Contraceptive UsageNCT05774626
Injectable Contraception Cohort Study in Punjab, Pakistan
An observational study of Contraceptive Usage, run by Jhpiego at 41 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Contraceptive usage
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 1,009 participants
- Where
- 41 sitesPakistan
- Study dates
- 18 Jan 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Clients receiving family planning counseling and services at participating public and private health facilities in Kasur and Khanewal districts of Punjab, Pakistan
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
Pakistan41 sites
BHU Fatehpur
Kasur, Punjab Province
BHU Herdo Sehari
Kasur, Punjab Province
BHU Pakhoki
Kasur, Punjab Province
BHU Rao Khan Wala
Kasur, Punjab Province
BHU Serhali
Kasur, Punjab Province
BHU Sheikh Bhago
Kasur, Punjab Province
Fatima Maternity Home
Kasur, Punjab Province
FHC Kasur
Kasur, Punjab Province
FWC Chunian-1
Kasur, Punjab Province
FWC Kasur 5
Kasur, Punjab Province
FWC Kotha Kalan
Kasur, Punjab Province
FWC Qaiser Garh
Kasur, Punjab Province
FWC Rosa Tibba
Kasur, Punjab Province
FWC Sheikh Umad Kohna
Kasur, Punjab Province
FWC Talwandi
Kasur, Punjab Province
Hajra Maternity Home
Kasur, Punjab Province
Rafique Maternity Home
Kasur, Punjab Province
RHC Changamanga
Kasur, Punjab Province
RHC Ellabad
Kasur, Punjab Province
RHC Gandasingh
Kasur, Punjab Province
RHC Khuddian
Kasur, Punjab Province
RHC Mustafabad
Kasur, Punjab Province
Bhu 76/10-R
Khanewal, Pubjab
Ali Maternity Home
Khanewal, Punjab Province
Bhu 171/10-R
Khanewal, Punjab Province
Bhu 30/10-R
Khanewal, Punjab Province
Bhu 44/15-L
Khanewal, Punjab Province
Bhu 79/10-R
Khanewal, Punjab Province
Bhu 92/10-R
Khanewal, Punjab Province
Bhu 92/15-L
Khanewal, Punjab Province
BHU Chack 131/15 L
Khanewal, Punjab Province
FHC DHQ Khanewal
Khanewal, Punjab Province
FHC THQ Mian Cahnu
Khanewal, Punjab Province
FWC Kacha Khuh
Khanewal, Punjab Province
FWC Makhdoom Pur
Khanewal, Punjab Province
FWC Model Center
Khanewal, Punjab Province
RHC Kacha Khuh
Khanewal, Punjab Province
RHC Makhdom pur
Khanewal, Punjab Province
RHC Tulamba
Khanewal, Punjab Province
Tehseen Surgical Clinic
Khanewal, Punjab Province
Zainab Maternity Home
Khanewal, Punjab Province
About this study
Official title: 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:
- 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
- To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
- 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:
- 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
- To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
- 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
- Conditions
- Contraceptive Usage
- Being tested
- Contraceptive usage
- Keywords
- injectable contraception, prospective cohort study, Pakistan
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive usageBehavioural
Continued use of injectable contraception, administered on a quarterly basis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Contraceptive usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
DMPA continuation rate
Participant use of DMPA measured at 3, 6 and 9 months following enrollment (providing coverage for 3 months with each dose)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start18 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah Tappis, DrPH, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774626
- Sponsor's protocol ID
- IRB00021562
- Status last verified
- Jul 2025
- First submitted
- 28 Nov 2022
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A deidentified analytical dataset will be posted in an open access repository upon study completion.
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of Subcutaneous and Intramuscular Injectable Contraception: a Non-randomized Prospective Cohort Study in Punjab, Pakistan
- ClinicalTrials.gov ID
- NCT05774626
- Acronym / sponsor ID
- IRB00021562
- Conditions
- Contraceptive Usage
- Keywords
- injectable contraception, prospective cohort study, Pakistan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,009 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
- 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
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:
- 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
- To understand how characteristics and experiences of DMPA-SC and DMPA-IM users differ.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMPA-SC | – | Behavioral: Contraceptive usageAll 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. |
| DMPA-IM | – | Behavioral: Contraceptive usageAll 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). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Clients receiving family planning counseling and services at participating public and private health facilities in Kasur and Khanewal districts of Punjab, Pakistan
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraceptive usageContinued use of injectable contraception, administered on a quarterly basis | Behavioural | DMPA-IM, DMPA-SC |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 40916043Tappis 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.
- Individual participant dataSharing planned: No. A deidentified analytical dataset will be posted in an open access repository upon study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Tappis, DrPH principal investigator
Jhpiego
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraceptive Usage, run by Jhpiego at 41 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMPA continuation rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.