Strengthening Contraceptive Counseling in Pakistan

NCT ID: NCT04915885

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Contraception

Study Design

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

Study Groups

Control arm

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

Group Type: OTHER

Routine care

Intervention Type: OTHER

Routine contraceptive counseling and routine method availability

Intervention package

contraceptive counseling package but still with a range of family planning methods that are routinely available at field level

Group Type: EXPERIMENTAL

Package of contraceptive counseling interventions

Intervention Type: OTHER

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

Intervention package & expanded methods

contraceptive counseling package but with an expanded range of family planning methods that are recommended by national guidance

Group Type: EXPERIMENTAL

Package of contraceptive counseling interventions

Intervention Type: OTHER

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

Expanded methods

Intervention Type: OTHER

Expanded range of contraceptive methods as recommended by national policies

Interventions

Routine care

Routine contraceptive counseling and routine method availability

Intervention Type: OTHER

Package of contraceptive counseling interventions

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

Intervention Type: OTHER

Expanded methods

Expanded range of contraceptive methods as recommended by national policies

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

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

Sponsors

Nguyen-Toan Tran

OTHER

Sponsor Role: lead

Responsible Party

Nguyen-Toan Tran

World Health Organization consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

FPC21

Identifier Type: -

Identifier Source: org_study_id