Injectable Contraception Cohort Study in Punjab, Pakistan

NCT ID: NCT05774626

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1009 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-18

Study Completion Date

2025-06-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Contraceptive Usage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Contraceptive usage

Intervention Type BEHAVIORAL

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).

Contraceptive usage

Intervention Type BEHAVIORAL

Continued use of injectable contraception, administered on a quarterly basis

Interventions

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Contraceptive usage

Continued use of injectable contraception, administered on a quarterly basis

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jhpiego

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannah Tappis, DrPH

Role: PRINCIPAL_INVESTIGATOR

Jhpiego

Locations

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Bhu 76/10-R

Khanewal, Pubjab, Pakistan

Site Status

BHU Fatehpur

Kasur, Punjab Province, Pakistan

Site Status

BHU Herdo Sehari

Kasur, Punjab Province, Pakistan

Site Status

BHU Pakhoki

Kasur, Punjab Province, Pakistan

Site Status

BHU Rao Khan Wala

Kasur, Punjab Province, Pakistan

Site Status

BHU Serhali

Kasur, Punjab Province, Pakistan

Site Status

BHU Sheikh Bhago

Kasur, Punjab Province, Pakistan

Site Status

Fatima Maternity Home

Kasur, Punjab Province, Pakistan

Site Status

FHC Kasur

Kasur, Punjab Province, Pakistan

Site Status

FWC Chunian-1

Kasur, Punjab Province, Pakistan

Site Status

FWC Kasur 5

Kasur, Punjab Province, Pakistan

Site Status

FWC Kotha Kalan

Kasur, Punjab Province, Pakistan

Site Status

FWC Qaiser Garh

Kasur, Punjab Province, Pakistan

Site Status

FWC Rosa Tibba

Kasur, Punjab Province, Pakistan

Site Status

FWC Sheikh Umad Kohna

Kasur, Punjab Province, Pakistan

Site Status

FWC Talwandi

Kasur, Punjab Province, Pakistan

Site Status

Hajra Maternity Home

Kasur, Punjab Province, Pakistan

Site Status

Rafique Maternity Home

Kasur, Punjab Province, Pakistan

Site Status

RHC Changamanga

Kasur, Punjab Province, Pakistan

Site Status

RHC Ellabad

Kasur, Punjab Province, Pakistan

Site Status

RHC Gandasingh

Kasur, Punjab Province, Pakistan

Site Status

RHC Khuddian

Kasur, Punjab Province, Pakistan

Site Status

RHC Mustafabad

Kasur, Punjab Province, Pakistan

Site Status

Ali Maternity Home

Khanewal, Punjab Province, Pakistan

Site Status

Bhu 171/10-R

Khanewal, Punjab Province, Pakistan

Site Status

Bhu 30/10-R

Khanewal, Punjab Province, Pakistan

Site Status

Bhu 44/15-L

Khanewal, Punjab Province, Pakistan

Site Status

Bhu 79/10-R

Khanewal, Punjab Province, Pakistan

Site Status

Bhu 92/10-R

Khanewal, Punjab Province, Pakistan

Site Status

Bhu 92/15-L

Khanewal, Punjab Province, Pakistan

Site Status

BHU Chack 131/15 L

Khanewal, Punjab Province, Pakistan

Site Status

FHC DHQ Khanewal

Khanewal, Punjab Province, Pakistan

Site Status

FHC THQ Mian Cahnu

Khanewal, Punjab Province, Pakistan

Site Status

FWC Kacha Khuh

Khanewal, Punjab Province, Pakistan

Site Status

FWC Makhdoom Pur

Khanewal, Punjab Province, Pakistan

Site Status

FWC Model Center

Khanewal, Punjab Province, Pakistan

Site Status

RHC Kacha Khuh

Khanewal, Punjab Province, Pakistan

Site Status

RHC Makhdom pur

Khanewal, Punjab Province, Pakistan

Site Status

RHC Tulamba

Khanewal, Punjab Province, Pakistan

Site Status

Tehseen Surgical Clinic

Khanewal, Punjab Province, Pakistan

Site Status

Zainab Maternity Home

Khanewal, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 40916043 (View on PubMed)

Other Identifiers

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IRB00021562

Identifier Type: -

Identifier Source: org_study_id

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