Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000750482
Ethics application status
Approved
Date submitted
18/05/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Empowering Contraceptive Choice through a Client-Centered Counselling Approach: An Experimental Study in Family Planning Centres of Rawalpindi, Pakistan
Scientific title
Empowering Contraceptive Choice through a Client-Centered Counselling Approach: An Experimental Study in Family Planning Centres of Rawalpindi, Pakistan
Secondary ID [1] 314474 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 337694 0
Condition category
Condition code
Public Health 334029 334029 0 0
Health service research
Reproductive Health and Childbirth 334167 334167 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enhanced Counseling Protocols (Intervention Arms)
This experimental study introduces two structured, client-centered counseling interventions aimed at strengthening informed contraceptive decision-making among women attending family planning centers in Rawalpindi, Pakistan. The interventions are grounded in principles of respectful care, autonomy, and shared decision-making, with an emphasis on ensuring that women feel supported, well-informed, and empowered throughout their contraceptive journey. The two interventions tested in this study are the GATHER Approach and the Balanced Counseling Strategy (BCS).

1. GATHER Approach
The GATHER approach provides a structured, sequential model for engaging clients in meaningful contraceptive counseling. It is designed to create a respectful and interactive environment where the client’s individual needs, values, and reproductive goals are acknowledged and prioritized. This method includes six core steps:

Greet – Establishing a welcoming, respectful, and non-judgmental atmosphere to build rapport and trust.

Ask – Exploring the client’s reproductive intentions, concerns, and preferences related to contraception.

Tell – Providing evidence-based, comprehensible information about a full range of contraceptive methods, including benefits, side effects, and effectiveness.

Help – Guiding the client in aligning contraceptive choices with her reproductive needs and personal context.

Explain – Offering detailed instructions on method use, managing side effects, and follow-up.

Return – Encouraging continued engagement, return visits, and access to future support.

In this study, each client will receive a single counseling session under this model, lasting between 15 to 25 minutes. Sessions will be conducted in a private space, respecting the confidentiality and dignity of each client.

To aid understanding and decision-making, clients will be given culturally adapted visual job aids and information leaflets based on WHO’s GATHER framework, translated into local languages and simplified for low-literacy populations. These materials were either adapted from existing WHO content or developed specifically for the local context of this study.

Counseling will be delivered by trained healthcare providers, including family welfare workers, nurses and midwives, and physicians currently engaged in family planning service delivery within the participating facilities.

Quality assurance mechanisms will be embedded into the intervention through the use of:

Structured supervision checklists

Client exit interviews to assess satisfaction, comprehension, and recall

WhatsApp-based peer support groups for real-time supervision, knowledge sharing, and ongoing reinforcement of key counseling principles. The WhatsApp-based peer support groups will be moderated by trained healthcare personnel, and they will remain active for a duration of 6 months from the enrolment of the first participant.

Quick Investigation of Quality (QIQ) indicators to monitor fidelity to the counseling model and measure key process and outcome metrics

Follow-up reinforcement will be provided during clients’ subsequent visits, ensuring continuity of care and addressing any emerging needs or concerns.

2. Balanced Counseling Strategy (BCS)
The Balanced Counseling Strategy (BCS) is an evidence-informed, decision-support tool that simplifies and standardizes family planning counseling. It helps providers efficiently deliver tailored contraceptive information while ensuring clients play an active role in the decision-making process. BCS is delivered in three key phases:

Pre-choice Stage – The provider briefly assesses the client’s reproductive goals and medical history to identify and exclude methods that may not be medically appropriate or acceptable. This step ensures safety and aligns counseling to the client’s context.

Method-choice Stage – The client is presented with visual cards for eligible contraceptive methods. The provider discusses each option concisely, highlighting only relevant information regarding effectiveness, use, side effects, and acceptability. The client is encouraged to compare and ask questions to facilitate an informed choice.

Post-choice Stage – Once a method is selected, the provider offers clear, practical guidance on method use, possible side effects, management strategies, and follow-up planning. The aim is to promote method adherence and continued satisfaction.

Each session using the BCS model will last approximately 20–30 minutes and will be conducted in a supportive and respectful environment. Clients will receive method-specific brochures and decision-support cards developed for this study, designed for clarity and cultural appropriateness.

