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

NCT02509767

Last updated date
Study Location
Planned Parenthood of Central and Greater Northern New Jersey
Morristown, New Jersey, 07960, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Contraception
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-44 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Official Title  ICMJE Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
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 ?=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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Contraception
Intervention  ICMJE 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 Name: depo-subQ provera 104?
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Subcutaneous depot medroxyprogesterone acetate
  • 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.
    Intervention: Drug: Subcutaneous depot medroxyprogesterone acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2019)
401
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2015)
400
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 15 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02509767
Other Study ID Numbers  ICMJE Pro00012433
DSAS-2015 ( Other Identifier: Planned Parenthood Federation of America )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Planned Parenthood Federation of America
Study Sponsor  ICMJE Planned Parenthood Federation of America
Collaborators  ICMJE
  • Pfizer
  • Tara Health Foundation
Investigators  ICMJE
Principal Investigator:Julia E Kohn, PhD, MPAPlanned Parenthood Federation of America
PRS Account Planned Parenthood Federation of America
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP