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NCT05774626 Clinical Trial

Injectable Contraception Cohort Study in Punjab, Pakistan

Contraceptive Usage Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05774626
Other study ID # IRB00021562
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 18, 2024
Est. completion date June 30, 2025

Study information
Verified date June 2024
Source Jhpiego
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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

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 information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Contraceptive usage
Continued use of injectable contraception, administered on a quarterly basis

Locations
Country Name City State
Pakistan BHU Fetehpur Kasur Punjab
Pakistan BHU Herdo Sehari Kasur Punjab
Pakistan BHU Pakhoki Village 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 - V Kasur Punjab
Pakistan FWC Chunian-1 Kasur Punjab
Pakistan FWC Kotha Kalan Kasur Punjab
Pakistan FWC Qaiser Gerh Kasur Punjab
Pakistan FWC Rosa Tibba Kasur Punjab
Pakistan FWC Sheikh Ummad Kohna Kasur Punjab
Pakistan FWC Talwandi Kasur Punjab
Pakistan Hajra Maternity Home Kasur Punjab
Pakistan Rafiq Maternity Home Kasur Punjab
Pakistan RHC Change Manga Kasur Punjab
Pakistan RHC Ellabad Kasur Punjab
Pakistan RHC Ganda Singh Wala Kasur Punjab
Pakistan RHC Khudian Kasur Punjab
Pakistan RHC Mustafabad Kasur Punjab
Pakistan Ali Maternity Home Khanewal Punjab
Pakistan Bhu 171/10-R Khanewal Punjab
Pakistan Bhu 30/10-R Khanewal Punjab
Pakistan Bhu 44/15-L Khanewal Punjab
Pakistan Bhu 76/10-R Khanewal Pubjab
Pakistan Bhu 79/10-R Khanewal Punjab
Pakistan Bhu 92/10-R Khanewal Punjab
Pakistan Bhu 92/15-L Khanewal Punjab
Pakistan BHU Chack 131/15 L Khanewal Punjab
Pakistan FHC Khanewal Khanewal Punjab
Pakistan FHC THQ Mian Cahnu Khanewal Punjab
Pakistan FWC Kacha Khuh Khanewal Punjab
Pakistan FWC Makhdoom Pur Khanewal Punjab
Pakistan FWC Model Center Khanewal Punjab
Pakistan Kot Barkat Ali Khanewal Punjab
Pakistan RHC Kacha Khuh Khanewal Punjab
Pakistan RHC Makhdom pur Khanewal Punjab
Pakistan RHC Tulamba Khanewal Punjab
Pakistan Tehseen Surgical Clinic Khanewal Punjab
Pakistan Zainab Maternity Home Khanewal Punjab

Sponsors (1)
Lead Sponsor Collaborator
Jhpiego

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Other 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 At enrollment
Other 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 Up to 12 months
Primary DMPA continuation rate Participant use of DMPA measured at 3, 6 and 9 months following enrollment (providing coverage for 3 months with each dose) up to 12 months
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