ContraceptionPhase 4NCT02735551
LARC Forward Contraceptive Counseling at MHCC
A Phase 4 study testing Long Acting Reversible Contraception (LARC), Referral for Long Acting Reversible Contraception (LARC) and Prescription for Short-Acting Hormonal Contraception in people with Contraception, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Long Acting Reversible Contraception (LARC), Referral for Long Acting Reversible Contraception (LARC) and Prescription for Short-Acting Hormonal Contraception
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 Mar 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of LARC Forward Contraceptive Counseling and Same Day Placement in a Community College Population: A Randomized Intervention Project
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Long Acting Reversible Contraception (LARC), Referral for Long Acting Reversible Contraception (LARC), Prescription for Short-Acting Hormonal Contraception
- Keywords
- LARC, IUD, Contraceptive Implant, Contraception, Community college
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Acting Reversible Contraception (LARC)Drug
Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
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 ContraceptionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Prescription for Short-Acting Hormonal Contraception |
| 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. Receives: Other: Referral for Long Acting Reversible Contraception (LARC) |
| 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). Receives: Drug: Long Acting Reversible Contraception (LARC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion13 Mar 2017
- Study completion31 Mar 2017
Why it stopped: Inadequate participant enrollment during recruitment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Bayer, Society of Family Planning
- Responsible party
- Principal investigator, Jacqueline Lamme, Oregon Health and Science University
- Investigators
- Jacqueline Lamme, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735551
- Sponsor's protocol ID
- OHSU IRB 15715
- Status last verified
- Oct 2019
- First submitted
- 6 Apr 2016
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29201430
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of LARC Forward Contraceptive Counseling and Same Day Placement in a Community College Population: A Randomized Intervention Project
- ClinicalTrials.gov ID
- NCT02735551
- Acronym / sponsor ID
- OHSU IRB 15715
- Conditions
- Contraception
- Keywords
- LARC, IUD, Contraceptive Implant, Contraception, Community college
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate participant enrollment during recruitment period.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Bayer, Society of Family Planning
- Study start
- Apr 2016
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-LARC Group: Short Acting Method | Active comparator | Other: Prescription for Short-Acting Hormonal ContraceptionAll 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 | Other: Referral for Long Acting Reversible Contraception (LARC)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 | Drug: Long Acting Reversible Contraception (LARC)All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention). |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long Acting Reversible Contraception (LARC)Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon | Drug | LARC Group: Same Day LARC Placement |
| Referral for Long Acting Reversible Contraception (LARC)Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.) | Other | Control Group: Referral for LARC Placement |
| Prescription for Short-Acting Hormonal ContraceptionParticipants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice | Other | Non-LARC Group: Short Acting Method |
Primary outcome
Number of Participants Reporting Ongoing Use and Satisfaction
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29201430Lamme 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Lamme, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long Acting Reversible Contraception (LARC), Referral for Long Acting Reversible Contraception (LARC) and Prescription for Short-Acting Hormonal Contraception in people with Contraception, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Ongoing Use and Satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.