Clinical Trials Directory

Trials / Completed

CompletedNCT05774626

Injectable Contraception Cohort Study in Punjab, Pakistan

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,009 (actual)
Sponsor
Jhpiego · Academic / Other
Sex
Female
Age
18 Years – 49 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALContraceptive usageContinued use of injectable contraception, administered on a quarterly basis

Timeline

Start date
2024-01-18
Primary completion
2025-06-30
Completion
2025-06-30
First posted
2023-03-17
Last updated
2025-07-22

Locations

41 sites across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT05774626. Inclusion in this directory is not an endorsement.