ContraceptionPhase 4PROTECTNCT00436306
Stage Matched Intervention to Increase Dual Method Use
A Phase 4 study testing Individualized Intervention and Computer-based contraceptive information in people with Contraception and Sexually Transmitted Diseases, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The primary purpose of Project PROTECT was to evaluate two different intervention approaches that encourage young women to use dual methods of contraception. The individualized intervention is a computer assisted, fully-tailored, interactive intervention based on the transtheoretical model of behavior change. Read more about this study
- Who is it for?
- Ages 13 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Sexually Transmitted Diseases, Pregnancy
- What is being tested?
- Individualized Intervention and Computer-based contraceptive information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Dec 2005
- Phase
- Phase 4
- 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 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- English-speaking
- Sexually active with a male partner in the past 6 months
- Desire to avoid conception for 24 months or more
- High risk for unintended pregnancy or STI:
- Age less than 25
- Age 25 and older with:
Show all 10Show fewer
- History of unplanned pregnancy
- History of a sexually transmitted infection
- Inconsistent use of contraception
- Other factors felt to place a patient at above average risk for unplanned pregnancy or STI
Who cannot join
- currently using dual methods of contraception consistently and correctly.
- incompetent or unable to give consent;
- currently pregnant or desires pregnancy in the next 24 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
The primary purpose of Project PROTECT was to evaluate two different intervention approaches that encourage young women to use dual methods of contraception. The individualized intervention is a computer assisted, fully-tailored, interactive intervention based on the transtheoretical model of behavior change. This intervention was compared to an enhanced standard care intervention that provided computer-based, non-tailored information and advice regarding the use of contraceptive methods. The two primary outcomes of this trial include: 1) a behavioral outcome: the reported use of dual methods of contraception; and 2) a biological outcome: an incident or recurrent STI or unintended pregnancy. The hypotheses of this trial were: 1) the individualized intervention will result in a greater increase in dual contraceptive use than the standard care approach; and 2) the individualized intervention would result in greater protection against incident or recurrent cases of sexually transmitted infections and unplanned pregnancies.
Read the detailed description
Protection from both sexually transmitted infections (STIs), human immunodeficiency virus (HIV), and unintended pregnancy can be achieved with the use of dual methods of contraception. This proposal was designed to develop, implement, and evaluate the impact of an innovative, computer-assisted stage-based individualized interactive intervention (Individualized Intervention) based on the transtheoretical compared to enhanced standard care counseling on the use of dual methods of contraception. Primary outcomes, including behavioral and biological outcomes, were assessed in this randomized clinical trial of 550 high-risk women. Participants were followed at 6 month intervals for 24 months with follow-up interviews to determine reported use of dual methods of contraception (behavioral outcome). Clinical examinations at 12 and 24 months and with new onset of symptoms assessed biological outcomes including incident or recurrent cases of STI and unintended pregnancy. Secondary outcomes included intermediate outcome variables such as changes in stage of change, processes of change, decisional balance, and self-efficacy. The primary hypotheses of this study were: 1. the Individualized Intervention will result in increased dual contraceptive use; 2. the Individualized Intervention will result in protection against new cases of STIs, re-infection with sexually transmitted organisms, and unplanned pregnancies; and 3. the Individualized Intervention will lead to the greatest changes in secondary outcome measures. If found to be effective, the stage-matched intervention has potential for widespread dissemination in schools, clinics, offices, and community centers to prevent STIs/HIV and unintended pregnancy.
- Conditions
- Contraception, Sexually Transmitted Diseases, Pregnancy
- Being tested
- Individualized Intervention, Computer-based contraceptive information
- Keywords
- prevention, behavior, risk reduction behavior
- Medical subject headings
- Sexually Transmitted Diseases, Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized InterventionBehavioural
Individualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention.
Computer-based contraceptive informationBehavioural
Contraceptive method information is provided on a computer.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Intervention: stage-matched/tailored counseling | Experimental | Individualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention. Receives: Behavioral: Individualized Intervention; Behavioral: Computer-based contraceptive information |
| Control: Enhanced usual care counseling | Placebo comparator | The Enhanced Usual Care arm was the control group. It provided computer-based information regarding contraceptive methods, but was not individualized or tailored to the participant stage of change. Receives: Behavioral: Computer-based contraceptive information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral: reported use of dual methods of contraception
Outcome: ANY use of dual methods of contraception.
