Not provided
Not provided
Not provided
Not provided
Not provided
Inadequate participant enrollment during recruitment period.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Bayer | INDUSTRY |
| Society of Family Planning | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-LARC Group: Short Acting Method | Active Comparator | 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 |
|
| Control Group: Referral for LARC Placement | Active Comparator | All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to referral for LARC placement to local clinic. |
|
| LARC Group: Same Day LARC Placement | Active Comparator | All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long Acting Reversible Contraception (LARC) | Drug | Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Lamme, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Hood Community College | Gresham | Oregon | 97030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29201430 | Derived | Lamme J, Edelman A, Padua E, Jensen JT. Evaluation of the challenges faced in increasing contraceptive access within a community college population. Contracept Reprod Med. 2017 Oct 23;2:25. doi: 10.1186/s40834-017-0051-8. eCollection 2017. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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.) |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Overall, 3 participants enrolled in the study. All 3 participants chose to receive short acting methods and could not be randomized to either same day LARC placement or referral for LARC placement.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 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. | No participants enrolled in both the Control Group or the LARC Group. All 3 participants analyzed met the criteria specified for this analysis. | Posted | Count of Participants | Participants | 3 months |
|
3 months
Participants were asked during the 3-month follow up questionnaire if they had seen a healthcare provider since their first study visits because of any problems or concerns about their birth control method.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ob/Gyn Regulatory Specialist | Oregon Health & Science University | 5034940757 | mccrimmo@ohsu.edu |
Not provided
| 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 | Jan 31, 2017 | Dec 7, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000075523 | Long-Acting Reversible Contraception |
| D012017 | Referral and Consultation |
| D055656 | Prescriptions |
| ID | Term |
|---|---|
| D003267 | Contraception |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D011364 | Professional Practice |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Referral for Long Acting Reversible Contraception (LARC) | Other | Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.) |
|
| Prescription for Short-Acting Hormonal Contraception | Other | 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 |
|
| BG001 | 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.) |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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.) |
| OG002 | 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 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |