Contraception
Conditions
Keywords
Contraceptive Methods, Female Contraception, Contraceptive satisfaction, Injectable contraception, Birth control
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.
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.
Interventions
DRUGSubcutaneous 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.
Sponsors
Pfizer
Tara Health Foundation
Planned Parenthood Federation of America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 44 Years
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
Design outcomes
Primary
| Measure | Time frame | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Costs Associated With Contraceptive Care | 6 and 12 months from enrollment | Costs associated with contraceptive care measured by self-administered questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 200 |
| 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. | 200 |
| Total | 400 |
Baseline characteristics
| Characteristic | Clinic Administration (Standard Care) | Total | Self-Administration |
|---|---|---|---|
| Age, Continuous | 26.0 years STANDARD_DEVIATION 6.2 | 26.2 years STANDARD_DEVIATION 6.3 | 26.4 years STANDARD_DEVIATION 6.5 |
| DMPA user status at enrollment Current DMPA user | 88 Participants | 171 Participants | 83 Participants |
| DMPA user status at enrollment New DMPA user | 85 Participants | 174 Participants | 89 Participants |
| DMPA user status at enrollment Past DMPA user | 26 Participants | 53 Participants | 27 Participants |
| DMPA user status at enrollment Unknown | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Asian / Pacific Islander | 6 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 106 Participants | 204 Participants | 98 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Black | 51 Participants | 107 Participants | 56 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic White | 31 Participants | 71 Participants | 40 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | 6 Participants | 7 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Unknown | 0 Participants | 3 Participants | 3 Participants |
| Region of Enrollment United States Northeast | 100 Participants | 200 Participants | 100 Participants |
| Region of Enrollment United States South | 100 Participants | 200 Participants | 100 Participants |
| Sex: Female, Male Female | 200 Participants | 400 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 201 | 0 / 200 |
| other Total, other adverse events | 0 / 201 | 0 / 200 |
| serious Total, serious adverse events | 0 / 201 | 0 / 200 |
Outcome results
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.
Time frame: 12 months from enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Administration | 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 |
| Clinic Administration (Standard Care) | Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms | 85 Participants |
Secondary
Costs Associated With Contraceptive Care
Costs associated with contraceptive care measured by self-administered questionnaire.
Time frame: 6 and 12 months from enrollment
Population: 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.
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.
Time frame: 12 months from enrollment
Population: Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Administration | 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 |
| Clinic Administration (Standard Care) | 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 | 137 Participants |
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.
Time frame: 12 months from enrollment
Population: Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-Administration | 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 |