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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Subcutaneous depot medroxyprogesterone acetate

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.

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Planned Parenthood of Central and Greater Northern New Jersey
  • Texas
    • Houston, Texas, United States, 77023
      • Planned Parenthood Gulf Coast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: depo-subQ provera 104™
Other: 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.	Drug: 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.; Other Names: depo-subQ provera 104™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	12 months from enrollment
Costs Associated With Contraceptive Care	Costs associated with contraceptive care measured by self-administered questionnaire.	6 and 12 months from enrollment

Collaborators and Investigators

• Sponsor: Planned Parenthood Federation of America
• Collaborators: Pfizer; Tara Health Foundation
• Investigators: Principal Investigator: Julia E Kohn, PhD, MPA, Planned Parenthood Federation of America

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 25, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Birth control; Contraceptive Methods; Female Contraception; Contraceptive satisfaction; Injectable contraception
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: Pro00012433; DSAS-2015 (Other Identifier: Planned Parenthood Federation of America)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No