PLACE Trial: Preserving Long-Acting Contraception Through Education

Sponsor
Pakistan Institute of Medical Sciences
Study ID
NCT07271836
Status
Recruiting
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Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Dec 9, 2025
Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Structured counseling
    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.
  • No Intervention: No counseling
    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.

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. ]

Central Contacts

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