HIVWTWNCT01235091
Prevention of HIV and STDs in Drug Using Women
A study testing NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing, Standard Intervention plus Well-Woman Exam and Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention in people with HIV and Sexually Transmitted Diseases, run by Washington University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Sexually Transmitted Diseases, Substance Abuse
- What is being tested?
- NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing, Standard Intervention plus Well-Woman Exam and Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Nov 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- HIV, Sexually Transmitted Diseases, Substance Abuse
- Being tested
- 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
- Keywords
- HIV prevention, substance abuse, high risk behaviors, peer intervention
- Medical subject headings
- Sexually Transmitted Diseases, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIDA Cooperative Agreement Standard Intervention plus HIV/STD testingBehavioural
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 ExamBehavioural
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 InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard | Other | NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing Receives: Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing |
| SI/WWE | Experimental | NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam Receives: Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing; Behavioral: Standard Intervention plus Well-Woman Exam |
| SI/WWE/PD | Experimental | NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam and Peer-delivered Enhanced Intervention Receives: Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing; Behavioral: Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startAug 2000
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Linda B. Cottler, PhD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235091
- Sponsor's protocol ID
- 97-0438
- Other IDs
- R01DA011622
- Acronym
- WTW
- Status last verified
- Dec 2025
- First submitted
- 3 Nov 2010
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of HIV and STDs in Drug Using Women
- ClinicalTrials.gov ID
- NCT01235091
- Acronym / sponsor ID
- WTW / 97-0438
- Conditions
- HIV, Sexually Transmitted Diseases, Substance Abuse
- Keywords
- HIV prevention, substance abuse, high risk behaviors, peer intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2000
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 5 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Other | Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testingNIDA Cooperative Agreement Standard Intervention plus HIV/STD testing |
| SI/WWE | Experimental | Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing, Behavioral: Standard Intervention plus Well-Woman ExamNIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam |
| SI/WWE/PD | Experimental | Behavioral: NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing, Behavioral: Standard Intervention plus Well-Woman Exam and Peer-Delivered InterventionNIDA Cooperative Agreement Standard Intervention plus HIV/STD testing along with Well-Woman Exam and Peer-delivered Enhanced Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIDA Cooperative Agreement Standard Intervention plus HIV/STD testingAt 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. | Behavioural | SI/WWE, SI/WWE/PD, Standard |
| Standard Intervention plus Well-Woman ExamAt 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. | Behavioural | SI/WWE |
| Standard Intervention plus Well-Woman Exam and Peer-Delivered InterventionAt 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. | Behavioural | SI/WWE/PD |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 22448255Ruger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda B. Cottler, PhD, MPH principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing, Standard Intervention plus Well-Woman Exam and Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention in people with HIV and Sexually Transmitted Diseases, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.