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 |
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.
(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.
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
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