Peer CounselingImPACCTNCT02157285
Influence of Peer Mentoring on Adolescent Contraceptive Decision Making
A study testing Peer Mentor Counseling in people with Peer Counseling and LARC Desire, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a prospective, randomized-controlled trial in which subjects will be randomized to receive either routine contraceptive counseling or peer mentoring plus routine contraceptive counseling. Read more about this study
- Who is it for?
- Ages 13 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Peer Counseling, LARC Desire
- What is being tested?
- Peer Mentor Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- English speaking
- Female
- Age 13-21 years old at enrollment
- Desiring contraception; either currently not taking any method of contraception, or not satisfied with current method, and not desiring pregnancy in the next 12 months
- Willing and able to follow the study protocol
Who cannot join
- Male gender
- Younger than 13 years old, older than 21 years old
- Pregnant or desiring pregnancy within the coming year
- Issues or concerns in the judgement of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Influence of Peer Mentoring on Contraceptive Decision Making Among Adolescents
This is a prospective, randomized-controlled trial in which subjects will be randomized to receive either routine contraceptive counseling or peer mentoring plus routine contraceptive counseling.
Read the detailed description
Unintended adolescent pregnancy continues to be a significant public health problem in the United States. While the use of highly effective forms of birth control, such as the long-acting, reversible contraceptives (LARC) have been found to be more effective in decreasing pregnancy rates than non-LARC methods of birth control, knowledge and use of LARC has been shown to be low in this vulnerable population. We are interested in better understanding the influence peers may have on contraceptive decision making among adolescents. The purpose of this study is to evaluate the impact of a peer mentoring intervention on adolescent contraceptive decision making, specifically with regard to increasing long-acting, reversible contraceptive uptake. The main study intervention will consist of randomization to usual contraceptive counseling versus peer-mentoring plus usual contraceptive counseling. Pre- and post-intervention questionnaires will be used to better understand peer influence on contraceptive decision making, and to assess the peer mentor-teen intervention interaction.
- Conditions
- Peer Counseling, LARC Desire
- Being tested
- Peer Mentor Counseling
- Keywords
- Unintended pregnancy in adolescence, LARC, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Mentor CounselingBehavioural
Peer mentoring will entail the peer mentor describing her positive experience with her LARC method. The participant will then have a chance to ask any experience related questions to the mentor. Any clinical inquiries or questions the mentor does not feel comfortable answering, she will defer to the contraceptive counselor/ physician who will be subsequently providing the routine counseling. The entire peer mentor encounter should not last more than 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Routine Counseling | No intervention | Subjects randomized to receive routine counseling before selecting a method of contraception |
| Peer Mentor counseling | Experimental | Subjects randomized to receive peer counseling before selecting a method of contraception Receives: Behavioral: Peer Mentor Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study participants who chose long-acting reversible contraception (LARC) after all contraceptive counseling was done.
This data was obtained by the number of participants who chose to have an IUD or Implant inserted after counseling at their clinic visit.
Measured: at enrollment/baseline visit
Secondary outcomes (2)
Number of participants who maintained LARC uptake
This data is being obtained through a brief follow-up questionnaire conducted over the phone.
Measured: 4 months from enrollment/baseline visit
Number of participants who maintained a positive opinion of LARC method as their primary choice for birth control
This data is being obtained through a brief follow-up questionnaire conducted over the phone.
Measured: 4 months after enrollment/baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer CounselingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Schreiber, University of Pennsylvania
- Investigators
- Courtney A Schreiber, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157285
- Sponsor's protocol ID
- 816769
- Acronym
- ImPACCT
- Status last verified
- Jun 2014
- First submitted
- 19 Mar 2013
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Peer Mentoring on Contraceptive Decision Making Among Adolescents
- ClinicalTrials.gov ID
- NCT02157285
- Acronym / sponsor ID
- ImPACCT / 816769
- Conditions
- Peer Counseling, LARC Desire
- Keywords
- Unintended pregnancy in adolescence, LARC, contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized-controlled trial in which subjects will be randomized to receive either routine contraceptive counseling or peer mentoring plus routine contraceptive counseling.
Detailed description
Unintended adolescent pregnancy continues to be a significant public health problem in the United States. While the use of highly effective forms of birth control, such as the long-acting, reversible contraceptives (LARC) have been found to be more effective in decreasing pregnancy rates than non-LARC methods of birth control, knowledge and use of LARC has been shown to be low in this vulnerable population. We are interested in better understanding the influence peers may have on contraceptive decision making among adolescents. The purpose of this study is to evaluate the impact of a peer mentoring intervention on adolescent contraceptive decision making, specifically with regard to increasing long-acting, reversible contraceptive uptake. The main study intervention will consist of randomization to usual contraceptive counseling versus peer-mentoring plus usual contraceptive counseling. Pre- and post-intervention questionnaires will be used to better understand peer influence on contraceptive decision making, and to assess the peer mentor-teen intervention interaction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Counseling | No intervention | –Subjects randomized to receive routine counseling before selecting a method of contraception |
| Peer Mentor counseling | Experimental | Behavioral: Peer Mentor CounselingSubjects randomized to receive peer counseling before selecting a method of contraception |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- English speaking
- Female
- Age 13-21 years old at enrollment
- Desiring contraception; either currently not taking any method of contraception, or not satisfied with current method, and not desiring pregnancy in the next 12 months
- Willing and able to follow the study protocol
Key exclusion criteria (4 listed)
- Male gender
- Younger than 13 years old, older than 21 years old
- Pregnant or desiring pregnancy within the coming year
- Issues or concerns in the judgement of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
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 |
|---|---|---|
| Peer Mentor CounselingPeer mentoring will entail the peer mentor describing her positive experience with her LARC method. The participant will then have a chance to ask any experience related questions to the mentor. Any clinical inquiries or questions the mentor does not feel comfortable answering, she will defer to the contraceptive counselor/ physician who will be subsequently providing the routine counseling. The entire peer mentor encounter should not last more than 10 minutes. | Behavioural | Peer Mentor counseling |
Primary outcome
Number of study participants who chose long-acting reversible contraception (LARC) after all contraceptive counseling was done.
Time frame: at enrollment/baseline visit
This data was obtained by the number of participants who chose to have an IUD or Implant inserted after counseling at their clinic visit.
2 secondary outcomes
Number of participants who maintained LARC uptake
Time frame: 4 months from enrollment/baseline visit
Number of participants who maintained a positive opinion of LARC method as their primary choice for birth control
Time frame: 4 months after enrollment/baseline visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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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.
Courtney A Schreiber, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Mentor Counseling in people with Peer Counseling and LARC Desire, run by University of Pennsylvania 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 5 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: finished, as of the sponsor's last update on 6 Jun 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 study participants who chose long-acting reversible contraception (LARC) after all contraceptive counseling was done. (time frame: at enrollment/baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2014.