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

Primary Purpose

HIV, Sexually Transmitted Diseases, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing
Standard Intervention plus Well-Woman Exam
Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV prevention, substance abuse, high risk behaviors, peer intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Experimental

    Experimental

    Arm Label

    Standard

    SI/WWE

    SI/WWE/PD

    Arm Description

    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing

    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam

    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam and Peer-delivered Enhanced Intervention

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 3, 2010
    Last Updated
    November 4, 2010
    Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01235091
    Brief Title
    Prevention of HIV and STDs in Drug Using Women
    Acronym
    WTW
    Official Title
    Prevention of HIV and STDs in Drug Using Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    November 2004 (Actual)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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: 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. 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. Assess the effectiveness of the interventions in reducing drug and sexual risk at 4 and 12 months post-intervention, controlling for baseline characteristics. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV, Sexually Transmitted Diseases, Substance Abuse
    Keywords
    HIV prevention, substance abuse, high risk behaviors, peer intervention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized
    Enrollment
    501 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard
    Arm Type
    Other
    Arm Description
    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing
    Arm Title
    SI/WWE
    Arm Type
    Experimental
    Arm Description
    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam
    Arm Title
    SI/WWE/PD
    Arm Type
    Experimental
    Arm Description
    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam and Peer-delivered Enhanced Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Intervention plus Well-Woman Exam
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention
    Intervention Description
    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.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Linda B. Cottler, PhD, MPH
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22448255
    Citation
    Ruger JP, Abdallah AB, Luekens C, Cottler L. Cost-effectiveness of peer-delivered interventions for cocaine and alcohol abuse among women: a randomized controlled trial. PLoS One. 2012;7(3):e33594. doi: 10.1371/journal.pone.0033594. Epub 2012 Mar 20. Erratum In: PLoS One. 2012;7(8): doi/10.1371/annotation/d9d8b547-8154-48a1-b527-d0c51285ed3c. Prah Ruger, Jennifer [corrected to Ruger, Jennifer Prah].
    Results Reference
    derived

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    Prevention of HIV and STDs in Drug Using Women

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