Strengthening Contraceptive Counseling in Pakistan

NCT04915885 | Withdrawn DMC

• 1 other identifier: FPC21
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Contraception

Keywords

Counseling; Empowerment; Autonomy

Outcome Measures

Primary Outcomes (2)

• Change in clients' decision-making autonomy

  Person-Centered Contraceptive Counseling scale (PCCC), developed and tested by Dehlendorf et al. (2021)

  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

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Change in modern contraceptive prevalence

  6 months and 12 months post enrollment

Study Arms (3)

Control arm

OTHER

routine contraceptive counseling and care and a range of family planning methods that are routinely available at field level

Other: Routine care

Intervention package

EXPERIMENTAL

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

Intervention package & expanded methods

EXPERIMENTAL

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

Interventions

Routine care OTHER

Routine contraceptive counseling and routine method availability

Control arm

Package of contraceptive counseling interventions OTHER

The implementation package will be co-designed by providers and clients during the formative and research design phases

Intervention package; Intervention package & expanded methods

Expanded methods OTHER

Expanded range of contraceptive methods as recommended by national policies

Intervention package & expanded methods

Eligibility Criteria

• Age: 15 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

1. she comes to the family planning clinic with the intention to 1.a. use contraception for the first time in her life (new user), or 1.b. switch from a contraceptive method to another one (switching user), or 1.c. resume a method after not using any in the prior three months (lapse user), or 1.d. discontinue a modern method (discontinuing user); 2. she is not coming for the resupply of a currently used method, such as pills or injectables; 3. she has the intention to continue her follow-up at the health center during the 12-month study follow-up; 4. she does not participate in another study; and 5. she provides informed consent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nguyen-Toan Tran: lead

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: World Health Organization consultant

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 7, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Supporting information will become available 6 months after data collection and will be available for at least 3 years
• Access Criteria: Upon reasonable request from the World Health Organization