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

NCT ID: NCT06081842

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7920 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2026-06-30

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.

Detailed Description

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.

Conditions

Contraception; Empowerment; Decision Making

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Arm 1. Routine care

Routine contraceptive counseling and routine method availability

Group Type: ACTIVE_COMPARATOR

Contraceptive counseling strengthening intervention package

Intervention Type: OTHER

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

Arm 2. Package of contraceptive counseling interventions

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

Group Type: EXPERIMENTAL

Contraceptive counseling strengthening intervention package

Intervention Type: OTHER

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

Arm 3. Expanded methods

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

Group Type: EXPERIMENTAL

Contraceptive counseling strengthening intervention package

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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);

2. Client is not coming for the resupply of a currently used method, such as pills or injectables;

3. Client has the intention to continue her follow-up at the health center during the duration of study follow-up;

4. Client does not participate in another study; and

5. Client provides informed consent.

Exclusion Criteria

Not willing to participate in the complete duration of the trial

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jinnah Sindh Medical University

OTHER

Sponsor Role: collaborator

University of Ibadan

OTHER

Sponsor Role: collaborator

World Health Organization

OTHER

Sponsor Role: lead

Responsible Party

Moazzam Ali

Medical officer / Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 38839392 (View on PubMed)

Other Identifiers

WHO

Identifier Type: -

Identifier Source: org_study_id