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| ID | Type | Description | Link |
|---|---|---|---|
| DSAS-2015 | Other Identifier | Planned Parenthood Federation of America |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Tara Health Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Administration | Experimental | 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. |
|
| Clinic Administration (Standard Care) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous depot medroxyprogesterone acetate | Drug | Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia E Kohn, PhD, MPA | Planned Parenthood Federation of America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of Central and Greater Northern New Jersey | Morristown | New Jersey | 07960 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject who was randomized to the self-administration arm enrolled and immediately withdrew from the study. Therefore the total number enrolled was 401, but the total number analyzed was 400.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months from enrollment |
|
Adverse Event data were collected for subjects for a period of 1 year following study enrollment (i.e. baseline).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Kohn | Planned Parenthood Federation of America | 2122614636 | julia.kohn@ppfa.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2015 | Apr 3, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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|
| 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 |
| Costs Associated With Contraceptive Care | Costs associated with contraceptive care measured by self-administered questionnaire. | 6 and 12 months from enrollment |
| Planned Parenthood Gulf Coast |
| Houston |
| Texas |
| 77023 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | 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). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| DMPA user status at enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys. | Posted | Count of Participants | Participants | 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. | Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys. | Posted | Count of Participants | Participants | 12 months from enrollment |
|
|
|
| Secondary | Costs Associated With Contraceptive Care | Costs associated with contraceptive care measured by self-administered questionnaire. | 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. | Posted | 6 and 12 months from enrollment |
|
|
| 0 |
| 201 |
| 0 |
| 201 |
| 0 |
| 201 |
| EG001 | 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. | 0 | 200 | 0 | 200 | 0 | 200 |
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| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |