S.T.A.R.S.: Sistas Talking About Real Solutions (STARS)
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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 |
- 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 ]
- 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:
|
| 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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 29 Years |
| Genders 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| United States, Georgia | |
| Emory University, Rollins School of Public Health | |
| Atlanta, Georgia, United States, 30322 | |
| 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 Wingood, ScD, MPH, Emory University |
| ClinicalTrials.gov Identifier: | NCT01028157 History of Changes |
| Other Study ID Numbers: | 524-2002, 5R01MH062717 |
| Study First Received: | December 4, 2009 |
| Last Updated: | December 4, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
HIV risk reduction behavioral intervention |
ClinicalTrials.gov processed this record on June 17, 2013