ContraceptionPLACENCT07271836
PLACE Trial: Preserving Long-Acting Contraception Through Education
A study testing Structured counseling in people with Contraception, run by Pakistan Institute of Medical Sciences at 3 sites in Pakistan.
Trial summary
Study Overview Summary This randomized controlled trial will evaluate the effectiveness of structured counseling in improving the continuation rates of long-acting reversible contraception (LARC) among women in Islamabad, Pakistan, who present to family planning clinics for early removal of their contraception devices… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Structured counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesPakistan
- Study dates
- 15 Dec 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women presenting at the clinics exclusively for removal of a copper-T IUD or Jadelle subdermal implant within 2 years of use and within the first 2 months of the study.
Who cannot join
- Women not wishing to participate or unable to provide informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan3 sites, 3 recruiting
- Recruiting
Rhs 'A' Center Federal Government Poly Clinic (Fgpc)
Islamabad, Islamabad, 44100
Muhammad Ibrahim Khan Dr., +923325467034, ibrahim.k2000@gmail.com
- Recruiting
RHS 'A' CENTER Mother and Child Health Centre Aabpara
Islamabad, Islamabad, 44100
Alvina Abdullah Dr., +923025100905, alvinaabdullah@gmail.com
- Recruiting
RHS-A centre, Pakistan Institute of Medical Sciences
Islamabad, Islamabad, 44100
Muhammad Ibrahim Khan Dr., MBBS, +923325467034, ibrahim.k2000@gmail.com
About this study
Official title: Effect of Structured Counseling on Continuation Rates of Long Acting Reversible Contraception Among Clients Requesting Early Removal: A Multicenter Randomized Controlled Trial (PLACE Trial)
Study Overview Summary
This randomized controlled trial will evaluate the effectiveness of structured counseling in improving the continuation rates of long-acting reversible contraception (LARC) among women in Islamabad, Pakistan, who present to family planning clinics for early removal of their contraception devices (copper-T IUD or Jadelle implant). The study, starting December 15, 2025, will recruit women from three federal government-approved clinics.
The trial will randomly assign participants to either an intervention group, where they will receive culturally sensitive counseling to encourage continued use of LARC, or a control group, where contraception will be removed upon client request without counseling. The goal is to determine if structured counseling can increase the likelihood of women continuing their LARC method.
Read the detailed description
Study Overview
This randomized controlled trial aims to assess the effectiveness of structured counseling on the continuation rates of long-acting reversible contraception (LARC) among women who present to family planning clinics in Islamabad, Pakistan, for early (within two years of use) removal of their contraception devices. The study will specifically target women who seek to remove either the copper-T intrauterine contraceptive device (IUD) or the Jadelle subdermal implant.
Starting December 15th, 2025, the research team will recruit eligible participants from three major federal government-approved family planning clinics in Islamabad. The clinics will serve as the intervention and control settings, with half of the healthcare providers trained in a standardized, culturally sensitive counseling approach, while the other half will provide standard care by simply removing the contraceptive device upon request.
The trial will aim to determine whether structured counseling can effectively increase the likelihood of women continuing with their LARC method as compared to the control group, where no counseling intervention is provided.
Study Design
This is a multicenter, randomized controlled trial with a parallel-group design conducted across three family planning clinics in Islamabad, Pakistan. The study will randomly assign participants to one of two groups:
Intervention and Control Groups (Please refer to the 'arms and interventions' pane for details).
The intervention group will also be followed up for 6 months post-visit either in clinic or via teleconsultation to assess the continuation of the contraception method.
Recruitment and Randomization
Recruitment: Starting December 15, 2025 for the first two months, women will be recruited from the family planning clinics when they present for the removal of either a copper-T IUD or a Jadelle implant that has been in place for 2 years or less. Participants who do not meet the inclusion criteria (e.g., not presenting within the first two months of start of the study) will be excluded. Informed written consent will be taken from each client and clients asked to fill a questionnaire.
