Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04915885

Strengthening Contraceptive Counseling in Pakistan

Strengthening Contraceptive Counseling Services to Empower Clients and Meet Their Needs: Protocol for a Multi-phase Complex Intervention in Pakistan

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Nguyen-Toan Tran · Academic / Other
Sex
Female
Age
15 Years – 49 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERRoutine careRoutine contraceptive counseling and routine method availability
OTHERPackage of contraceptive counseling interventionsThe implementation package will be co-designed by providers and clients during the formative and research design phases
OTHERExpanded methodsExpanded range of contraceptive methods as recommended by national policies

Timeline

Start date
2022-01-01
Primary completion
2024-12-01
Completion
2025-12-01
First posted
2021-06-07
Last updated
2024-05-17

Source: ClinicalTrials.gov record NCT04915885. Inclusion in this directory is not an endorsement.