Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Condition: Contraception
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Subcutaneous depot medroxyprogesterone acetate
Intervention type(s): Drug
Intervention description(s): Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.
Other intervention name(s): depo-subQ provera 104™
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Contraceptive Methods; Female Contraception; Contraceptive satisfaction; Injectable contraception; Birth control