Trial Outcomes & Findings for Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood (NCT NCT02509767)
NCT ID: NCT02509767
Last Updated: 2019-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
401 participants
Primary outcome timeframe
12 months from enrollment
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
200
|
|
Overall Study
COMPLETED
|
157
|
159
|
|
Overall Study
NOT COMPLETED
|
44
|
41
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject randomized to the self-administration group enrolled and then immediately withdrew from the study. Therefore a total of 401 subjects were enrolled (201 in the self-administration arm and 200 in the clinic administration arm), but only 400 were included in the analysis population (200 in each study arm).
Baseline characteristics by cohort
| Measure |
Self-Administration
n=200 Participants
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.
|
Clinic Administration (Standard Care)
n=200 Participants
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
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
26.0 years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
26.2 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
200 Participants
n=99 Participants • One subject randomized to the self-administration group enrolled and then immediately withdrew from the study. Therefore a total of 401 subjects were enrolled (201 in the self-administration arm and 200 in the clinic administration arm), but only 400 were included in the analysis population (200 in each study arm).
|
200 Participants
n=107 Participants • One subject randomized to the self-administration group enrolled and then immediately withdrew from the study. Therefore a total of 401 subjects were enrolled (201 in the self-administration arm and 200 in the clinic administration arm), but only 400 were included in the analysis population (200 in each study arm).
|
400 Participants
n=206 Participants • One subject randomized to the self-administration group enrolled and then immediately withdrew from the study. Therefore a total of 401 subjects were enrolled (201 in the self-administration arm and 200 in the clinic administration arm), but only 400 were included in the analysis population (200 in each study arm).
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants • One subject randomized to the self-administration group enrolled and then immediately withdrew from the study. Therefore a total of 401 subjects were enrolled (201 in the self-administration arm and 200 in the clinic administration arm), but only 400 were included in the analysis population (200 in each study arm).
|
0 Participants
n=107 Participants • One subject randomized to the self-administration group enrolled and then immediately withdrew from the study. Therefore a total of 401 subjects were enrolled (201 in the self-administration arm and 200 in the clinic administration arm), but only 400 were included in the analysis population (200 in each study arm).
|
0 Participants
n=206 Participants • One subject randomized to the self-administration group enrolled and then immediately withdrew from the study. Therefore a total of 401 subjects were enrolled (201 in the self-administration arm and 200 in the clinic administration arm), but only 400 were included in the analysis population (200 in each study arm).
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
98 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic White
|
40 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic Black
|
56 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian / Pacific Islander
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Unknown
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States · Northeast
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Region of Enrollment
United States · South
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
DMPA user status at enrollment
Current DMPA user
|
83 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
DMPA user status at enrollment
Past DMPA user
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
DMPA user status at enrollment
New DMPA user
|
89 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
DMPA user status at enrollment
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months from enrollmentNumber 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.
Outcome measures
| Measure |
Self-Administration
n=157 Participants
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.
|
Clinic Administration (Standard Care)
n=159 Participants
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.
|
|---|---|---|
|
Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms
|
108 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: 12 months from enrollmentPopulation: Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.
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.
Outcome measures
| Measure |
Self-Administration
n=159 Participants
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.
|
Clinic Administration (Standard Care)
n=157 Participants
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.
|
|---|---|---|
|
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
|
147 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: 12 months from enrollmentPopulation: Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.
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.
Outcome measures
| Measure |
Self-Administration
n=157 Participants
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.
|
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.
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.
|
|---|---|---|
|
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
|
137 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 and 12 months from enrollmentPopulation: 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.
Costs associated with contraceptive care measured by self-administered questionnaire.
Outcome measures
Outcome data not reported
Adverse Events
Self-Administration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinic Administration (Standard Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place