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

NCT01028157 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 855

Last updated 2013-12-17

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Emory University

    lead OTHER

Principal Investigators

  • Gina M Wingood, ScD, MPH · Emory University

  • LaShun R Robinson, PhD · Emory University

  • Ralph DiClemente, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028157 on ClinicalTrials.gov