PLACE Trial: Preserving Long-Acting Contraception Through Education
ConditionContraception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorPakistan Institute of Medical Sciences
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Women not wishing to participate or unable to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Structured counseling
BehavioralThe 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.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Structured counselingExperimental treatment 1 intervention
Group B: No counselingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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.Secondary outcomes
1
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)
Time frame
Eight months2
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.
Time frame
Eight monthsSponsors and contacts
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Source ClinicalTrials.gov