Injectable Contraception Cohort Study in Punjab, Pakistan

July 20, 2025 updated by: Jhpiego

Continuation of Subcutaneous and Intramuscular Injectable Contraception: a Non-randomized Prospective Cohort Study in Punjab, Pakistan

The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC).

Specific objectives are:

  1. To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan
  2. To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
  3. To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depot medroxyprogesterone acetate (DMPA) is a highly-effective, injectable contraceptive method that requires injections every 11 to 17 weeks. It is available in both intramuscular (IM) and subcutaneous (SC) formulations, which are therapeutically equivalent and have similar safety profiles. DMPA-IM has been included in the method mix for most countries for many years. DMPA-SC is a newer formulation being added to the method mix in select settings. Studies demonstrate that self-administration of subcutaneous DMPA (DMPA-SC) outside clinical settings is safe, effective, feasible, acceptable, and can improve continuation, and a recommendation in favor of self-injected DMPA-SC is included in WHO guidelines on self-care interventions for health and well-being.

The Bill and Melinda Gates Foundation is funding implementation research in multiple countries to understand how self-injection of DMPA-SC can best be introduced to specific markets to expand the contraceptive options available to women and girls, health system characteristics, the demand for self-injection when DMPA-SC is offered alongside a range of other methods, and women's and girl's ability to start and continue use. Jhpiego has received funding to conduct one of these 'market tests' in Punjab, Pakistan.

The aim of this study is to assess the value proposition of expanding contraceptive options available to women in Punjab, Pakistan to include subcutaneous depot medroxyprogesterone acetate (DMPA-SC).

Specific objectives are:

  1. To compare 12-month continuation rates for DMPA-SC and intramuscular DMPA (DMPA-IM) among married women 18- 49 years of age in two districts of Punjab, Pakistan
  2. To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
  3. To assess how well women opting for self-injection of DMPA-SC adhere to standards for commodity storage, injection timing, injection technique, and waste disposal

Study Type

Observational

Enrollment (Actual)

1009

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Pubjab
      • Khanewal, Pubjab, Pakistan
        • Bhu 76/10-R
    • Punjab
      • Kasur, Punjab, Pakistan
        • BHU Herdo Sehari
      • Kasur, Punjab, Pakistan
        • BHU Rao Khan Wala
      • Kasur, Punjab, Pakistan
        • BHU Serhali
      • Kasur, Punjab, Pakistan
        • BHU Sheikh Bhago
      • Kasur, Punjab, Pakistan
        • Fatima Maternity Home
      • Kasur, Punjab, Pakistan
        • FWC Chunian-1
      • Kasur, Punjab, Pakistan
        • FWC Kotha Kalan
      • Kasur, Punjab, Pakistan
        • FWC Rosa Tibba
      • Kasur, Punjab, Pakistan
        • FWC Talwandi
      • Kasur, Punjab, Pakistan
        • Hajra Maternity Home
      • Kasur, Punjab, Pakistan
        • RHC Ellabad
      • Kasur, Punjab, Pakistan
        • RHC Mustafabad
      • Kasur, Punjab, Pakistan
        • BHU Fatehpur
      • Kasur, Punjab, Pakistan
        • BHU Pakhoki
      • Kasur, Punjab, Pakistan
        • FHC Kasur
      • Kasur, Punjab, Pakistan
        • FWC Kasur 5
      • Kasur, Punjab, Pakistan
        • FWC Qaiser Garh
      • Kasur, Punjab, Pakistan
        • FWC Sheikh Umad Kohna
      • Kasur, Punjab, Pakistan
        • Rafique Maternity Home
      • Kasur, Punjab, Pakistan
        • RHC Changamanga
      • Kasur, Punjab, Pakistan
        • RHC Gandasingh
      • Kasur, Punjab, Pakistan
        • RHC Khuddian
      • Khanewal, Punjab, Pakistan
        • Ali Maternity Home
      • Khanewal, Punjab, Pakistan
        • Bhu 171/10-R
      • Khanewal, Punjab, Pakistan
        • Bhu 30/10-R
      • Khanewal, Punjab, Pakistan
        • Bhu 44/15-L
      • Khanewal, Punjab, Pakistan
        • Bhu 79/10-R
      • Khanewal, Punjab, Pakistan
        • Bhu 92/10-R
      • Khanewal, Punjab, Pakistan
        • Bhu 92/15-L
      • Khanewal, Punjab, Pakistan
        • BHU Chack 131/15 L
      • Khanewal, Punjab, Pakistan
        • FHC THQ Mian Cahnu
      • Khanewal, Punjab, Pakistan
        • FWC Kacha Khuh
      • Khanewal, Punjab, Pakistan
        • FWC Makhdoom Pur
      • Khanewal, Punjab, Pakistan
        • FWC Model Center
      • Khanewal, Punjab, Pakistan
        • RHC Kacha Khuh
      • Khanewal, Punjab, Pakistan
        • RHC Makhdom pur
      • Khanewal, Punjab, Pakistan
        • RHC Tulamba
      • Khanewal, Punjab, Pakistan
        • Tehseen Surgical Clinic
      • Khanewal, Punjab, Pakistan
        • Zainab Maternity Home
      • Khanewal, Punjab, Pakistan
        • FHC DHQ Khanewal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Clients receiving family planning counseling and services at participating public and private health facilities in Kasur and Khanewal districts of Punjab, Pakistan

