MedPath

Injectable Contraception Cohort Study in Punjab, Pakistan

Active, not recruiting
Conditions
Contraceptive Usage
Registration Number
NCT05774626
Lead Sponsor
Jhpiego
Brief 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

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

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
1000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
DMPA continuation rateup to 12 months

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (41)

Bhu 76/10-R

🇵🇰

Khanewal, Pubjab, Pakistan

BHU Fatehpur

🇵🇰

Kasur, Punjab, Pakistan

BHU Herdo Sehari

🇵🇰

Kasur, Punjab, Pakistan

BHU Pakhoki

🇵🇰

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

FHC Kasur

🇵🇰

Kasur, Punjab, Pakistan

FWC Chunian-1

🇵🇰

Kasur, Punjab, Pakistan

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Bhu 76/10-R
🇵🇰Khanewal, Pubjab, Pakistan
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