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CompletedNCT01235091WTWUpdated Dec 26, 2025

Prevention of HIV and STDs in Drug Using Women

An interventional study of NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing and Standard Intervention plus Well-Woman Exam in HIV, Sexually Transmitted Diseases and Substance Abuse, sponsored by Washington University School of Medicine. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
501
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.
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Conditions studied

  • HIV
  • Sexually Transmitted Diseases
  • Substance Abuse

Keywords

  • HIV prevention
  • substance abuse
  • high risk behaviors
  • peer intervention
03

In context

Sexually Transmitted Diseases

424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.

This study's enrollment of 501 is close to the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
501 participants (actual)

Study arms

  • Other
    Standard

    NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing

    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

    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

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

Interventions

  • BehavioralNIDA 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.

  • BehavioralStandard 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.

  • BehavioralStandard 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.

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Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 22448255 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01235091
Lead sponsor
Washington University School of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)
First posted
Nov 5, 2010
Start date
Aug 2000
Primary completion
Nov 2004
Completion
Nov 2004
Last update
Dec 26, 2025

Study contacts

Linda B. Cottler, PhD, MPH
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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