ContraceptionNCT00584038
Improving Adolescent Adherence to Hormonal Contraception
A study testing educational instruction and phone follow-up and educational instruction in clinic in people with Contraception, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care. Read more about this study
- Who is it for?
- Ages 16 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- educational instruction and phone follow-up and educational instruction in clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,155 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2012
- 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 16 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.
Who cannot join
- Women who are currently pregnant or breastfeeding.
- Women who wish to become pregnant within the next 12 months.
- Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding).
- Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring.
- Current and previous users of oral contraceptives.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77555-0587
About this study
The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.
- Conditions
- Contraception
- Being tested
- educational instruction and phone follow-up, educational instruction in clinic
- Keywords
- contraceptive compliance, educational intervention, oral contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational instruction and phone follow-upBehavioural
Educational instruction and phone follow-up.
educational instruction in clinicBehavioural
Educational instruction in clinic.
| Study group | Role | What they receive |
|---|---|---|
| 1 Standard Care (SC) | No intervention | Participants receive usual contraceptive care administered by clinic provider. |
| 2 Standard Care + Educational (SCE) | Other | Participants receive standard contraceptive care from clinic provider, followed by 45-minute educational intervention. Receives: Behavioral: educational instruction in clinic |
| 3 Standard Care + Educational + Phone Calls (SCEP) | Other | Participants receive standard contraceptive care from clinic provider, followed by phone calls weekly until onset of menses and monthly thereafter for six consecutive months. Receives: Behavioral: educational instruction and phone follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of contraceptive adherence
Measured: 12 months
Measurement of dual method use
Measured: 12 months
Measurement of pregnancy rates and sexually transmitted diseases (STDs)
Measured: 12 months
Secondary outcomes (3)
Measurement of contraceptive side effects
Measured: 12 months
Measurement of satisfaction with method
Measured: 12 months
Measurement of sexual activity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbey B. Berenson, MD, Principal investigator, The University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584038
- Sponsor's protocol ID
- 06-060
- Other IDs
- R40MC06634
- Status last verified
- May 2013
- First submitted
- 20 Dec 2007
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berenson AB, Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception. 2012 Dec;86(6):716-24. doi: 10.1016/j.contraception.2012.06.007. Epub 2012 Jul 25.
PubMed 22840278
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adolescent Adherence to Hormonal Contraception
- ClinicalTrials.gov ID
- NCT00584038
- Acronym / sponsor ID
- 06-060
- Conditions
- Contraception
- Keywords
- contraceptive compliance, educational intervention, oral contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,155 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jan 2008 (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.
The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Standard Care (SC) | No intervention | –Participants receive usual contraceptive care administered by clinic provider. |
| 2 Standard Care + Educational (SCE) | Other | Behavioral: educational instruction in clinicParticipants receive standard contraceptive care from clinic provider, followed by 45-minute educational intervention. |
| 3 Standard Care + Educational + Phone Calls (SCEP) | Other | Behavioral: educational instruction and phone follow-upParticipants receive standard contraceptive care from clinic provider, followed by phone calls weekly until onset of menses and monthly thereafter for six consecutive months. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.
Key exclusion criteria (5 listed)
- Women who are currently pregnant or breastfeeding.
- Women who wish to become pregnant within the next 12 months.
- Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding).
- Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring.
- Current and previous users of oral contraceptives.
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 |
|---|---|---|
| educational instruction and phone follow-upEducational instruction and phone follow-up. | Behavioural | 3 Standard Care + Educational + Phone Calls (SCEP) |
| educational instruction in clinicEducational instruction in clinic. | Behavioural | 2 Standard Care + Educational (SCE) |
Primary outcome
Measurement of contraceptive adherence
Time frame: 12 months
Measurement of dual method use
Time frame: 12 months
Measurement of pregnancy rates and sexually transmitted diseases (STDs)
Time frame: 12 months
3 secondary outcomes
Measurement of contraceptive side effects
Time frame: 12 months
Measurement of satisfaction with method
Time frame: 12 months
Measurement of sexual activity
Time frame: 12 months
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 24 May 2013.
- Derived from this study: PubMed 22840278Berenson AB, Rahman M. A randomized controlled study of two educational interventions on adherence with oral contraceptives and condoms. Contraception. 2012 Dec;86(6):716-24. doi: 10.1016/j.contraception.2012.06.007. Epub 2012 Jul 25.
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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.
Abbey B. Berenson, MD principal investigator
The University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational instruction and phone follow-up and educational instruction in clinic in people with Contraception, run by The University of Texas Medical Branch, Galveston 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 5 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 24 May 2013. 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?
Measurement of contraceptive adherence (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT00584038, 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 24 May 2013.