Also evaluated consistent condom use.
Measured: 24 months
Biological: incident sexually transmitted infection or unintended pregnancy
ANY sexually transmitted infection OR unintended pregnancy.
Measured: 24 months
Secondary outcomes (2)
Secondary outcomes will include intermediate outcomes variables such as
Secondary outcomes: ANY sexually transmitted infection; unplanned pregnancy; incident infection with Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, or pelvic inflammatory disease.
Measured: 24 months
changes in stage of change, processes of change, decisional balance, and self-efficacy.
Advancement through the stages of change, and changes in the processes of change, decisional balance, and self-efficacy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startOct 1999
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Jeffrey Peipert, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Jeffrey F Peipert, MD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436306
- Sponsor's protocol ID
- R01HD036663
- Acronym
- PROTECT
- Status last verified
- Oct 2015
- First submitted
- 15 Feb 2007
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Peipert J, Redding CA, Blume J, Allsworth JE, Iannuccillo K, Lozowski F, Mayer K, Morokoff PJ, Rossi JS. Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT). Contemp Clin Trials. 2007 Sep;28(5):626-37. doi: 10.1016/j.cct.2007.01.012. Epub 2007 Feb 7.
PubMed 17374567Matteson KA, Peipert JF, Allsworth J, Phipps MG, Redding CA. Unplanned pregnancy: does past experience influence the use of a contraceptive method? Obstet Gynecol. 2006 Jan;107(1):121-7. doi: 10.1097/01.AOG.0000192170.16746.ea.
PubMed 16394049Peipert JF, Lapane KL, Allsworth JE, Redding CA, Blume JL, Lozowski F, Stein MD. Women at risk for sexually transmitted diseases: correlates of intercourse without barrier contraception. Am J Obstet Gynecol. 2007 Nov;197(5):474.e1-8. doi: 10.1016/j.ajog.2007.03.032. Epub 2007 Aug 21.
PubMed 17714677Peipert JF, Lapane KL, Allsworth JE, Redding CA, Blume JD, Stein MD. Bacterial vaginosis, race, and sexually transmitted infections: does race modify the association? Sex Transm Dis. 2008 Apr;35(4):363-7. doi: 10.1097/OLQ.0b013e31815e4179.
PubMed 18360319Krings KM, Matteson KA, Allsworth JE, Mathias E, Peipert JF. Contraceptive choice: how do oral contraceptive users differ from condom users and women who use no contraception? Am J Obstet Gynecol. 2008 May;198(5):e46-7. doi: 10.1016/j.ajog.2007.12.025. Epub 2008 Mar 7.
PubMed 18313637Peipert JF, Redding CA, Blume JD, Allsworth JE, Matteson KA, Lozowski F, Mayer KH, Morokoff PJ, Rossi JS. Tailored intervention to increase dual-contraceptive method use: a randomized trial to reduce unintended pregnancies and sexually transmitted infections. Am J Obstet Gynecol. 2008 Jun;198(6):630.e1-8. doi: 10.1016/j.ajog.2008.01.038. Epub 2008 Apr 8.
PubMed 18395692Kuroki LM, Allsworth JE, Redding CA, Blume JD, Peipert JF. Is a previous unplanned pregnancy a risk factor for a subsequent unplanned pregnancy? Am J Obstet Gynecol. 2008 Nov;199(5):517.e1-7. doi: 10.1016/j.ajog.2008.03.049. Epub 2008 May 12.
PubMed 18468575Allsworth JE, Anand M, Redding CA, Peipert JF. Physical and sexual violence and incident sexually transmitted infections. J Womens Health (Larchmt). 2009 Apr;18(4):529-34. doi: 10.1089/jwh.2007.0757.
PubMed 19245303Allsworth JE, Peipert JF. Severity of bacterial vaginosis and the risk of sexually transmitted infection. Am J Obstet Gynecol. 2011 Aug;205(2):113.e1-6. doi: 10.1016/j.ajog.2011.02.060. Epub 2011 Feb 27.
PubMed 21514555Peipert JF, Zhao Q, Meints L, Peipert BJ, Redding CA, Allsworth JE. Adherence to dual-method contraceptive use. Contraception. 2011 Sep;84(3):252-8. doi: 10.1016/j.contraception.2011.01.023. Epub 2011 Apr 16.
