PLACE Trial: Preserving Long-Acting Contraception Through Education

NCT07271836 | Recruiting

• 1 other identifier: HSAIRB
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief 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 (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.

Conditions

Contraception

Keywords

long acting reversible contraception; LARC; subdermal implant; jadelle; intrauterine contraceptive device; copper-t; counseling

Outcome Measures

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.

  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

  Eight months

• Factors Influencing Contraceptive Continuation

  Eight months

Study Arms (2)

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.

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.

Interventions

Structured counseling BEHAVIORAL

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.

Structured counseling

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Females only.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women not wishing to participate or unable to provide informed consent.

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (3)

Rhs 'A' Center Federal Government Poly Clinic (Fgpc)

Islamabad, Islamabad, 44100, Pakistan

RECRUITING

RHS 'A' CENTER Mother and Child Health Centre Aabpara

Islamabad, Islamabad, 44100, Pakistan

RECRUITING

RHS-A centre, Pakistan Institute of Medical Sciences

Islamabad, Islamabad, 44100, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 27665153 BACKGROUND

Central Study Contacts

Dr. Muhammad I Khan, MBBS

CONTACT

+923325467034; ibrahim.k2000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 9, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From August 2026 onwards

Locations

PA (3)