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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04915885
Enrollment
0
Registered
2021-06-07
Start date
2022-01-31
Completion date
2025-12-31
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Counseling, Empowerment, Autonomy

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.

Interventions

OTHERRoutine care

Routine contraceptive counseling and routine method availability

OTHERPackage of contraceptive counseling interventions

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

OTHERExpanded methods

Expanded range of contraceptive methods as recommended by national policies

Sponsors

Nguyen-Toan Tran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in clients' decision-making autonomyThrough study completion, an average of 1 yearPerson-Centered Contraceptive Counseling scale (PCCC), developed and tested by Dehlendorf et al. (2021)
Change in clients' met need for family planningThrough study completion, an average of 1 yearnumber of participants who want to avoid a pregnancy and are using a contraceptive method / all participants

Secondary

MeasureTime frameDescription
Change in modern contraceptive prevalence6 months and 12 months post enrollmentnumber of participants using a modern contraceptive / all participants

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026