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



Status:Active, not recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:15 - 44
Updated:5/3/2017
Start Date:August 2015
End Date:December 2017

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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.

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.

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
We found this trial at
2
sites
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from
Morristown, NJ
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Houston, Texas 77023
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from
Houston, TX
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