As with the GATHER arm, trained healthcare personnel—primarily nurses, midwives, and family planning counselors—will deliver the sessions. These providers will receive additional supervision and monitoring to ensure the standardized application of BCS protocols across sites.

Performance monitoring and quality assurance will include:

Use of BCS checklists and cue cards

Exit interviews assessing client understanding, satisfaction, and confidence in their chosen method

Peer-support forums using mobile-based platforms for discussing case challenges and sharing best practices

Provider Training for Intervention Delivery
A comprehensive provider training program will be implemented to ensure high-quality and consistent delivery of both the GATHER and BCS interventions. The training is designed to build counseling competencies, strengthen communication skills, and promote client-centered attitudes among service providers.

The training will be modular and participatory, delivered over 3 full days, with an additional 1-day refresher session conducted midway through the study period. Training modules will include:

Foundations of Family Planning and Reproductive Rights

Principles of voluntary choice, confidentiality, and non-discrimination

Overview of modern contraceptive methods

Counseling Skills and Interpersonal Communication

Active listening

Empathy building

Handling myths and misconceptions

Cultural sensitivity and managing bias

Intervention-Specific Protocols

Hands-on training in the GATHER and BCS models

Use of counseling aids, cue cards, and decision-support tools

Simulated role plays and scenario-based discussions

Documentation and Data Recording

Accurate use of checklists and client records

Integrating counseling notes into routine service registers

Quality Assurance and Supervision Mechanisms

Understanding QIQ indicators

Participating in peer-learning via WhatsApp groups

Use of supervision feedback tools

Trainers will include senior reproductive health specialists and master trainers certified in rights-based counseling. Training will be delivered in Urdu and Punjabi, with a combination of lectures, practical exercises, group discussions, and real-time feedback. Each participant will receive a training manual, job aids, and a counseling toolkit tailored to their intervention arm.

Post-training, providers will be mentored through monthly supervisory visits, and their performance will be reviewed using structured observation checklists. Feedback will be shared in supportive, non-punitive formats to encourage continuous professional development and adherence to intervention standards.
Intervention code [1] 331209 0
Diagnosis / Prognosis
Intervention code [2] 331210 0
Diagnosis / Prognosis
Comparator / control treatment
Control Arm: Routine Counseling with Provider Sensitization
In the control arm of this study, participants will receive standard family planning counseling currently practiced in public sector family planning centers in Rawalpindi, Pakistan. This approach reflects the usual care model and is not influenced by the enhanced counseling protocols or intensive provider training implemented in the intervention arms. This arm aims to serve as a realistic benchmark for comparing the added value of structured, client-centered interventions.
Routine Counseling Procedures
Clients in this arm will be offered routine contraceptive counseling as part of the existing service delivery workflow. Counseling will be provided by regular staff at the family planning centers, including family welfare workers, nurses, and other frontline family planning providers. These providers will continue to offer services following their standard training and protocols, without additional inputs specific to the GATHER or Balanced Counseling Strategy (BCS) models.
While no formal upskilling will be introduced in this group, a brief sensitization session will be conducted for all providers in the control centers. This session aims to ethically align provider behavior and reinforce foundational principles, including respectful communication, informed consent, and reproductive rights awareness. These sensitization efforts will not include hands-on practice, structured counseling tools, or intensive skills-building, thus ensuring the control arm remains distinct from the interventions while upholding ethical standards of care.
Educational and Informational Materials
Participants in the control group will not receive any new or specially designed educational materials. Instead, they will have access to standard informational resources already available at their respective centers, such as wall posters, government-issued brochures, or any other static materials commonly in use. No client-specific handouts, visual aids, or decision-support tools will be introduced in this group to avoid contamination from the intervention arms.
Setting and Mode of Service Delivery
All counseling sessions will be conducted within the family planning centers assigned to the control arm, under usual clinic conditions. These are the same physical spaces and workflows used for routine FP services, with no modifications to infrastructure or patient flow to accommodate the study. Privacy, space, and client load will vary depending on the usual functioning of each site.
Number of Sessions and Duration
Each participant in the control group will receive one routine counseling session during their initial contact with a family planning provider. This session typically lasts 5 to 10 minutes, depending on provider availability, workload, and the client’s questions or concerns. The brevity of these interactions reflects current service norms in most high-volume public sector settings.
Participants in this group are not restricted to a single session. As per normal practice, clients may return for follow-up visits related to method continuation, management of side effects, or switching methods. Each return visit may include an additional counseling interaction, consistent with how services are typically offered. Thus, the frequency and number of sessions will be client-driven and based entirely on individual needs and health-seeking behavior, rather than dictated by the study design.
• Minimum exposure: One counseling session at initial enrollment.
• Maximum exposure: No formal cap; follow-up visits are open-ended and based on client demand.
Fidelity Monitoring and Contamination Prevention
To ensure internal validity and maintain the integrity of the comparison across study arms, several fidelity monitoring strategies will be employed:
• Periodic structured observations of counseling sessions will be conducted using standardized checklists to capture fidelity to routine counseling practices and detect any deviations or spillover from intervention content.
• Client exit interviews will be carried out to document satisfaction, method understanding, and message retention at baseline levels, serving as a comparator for outcomes in the enhanced counseling arms.
• Supervision teams will monitor for contamination risks, ensuring that providers trained in the intervention arms do not rotate into control facilities during the implementation phase. Any inadvertent crossover will be documented and considered in the analysis.
Control group
Active

