S.T.A.R.S.: Sistas Talking About Real Solutions

NCT01028157 | Completed Phase 1

• 2 other identifiers: 0524-20025R01MH062717
• Study Type: interventional
• Target: 855
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Prevention

Keywords

HIV; risk reduction; behavioral intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• 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.

  12 months

Study Arms (2)

General Health Control

PLACEBO COMPARATOR

Behavioral: General Health & Nutrition

HIV Risk Reduction & Relapse Prevention

EXPERIMENTAL

Behavioral: STARS: Sistas Talking About Real Solutions

Interventions

STARS: Sistas Talking About Real Solutions BEHAVIORAL

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.

Also known as: Risk reduction, safer sex options

HIV Risk Reduction & Relapse Prevention

General Health & Nutrition BEHAVIORAL

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.

Also known as: Placebo, Control, Health Control

General Health Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• pregnant or trying to get pregnant
• young adults who have a condition that precludes participation (i.e. schizophrenia, severe learning disability, or undergoing chemotherapy)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University, Rollins School of Public Health

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Numbers Needed To Treat; Health Status; Nutritional Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Sample Size; Research Design; Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Gina M Wingood, ScD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

• LaShun R Robinson, PhD

  Emory University

  STUDY DIRECTOR

• Ralph DiClemente, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2002
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (1)