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

Tracking Information
First Submitted Date ICMJE	November 3, 2010
First Posted Date ICMJE	November 5, 2010
Last Update Posted Date	November 5, 2010
Study Start Date ICMJE	August 2000
Actual Primary Completion Date	November 2004 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Prevention of HIV and STDs in Drug Using Women
Official Title ICMJE	Prevention of HIV and STDs in Drug Using Women
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Prevention
Condition ICMJE	HIV; Sexually Transmitted Diseases; Substance Abuse
Intervention ICMJE	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.; 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.
Study Arms	Standard NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing Intervention: Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing; Experimental: SI/WWE NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam Interventions: Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing Behavioral: Standard Intervention plus Well-Woman Exam; Experimental: SI/WWE/PD NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam and Peer-delivered Enhanced Intervention Interventions: Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing Behavioral: Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention
Publications *	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]..
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 4, 2010)	501
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2004
Actual Primary Completion Date	November 2004 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01235091
Other Study ID Numbers ICMJE	97-0438; R01DA011622 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Linda B. Cottler, Principal Investigator, Professor of Epidemiology in Psychiatry, Washington University School of medicine
Study Sponsor ICMJE	Washington University School of Medicine
Collaborators ICMJE	National Institute on Drug Abuse (NIDA)
Investigators ICMJE	Principal Investigator: Linda B. Cottler, PhD, MPH Washington University School of Medicine
PRS Account	Washington University School of Medicine
Verification Date	November 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP