Clinical trial NCT02509767: Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Official title: Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Contraceptive Methods
Female Contraception
Contraceptive satisfaction
Injectable contraception
Birth control
Lead sponsor: Planned Parenthood Federation of America
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Tara Health Foundation
First posted: 2015-07-28
Enrollment: 401
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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 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

Primary outcomes:
measure: Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms
timeFrame: 12 months from enrollment
Secondary outcomes:
measure: Number of Participants Who Were Satisfied With Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in Both the Self- and Clinic Administration Arms
timeFrame: 12 months from enrollment
measure: Number of Participants Who Were Satisfied With Home Use of Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in the Self-Administration Arm
timeFrame: 12 months from enrollment
measure: Costs Associated With Contraceptive Care
timeFrame: 6 and 12 months from enrollment
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Planned Parenthood of Central and Greater Northern New Jersey
state: New Jersey
city: Houston
country: United States
facility: Planned Parenthood Gulf Coast
state: Texas
Study officials:
affiliation: Planned Parenthood Federation of America
name: Julia E Kohn, PhD, MPA
role: PRINCIPAL_INVESTIGATOR
References: