ClinicalTrials.gg
CompletedNCT05774626Updated Jul 22, 2025

Injectable Contraception Cohort Study in Punjab, Pakistan

An observational study in Contraceptive Usage, sponsored by Jhpiego. Completed at 41 sites in Pakistan. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-22.

Sponsored by Jhpiego · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,009
Ages
18 Years to 49 Years
Sex
Female
01

Study summary

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
Read the 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
02

Conditions studied

  • Contraceptive Usage

Keywords

  • injectable contraception
  • prospective cohort study
  • Pakistan
03

In context

Contraception Behavior

132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.

This study's enrollment of 1,009 is above the median of 149 across 22 observational studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Jhpiego is the lead sponsor of 32 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Married women aged 18-49 years
  • Decide to use injectable 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

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 or complete interviews
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,009 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • BehavioralContraceptive usage

    Continued use of injectable contraception, administered on a quarterly basis

06

What researchers measure

Primary outcomes

  1. DMPA continuation rate

    Participant use of DMPA measured at 3, 6 and 9 months following enrollment (providing coverage for 3 months with each dose)

    Time frame: up to 12 months

Other outcomes

  1. Characteristics of women in the two study groups (DMPA-SC and DMPA-IM users)

    Demographics, contraceptive history, decision-making, reasons for choosing method, reproductive empowerment, self-confidence

    Time frame: At enrollment

  2. Family planning service provision and injectable contraceptive use experiences of women in the two study groups (DMPA-SC and DMPA-IM users)

    Experiences receiving family planning services and with chosen contraceptive method

    Time frame: Up to 12 months

07

Study locations

41 sites
  • Bhu 76/10-R
    Khanewal, Pubjab, Pakistan
  • BHU Fatehpur
    Kasur, Punjab Province, Pakistan
  • BHU Herdo Sehari
    Kasur, Punjab Province, Pakistan
  • BHU Pakhoki
    Kasur, Punjab Province, Pakistan
  • BHU Rao Khan Wala
    Kasur, Punjab Province, Pakistan
  • BHU Serhali
    Kasur, Punjab Province, Pakistan
  • BHU Sheikh Bhago
    Kasur, Punjab Province, Pakistan
  • Fatima Maternity Home
    Kasur, Punjab Province, Pakistan
  • FHC Kasur
    Kasur, Punjab Province, Pakistan
  • FWC Chunian-1
    Kasur, Punjab Province, Pakistan
  • FWC Kasur 5
    Kasur, Punjab Province, Pakistan
  • FWC Kotha Kalan
    Kasur, Punjab Province, Pakistan
  • FWC Qaiser Garh
    Kasur, Punjab Province, Pakistan
  • FWC Rosa Tibba
    Kasur, Punjab Province, Pakistan
  • FWC Sheikh Umad Kohna
    Kasur, Punjab Province, Pakistan
  • FWC Talwandi
    Kasur, Punjab Province, Pakistan
  • Hajra Maternity Home
    Kasur, Punjab Province, Pakistan
  • Rafique Maternity Home
    Kasur, Punjab Province, Pakistan
  • RHC Changamanga
    Kasur, Punjab Province, Pakistan
  • RHC Ellabad
    Kasur, Punjab Province, Pakistan
  • RHC Gandasingh
    Kasur, Punjab Province, Pakistan
  • RHC Khuddian
    Kasur, Punjab Province, Pakistan
  • RHC Mustafabad
    Kasur, Punjab Province, Pakistan
  • Ali Maternity Home
    Khanewal, Punjab Province, Pakistan
  • Bhu 171/10-R
    Khanewal, Punjab Province, Pakistan
  • Bhu 30/10-R
    Khanewal, Punjab Province, Pakistan
  • Bhu 44/15-L
    Khanewal, Punjab Province, Pakistan
  • Bhu 79/10-R
    Khanewal, Punjab Province, Pakistan
  • Bhu 92/10-R
    Khanewal, Punjab Province, Pakistan
  • Bhu 92/15-L
    Khanewal, Punjab Province, Pakistan
  • BHU Chack 131/15 L
    Khanewal, Punjab Province, Pakistan
  • FHC DHQ Khanewal
    Khanewal, Punjab Province, Pakistan
  • FHC THQ Mian Cahnu
    Khanewal, Punjab Province, Pakistan
  • FWC Kacha Khuh
    Khanewal, Punjab Province, Pakistan
  • FWC Makhdoom Pur
    Khanewal, Punjab Province, Pakistan
  • FWC Model Center
    Khanewal, Punjab Province, Pakistan
  • RHC Kacha Khuh
    Khanewal, Punjab Province, Pakistan
  • RHC Makhdom pur
    Khanewal, Punjab Province, Pakistan
  • RHC Tulamba
    Khanewal, Punjab Province, Pakistan
  • Tehseen Surgical Clinic
    Khanewal, Punjab Province, Pakistan
  • Zainab Maternity Home
    Khanewal, Punjab Province, Pakistan
08

References and documents

Publications

  • Tappis H, Qayyum K, Bryce E, Fatima A, Christofield M, Haider H, Ameen A, Gardezi SMA, Rafay F, Assad F. Injectable contraceptive continuation and user experiences in Punjab, Pakistan: a non-randomized prospective cohort study protocol. BMC Womens Health. 2025 Sep 7;25(Suppl 1):427. doi: 10.1186/s12905-025-03969-9. PubMed 40916043 ↗

Individual participant data

Plan to share: No — A deidentified analytical dataset will be posted in an open access repository upon study completion.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05774626
Lead sponsor
Jhpiego
Responsible party
Sponsor
First posted
Mar 17, 2023
Start date
Jan 18, 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Jul 22, 2025

Study contacts

Hannah Tappis, DrPH
principal investigator · Jhpiego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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