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

Strengthening Contraceptive Counseling Services, a Multi-country Study Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contraception; Decision Making; Empowerment
• Intervention / Treatment: Other: Contraceptive counseling strengthening intervention package

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.

• Study Type: Interventional
• Enrollment (Estimated): 7920
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1. Routine care; Routine contraceptive counseling and routine method availability	Other: 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.
Experimental: 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	Other: 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.
Experimental: Arm 3. Expanded methods; Routine care with the contraceptive counseling package combined with wider method availability as recommended by national policies.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in modern contraceptive prevalence	Number of participants using a modern contraceptive / all participants	6 months and 12 months post enrollment

Collaborators and Investigators

• Sponsor: World Health Organization
• Collaborators: University of Ibadan; Jinnah Sindh Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Family Planning, Counselling, choice
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: WHO (Other Identifier: U1111-1303-0085)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: (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 Individual Participant Data (IPD) from trial participants with adequate assurance that patient privacy and confidentiality will be maintained
• IPD Sharing Time Frame: Supporting information will become available 6 months after data collection and will be available for at least 5 years
• IPD Sharing Access Criteria: Upon reasonable request from the World Health Organization
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No