Contraception
Conditions
Brief summary
Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.
Interventions
subcutaneous depot medroxyprogesterone acetate
Sponsors
Study design
Eligibility
Inclusion criteria
* Patient planning DMPA for post-abortion contraception.
Exclusion criteria
* Patient cannot speak and read English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DMPA Continuation Rate | 6 months | Continuation rates of DMPA-SC and DMPA-IM at 6 months via patient report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DMPA Continuation Rate | 3 months | Continuation rate of DMPA-SC and DMPA-IM at 3 months by patient report |
| Patient Satisfaction and Ease of Use | 6 months | Participants were given a study-bespoke questionnaire with 2 items each scored from 0 to 4 to gauge satisfaction and ease of use. Min score 0, max score 8 with higher scores indicating greater ease of use and satisfaction. |
Countries
United States
Participant flow
Recruitment details
Of the 274 consented participants, 263 enrolled in the study and were included in the study.
Pre-assignment details
Of the 274 consented participants, 11 were not enrolled because they did not receive DMPA according to study protocol
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27.7 Years STANDARD_DEVIATION 5.3 |
| Annual Household Income | 30000 U.S. Dollars |
| Employment Status Full Time | 43 Participants |
| Employment Status In School | 9 Participants |
| Employment Status Not Employed | 47 Participants |
| Employment Status Part Time | 29 Participants |
| Employment Status Unknown/missing | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 216 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gravidity | 4 Number of total pregnancies |
| Highest level of education Associate's | 21 Participants |
| Highest level of education Bachelor's | 5 Participants |
| Highest level of education Doctorate | 0 Participants |
| Highest level of education High school diploma/GED | 123 Participants |
| Highest level of education Less than high school | 7 Participants |
| Highest level of education Master's | 0 Participants |
| Highest level of education Some College | 49 Participants |
| Highest level of education Unknown/missing | 1 Participants |
| Insurance Type Medicaid | 112 Participants |
| Insurance Type Medicare | 19 Participants |
| Insurance Type None | 20 Participants |
| Insurance Type Other | 6 Participants |
| Insurance Type Private | 3 Participants |
| Insurance Type Unknown/missing | 8 Participants |
| Parity | 2 Number of births |
| Prior abortions | 1 Number of prior abortions |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 200 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Relationship Status Divorced | 4 Participants |
| Relationship Status Long term relationship | 15 Participants |
| Relationship Status Married | 5 Participants |
| Relationship Status Other | 5 Participants |
| Relationship Status Separated | 4 Participants |
| Relationship Status Single | 212 Participants |
| Relationship Status Unknown/missing | 1 Participants |
| Relationship Status Widowed | 0 Participants |
| Sex: Female, Male Female | 157 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sexuality Bisexual | 9 Participants |
| Sexuality Gay/Lesbian | 0 Participants |
| Sexuality Other | 0 Participants |
| Sexuality Straight | 95 Participants |
| Sexuality Unknown/Missing | 0 Participants |
| Type of Abortion Medication | 52 Participants |
| Type of Abortion Procedural | 82 Participants |
| Type of Abortion Unknown/Missing | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 106 | 0 / 157 |
| other Total, other adverse events | 0 / 106 | 0 / 157 |
| serious Total, serious adverse events | 0 / 106 | 0 / 157 |