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

Planned Parenthood Federation of America

Status and phase: Completed; Phase 4

Conditions: Contraception

Treatments: Drug: Subcutaneous depot medroxyprogesterone acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02509767

DSAS-2015 (Other Identifier)

Pro00012433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 401 patients

Sex: Female

Ages: 15 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 2 patient groups

Self-Administration

Experimental group

Description:

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.

Treatment:

Drug: Subcutaneous depot medroxyprogesterone acetate

Clinic Administration (Standard Care)

Other group

Description:

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.

Treatment:

Drug: Subcutaneous depot medroxyprogesterone acetate