An interventional study of Contraceptive counseling strengthening intervention package in Contraception, Empowerment and Decision Making, sponsored by World Health Organization. Not yet recruiting. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by World Health Organization · Not applicable, Interventional, and Health services research
High-quality contraceptive counseling can strengthen global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of contraceptive counseling interventions for Pakistan and Nigeria designed to strengthen existing contraceptive services and determine its effectiveness in increasing clients' level of decision-making autonomy and meeting their contraceptive needs.
The research will be a multi-intervention, three-arm, single-blinded, parallel, cluster RCT done in selected primary health centers (clusters) in Pakistan and in Nigeria. Centers will be randomly allocated to the three study arms in matched ratios (1:1:1) on the basis of the number of monthly family planning encounters, the number of available contraceptive types, the ratio of health workers per population in the clinic coverage zone, the location in urban or rural settings, and selected district-level variables that may have an influence on the study outcomes, including the unmet need for family planning, the level of literacy among women, and household income quartiles. Only data analysts will be masked to trial-arm allocation. Service providers skilled in family planning services will implement the clinical components of the contraceptive counseling package. The cluster RCT design is justified by the fact that some of the components of the intervention package to be identified in the intervention design phase will not be delivered directly to individual participants but only applied at the level of the health center, such as refresher training of service providers.
The two-part formative phase first uses participatory approaches to identify the perspectives of clients, including young people and providers, to ensure research contextualization and address each interest group's needs and priorities; clinical observations of client-provider encounters to document routine care form the second part. The design workshop of the third phase will result in the development of a package of contraceptive counseling interventions. In the fourth and experimental phase, a multi-intervention, three-arm, single-blinded, parallel cluster randomized-controlled trial will compare routine care (arm 1) with the contraceptive counseling package (arm 2) and the same package combined with wider method availability (arm 3). The fifth and reflective phase aims to analyze the package's cost-effectiveness and identify implementation barriers and enablers. The primary outcomes are clients' level of decision-making autonomy and met need for modern contraceptives.
World Health Organization is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Not willing to participate in the complete duration of the trial
Routine contraceptive counseling and routine method availability
Other: Contraceptive counseling strengthening intervention package
The implementation package will be co-designed by providers and clients during the formative and research design phases
Other: Contraceptive counseling strengthening intervention package
Routine care with the contraceptive counseling package combined with wider method availability as recommended by national policies.
Other: Contraceptive counseling strengthening intervention package
Development of contraceptive counseling strengthening intervention package that strengthens existing family planning services and is effective, safe, sustainable, scalable, and culturally appropriate.
Change in clients' decision-making autonomy
Person-Centered Contraceptive Counseling scale (PCCC). On a scale of 1-5, with score range between 4 to a maximum score of 20, with the highest possible score on a scale will be considered good.
Time frame: Through study completion, an average of 1 year
Change in clients' met need for family planning
Number of participants who want to avoid a pregnancy and are using a contraceptive method / all participants
Time frame: Through study completion, an average of 1 year
Change in modern contraceptive prevalence
Number of participants using a modern contraceptive / all participants
Time frame: 6 months and 12 months post enrollment
No study locations are listed for this record.
Plan to share: Yes — (i) use of a controlled access approach, such as upon reasonable request from the World Health Organization; (ii) the trial will seek consent for sharing Individual Participant Data (IPD) from trial participants with adequate assurance that patient privacy and confidentiality will be maintained
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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