Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
NCT02509767
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- 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
- 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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Descriptive Information | |||||||
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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 |
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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 | 401 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Planned Parenthood Federation of America | ||||||
Study Sponsor ICMJE | Planned Parenthood Federation of America | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |