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Clinical Trials

MainTitle

Prevention of HIV and STDs in Drug Using Women (WTW)

This study has been completed
Sponsor
Washington University School of Medicine

Collaborator
National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party)
Washington University School of Medicine
ClinicalTrials.gov Identifier
NCT01235091

First received: November 3, 2010
Last updated: November 4, 2010
Last Verified: November 2010
History of Changes
Purpose

Purpose

Women Teaching Women (WTW) is proposed by a team of Washington University investigators who have focused on HIV prevention efforts among out-of-treatment injecting drug users (IDUs) and crack cocaine users, since 1988. Our peer-delivered prevention model was successful in reducing cocaine use among men. The investigators believe no differences were found in drug and sexual risk behaviors for women because the intervention lacked gender-specificity. Thus, the investigators propose to tailor our previous intervention to women's needs to determine the shorter and intermediate term effectiveness of a gender-specific model on reducing drug use and sexual risks. The urgency for women-focused interventions is highlighted by increasing HIV/STD rates among women nationwide. The intervention is designed to bring the HIV prevention message to women in a public health environment. The three-arm intervention, which targets out-of-treatment drug-using women, will assess the differential impact of a woman-centered standard intervention alone, the same standard intervention plus a well-woman exam, and those plus the addition of 4 educational sessions. This proposal responds to two NIDA PAs: 95-083 (Women's HIV Risk and Protective Behaviors) and 96-018 (Drug Abuse Prevention Intervention for Women and Minorities). Our risk reduction, epidemiological and technology transfer aims include:

Risk Reduction Aims:

  1. Recruit out-of-treatment female drug injectors, heroin, crack/cocaine and methamphetamine users to into an intervention aimed at reducing high risk sexual and drug use behaviors. Street outreach, bars and clubs, shelters, health fairs and daycare facilities will be used to reach these vulnerable women at risk.
  2. Administer a modified theory-based, peer-delivered, gender and culture-specific intervention that encourages women to reduce their high risk drug and sexual behaviors. Women will be randomly assigned to one of three peer-delivered interventions: a modified NIDA Cooperative Agreement Standard Intervention (SI), the SI + Well-Woman Exam (SI+WWE), or the SI+Well-Woman Exam + 4 Educational Sessions (SI+WWE+4ES). The Standard Intervention will be delivered by peers; the Well-Woman Examination will be conducted by a nurse practitioner; the four 2 hour educational sessions will be conducted by peer facilitators from area drug treatment programs paired with a community mental health or health professional.
  3. Assess the effectiveness of the interventions in reducing drug and sexual risk at 4 and 12 months post-intervention, controlling for baseline characteristics.
  4. Evaluate the relative cost-effectiveness of each intervention.

Epidemiologic Aim:
  • Assess: a) incidence of HIV, Hepatitis B and C, syphilis, chlamydia and gonorrhea 12 months post-intervention; b) change in HIV risk and drug and alcohol use at 4 and 12 months post-intervention; c) the effect of psychopathology on behavior change at 12 months post-intervention; d) lifetime history of substance abuse and service utilization for mental and physical problems at baseline.

  • Technology Transfer Aim:
  • Disseminate findings to the scientific community, practitioners and community members in formats that are appropriate, understandable, and usable in order that the best possible women-centered intervention can be developed for reducing HIV risk behaviors. The investigators propose to create a WebSite and present findings at local, national and international symposia. Manuals describing the interventions will be developed and made available to the field.

    Condition Intervention
    HIV
    Sexually Transmitted Diseases
    Substance Abuse

    Behavioral : NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing
    Behavioral : Standard Intervention plus Well-Woman Exam
    Behavioral : Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention

    Study Type: Interventional
    Study Design: Allocation: Randomized
    Intervention Model: Parallel Assignment
    Primary Purpose: Prevention
    Official Title: Prevention of HIV and STDs in Drug Using Women

    Further study details as provided by Washington University School of Medicine:

    Enrollment: 501
    Study Start Date: August 2000
    Study Completion Date: November 2004
    Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)

    Arms Assigned Interventions
    Other: Standard
    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing
    Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing

    At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment.

    Experimental: SI/WWE
    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam
    Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing

    At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment.

    Behavioral: Standard Intervention plus Well-Woman Exam

    At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment. This group was assigned to additionally receive a well-woman examination within seven days.

    Experimental: SI/WWE/PD
    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam and Peer-delivered Enhanced Intervention
    Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing

    At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment.

    Behavioral: Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention

    At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment. This group was assigned to receive a well-woman exam within seven days along with four two-hour peer-delivered educational sessions, covering health and nutrition, stress and coping, substance abuse, and HIV/AIDS.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: Female  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • Over age 18
    • Reported sexual activity in the prior 4 months
    • Recent cocaine, heroin or amphetamine use
    • Reported living in the St. Louis metropolitan area


    Exclusion Criteria:
    • Under age 18
    • No sexual activity in the prior 4 months
    • No recent use of cocaine, heroin or amphetamines
    • Resides outside the St. Louis metropolitan area

    contacts and locations

    Contacts and Locations

    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, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT01235091

    Sponsors and Collaborators

    Washington University School of Medicine
    National Institute on Drug Abuse (NIDA)

    Investigators

    Principal Investigator: Linda B. Cottler, PhD, MPH Washington University School of Medicine
    More Information

    More Information


    Responsible Party: Linda B. Cottler, Principal Investigator, Professor of Epidemiology in Psychiatry, Washington University School of medicine  
    ClinicalTrials.gov Identifier: NCT01235091   History of Changes  
    Other Study ID Numbers: 97-0438  
      R01DA011622  
    Study First Received: November 3, 2010  
    Last Updated: November 4, 2010  

    Keywords provided by Washington University School of Medicine:

    HIV prevention
    substance abuse
    high risk behaviors
    peer intervention

    Additional relevant MeSH terms:
    Substance-Related Disorders
    Sexually Transmitted Diseases

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.