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NCT01028157 · ClinicalTrials.gov registry record · Phase 1
S.T.A.R.S.: Sistas Talking About Real Solutions
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 855
- Enrollment target
NCT01028157 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 855 participants.
The verdict
NCT01028157, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 855 participants
- Enrollment target
Study Summary
STARS: Sistas Talking About Real Solutions is a health education intervention for African-American women, ages 18-29 aimed at reducing their risk for HIV. A total of 855 subjects were recruited from three Kaiser Permanente Medical Centers. Members were randomly selected from the membership database and sent a letter via mail introducing them to the project and inviting them to participate. Letters were followed up with a phone call and potential participants were screened for eligibility. To be able to participate, participants had to be African-American, female, between the ages of 18-29, single, and have at least one act of unprotected sexual intercourse within the last 6 months. Members who were eligible and willing to participate completed a 1-hour baseline assessment survey; STD testing for Chlamydia, gonorrhea, trichomoniasis, and HPV; a vaginal swab that was used to determine if they had unprotected sex. They were then randomized into one of two study conditions: (1) a 2-session HIV risk-reduction condition with a safer sex relapse prevention component (2) a 1-session control condition in which participants receive general women's health information and brochures. Participants received a booster session at 6 and 9 months to reinforce intervention materials. Participants completed an assessment survey and received STD testing at 6 and 12 months. The primary aim of this project is to evaluate the efficacy of the HIV risk-reduction/safer sex relapse prevention condition relative to the health and nutritional control group in reducing HIV-associated sexual behaviors and incident STDs over a 12-month follow-up period is to implement.
Interventions
- BEHAVIORAL STARS: Sistas Talking About Real Solutions
- BEHAVIORAL General Health & Nutrition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 855 participants |
| Start Date | 2002-10 |
| Est. Completion | 2006-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01028157
The ClinicalTrials.gov registry entry for NCT01028157 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 855 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which STARS: Sistas Talking About Real Solutions is the first listed.
NCT01028157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01028157 about?
NCT01028157 is a clinical study titled "S.T.A.R.S.: Sistas Talking About Real Solutions". STARS: Sistas Talking About Real Solutions is a health education intervention for African-American women, ages 18-29 aimed at reducing their risk for HIV. A total of 855 subjects were recruited from three Kaiser Permanente Medical Centers. Members were randomly selected from the membership database ...
What is the current status of trial NCT01028157?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 855 participants. The study started on 2002-10. Estimated completion is 2006-03.
What interventions are being tested in trial NCT01028157?
The interventions under investigation include: STARS: Sistas Talking About Real Solutions (BEHAVIORAL), General Health & Nutrition (BEHAVIORAL).
Who is sponsoring clinical trial NCT01028157?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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