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.