Contraception
Conditions
Keywords
LARC, IUD, Contraceptive Implant, Contraception, Community college
Brief summary
This prospective randomized controlled study will evaluate if Long Acting Reversible Contraceptive (LARC) forward counseling in combination with same-day LARC placement increases overall LARC uptake within a community college population compared to LARC forward counseling and referral to a secondary clinic for LARC placement. The study will be conducted at Mount Hood Community College (MHCC) in Oregon. Participants will be enrolled into three groups. All groups will receive the same standardized contraceptive counseling (LARC forward counseling) and participants will be able to choose between a LARC method and short-acting method of birth control.
Detailed description
The purpose of this study is to evaluate the benefit of an on-campus birth control counseling and services clinic. Currently there are no health services that provide access to birth control located on the Mount Hood Community College (MHCC) campus. We are offering a temporary 'Birth Control Resource Center' for eligible students. All forms of birth control in this study are FDA approved. During the study participants will undergo counseling to choose the method of birth control that is right for them. This will include watching an informational video and having a discussion with study staff. If participants choose pills, the patch the ring, or a diaphragm and do not have any contraindications to this method, they will receive a prescription for this method to be filled at the pharmacy of their choice. If participants choose Depo-Provera (the shot), they will receive their first shot on the day of their visit and a prescription for repeat shots every 3 months. If participants choose to have an IUD or Implant as their method of birth control, they will be randomized to one of two groups. There is a 50% chance of having the intrauterine device (IUD) or Implant placed immediately after the counseling session and a 50% chance of receiving a list of local clinics that can place the device at a later time.
Interventions
DRUGLong Acting Reversible Contraception (LARC)
Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
OTHERReferral for Long Acting Reversible Contraception (LARC)
Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
OTHERPrescription for Short-Acting Hormonal Contraception
Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
Sponsors
Merck Sharp & Dohme LLC
Bayer
Society of Family Planning
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* English or Spanish-speaking women. * 17-30 years of age. * Currently enrolled in a 2-year certificate program at Mount Hood Community College. * At risk for pregnancy (sexually active with men or anticipate becoming sexually active in the next 6 months). * Do not desire pregnancy within the next 12 months. * No contraindications to LARC according to the Center for Disease Control and Prevention medical eligibility criteria (CDC MEC)
Exclusion criteria
* Women who are not currently sexually active with men and who do not anticipate becoming sexually active with a male partner in the next 6 months. * Women who have had a tubal ligation or other sterilization procedure. * Women who desire pregnancy within the next 12 months. * Women currently already using a LARC method for contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Ongoing Use and Satisfaction | 3 months | Proportion of Long Acting Reversible Contraception (LARC) uptake among women, by group assignment. This will be evaluated based on participants' self-reported ongoing use and satisfaction by group assignment on the 3-month questionnaire after the initial visit. 3 months following placement of LARC device, initiation of short acting method, and those in the control group, participants will complete a questionnaire in order to assess ongoing use and satisfaction of their contraceptive method. This will be measured on the 3-month questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-LARC Group: Short Acting Method All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services
Prescription for Short-Acting Hormonal Contraception: Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice | 3 |
| Control Group: Referral for LARC Placement All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to referral for LARC placement to local clinic.
Referral for Long Acting Reversible Contraception (LARC): Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.) | 0 |
| LARC Group: Same Day LARC Placement All groups will receive the same standardized contraceptive counseling (LARC forward counseling). Randomized to same day LARC placement (intervention).
Long Acting Reversible Contraception (LARC): Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Non-LARC Group: Short Acting Method | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants |
| Age, Continuous | 21.3 years STANDARD_DEVIATION 0.58 | 21.3 years STANDARD_DEVIATION 0.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American/Black | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian/White | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Latino | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Mutli-racial | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants |
| Region of Enrollment United States | 3 participants | 3 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Reporting Ongoing Use and Satisfaction
Proportion of Long Acting Reversible Contraception (LARC) uptake among women, by group assignment. This will be evaluated based on participants' self-reported ongoing use and satisfaction by group assignment on the 3-month questionnaire after the initial visit. 3 months following placement of LARC device, initiation of short acting method, and those in the control group, participants will complete a questionnaire in order to assess ongoing use and satisfaction of their contraceptive method. This will be measured on the 3-month questionnaire.
Time frame: 3 months
Population: No participants enrolled in both the Control Group or the LARC Group. All 3 participants analyzed met the criteria specified for this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-LARC Group: Short Acting Method | Number of Participants Reporting Ongoing Use and Satisfaction | 3 Participants |
| Control Group: Referral for LARC Placement | Number of Participants Reporting Ongoing Use and Satisfaction | 0 Participants |
| LARC Group: Same Day LARC Placement | Number of Participants Reporting Ongoing Use and Satisfaction | 0 Participants |