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

NCT02509767 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Pro00012433DSAS-2015
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 2

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.

Conditions

Contraception

Keywords

Contraceptive Methods; Female Contraception; Contraceptive satisfaction; Injectable contraception; Birth control

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms

  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.

  12 months from enrollment

Secondary Outcomes (3)

• 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 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

• Costs Associated With Contraceptive Care

  6 and 12 months from enrollment

Study Arms (2)

Self-Administration

EXPERIMENTAL

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.

Drug: Subcutaneous depot medroxyprogesterone acetate

Clinic Administration (Standard Care)

OTHER

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.

Drug: Subcutaneous depot medroxyprogesterone acetate

Interventions

Subcutaneous depot medroxyprogesterone acetate DRUG

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

Also known as: depo-subQ provera 104™

Clinic Administration (Standard Care); Self-Administration

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood Federation of America: lead
• Pfizer: collaborator
• Tara Health Foundation: collaborator

Study Sites (2)

Planned Parenthood of Central and Greater Northern New Jersey

Morristown, New Jersey, 07960, United States

Location

Planned Parenthood Gulf Coast

Houston, Texas, 77023, United States

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Julia Kohn
• Organization: Planned Parenthood Federation of America

julia.kohn@ppfa.org

2122614636

Study Officials

• Julia E Kohn, PhD, MPA

  Planned Parenthood Federation of America

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2015
• First Posted: July 28, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)