Randomization: Women will be randomly assigned to either the intervention group (structured counseling) or the control group (standard care). Randomization will be performed using a computer-generated randomization scheme. Each participant will be assigned a unique clinic visit slip that indicates the assigned group (intervention or control) and specifies the clinic room number.
Provider Training
Intervention Group: Healthcare providers at each of the three clinics will receive training on standardized counseling techniques, focusing on culturally sensitive approaches. The training will cover topics such as addressing questions, common myths and misconceptions about LARC, such as fears related to amenorrhea, concerns about pregnancy, and misattributions of symptoms unrelated to contraception. The aim of the counseling will be to encourage clients to continue their contraception method, provided they do not meet the WHO criteria for removal (e.g., medical complications, side effects, or personal preference).
After the training, feedback and detailed assessments of the providers will be conducted to ensure provider bias is minimized and that the counseling is delivered as per the protocol.
Control Group: The remaining providers at the clinics will not receive any training on counseling. These providers will be instructed to remove the contraceptive device upon client request without providing any counseling or intervention to encourage continuation. However, clients will be asked to complete a questionnaire to help analyze the reasons for contraceptive removal, which will be used to assess the potential impact of counseling on the continuation of the LARC method.
Sample Size Calculation
The sample size was calculated based on the contraceptive prevalence rate for Pakistan, which is approximately 34%. The expected effect size is a 30% difference in continuation rates between the intervention and control groups. The 95% confidence interval and a 5% margin of error were used to calculate the required sample size. A statistical power of 90% was used. Furthermore, an anticipated 50% loss to follow-up was factored into the sample size calculation.
For each contraceptive method (IUD or implant) and each clinic, the sample size for both arms (intervention and control) is estimated to be 49 participants per method, per clinic. Therefore, the total sample size for all three clinics, across both arms and methods, is calculated to be 588 participants. To account for potential record losses, the sample size has been increased by 50%, bringing the total required sample size to 900 participants (300 participants per center).
Statistical Analysis
Statistical analysis will compare the continuation rates of LARC between the intervention group (structured counseling) and the control group (standard care) using an intention-to-treat approach. Descriptive statistics will be used to summarize demographic data, and Chi-square tests will be used to compare proportions of women continuing contraception in both groups.
- Conditions
- Contraception
- Being tested
- Structured counseling
- Keywords
- long acting reversible contraception, LARC, subdermal implant, jadelle, intrauterine contraceptive device, copper-t, counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured counselingBehavioural
The intervention is a behavioral intervention where healthcare providers deliver structured, culturally sensitive counseling to women who present for early removal of their long-acting reversible contraception (LARC), such as the copper-T intrauterine device (IUD) or Jadelle subdermal implant. The counseling is designed to address common misconceptions and myths about contraception, such as fears related to side effects (e.g., amenorrhea, concerns about pregnancy) or the belief that symptoms are unrelated to the contraception method. The aim is to encourage the continuation of the contraceptive method unless the woman meets the WHO criteria for removal (e.g., medical reasons or personal preference). This intervention will involve a one-time counseling session with follow-up at 6 months to assess whether the participant continued or discontinued the method.
| Study group | Role | What they receive |
|---|---|---|
| Structured counseling | Experimental | Women in this arm will receive structured, culturally sensitive counseling by trained healthcare providers. The counseling aims to address common myths and misconceptions about long-acting reversible contraception (LARC), such as concerns about side effects (e.g., amenorrhea, pregnancy worries) and general fears related to the method. The goal is to encourage continued use of LARC unless women meet the WHO criteria for removal (e.g., medical complications or personal preference). Participants will be followed up for 6 months to assess if they continue using their LARC method. Receives: Behavioral: Structured counseling |
| No counseling | No intervention | Women in this arm will receive standard care, which is the typical practice at the clinics. If they request to remove their contraceptive device (either a copper-T IUD or Jadelle implant), it will be removed upon request without any counseling or encouragement to continue the method. There will be no structured intervention. Participants will not be asked to follow-up after the initial visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation Rate of Long-Acting Reversible Contraception (LARC) at 6 Months
The primary outcome of the study is the rate of LARC continuation in women who received either structured counseling (intervention arm) or standard care (control arm) for the continuation of their intrauterine contraceptive device (IUD) or subdermal implant (Jadelle). The continuation rate will be assessed at a 6-month follow-up after the initial clinic visit.
