ContraceptionNCT06081842
Strengthening Contraceptive Counseling Services: Research Protocol for a Multi-phase Complex Intervention in Pakistan and Nigeria
A study testing Contraceptive counseling strengthening intervention package in people with Contraception and Empowerment, run by World Health Organization.
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 for Pakistan and Nigeria designed to strengthen existing contraceptive services and determine its… 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, Empowerment, Decision Making
- What is being tested?
- Contraceptive counseling strengthening intervention package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,920 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jun 2026
- 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
Who may be able to join
- Client 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);
- Client is not coming for the resupply of a currently used method, such as pills or injectables;
- Client has the intention to continue her follow-up at the health center during the duration of study follow-up;
- Client does not participate in another study; and
- Client provides informed consent.
Who cannot join
- Not willing to participate in the complete duration of the trial
About this study
Official title: Strengthening Contraceptive Counseling Services, a Multi-country Study Trial
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 for Pakistan and Nigeria 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
The research will be a multi-intervention, three-arm, single-blinded, parallel, cluster RCT done in selected primary health centers (clusters) in Pakistan and in Nigeria. Centers will be randomly allocated to the three study arms in matched ratios (1:1:1) on the basis of the number of monthly family planning encounters, the number of available contraceptive types, the ratio of health workers per population in the clinic coverage zone, the location in urban or rural settings, and selected district-level variables that may have an influence on the study outcomes, including the unmet need for family planning, the level of literacy among women, and household income quartiles. Only data analysts will be masked to trial-arm allocation. Service providers skilled in family planning services will implement the clinical components of the contraceptive counseling package. The cluster RCT design is justified by the fact that some of the components of the intervention package to be identified in the intervention design phase will not be delivered directly to individual participants but only applied at the level of the health center, such as refresher training of service providers.
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.
- Conditions
- Contraception, Empowerment, Decision Making
- Being tested
- Contraceptive counseling strengthening intervention package
- Keywords
- Family Planning, Counselling, choice
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive counseling strengthening intervention packageOther
Development of contraceptive counseling strengthening intervention package that strengthens existing family planning services and is effective, safe, sustainable, scalable, and culturally appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1. Routine care | Active comparator | Routine contraceptive counseling and routine method availability Receives: Other: Contraceptive counseling strengthening intervention package |
| Arm 2. Package of contraceptive counseling interventions | Experimental | The implementation package will be co-designed by providers and clients during the formative and research design phases Receives: Other: Contraceptive counseling strengthening intervention package |
| Arm 3. Expanded methods | Experimental | Routine care with the contraceptive counseling package combined with wider method availability as recommended by national policies. Receives: Other: Contraceptive counseling strengthening intervention package |
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). On a scale of 1-5, with score range between 4 to a maximum score of 20, with the highest possible score on a scale will be considered good.
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 posted13 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- The research entails a complex multi-site, two-stage and 5-phase: STAGE 1 is formative and will comprise of a pre-formative (phase 1) and a formative (phase 2). While the STAGE 2 is experimental and will include intervention design (phase 3), experimental (phase 4), and reflective (phase 5).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- World Health Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Jinnah Sindh Medical University, University of Ibadan
- Responsible party
- Principal investigator, Moazzam Ali, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081842
- Sponsor's protocol ID
- WHO
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 Individual Participant Data (IPD) from trial participants with adequate assurance that patient privacy and confidentiality will be maintained
Publications
Azmat SK, Awan MA, Thom EM, Uzma Q, Sheikh I, Kapustianyk G, Kiarie J, Ali M. Closing the counselling gap: a qualitative study to strengthen rights-based family planning in Pakistan. BMJ Open. 2026 Aug 24;16(8):e116059. doi: 10.1136/bmjopen-2025-116059.
PubMed 42637256Tran NT, Ali M, Azmat SK, Seuc A, Olaolorun FM, Awan MA, Morhason-Bello I, Thom EM, Martin J, Abubakar HD, Uzma Q, Kiarie J. Strengthening contraceptive counselling services to empower clients and meet their needs: protocol for a two-stage, multiphase complex intervention in Pakistan and Nigeria. BMJ Open. 2024 Jun 5;14(6):e081967. doi: 10.1136/bmjopen-2023-081967.
