ContraceptionNCT04915885
Strengthening Contraceptive Counseling in Pakistan
A study testing Routine care, Package of contraceptive counseling interventions and Expanded methods in people with Contraception, run by Nguyen-Toan Tran.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Routine care, Package of contraceptive counseling interventions and Expanded methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
- 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);
- she is not coming for the resupply of a currently used method, such as pills or injectables;
- she has the intention to continue her follow-up at the health center during the 12-month study follow-up;
- she does not participate in another study; and
- she provides informed consent.
About this study
Official title: 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.
Read the 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
- Being tested
- Routine care, Package of contraceptive counseling interventions, Expanded methods
- Keywords
- Counseling, Empowerment, Autonomy
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
Routine contraceptive counseling and routine method availability
Package of contraceptive counseling interventionsOther
The implementation package will be co-designed by providers and clients during the formative and research design phases
Expanded methodsOther
Expanded range of contraceptive methods as recommended by national policies
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | routine contraceptive counseling and care and a range of family planning methods that are routinely available at field level Receives: Other: Routine care |
| Intervention package | Experimental | contraceptive counseling package but still with a range of family planning methods that are routinely available at field level Receives: Other: Package of contraceptive counseling interventions |
| Intervention package & expanded methods | Experimental | contraceptive counseling package but with an expanded range of family planning methods that are recommended by national guidance Receives: Other: Package of contraceptive counseling interventions; Other: Expanded methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clients' decision-making autonomy
Person-Centered Contraceptive Counseling scale (PCCC), developed and tested by Dehlendorf et al. (2021)
Measured: 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
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Change in modern contraceptive prevalence
number of participants using a modern contraceptive / all participants
Measured: 6 months and 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study startJan 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Additional country (Nigeria) has been added to original country, Pakistan. Therefore, an updated protocol has been submitted (NCT06081842)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nguyen-Toan Tran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nguyen-Toan Tran, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915885
- Sponsor's protocol ID
- FPC21
- Status last verified
- May 2024
- First submitted
- 24 May 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: (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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Contraceptive Counseling Services to Empower Clients and Meet Their Needs: Protocol for a Multi-phase Complex Intervention in Pakistan
- ClinicalTrials.gov ID
- NCT04915885
- Acronym / sponsor ID
- FPC21
- Conditions
- Contraception
- Keywords
- Counseling, Empowerment, Autonomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Additional country (Nigeria) has been added to original country, Pakistan. Therefore, an updated protocol has been submitted (NCT06081842)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nguyen-Toan TranUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Other: Routine careroutine contraceptive counseling and care and a range of family planning methods that are routinely available at field level |
| Intervention package | Experimental | Other: Package of contraceptive counseling interventionscontraceptive counseling package but still with a range of family planning methods that are routinely available at field level |
| Intervention package & expanded methods | Experimental | Other: Package of contraceptive counseling interventions, Other: Expanded methodscontraceptive counseling package but with an expanded range of family planning methods that are recommended by national guidance |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine careRoutine contraceptive counseling and routine method availability | Other | Control arm |
| Package of contraceptive counseling interventionsThe implementation package will be co-designed by providers and clients during the formative and research design phases | Other | Intervention package, Intervention package & expanded methods |
| Expanded methodsExpanded range of contraceptive methods as recommended by national policies | Other | Intervention package & expanded methods |
Primary outcome
Change in clients' decision-making autonomy
Time frame: Through study completion, an average of 1 year
Person-Centered Contraceptive Counseling scale (PCCC), developed and tested by Dehlendorf et al. (2021)
Change in clients' met need for family planning
Time frame: Through study completion, an average of 1 year
number of participants who want to avoid a pregnancy and are using a contraceptive method / all participants
1 secondary outcome
Change in modern contraceptive prevalence
Time frame: 6 months and 12 months post enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Yes. (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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Routine care, Package of contraceptive counseling interventions and Expanded methods in people with Contraception, run by Nguyen-Toan Tran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clients' decision-making autonomy (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.