Intervention Group: Participants who receive structured, culturally sensitive counseling will be encouraged to continue using their LARC method unless they meet the WHO criteria for removal (e.g., medical complications, side effects, or personal preference).
Control Group: Participants in the control group, who receive standard care (removal of the device upon request without any counseling), will be asked to return for a 6-month follow-up to determine if they have continued or discontinued their contraception method.
Unit of measurement: Percentage of women that continued the chosen method following the visit.
Measured: The total study duration will be eight months: the first two months will be allocated to enrolling participants and completing their baseline visits, followed by a six-month follow-up period for all enrolled clients.
Secondary outcomes (2)
Client Satisfaction and Factors Influencing Contraceptive Continuation
The secondary outcomes of this study aim to assess client satisfaction with the LARC method.
Client Satisfaction: At the 6-month follow-up, participants will be asked to complete a brief survey or interview assessing their overall satisfaction with the contraception method they are using (IUD or subdermal implant). This will include questions about the comfort, effectiveness, and side effects of the method, as well as their level of confidence in the method.
Unit of measurement: Likert scale score (1-5, where 1 = very unsatisfied and 5 = very satisfied)
Measured: Eight months
Factors Influencing Contraceptive Continuation
Another secondary outcome is to identify the factors influencing the decision to continue or discontinue the contraceptive method, focusing on those who received structured counseling (intervention group) and those who received standard care (control group).
The study will gather detailed information on the reasons for discontinuation or continuation of the LARC method. This includes identifying specific concerns related to side effects-such as amenorrhea, irregular or heavy bleeding, cramping, discomfort, weight changes, and perceived hormonal effects-as well as fears rooted in myths and misconceptions (e.g., infertility, device migration, long-term health risks).
Unit of measurement: Categorical variables e.g. amenorrhea with frequency counts.
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Dec 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Ibrahim Khan, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271836
- Sponsor's protocol ID
- HSAIRB
- Acronym
- PLACE
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including demographics, clinical outcomes, and adverse events, will be available beginning 6 months after publication of the primary results. Data will be shared through a controlled-access repository to qualified researchers upon request and after signing a data use agreement
Publications
Gibbs SE, Rocca CH, Bednarek P, Thompson KMJ, Darney PD, Harper CC. Long-Acting Reversible Contraception Counseling and Use for Older Adolescents and Nulliparous Women. J Adolesc Health. 2016 Dec;59(6):703-709. doi: 10.1016/j.jadohealth.2016.07.018. Epub 2016 Sep 21.
PubMed 27665153
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Counseling on Continuation Rates of Long Acting Reversible Contraception Among Clients Requesting Early Removal: A Multicenter Randomized Controlled Trial (PLACE Trial)
- ClinicalTrials.gov ID
- NCT07271836
- Acronym / sponsor ID
- PLACE / HSAIRB
- Conditions
- Contraception
- Keywords
- long acting reversible contraception, LARC, subdermal implant, jadelle, intrauterine contraceptive device, copper-t, counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Dec 2025 (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.
Study Overview Summary
This randomized controlled trial will evaluate the effectiveness of structured counseling in improving the continuation rates of long-acting reversible contraception (LARC) among women in Islamabad, Pakistan, who present to family planning clinics for early removal of their contraception devices (copper-T IUD or Jadelle implant). The study, starting December 15, 2025, will recruit women from three federal government-approved clinics.
The trial will randomly assign participants to either an intervention group, where they will receive culturally sensitive counseling to encourage continued use of LARC, or a control group, where contraception will be removed upon client request without counseling. The goal is to determine if structured counseling can increase the likelihood of women continuing their LARC method.
