Prevention of HIV and STDs in Drug Using Women

HIV Clinical Trial

— WTW  

Official title:

Prevention of HIV and STDs in Drug Using Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235091
• Other study ID #: 97-0438
• Secondary ID: R01DA011622
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: November 4, 2010
• Start date: August 2000
• Est. completion date: November 2004

Study information

• Verified date: November 2010
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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:

5. 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:

6. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases
• Substance Abuse

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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