Overview

This trial is active, not recruiting.

Condition contraception
Treatment subcutaneous depot medroxyprogesterone acetate
Phase phase 4
Sponsor Planned Parenthood Federation of America
Collaborator Tara Health Foundation
Start date August 2015
End date April 2017
Trial size 400 participants
Trial identifier NCT02509767, DSAS-2015, Pro00012433

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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.
subcutaneous depot medroxyprogesterone acetate depo-subQ provera 104™
Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.
(Other)
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.
subcutaneous depot medroxyprogesterone acetate depo-subQ provera 104™
Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Patient-reported satisfaction with DMPA sc
time frame: 6 and 12 months from enrollment
Patient-reported satisfaction with home use of DMPA sc
time frame: 6 and 12 months from enrollment
Costs associated with contraceptive care
time frame: 6 and 12 months from enrollment

Eligibility Criteria

Female participants from 15 years up to 44 years old.

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

Additional Information

Official title Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Principal investigator Julia E Kohn, PhD, MPA
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Planned Parenthood Federation of America.