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

Information source: Planned Parenthood Federation of America
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Subcutaneous depot medroxyprogesterone acetate (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Planned Parenthood Federation of America

Official(s) and/or principal investigator(s):
Julia E Kohn, PhD, MPA, Principal Investigator, Affiliation: Planned Parenthood Federation of America

Overall contact:
Julia E Kohn, PhD, MPA, Email: julia.kohn@ppfa.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Depot medroxyprogesterone acetate (DMPA sc) continuation at one year by self-report in both the self- and clinic administration arms.

Secondary outcome:

Patient-reported satisfaction with DMPA sc

Patient-reported satisfaction with home use of DMPA sc

Costs associated with contraceptive care

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.

Eligibility

Minimum age: 15 Years. Maximum age: 44 Years. Gender(s): Female.

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

Locations and Contacts

Julia E Kohn, PhD, MPA, Email: julia.kohn@ppfa.org

Planned Parenthood of Central and Greater Northern New Jersey, Morristown, New Jersey 07960, United States; Not yet recruiting
Maggie Turmel, MSN, WHNP-BC
Maggie Turmel, MSN, WHNP-BC, Principal Investigator

Planned Parenthood Gulf Coast, Houston, Texas 77023, United States; Not yet recruiting
Anitra D Beasley, MD, MPH
Anitra D Beasley, MD, MPH, Principal Investigator

Additional Information

Starting date: August 2015
Last updated: August 7, 2015

Page last updated: August 23, 2015

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