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S.T.A.R.S.: Sistas Talking About Real Solutions (STARS)

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gina M Wingood, Emory University Identifier:
First received: December 4, 2009
Last updated: December 16, 2013
Last verified: December 2013
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.

Condition Intervention Phase
HIV Prevention
Behavioral: STARS: Sistas Talking About Real Solutions
Behavioral: General Health & Nutrition
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: STARS: Sistas Talking About Real Solutions

Resource links provided by NLM:

Further study details as provided by Emory University:

Primary Outcome Measures:
  • To evaluate the efficacy of a HIV risk-reduction condition relative to general health control condition in reducing HIV-associated sexual behaviors and incident STDs. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • To evaluate the efficacy of a HIV risk-reduction condition relative to general health control condition in enhancing theoretically-derived mediators of HIV-preventive behaviors. [ Time Frame: 12 months ]

Enrollment: 855
Study Start Date: October 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: General Health Control Behavioral: General Health & Nutrition
Participants in this condition received a 2 hour group session which consisted of general health information and women's health brochures facilitated by a trained health educator. The control group received bi-monthly phone calls and quarterly mailings for retention purposes only, with no intervention material provided.
Other Names:
  • Placebo
  • Control
  • Health Control
Experimental: HIV Risk Reduction & Relapse Prevention Behavioral: STARS: Sistas Talking About Real Solutions
The intervention consisted of 2, 4-hour workshops. The first workshop focused on enhancing ethnic/gender pride, self-esteem, realizing values/setting goals, healthy/unhealthy relationships, partner violence, HIV/STD knowledge, heightening awareness of HIV susceptibility, safer-sex options/skills. The second workshop covered realistic choices in sexual decision making, consistent/proper condom use, setting limits/boundaries, communication styles, and condom skills negotiation. Participants received 3-hour booster sessions at 6- and 9-months to reinforce materials from the initial intervention. Bi-monthly phone calls and quarterly mailings were used to reinforce workshop material and facilitate retention.
Other Names:
  • Risk reduction
  • safer sex options

  Show Detailed Description


Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • African American
  • female
  • Age 18-29
  • unmarried
  • engaged in at least one act of unprotected sexual intercourse within the last 6 months
  • were members of one of the three Kaiser Permanente HMO study sites

Exclusion Criteria:

  • pregnant or trying to get pregnant
  • young adults who have a condition that precludes participation (i.e. schizophrenia, severe learning disability, or undergoing chemotherapy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01028157

United States, Georgia
Emory University, Rollins School of Public Health
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Principal Investigator: Gina M Wingood, ScD, MPH Emory University
Study Director: LaShun R Robinson, PhD Emory University
Principal Investigator: Ralph DiClemente, PhD Emory University
  More Information

Responsible Party: Gina M Wingood, Principal Investigator, Emory University Identifier: NCT01028157     History of Changes
Other Study ID Numbers: 0524-2002
5R01MH062717 ( US NIH Grant/Contract Award Number )
Study First Received: December 4, 2009
Last Updated: December 16, 2013

Keywords provided by Emory University:
risk reduction
behavioral intervention

Additional relevant MeSH terms:
Pharmaceutical Solutions processed this record on May 23, 2017