PubMed 21843690
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage Matched Intervention to Increase Dual Method Use
- ClinicalTrials.gov ID
- NCT00436306
- Acronym / sponsor ID
- PROTECT / R01HD036663
- Conditions
- Contraception, Sexually Transmitted Diseases, Pregnancy
- Keywords
- prevention, behavior, risk reduction behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Oct 1999
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 19 Feb 2007 (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 primary purpose of Project PROTECT was to evaluate two different intervention approaches that encourage young women to use dual methods of contraception. The individualized intervention is a computer assisted, fully-tailored, interactive intervention based on the transtheoretical model of behavior change. This intervention was compared to an enhanced standard care intervention that provided computer-based, non-tailored information and advice regarding the use of contraceptive methods. The two primary outcomes of this trial include: 1) a behavioral outcome: the reported use of dual methods of contraception; and 2) a biological outcome: an incident or recurrent STI or unintended pregnancy. The hypotheses of this trial were: 1) the individualized intervention will result in a greater increase in dual contraceptive use than the standard care approach; and 2) the individualized intervention would result in greater protection against incident or recurrent cases of sexually transmitted infections and unplanned pregnancies.
Detailed description
Protection from both sexually transmitted infections (STIs), human immunodeficiency virus (HIV), and unintended pregnancy can be achieved with the use of dual methods of contraception. This proposal was designed to develop, implement, and evaluate the impact of an innovative, computer-assisted stage-based individualized interactive intervention (Individualized Intervention) based on the transtheoretical compared to enhanced standard care counseling on the use of dual methods of contraception. Primary outcomes, including behavioral and biological outcomes, were assessed in this randomized clinical trial of 550 high-risk women. Participants were followed at 6 month intervals for 24 months with follow-up interviews to determine reported use of dual methods of contraception (behavioral outcome). Clinical examinations at 12 and 24 months and with new onset of symptoms assessed biological outcomes including incident or recurrent cases of STI and unintended pregnancy. Secondary outcomes included intermediate outcome variables such as changes in stage of change, processes of change, decisional balance, and self-efficacy. The primary hypotheses of this study were: 1. the Individualized Intervention will result in increased dual contraceptive use; 2. the Individualized Intervention will result in protection against new cases of STIs, re-infection with sexually transmitted organisms, and unplanned pregnancies; and 3. the Individualized Intervention will lead to the greatest changes in secondary outcome measures. If found to be effective, the stage-matched intervention has potential for widespread dissemination in schools, clinics, offices, and community centers to prevent STIs/HIV and unintended pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Intervention: stage-matched/tailored counseling | Experimental | Behavioral: Individualized Intervention, Behavioral: Computer-based contraceptive informationIndividualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention. |
| Control: Enhanced usual care counseling | Placebo comparator | Behavioral: Computer-based contraceptive informationThe Enhanced Usual Care arm was the control group. It provided computer-based information regarding contraceptive methods, but was not individualized or tailored to the participant stage of change. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- English-speaking
- Sexually active with a male partner in the past 6 months
- Desire to avoid conception for 24 months or more
- High risk for unintended pregnancy or STI:
Key exclusion criteria (3 listed)
- currently using dual methods of contraception consistently and correctly.
- incompetent or unable to give consent;
- currently pregnant or desires pregnancy in the next 24 months.
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 |
|---|---|---|
| Individualized InterventionIndividualized Intervention is a computer-based, stage-matched, tailored intervention to promote the use of dual methods of contraception for STD and unplanned pregnancy prevention. | Behavioural | Individualized Intervention: stage-matched/tailored counseling |
| Computer-based contraceptive informationContraceptive method information is provided on a computer. | Behavioural | Control: Enhanced usual care counseling, Individualized Intervention: stage-matched/tailored counseling |
Primary outcome
Behavioral: reported use of dual methods of contraception
Time frame: 24 months
Outcome: ANY use of dual methods of contraception. Also evaluated consistent condom use.
Biological: incident sexually transmitted infection or unintended pregnancy
Time frame: 24 months
ANY sexually transmitted infection OR unintended pregnancy.
2 secondary outcomes
Secondary outcomes will include intermediate outcomes variables such as
Time frame: 24 months
changes in stage of change, processes of change, decisional balance, and self-efficacy.
Time frame: 24 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 8 Oct 2015.
- Background: PubMed 17374567Peipert J, Redding CA, Blume J, Allsworth JE, Iannuccillo K, Lozowski F, Mayer K, Morokoff PJ, Rossi JS. Design of a stage-matched intervention trial to increase dual method contraceptive use (Project PROTECT). Contemp Clin Trials. 2007 Sep;28(5):626-37. doi: 10.1016/j.cct.2007.01.012. Epub 2007 Feb 7.
- Results publication: PubMed 16394049Matteson KA, Peipert JF, Allsworth J, Phipps MG, Redding CA. Unplanned pregnancy: does past experience influence the use of a contraceptive method? Obstet Gynecol. 2006 Jan;107(1):121-7. doi: 10.1097/01.AOG.0000192170.16746.ea.
- Results publication: PubMed 17714677Peipert JF, Lapane KL, Allsworth JE, Redding CA, Blume JL, Lozowski F, Stein MD. Women at risk for sexually transmitted diseases: correlates of intercourse without barrier contraception. Am J Obstet Gynecol. 2007 Nov;197(5):474.e1-8. doi: 10.1016/j.ajog.2007.03.032. Epub 2007 Aug 21.
- Results publication: PubMed 18360319Peipert JF, Lapane KL, Allsworth JE, Redding CA, Blume JD, Stein MD. Bacterial vaginosis, race, and sexually transmitted infections: does race modify the association? Sex Transm Dis. 2008 Apr;35(4):363-7. doi: 10.1097/OLQ.0b013e31815e4179.
- Results publication: PubMed 18313637Krings KM, Matteson KA, Allsworth JE, Mathias E, Peipert JF. Contraceptive choice: how do oral contraceptive users differ from condom users and women who use no contraception? Am J Obstet Gynecol. 2008 May;198(5):e46-7. doi: 10.1016/j.ajog.2007.12.025. Epub 2008 Mar 7.
- Results publication: PubMed 18395692Peipert JF, Redding CA, Blume JD, Allsworth JE, Matteson KA, Lozowski F, Mayer KH, Morokoff PJ, Rossi JS. Tailored intervention to increase dual-contraceptive method use: a randomized trial to reduce unintended pregnancies and sexually transmitted infections. Am J Obstet Gynecol. 2008 Jun;198(6):630.e1-8. doi: 10.1016/j.ajog.2008.01.038. Epub 2008 Apr 8.
- Results publication: PubMed 18468575Kuroki LM, Allsworth JE, Redding CA, Blume JD, Peipert JF. Is a previous unplanned pregnancy a risk factor for a subsequent unplanned pregnancy? Am J Obstet Gynecol. 2008 Nov;199(5):517.e1-7. doi: 10.1016/j.ajog.2008.03.049. Epub 2008 May 12.
- Results publication: PubMed 19245303Allsworth JE, Anand M, Redding CA, Peipert JF. Physical and sexual violence and incident sexually transmitted infections. J Womens Health (Larchmt). 2009 Apr;18(4):529-34. doi: 10.1089/jwh.2007.0757.
- Results publication: PubMed 21514555Allsworth JE, Peipert JF. Severity of bacterial vaginosis and the risk of sexually transmitted infection. Am J Obstet Gynecol. 2011 Aug;205(2):113.e1-6. doi: 10.1016/j.ajog.2011.02.060. Epub 2011 Feb 27.
- Results publication: PubMed 21843690Peipert JF, Zhao Q, Meints L, Peipert BJ, Redding CA, Allsworth JE. Adherence to dual-method contraceptive use. Contraception. 2011 Sep;84(3):252-8. doi: 10.1016/j.contraception.2011.01.023. Epub 2011 Apr 16.
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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.
Jeffrey F Peipert, MD, MPH principal investigator
Washington University School of Medicine
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 Individualized Intervention and Computer-based contraceptive information in people with Contraception and Sexually Transmitted Diseases, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 10 inclusion and 3 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 8 Oct 2015. 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. Some participants in this study may receive a placebo. 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?
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?
Behavioral: reported use of dual methods of contraception (time frame: 24 months). The study lists 2 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 NCT00436306, which also lists 10 linked publications.
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 8 Oct 2015.