive behaviors. https://fphighimpactpractices.org/briefs/mass-media
- Federal Ministry of Health Social Welfare of Nigeria (FMoHSW), National Population Commission - NPC/Nigeria, & ICF. (2025). Nigeria Demographic and Health Survey 2024. https://www.dhsprogram.com/pubs/pdf/FR395/FR395.pdf
- Dasgupta, A., Kantorová, V., Ueffing, P., & Wheldon, M. (2022). Contraceptive use and fertility transitions: The distinctive experience of sub-Saharan Africa. Demographic Research, 46(4), 97-130. https://doi.org/10.4054/DemRes.2022.46.4
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 813938
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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