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
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
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
NCT ID
NCT01235091
First Posted
November 3, 2010
Last Updated
November 4, 2010
Sponsor
Washington University School of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)
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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