Strengthening Contraceptive Counseling Services: Research Protocol for a Multi-phase Complex Intervention in Pakistan and Nigeria

NCT06081842 | Not Yet Recruiting

• 1 other identifier: WHO
• Study Type: interventional
• Target: 7,920
• 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 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.

Conditions

Contraception; Empowerment; Decision Making

Keywords

Family Planning, Counselling, choice

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

Arm 1. Routine care

ACTIVE COMPARATOR

Routine contraceptive counseling and routine method availability

Other: Contraceptive counseling strengthening intervention package

Arm 2. Package of contraceptive counseling interventions

EXPERIMENTAL

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

Other: Contraceptive counseling strengthening intervention package

Arm 3. Expanded methods

EXPERIMENTAL

Routine care with the contraceptive counseling package combined with wider method availability as recommended by national policies.

Other: Contraceptive counseling strengthening intervention package

Interventions

Contraceptive counseling strengthening intervention package OTHER

Development of contraceptive counseling strengthening intervention package that strengthens existing family planning services and is effective, safe, sustainable, scalable, and culturally appropriate.

Arm 1. Routine care; Arm 2. Package of contraceptive counseling interventions; Arm 3. Expanded methods

Eligibility Criteria

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

You may qualify if:

• Client 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);
• Client is not coming for the resupply of a currently used method, such as pills or injectables;
• Client has the intention to continue her follow-up at the health center during the duration of study follow-up;
• Client does not participate in another study; and
• Client provides informed consent.

You may not qualify if:

• Not willing to participate in the complete duration of the trial

Sponsors & Collaborators

• World Health Organization: lead
• Jinnah Sindh Medical University: collaborator
• University of Ibadan: collaborator

Related Publications (1)

• Tran NT, Ali M, Azmat SK, Seuc A, Olaolorun FM, Awan MA, Morhason-Bello I, Thom EM, Martin J, Abubakar HD, Uzma Q, Kiarie J. Strengthening contraceptive counselling services to empower clients and meet their needs: protocol for a two-stage, multiphase complex intervention in Pakistan and Nigeria. BMJ Open. 2024 Jun 5;14(6):e081967. doi: 10.1136/bmjopen-2023-081967.

  PMID: 38839392 DERIVED

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
• Masking Details: 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). Only data analysts will be masked to trial-arm allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical officer / Epidemiologist

Model Details: The research entails a complex multi-site, two-stage and 5-phase: STAGE 1 is formative and will comprise of a pre-formative (phase 1) and a formative (phase 2). While the STAGE 2 is experimental and will include intervention design (phase 3), experimental (phase 4), and reflective (phase 5).

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 13, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 13, 2023

Record last verified: 2023-10

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 5 years
• Access Criteria: Upon reasonable request from the World Health Organization