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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: Completed Phase 1 study, sponsored by Emory University.

NCT01028157 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 855 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1325% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 855 participants
Start Date 2002-10
Est. Completion 2006-03
Phase Phase 1
Emory University

1,208 total trials

What the finished NCT01028157 record still lists

NCT01028157 is an interventional study that assigns participants to a tested intervention. The registered 855 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1325% higher).

The record links to 0 conditions, and to 2 interventions - of which STARS: Sistas Talking About Real Solutions is the first listed.

NCT01028157 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01028157's enrollment target sits among peer trials

855 12th of 2000 higher than 1,989 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01028157, the US trial registry maintained by the National Library of Medicine. NCT01028157 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.