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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,009

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2024

Geographic Reach

1 country

41 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

November 28, 2022

Completed

4 months until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed

10 months until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed

Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

November 28, 2022

Last Update Submit

July 20, 2025

Conditions

Contraceptive Usage

Keywords

injectable contraceptionprospective cohort studyPakistan

Outcome Measures

Primary Outcomes (1)

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

Other Outcomes (2)

Characteristics of women in the two study groups (DMPA-SC and DMPA-IM users)
At enrollment
Family planning service provision and injectable contraceptive use experiences of women in the two study groups (DMPA-SC and DMPA-IM users)
Up to 12 months

Study Arms (2)

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.

Behavioral: Contraceptive usage

DMPA-IM

Behavioral: Contraceptive usage

Interventions

Contraceptive usageBEHAVIORAL

Continued use of injectable contraception, administered on a quarterly basis

DMPA-IMDMPA-SC

Eligibility Criteria

Age18 Years - 49 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Clients receiving family planning counseling and services at participating public and private health facilities in Kasur and Khanewal districts of Punjab, Pakistan

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Jhpiegolead

Study Sites (41)

Bhu 76/10-R

Khanewal, Pubjab, Pakistan

Location

BHU Fatehpur