Outcomes
Primary outcome [1] 341506 0
Any change in the use of available modern contraceptive methods among clients visiting the selected family planning centers will be measured.
Timepoint [1] 341506 0
• Baseline data will be collected at the time of enrollment, assessing current uptake rates. • Endline data will be collected three and six months after the intervention to measure changes in contraceptive uptake.
Secondary outcome [1] 447804 0
1. Healthcare provider knowledge related to client-centered contraceptive counseling Measured using a structured knowledge assessment tool administered pre- and post-training.
Timepoint [1] 447804 0
4 weeks and 8 weeks post intervention

Eligibility
Key inclusion criteria
Married Women of Reproductive age.
Inclusion Criteria:
Clients currently using modern contraceptive methods, recently initiating contraceptive use or seeking family planning services.



Service providers in the selected family planning centers
Inclusion Criteria:
Family planning centers will be selected based on the following
Client load of more than 200 / month
Availability of at least 3 family planning service providers
Availability of modern contraceptives
Minimum age
15 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Clients seeking Family Planning ( FP) services for emergency contraception
Those already enrolled in another intervention program
Clients who wish to discontinue due to some systemic diseases Married Women of Reproductive age.

Service providers in the selected family planning centers
Exclusion Criteria:
Centers engaged in any other training during the intervention phase

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/07/2025
Date of last participant enrolment
Anticipated
25/07/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 27070 0
Pakistan
State/province [1] 27070 0
Punjab
Country [2] 27071 0
Pakistan
State/province [2] 27071 0

Funding & Sponsors
Funding source category [1] 319133 0
University
Name [1] 319133 0
Rawalpindi Medical University
Country [1] 319133 0
Pakistan
Primary sponsor type
University
Name
Health services Academy
Address
Country
Pakistan
Secondary sponsor category [1] 321477 0
None
Name [1] 321477 0
Address [1] 321477 0
Country [1] 321477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317623 0
Health services Academy
Ethics committee address [1] 317623 0
Ethics committee country [1] 317623 0
Pakistan
Date submitted for ethics approval [1] 317623 0
04/11/2024
Approval date [1] 317623 0
07/03/2025
Ethics approval number [1] 317623 0
F.No 00010/HSA/PhD-2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141602 0
Dr Farrah Pervaiz
Address 141602 0
Rawalpindi Medical University Tipu Road Rawalpindi 46000 Punjab
Country 141602 0
Pakistan
Phone 141602 0
+923005146616
Fax 141602 0
Email 141602 0
[email protected]
Contact person for public queries
Name 141603 0
Farrah Pervaiz
Address 141603 0
Rawalpindi Medical University Tipu Road Rawalpindi 46000 Punjab
Country 141603 0
Pakistan
Phone 141603 0
+923005146616
Fax 141603 0
Email 141603 0
[email protected]
Contact person for scientific queries
Name 141604 0
Dr Babar Tasneem Shaikh
Address 141604 0
Health Services Academy Park Road, Chak Shahzad, Islamabad-44000
Country 141604 0
Pakistan
Phone 141604 0
+92333 2303403
Fax 141604 0
Email 141604 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Dr. Farrah Pervaiz Email: [email protected]

• Dr. Farrah Pervaiz Email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Data collection letter- Dr. Farrah Pervaiz.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.