Detailed description
Study Overview
This randomized controlled trial aims to assess the effectiveness of structured counseling on the continuation rates of long-acting reversible contraception (LARC) among women who present to family planning clinics in Islamabad, Pakistan, for early (within two years of use) removal of their contraception devices. The study will specifically target women who seek to remove either the copper-T intrauterine contraceptive device (IUD) or the Jadelle subdermal implant.
Starting December 15th, 2025, the research team will recruit eligible participants from three major federal government-approved family planning clinics in Islamabad. The clinics will serve as the intervention and control settings, with half of the healthcare providers trained in a standardized, culturally sensitive counseling approach, while the other half will provide standard care by simply removing the contraceptive device upon request.
The trial will aim to determine whether structured counseling can effectively increase the likelihood of women continuing with their LARC method as compared to the control group, where no counseling intervention is provided.
Study Design
This is a multicenter, randomized controlled trial with a parallel-group design conducted across three family planning clinics in Islamabad, Pakistan. The study will randomly assign participants to one of two groups:
Intervention and Control Groups (Please refer to the 'arms and interventions' pane for details).
The intervention group will also be followed up for 6 months post-visit either in clinic or via teleconsultation to assess the continuation of the contraception method.
Recruitment and Randomization
Recruitment: Starting December 15, 2025 for the first two months, women will be recruited from the family planning clinics when they present for the removal of either a copper-T IUD or a Jadelle implant that has been in place for 2 years or less. Participants who do not meet the inclusion criteria (e.g., not presenting within the first two months of start of the study) will be excluded. Informed written consent will be taken from each client and clients asked to fill a questionnaire.
Randomization: Women will be randomly assigned to either the intervention group (structured counseling) or the control group (standard care). Randomization will be performed using a computer-generated randomization scheme. Each participant will be assigned a unique clinic visit slip that indicates the assigned group (intervention or control) and specifies the clinic room number.
Provider Training
Intervention Group: Healthcare providers at each of the three clinics will receive training on standardized counseling techniques, focusing on culturally sensitive approaches. The training will cover topics such as addressing questions, common myths and misconceptions about LARC, such as fears related to amenorrhea, concerns about pregnancy, and misattributions of symptoms unrelated to contraception. The aim of the counseling will be to encourage clients to continue their contraception method, provided they do not meet the WHO criteria for removal (e.g., medical complications, side effects, or personal preference).
After the training, feedback and detailed assessments of the providers will be conducted to ensure provider bias is minimized and that the counseling is delivered as per the protocol.
Control Group: The remaining providers at the clinics will not receive any training on counseling. These providers will be instructed to remove the contraceptive device upon client request without providing any counseling or intervention to encourage continuation. However, clients will be asked to complete a questionnaire to help analyze the reasons for contraceptive removal, which will be used to assess the potential impact of counseling on the continuation of the LARC method.
Sample Size Calculation
The sample size was calculated based on the contraceptive prevalence rate for Pakistan, which is approximately 34%. The expected effect size is a 30% difference in continuation rates between the intervention and control groups. The 95% confidence interval and a 5% margin of error were used to calculate the required sample size. A statistical power of 90% was used. Furthermore, an anticipated 50% loss to follow-up was factored into the sample size calculation.
For each contraceptive method (IUD or implant) and each clinic, the sample size for both arms (intervention and control) is estimated to be 49 participants per method, per clinic. Therefore, the total sample size for all three clinics, across both arms and methods, is calculated to be 588 participants. To account for potential record losses, the sample size has been increased by 50%, bringing the total required sample size to 900 participants (300 participants per center).
