S.T.A.R.S.: Sistas Talking About Real Solutions
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The primary aims of the study are: 1) to evaluate the efficacy of the HIV risk-reduction,
      safer sex relapse prevention condition relative to the general health and nutrition control
      condition in reducing HIV-associated sexual behaviors and incident STDs over a 12-month
      follow-up period; 2) to evaluate the efficacy of the HIV risk-reduction, safer sex relapse
      prevention condition relative to the general health and nutrition control condition in
      enhancing theoretically-derived mediators of HIV-preventive behaviors.

      The study began recruitment into the main trial in October, 2002. By the close of the
      recruitment window in March 2006, 855 African American women had been randomized to either of
      the study conditions. The study participants were eligible if they were: (a) unmarried, (b)
      African American women, (c) ages 18-29, (d) not pregnant, (e) reported at least one act of
      unprotected sexual intercourse within the last 6 months and, (f) were members of one of the
      three Kaiser Permanente HMO study sites. The three medical facilities included the Cascade
      Kaiser Permanente Center, the Southwood Kaiser Permanente Center and, the Panola Kaiser
      Permanente Center. While there are other Kaiser Permanente Medical facilities in Atlanta,
      these sites were selected because of the high prevalence of African-American women.

      Once recruited via a random selection process, participants returned to a Kaiser Medical
      Center on a specified Saturday morning for their baseline visit. At the baseline visit
      participants were: (1) provided a brief overview of the STARS study; (2) provided written
      informed consent; (3) asked to complete a one hour ACASI survey; (4) asked to provide
      self-obtained vaginal swab specimen that were assessed for four STDs (Chlamydia, gonorrhea,
      trichomonas, and human papilloma virus) and a new PCR procedure to detect the presence of
      sperm in vaginal specimen and; (5) randomized to one of the two study conditions using
      concealment of allocation techniques to minimize assignment bias.

      The ACASI is guided by the Theory of Gender and Power and Social Cognitive Theory. The
      interview has sections on sociodemographics, sexual history, alcohol and drug use, attitudes
      and outcome expectations related to abstinence and condom use, peer norms, and stress and
      coping. The administration of the ACASI interview was enhanced by the inclusion of a 60-day
      calendar that participants complete prior to the interview. This allows a more realistic time
      frame to reference interview questions and time for the participant to recall and document
      behavior before beginning the interview. Upon completion of the full assessment, participants
      provided swabs for STI specimens. All participants with a positive test result were offered
      free directly observed therapy (DOT) at their participating medical center.

      Participants were randomized to one of two study conditions: (1) an HIV safer sex
      risk-reduction condition with a relapse prevention component and; (2) a general health and
      nutrition control condition. the HIV safer sex risk-reduction condition consisted of two
      4-hour safer sex workshops; the two workshops were guided by the Theory of Gender and Power
      and Social Cognitive Theory and; held on consecutive Saturdays at the participating medical
      centers. The sessions were implemented by a team of African American female health educators
      and had on average of 6 - 8 participants per session. The two study conditions are outlined
      below:

      The HIV safer sex risk-reduction condition with a relapse prevention component: Participants
      in this condition received the two 4-hour safer sex workshops. The first workshop focused on
      enhancing ethnic and gender pride, self-esteem, realizing values and setting goals, healthy
      vs. unhealthy relationships, HIV/STD knowledge, heightening awareness of HIV susceptibility,
      safer-sex options. The second workshop offered realistic choices in sexual decision making,
      covering topics including abstinence, masturbation, oral, vaginal, and anal sex. The risk and
      benefits related to each safer-sex option were examined. Participants also received
      instruction on safer-sex skills corresponding to each option. Consistent and proper condom
      use was also discussed and demonstrated with a module on condom skills. This module included
      activities demonstrating the increased difficulty of proper condom use when under the
      influence of substances such and drugs and alcohol. Modules on setting limits and boundaries,
      communication styles, and condom skills negotiation were also a part of this workshop. In
      addition, an activity was included on indications and ways to deal with partner violence.
      Workshop II included several role-play scenarios demonstrating how to handle excuses related
      to safer-sex options and also exhibiting realistic situations that women may face in their
      sexual relationships. Participants in this condition received 3-hour booster sessions at 6-
      and 9-months to reinforce materials from the initial intervention. The 6-month booster
      session included modules that reinforced concepts such as gender and ethnic pride,
      self-esteem, communicating safer-sex options, assertive communication skills, difficulties
      communicating with long-term partners, and standing by one's safer-sex decisions. Again, role
      plays and interactive activities facilitated participants' ability to explore and examine
      challenges they experienced related to these topics. In a similar fashion, the 9-month
      booster session reinforced positive safer-sex messages, exploration of past unsafe sexual
      experiences, mastering safer sex techniques, identifying and making wise decisions about
      healthy and unhealthy partner characteristics, creative options for safer sex, gender and
      ethnic pride, and empowerment to make and maintain healthy choices. Bi-monthly phone calls
      and quarterly mailings were used to reinforce workshop material and facilitate retention.

      The control condition: 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.

      Participants in all study conditions received a group introduction including group
      guidelines, definition of a 'STARS Sista', the STARS motto, pact and group contract.

      Follow-up visits: At the 6-month follow-up visit all participants completed the 6-month ACASI
      to assess potential behavior change and change in the study mediators; and provided specimens
      for Chlamydia, gonorrhea and trichomoniasis; and provided a specimen for the PCR procedure to
      detect the presence of sperm in a vaginal sample.

      At the 12-month follow-up visit participants completed the 12-month ACASI to assess potential
      behavior change and change in the study mediators; provided specimens for Chlamydia,
      gonorrhea and trichomoniasis and HPV (if they did not test positive for HPV at baseline); and
      provided a specimen for the PCR procedure to detect the presence of sperm in a vaginal
      sample.
    

Intervention name(s): STARS: Sistas Talking About Real Solutions; General Health & Nutrition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): Risk reduction; safer sex options; Placebo; Control; Health Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HIV; risk reduction; behavioral intervention