Injectable Contraception Cohort Study in Punjab, Pakistan

Overview

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

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

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: June 30, 2024

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

Interventions

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

Arms, Groups and Cohorts

• 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.
• 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).

Clinical Trial Outcome Measures

Primary Measures

• 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Jhpiego
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Hannah Tappis, DrPH, Principal Investigator, Jhpiego
• Overall Contact(s)
  • Hannah Tappis, DrPH, 9177564180, hannah.tappis@jhpiego.org