Description

Inclusion Criteria:

  • Married women aged 18-49 years
  • Decide to use injectable contraception and meet WHO medical eligibility criteria for injectable use
  • Want to avoid pregnancy for at least 12 months
  • Live within study districts
  • Are willing to be contacted by study team members via telephone and/or in-person

Exclusion Criteria:

  • Women under age 18 and above 49
  • Unmarried women
  • Hope to become pregnant within next 12 months
  • Do not reside within study districts
  • Are not willing to be contacted by study team members via telephone or in-person
  • Lack cognitive capacity to give informed consent or complete interviews

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DMPA-SC
All married women of reproductive age who receive family planning counseling at a participating health facility and who choose to receive injectable contraception will be given an option of either DMPA-IM (current health worker administered standard of care) or DMPA-SC (new administration method, with option for self-injection after completing training). Those opting for DMPA-SC will receive training on self-injection procedures and an opportunity to practice injection procedures on a model (e.g. condom filled with salt) to demonstrate confidence and proficiency to inject herself under the supervision of a healthcare provider. Clients will then be shown how to use a calendar to determine when their next injection is due, and provided a calendar/reminder card, job aids that illustrate self-injection steps (including safe disposal of needles), and 3 doses of DMPA-SC to take home for future use.
Behavioral: Contraceptive usage
Continued use of injectable contraception, administered on a quarterly basis
DMPA-IM
All married women of reproductive age who receive family planning counseling at a participating health facility and who choose to receive injectable contraception will be given an option of either DMPA-IM (current health worker administered standard of care) or DMPA-SC (new administration method, with option for self-injection after completing training).
Behavioral: Contraceptive usage
Continued use of injectable contraception, administered on a quarterly basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DMPA continuation rate
Time Frame: up to 12 months
Participant use of DMPA measured at 3, 6 and 9 months following enrollment (providing coverage for 3 months with each dose)
up to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of women in the two study groups (DMPA-SC and DMPA-IM users)
Time Frame: At enrollment
Demographics, contraceptive history, decision-making, reasons for choosing method, reproductive empowerment, self-confidence
At enrollment
Family planning service provision and injectable contraceptive use experiences of women in the two study groups (DMPA-SC and DMPA-IM users)
Time Frame: Up to 12 months
Experiences receiving family planning services and with chosen contraceptive method
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jhpiego

Investigators

  • Principal Investigator: Hannah Tappis, DrPH, Jhpiego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 20, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00021562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A deidentified analytical dataset will be posted in an open access repository upon study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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