Statistical Analysis
Statistical analysis will compare the continuation rates of LARC between the intervention group (structured counseling) and the control group (standard care) using an intention-to-treat approach. Descriptive statistics will be used to summarize demographic data, and Chi-square tests will be used to compare proportions of women continuing contraception in both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured counseling | Experimental | Behavioral: Structured counselingWomen in this arm will receive structured, culturally sensitive counseling by trained healthcare providers. The counseling aims to address common myths and misconceptions about long-acting reversible contraception (LARC), such as concerns about side effects (e.g., amenorrhea, pregnancy worries) and general fears related to the method. The goal is to encourage continued use of LARC unless women meet the WHO criteria for removal (e.g., medical complications or personal preference). Participants will be followed up for 6 months to assess if they continue using their LARC method. |
| No counseling | No intervention | –Women in this arm will receive standard care, which is the typical practice at the clinics. If they request to remove their contraceptive device (either a copper-T IUD or Jadelle implant), it will be removed upon request without any counseling or encouragement to continue the method. There will be no structured intervention. Participants will not be asked to follow-up after the initial visit. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women presenting at the clinics exclusively for removal of a copper-T IUD or Jadelle subdermal implant within 2 years of use and within the first 2 months of the study.
Key exclusion criteria (1 listed)
- Women not wishing to participate or unable to provide informed consent.
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 |
|---|---|---|
| Structured counselingThe intervention is a behavioral intervention where healthcare providers deliver structured, culturally sensitive counseling to women who present for early removal of their long-acting reversible contraception (LARC), such as the copper-T intrauterine device (IUD) or Jadelle subdermal implant. The counseling is designed to address common misconceptions and myths about contraception, such as fears related to side effects (e.g., amenorrhea, concerns about pregnancy) or the belief that symptoms are unrelated to the contraception method. The aim is to encourage the continuation of the contraceptive method unless the woman meets the WHO criteria for removal (e.g., medical reasons or personal preference). This intervention will involve a one-time counseling session with follow-up at 6 months to assess whether the participant continued or discontinued the method. | Behavioural | Structured counseling |
Primary outcome
Continuation Rate of Long-Acting Reversible Contraception (LARC) at 6 Months
Time frame: The total study duration will be eight months: the first two months will be allocated to enrolling participants and completing their baseline visits, followed by a six-month follow-up period for all enrolled clients.
The primary outcome of the study is the rate of LARC continuation in women who received either structured counseling (intervention arm) or standard care (control arm) for the continuation of their intrauterine contraceptive device (IUD) or subdermal implant (Jadelle). The continuation rate will be assessed at a 6-month follow-up after the initial clinic visit. Intervention Group: Participants who receive structured, culturally sensitive counseling will be encouraged to continue using their LARC method unless they meet the WHO criteria for removal (e.g., medical complications, side effects, or personal preference). Control Group: Participants in the control group, who receive standard care (removal of the device upon request without any counseling), will be asked to return for a 6-month follow-up to determine if they have continued or discontinued their contraception method. Unit of measurement: Percentage of women that continued the chosen method following the visit.
2 secondary outcomes
Client Satisfaction and Factors Influencing Contraceptive Continuation
Time frame: Eight months
Factors Influencing Contraceptive Continuation
Time frame: Eight months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 27665153Gibbs SE, Rocca CH, Bednarek P, Thompson KMJ, Darney PD, Harper CC. Long-Acting Reversible Contraception Counseling and Use for Older Adolescents and Nulliparous Women. J Adolesc Health. 2016 Dec;59(6):703-709. doi: 10.1016/j.jadohealth.2016.07.018. Epub 2016 Sep 21.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including demographics, clinical outcomes, and adverse events, will be available beginning 6 months after publication of the primary results. Data will be shared through a controlled-access repository to qualified researchers upon request and after signing a data use agreement
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured counseling in people with Contraception, run by Pakistan Institute of Medical Sciences at 3 sites in Pakistan.
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 1 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Muhammad I Khan, MBBS (+923325467034, ibrahim.k2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuation Rate of Long-Acting Reversible Contraception (LARC) at 6 Months (time frame: The total study duration will be eight months: the first two months will be allocated to enrolling participants and completing their baseline visits, followed by a six-month follow-up period for all enrolled clients.). 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 NCT07271836, which also lists 1 linked publication.
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 16 Dec 2025.