Behavioral Intervention for Minority Adolescent Women
Condition: Sexually Transmitted Infection; Substance Use; Abuse; Pregnancy
MeSH terms: Sexually Transmitted Diseases; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Stage II clinical trial is to test the efficacy of a culturally
      sensitive, cognitive-behavioral intervention to reduce sexual risk behavior among minority
      adolescents for prevention of sexually transmitted infection (STI/HIV), unintended pregnancy
      and abuse by changing high-risk sexual behaviors, decreasing substance use and encouraging
      contraceptive use. Its primary goal is to expand risk-reduction interventions created in
      previous studies to further increase intervention efficacy for this particularly vulnerable,
      high-risk group. An adolescent intervention has been created and pilot tested in
      developmental studies. Results indicated reductions in substance use, risk behaviors,
      unintended pregnancy, STI and abuse without reports of adverse outcomes. Specific aims of the
      current study include: 1) To obtain a more in-depth understanding of configurations of
      psychosocial and situational factors associated with high-risk sexual behavior, substance
      use, STI/HIV and contraceptive use among abused minority adolescent women with STI; 2) To
      implement a controlled randomized trial of a cognitive behavioral risk-reduction intervention
      consisting of 2 small group sessions, 2 individual counseling and 3 support groups for this
      group; 3) To evaluate the effects of the adolescent intervention model versus enhanced
      counseling for this group on AIDS Risk Reduction Model (ARRM)-related constructs, high-risk
      sexual behavior, substance use, abuse recurrence, contraceptive use, unintended pregnancy and
      STI/HIV at 6 and 12 months follow-up. Participants will include a convenience sample of 600
      Mexican-and African American adolescent women, aged 14-18 years with a history of sexual or
      physical abuse and current STI.
    

Detailed description: 
      African-and Mexican-American adolescent women with a current STI and history of abuse will be
      identified at public health and STI clinics within the San Antonio Metropolitan Health
      District system. Women who agree to participate and give informed consent will be randomized
      into the intervention or control arm. Women in the control arm will be interviewed at
      baseline, be given a targeted physical exam including a STI/HIV screen, pap smear and
      contraception counseling and will receive abuse and enhanced clinical counseling. Women in
      the intervention arm will be interviewed at baseline, given a targeted physical exam
      including a STI/HIV screen, pap smear and contraception counseling and enrolled in the
      intervention. Women in the intervention arm will be interviewed and examined again after
      completing the intervention, to establish a post-intervention baseline. All women in the
      study will be followed over one year, with follow-up interviews including an inquiry about
      any Adverse Events (AEs) or Serious Adverse Events (SAEs), and a targeted physical exams and
      contraception counseling at 6 and 12 months. During the study period, women will be
      encouraged to return to the study clinic for problem visits if they suspect they have been
      infected with a STI or require contraception or abuse counseling. All analyses of
      intervention effects will be performed on an intent-to-treat basis.
    

Intervention name(s): Project IMAGE
Intervention type(s): Behavioral
Intervention description(s): Participants in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention. The intervention will include 2 workshops, 5 support groups sessions and 2 individual counseling sessions. They will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: STI, abuse, substance use, unintended pregnancy