S.T.A.R.S.: Sistas Talking About Real Solutions (STARS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01028157 |
Recruitment Status
:
Completed
First Posted
: December 9, 2009
Last Update Posted
: December 17, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Prevention | Behavioral: STARS: Sistas Talking About Real Solutions Behavioral: General Health & Nutrition | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 855 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | STARS: Sistas Talking About Real Solutions |
Study Start Date : | October 2002 |
Actual Primary Completion Date : | March 2006 |
Actual Study Completion Date : | March 2006 |

Arm | Intervention/treatment |
---|---|
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:
|
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028157
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 |
Responsible Party: | Gina M Wingood, Principal Investigator, Emory University |
ClinicalTrials.gov Identifier: | NCT01028157 History of Changes |
Other Study ID Numbers: |
0524-2002 5R01MH062717 ( U.S. NIH Grant/Contract ) |
First Posted: | December 9, 2009 Key Record Dates |
Last Update Posted: | December 17, 2013 |
Last Verified: | December 2013 |
Keywords provided by Gina M Wingood, Emory University:
HIV risk reduction behavioral intervention |
Additional relevant MeSH terms:
Pharmaceutical Solutions |