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

Contraception Clinical Trial

— DSAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509767
• Other study ID #: Pro00012433
• Secondary ID: DSAS-2015
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2019
• Source: Planned Parenthood Federation of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Subcutaneous depot medroxyprogesterone acetate
Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.

Locations

Country	Name	City	State
United States	Planned Parenthood Gulf Coast	Houston	Texas
United States	Planned Parenthood of Central and Greater Northern New Jersey	Morristown	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Planned Parenthood Federation of America	Pfizer, Tara Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms	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.	12 months from enrollment
Secondary	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	Number of participants who reported being very or somewhat satisfied with Depot Medroxyprogesterone Acetate (DMPA sc) at one year in both the self- and clinic administration arms measured by self-administered questionnaire.	12 months from enrollment
Secondary	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	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 only as measured by self-administered questionnaire.	12 months from enrollment
Secondary	Costs Associated With Contraceptive Care	Costs associated with contraceptive care measured by self-administered questionnaire.	6 and 12 months from enrollment