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

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.

Study Overview

• Status: Withdrawn
• Conditions: Contraception
• Intervention / Treatment: Other: Routine care; Other: Package of contraceptive counseling interventions; Other: Expanded methods

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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
Other: Control arm; routine contraceptive counseling and care and a range of family planning methods that are routinely available at field level	Other: Routine care; Routine contraceptive counseling and routine method availability
Experimental: Intervention package; 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; The implementation package will be co-designed by providers and clients during the formative and research design phases
Experimental: Intervention package & expanded methods; contraceptive counseling package but with an expanded range of family planning methods that are recommended by national guidance	Other: Package of contraceptive counseling interventions; The implementation package will be co-designed by providers and clients during the formative and research design phases; Other: Expanded methods; Expanded range of contraceptive methods as recommended by national policies

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), 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 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: Nguyen-Toan Tran

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Counseling; Empowerment; Autonomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: FPC21

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 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 3 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