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

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Females ages 15-44
Current or past users of DMPA or desires initiation of DMPA for contraception
Can understand spoken and written English or Spanish
Willing to consider/attempt DMPA self-injection
Willing to be randomized to either self- or clinic administration of DMPA
Do not want to become pregnant in the next 12 months
Willing to provide contact information and to complete three surveys at baseline, 6 months, and 12 months
Have consistent access to a working telephone, email, and Internet
No contraindications to DMPA use

Exclusion Criteria

Suspected or confirmed pregnancy
Vaginal bleeding of unknown etiology
Known or suspected breast cancer
Acute liver disease
High blood pressure (Systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg)
Known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
Desire for pregnancy within one year

Arm && Interventions

Group	Intervention	Description
Self-Administration	Subcutaneous depot medroxyprogesterone acetate	Subjects who are randomized to self-administration will be taught self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA sc) by a clinic nurse or other qualified personnel using instructions based on the packaging insert. If willing, subjects will then self-administer DMPA sc under supervision. Subjects who are able to correctly self-administer DMPA sc as assessed by the supervising nurse and who are interested in continued home self-administration will then be provided medication (3 doses of DMPA sc), a self-administration kit (includes alcohol swabs, cotton pads, bandages, mini sharps disposal container), and instructions to do so for the subsequent 3 injections indicating the appropriate dates for injection. All subjects will receive reminders when their next injection is due.
Clinic Administration (Standard Care)	Subcutaneous depot medroxyprogesterone acetate	Subjects who are randomized to clinic administration will receive subcutaneous depot medroxyprogesterone acetate (DMPA sc) injection administered by a clinic nurse or other qualified personnel and receive standard care. They will be instructed to make an appointment to return to the clinic as usual to receive subsequent injections every 12-14 weeks. All subjects will receive reminders when their next injection is due.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms	12 months from enrollment	Number of participants with Depot Medroxyprogesterone Acetate (DMPA sc) continuation at one year by self-report in both the self- and clinic administration arms measured by self-administered questionnaire.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Were Satisfied With Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in Both the Self- and Clinic Administration Arms	12 months from enrollment	Number of participants who reported being very or somewhat satisfied with Depot Medroxyprogesterone Acetate (DMPA sc) at one year in both the self- and clinic administration arms measured by self-administered questionnaire.
Number of Participants Who Were Satisfied With Home Use of Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in the Self-Administration Arm	12 months from enrollment	Number of participants who were satisfied with home use of Depot Medroxyprogesterone Acetate (DMPA sc) at one year by self-report in the self-administration arm only as measured by self-administered questionnaire.
Costs Associated With Contraceptive Care	6 and 12 months from enrollment	Costs associated with contraceptive care measured by self-administered questionnaire.

Locations (2): Planned Parenthood Gulf Coast
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Houston, Texas, United States
Planned Parenthood of Central and Greater Northern New Jersey
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Morristown, New Jersey, United States