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

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ClinicalTrials.gov Identifier: NCT02509767
Recruitment Status : Completed
First Posted : July 28, 2015
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Collaborators:
Pfizer
Tara Health Foundation
Information provided by (Responsible Party):
Planned Parenthood Federation of America

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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Subcutaneous depot medroxyprogesterone acetate Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Actual Study Start Date : August 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: depo-subQ provera 104™

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 Name: depo-subQ provera 104™




Primary Outcome Measures :
  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 [ Time Frame: 12 months from enrollment ]
    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 months from enrollment ]
    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.

  2. 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 [ Time Frame: 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 only as measured by self-administered questionnaire.

  3. Costs Associated With Contraceptive Care [ Time Frame: 6 and 12 months from enrollment ]
    Costs associated with contraceptive care measured by self-administered questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509767


Locations
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United States, New Jersey
Planned Parenthood of Central and Greater Northern New Jersey
Morristown, New Jersey, United States, 07960
United States, Texas
Planned Parenthood Gulf Coast
Houston, Texas, United States, 77023
Sponsors and Collaborators
Planned Parenthood Federation of America
Pfizer
Tara Health Foundation
Investigators
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Principal Investigator: Julia E Kohn, PhD, MPA Planned Parenthood Federation of America
  Study Documents (Full-Text)

Documents provided by Planned Parenthood Federation of America:

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Responsible Party: Planned Parenthood Federation of America
ClinicalTrials.gov Identifier: NCT02509767     History of Changes
Other Study ID Numbers: Pro00012433
DSAS-2015 ( Other Identifier: Planned Parenthood Federation of America )
First Posted: July 28, 2015    Key Record Dates
Results First Posted: September 18, 2019
Last Update Posted: September 18, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Planned Parenthood Federation of America:
Contraceptive Methods
Female Contraception
Contraceptive satisfaction
Injectable contraception
Birth control
Additional relevant MeSH terms:
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Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents