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NCT00436306 · ClinicalTrials.gov registry record · Phase 4
Stage Matched Intervention to Increase Dual Method Use
A Phase 4 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 4
- Development phase
- 550
- Enrollment target
NCT00436306: Completed Phase 4 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00436306 is a Phase 4 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 550 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00436306, a Phase 4 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 550 participants
- Enrollment target
Study 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. 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.
Primary Outcome
Outcome: ANY use of dual methods of contraception. Also evaluated consistent condom use.
Interventions
- BEHAVIORAL Individualized Intervention
- BEHAVIORAL Computer-based contraceptive information
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 1999-10 |
| Est. Completion | 2005-12 |
| Phase | Phase 4 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00436306 record still lists
NCT00436306 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Individualized Intervention is the first listed.
NCT00436306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00436306 about?
NCT00436306 is a clinical study titled "Stage Matched Intervention to Increase Dual Method Use". 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 behavi...
What is the current status of trial NCT00436306?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 550 participants. The study started on 1999-10. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00436306?
The interventions under investigation include: Individualized Intervention (BEHAVIORAL), Computer-based contraceptive information (BEHAVIORAL).
Who is sponsoring clinical trial NCT00436306?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00436306's enrollment target sits among peer trials
550 152nd of 2000 higher than 1,848 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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