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

NCT ID: NCT02509767

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Self-Administration

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.

Group Type: EXPERIMENTAL

Subcutaneous depot medroxyprogesterone acetate

Intervention Type: DRUG

Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.

Clinic Administration (Standard Care)

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.

Group Type: OTHER

Subcutaneous depot medroxyprogesterone acetate

Intervention Type: DRUG

Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

depo-subQ provera 104™

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Tara Health Foundation

UNKNOWN

Sponsor Role: collaborator

Planned Parenthood Federation of America

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia E Kohn, PhD, MPA

Role: PRINCIPAL_INVESTIGATOR

Planned Parenthood Federation of America

Locations

Planned Parenthood of Central and Greater Northern New Jersey

Morristown, New Jersey, United States

Planned Parenthood Gulf Coast

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DSAS-2015

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00012433

Identifier Type: -

Identifier Source: org_study_id