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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gina M Wingood, Emory University
ClinicalTrials.gov Identifier:
NCT01028157
First received: December 4, 2009
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01028157

Locations
United States, Georgia
Emory University, Rollins School of Public Health
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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

No publications provided

Responsible Party: Gina M Wingood, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01028157     History of Changes
Other Study ID Numbers: 0524-2002, 5R01MH062717
Study First Received: December 4, 2009
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
HIV
risk reduction
behavioral intervention

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014