An interventional study of Routine care and Package of contraceptive counseling interventions in Contraception, sponsored by Nguyen-Toan Tran. Withdrawn. Open to female participants aged 15 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Nguyen-Toan Tran · 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 designed to strengthen existing contraceptive services and determine its effectiveness in increasing clients' level of decision-making autonomy and meeting their contraceptive needs.
Methods The five-phase complex intervention design starts with a pre-formative phase aimed at mapping potential study sites to establish the sampling frame. 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.
Discussion Applying participatory action research principles in designing, testing, and scaling up effective, affordable, and sustainable counseling interventions could help optimize clients' decision-making autonomy and meet their needs for modern contraceptives in low-resource settings. Recognizing the socio-cultural and health service complexities surrounding contraception, including client-provider power dynamics, the study assumes that engaging key stakeholders, including adolescents, women, men, service providers, and policymakers would be more effective. A set of low-technology interventions will likely affect, at the individual level and in a sustainable way, the knowledge, attitudes, and behaviors of women and couples toward contraceptive counseling and provision. At the health service delivery level, the trial implementation would necessitate a shift in providers' attitudes and accountability toward a systematic integration into their clinical practice of must-have and person-centered counseling components, as well as improved health service organization to ensure the availability of competent staff and diversity of contraceptive choices.
This is the only study on the registry with Nguyen-Toan Tran as lead sponsor.
Counted across the registry records on this site, refreshed daily.
routine contraceptive counseling and care and a range of family planning methods that are routinely available at field level
Other: Routine care
contraceptive counseling package but still with a range of family planning methods that are routinely available at field level
Other: Package of contraceptive counseling interventions
contraceptive counseling package but with an expanded range of family planning methods that are recommended by national guidance
Other: Package of contraceptive counseling interventions · Other: Expanded methods
Routine contraceptive counseling and routine method availability
The implementation package will be co-designed by providers and clients during the formative and research design phases
Expanded range of contraceptive methods as recommended by national policies
Change in clients' decision-making autonomy
Person-Centered Contraceptive Counseling scale (PCCC), developed and tested by Dehlendorf et al. (2021)
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 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 withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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