Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 2
- 主要终点
- Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Self-Administration
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.
干预措施: Subcutaneous depot medroxyprogesterone acetate (Drug)
Clinic Administration (Standard Care)
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.
干预措施: Subcutaneous depot medroxyprogesterone acetate (Drug)
结局指标
主要结局
Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms
时间窗: 12 months from enrollment
Number of participants with Depot Medroxyprogesterone Acetate (DMPA sc) continuation at one year by self-report in both the self- and clinic administration arms measured by self-administered questionnaire.
次要结局
- 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(12 months from enrollment)
- 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(12 months from enrollment)
- Costs Associated With Contraceptive Care(6 and 12 months from enrollment)