NCT02509767

Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Planned Parenthood Federation of America · Academic / Other
• Sex: Female
• Age: 15 Years – 44 Years
• Healthy volunteers: Accepted

Summary

This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible, and acceptable for women and adolescents. A total of 400 female patients (ages 15-44) requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration (usual care). Subjects will be followed for one year. The primary study outcome is DMPA continuation at one year by self-report in both study arms. Secondary outcomes include patient-reported satisfaction with treatment; satisfaction with home use; and costs associated with contraceptive care. The investigators hypothesize higher continuation rates among self-injection users compared to patients who receive standard care. Secondary exploratory hypotheses include higher patient satisfaction and lower costs associated with contraceptive care among self-injection users.

Detailed description

This open-label, randomized parallel group clinical trial will study subcutaneous depot medroxyprogesterone acetate (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible, and acceptable for women and adolescents. A total of 400 female patients (ages 15-44) requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration (usual care) in a 1:1 allocation. Subjects will be followed for one year. All subjects will receive reminders when their next injection is due. Follow-up surveys will be conducted at 6 and 12 months. Adherence will be monitored by subject self-report and study outcomes will be ascertained by self-report and medical record review. The primary study outcome is DMPA continuation at one year by self-report in both study arms. Secondary outcomes include patient-reported satisfaction with treatment; satisfaction with home use; and costs associated with contraceptive care. The investigators hypothesize higher continuation rates among self-injection users compared to patients who receive standard care (delta = .13; 80% power; one-sided α=0.05; allowing for 15% loss-to-follow-up). Secondary exploratory hypotheses include higher patient satisfaction and lower costs associated with contraceptive care among self-injection users.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Subcutaneous depot medroxyprogesterone acetate	Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-04-01
• Completion: 2017-12-01
• First posted: 2015-07-28
• Last updated: 2019-09-18
• Results posted: 2019-09-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study