New Behavioral ProtocolICCNCT02801266
Improving Contraceptive Counseling in the United States
A study of New Behavioral Protocol and Treatment as Usual, run by New York University at 1 site in United States.
Trial summary
This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- New Behavioral Protocol, Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,418 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2015
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be seeking contraception from clinic on day of recruitment
Who cannot join
- Not seeking contraception from clinic on day of recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University, Silver School of Social Work
New York, New York, 10001
About this study
This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.
- Conditions
- New Behavioral Protocol, Treatment as Usual
- Being tested
- Evidence informed birth control counseling
- Keywords
- Contraception, Reproductive and Sexual Health, Counseling, Contraceptive Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence informed birth control counselingBehavioural
Also called Improving contraceptive counseling in the United States
Counselors underwent training on the use of 10 best practices for contraceptive counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling. Receives: Behavioral: Evidence informed birth control counseling |
| No intervention | No intervention | The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.
Measured: immediately after counseling session
Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Measured: immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Measured: immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.
Measured: 6 months from initial clinic visit
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.
Measured: one year from initial clinic visit
Secondary outcomes (1)
Type of contraceptive method currently using (including none and dual use) as assessed by a questionnaire designed for this study (e.g., what method of birth control are you currently using).
Measured: six months to one year from initial clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startOct 2012
- Primary completionOct 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New Behavioral ProtocolStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Responsible party
- Sponsor
- Investigators
- James J Jaccard, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801266
- Sponsor's protocol ID
- FPRPA006057
- Other IDs
- 12-9103
- Acronym
- ICC
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Contraceptive Counseling in the United States
- ClinicalTrials.gov ID
- NCT02801266
- Acronym / sponsor ID
- ICC / FPRPA006057
- Conditions
- New Behavioral Protocol, Treatment as Usual
- Keywords
- Contraception, Reproductive and Sexual Health, Counseling, Contraceptive Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,418 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Jun 2016 (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 project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Evidence informed birth control counselingThe intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling. |
| No intervention | No intervention | –The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Must be seeking contraception from clinic on day of recruitment
Key exclusion criteria (1 listed)
- Not seeking contraception from clinic on day of recruitment
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 |
|---|---|---|
| Evidence informed birth control counselingAlso: Improving contraceptive counseling in the United StatesCounselors underwent training on the use of 10 best practices for contraceptive counseling. | Behavioural | Intervention |
Primary outcome
Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.
Time frame: immediately after counseling session
Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Time frame: immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.
Time frame: immediately after counseling session
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.
Time frame: 6 months from initial clinic visit
Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.
Time frame: one year from initial clinic visit
1 secondary outcome
Type of contraceptive method currently using (including none and dual use) as assessed by a questionnaire designed for this study (e.g., what method of birth control are you currently using).
Time frame: six months to one year from initial clinic 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 2 Nov 2022.
- 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.
James J Jaccard, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of New Behavioral Protocol and Treatment as Usual, run by New York 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 1 inclusion and 1 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 2 Nov 2022. 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?
Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest. (time frame: immediately after counseling session). The study lists 5 primary outcomes in all. 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 2 Nov 2022.