PubMed 38839392
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Contraceptive Counseling Services, a Multi-country Study Trial
- ClinicalTrials.gov ID
- NCT06081842
- Acronym / sponsor ID
- WHO
- Conditions
- Contraception, Empowerment, Decision Making
- Keywords
- Family Planning, Counselling, choice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,920 participants (estimated)
- Lead sponsor
- World Health OrganizationUniversity, hospital or other
- Collaborators
- Jinnah Sindh Medical University, University of Ibadan
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Oct 2023 (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 for Pakistan and Nigeria 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
The research will be a multi-intervention, three-arm, single-blinded, parallel, cluster RCT done in selected primary health centers (clusters) in Pakistan and in Nigeria. Centers will be randomly allocated to the three study arms in matched ratios (1:1:1) on the basis of the number of monthly family planning encounters, the number of available contraceptive types, the ratio of health workers per population in the clinic coverage zone, the location in urban or rural settings, and selected district-level variables that may have an influence on the study outcomes, including the unmet need for family planning, the level of literacy among women, and household income quartiles. Only data analysts will be masked to trial-arm allocation. Service providers skilled in family planning services will implement the clinical components of the contraceptive counseling package. The cluster RCT design is justified by the fact that some of the components of the intervention package to be identified in the intervention design phase will not be delivered directly to individual participants but only applied at the level of the health center, such as refresher training of service providers.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The research entails a complex multi-site, two-stage and 5-phase: STAGE 1 is formative and will comprise of a pre-formative (phase 1) and a formative (phase 2). While the STAGE 2 is experimental and will include intervention design (phase 3), experimental (phase 4), and reflective (phase 5).
| Arm | Type | Receives |
|---|---|---|
| Arm 1. Routine care | Active comparator | Other: Contraceptive counseling strengthening intervention packageRoutine contraceptive counseling and routine method availability |
| Arm 2. Package of contraceptive counseling interventions | Experimental | Other: Contraceptive counseling strengthening intervention packageThe implementation package will be co-designed by providers and clients during the formative and research design phases |
| Arm 3. Expanded methods | Experimental | Other: Contraceptive counseling strengthening intervention packageRoutine care with the contraceptive counseling package combined with wider method availability as recommended by national policies. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Client 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);
- Client is not coming for the resupply of a currently used method, such as pills or injectables;
- Client has the intention to continue her follow-up at the health center during the duration of study follow-up;
- Client does not participate in another study; and
- Client provides informed consent.
Key exclusion criteria (1 listed)
- Not willing to participate in the complete duration of the trial
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 |
|---|---|---|
| Contraceptive counseling strengthening intervention packageDevelopment of contraceptive counseling strengthening intervention package that strengthens existing family planning services and is effective, safe, sustainable, scalable, and culturally appropriate. | Other | Arm 1. Routine care, Arm 2. Package of contraceptive counseling interventions, Arm 3. 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). On a scale of 1-5, with score range between 4 to a maximum score of 20, with the highest possible score on a scale will be considered good.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Derived from this study: PubMed 42637256Azmat SK, Awan MA, Thom EM, Uzma Q, Sheikh I, Kapustianyk G, Kiarie J, Ali M. Closing the counselling gap: a qualitative study to strengthen rights-based family planning in Pakistan. BMJ Open. 2026 Aug 24;16(8):e116059. doi: 10.1136/bmjopen-2025-116059.
- Derived from this study: PubMed 38839392Tran NT, Ali M, Azmat SK, Seuc A, Olaolorun FM, Awan MA, Morhason-Bello I, Thom EM, Martin J, Abubakar HD, Uzma Q, Kiarie J. Strengthening contraceptive counselling services to empower clients and meet their needs: protocol for a two-stage, multiphase complex intervention in Pakistan and Nigeria. BMJ Open. 2024 Jun 5;14(6):e081967. doi: 10.1136/bmjopen-2023-081967.
- 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 Individual Participant Data (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 Contraceptive counseling strengthening intervention package in people with Contraception and Empowerment, run by World Health Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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?
Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT06081842, which also lists 2 linked publications.
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 13 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.