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

• Sponsor: Planned Parenthood Federation of America (Other)
• Overall Status: Completed
• CT.gov ID: NCT02509767
• Collaborator: Pfizer (Industry), Tara Health Foundation (Other)
• Enrollment: 401
• Locations: 2
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site: 200.5
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Subcutaneous depot medroxyprogesterone acetate	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 401 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.; Other Names: depo-subQ provera 104™
Other: 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.	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.; Other Names: depo-subQ provera 104™

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms [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.

Secondary Outcome Measures

1. 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 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.

2. 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]

   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.

3. Costs Associated With Contraceptive Care [6 and 12 months from enrollment]

   Costs associated with contraceptive care measured by self-administered questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Planned Parenthood of Central and Greater Northern New Jersey	Morristown	New Jersey	United States	07960
2	Planned Parenthood Gulf Coast	Houston	Texas	United States	77023

Sponsors and Collaborators

• Planned Parenthood Federation of America
• Pfizer
• Tara Health Foundation

Investigators

• Principal Investigator: Julia E Kohn, PhD, MPA, Planned Parenthood Federation of America

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2015

More Information

Publications

None provided.

• Responsible Party: Planned Parenthood Federation of America
• ClinicalTrials.gov Identifier: NCT02509767
• Other Study ID Numbers: Pro00012433; DSAS-2015
• First Posted: Jul 28, 2015
• Last Update Posted: Sep 18, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Planned Parenthood Federation of America: Contraceptive Methods; Female Contraception; Contraceptive satisfaction; Injectable contraception; Birth control
• Additional relevant MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone

Study Results

Participant Flow

Arm/Group Title	Self-Administration	Clinic Administration (Standard Care)
Arm/Group Description	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. 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.	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. 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.
Period Title: Overall Study
STARTED	201	200
COMPLETED	157	159
NOT COMPLETED	44	41

Baseline Characteristics

Arm/Group Title	Self-Administration	Clinic Administration (Standard Care)	Total
Arm/Group Description	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. 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.	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. 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.	Total of all reporting groups
Overall Participants	200	200	400
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.4 (6.5)	26.0 (6.2)	26.2 (6.3)
Sex: Female, Male (Count of Participants)
Female	200 100%	200 100%	400 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	98 49%	106 53%	204 51%
Non-Hispanic White	40 20%	31 15.5%	71 17.8%
Non-Hispanic Black	56 28%	51 25.5%	107 26.8%
Asian / Pacific Islander	2 1%	6 3%	8 2%
Other	1 0.5%	6 3%	7 1.8%
Unknown	3 1.5%	0 0%	3 0.8%
Region of Enrollment (Count of Participants)
Northeast	100 50%	100 50%	200 50%
South	100 50%	100 50%	200 50%
DMPA user status at enrollment (Count of Participants)
Current DMPA user	83 41.5%	88 44%	171 42.8%
Past DMPA user	27 13.5%	26 13%	53 13.3%
New DMPA user	89 44.5%	85 42.5%	174 43.5%
Unknown	1 0.5%	1 0.5%	2 0.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms
Description	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.
Time Frame	12 months from enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Self-Administration	Clinic Administration (Standard Care)
Arm/Group Description	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. 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.	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. 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.
Measure Participants	157	159
Count of Participants [Participants]	108 54%	85 42.5%

2. Secondary Outcome

Title	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
Description	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.
Time Frame	12 months from enrollment

Outcome Measure Data

Analysis Population Description

Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.

Arm/Group Title	Clinic Administration (Standard Care)	Self-Administration
Arm/Group Description	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.	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.
Measure Participants	159	157
Count of Participants [Participants]	147 73.5%	137 68.5%

3. Secondary Outcome

Title	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
Description	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.
Time Frame	12 months from enrollment

Outcome Measure Data

Analysis Population Description

Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.

Arm/Group Title	Self-Administration
Arm/Group Description	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.
Measure Participants	157
Count of Participants [Participants]	137 68.5%

4. Secondary Outcome

Title	Costs Associated With Contraceptive Care
Description	Costs associated with contraceptive care measured by self-administered questionnaire.
Time Frame	6 and 12 months from enrollment

Outcome Measure Data

Analysis Population Description

We did not collect the data necessary to ascertain results for this outcome. While this was originally planned as a secondary study outcome, we utlimately determined that it was not feasible. Therefore we have reported "0" for this outcome and are unable to report results.

Arm/Group Title	Self-Administration	Clinic Administration (Standard Care)
Arm/Group Description	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. 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.	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. 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.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse Event data were collected for subjects for a period of 1 year following study enrollment (i.e. baseline).
Arm/Group Title	Self-Administration		Clinic Administration (Standard Care)
Arm/Group Description	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. 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.		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. 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.
All Cause Mortality
	Self-Administration		Clinic Administration (Standard Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/201 (0%)		0/200 (0%)
Serious Adverse Events
	Self-Administration		Clinic Administration (Standard Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/201 (0%)		0/200 (0%)
Other (Not Including Serious) Adverse Events
	Self-Administration		Clinic Administration (Standard Care)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/201 (0%)		0/200 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.