Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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:

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.


Options:
A: Inclusion Criteria:

* Applicants in methadone treatment may be eligible to participate in Phase 1 of the study.
* Applicants will be blind to the full details of the eligibility criteria.
* Unemployed
* Provided a urine sample at intake with a detectable concentration of cocaine metabolite or provided a cocaine positive sample during regular urinalysis testing at a methadone maintenance program
* Met DSM-IV criteria for cocaine dependence
* Were receiving welfare benefits in Baltimore, MD
* Received a score of less than or equal to 80% correct on a reading assessment

Exclusion Criteria

* Being at imminent risk for suicide
* Reported hallucinations
* Being incarcerated or otherwise under constant monitoring
* Earned less than or equal to $200 in unreported taxable income from legal activity in the previous month
* Having physical limitations that prevented typing
B: Inclusion Criteria:

* Males and females between ages of 18 and 50
* Enrolled in RNP methadone program and stable on methadone for at least 3 weeks
* Current cocaine abuse or dependence according to DSM-IV criteria
* No current medical problems and normal ECG
* If female, not currently pregnant or breast feeding and using reliable birth control
* Fluent in English and have at least a 6th grade reading level
* Can commit to 12 weeks of treatment and are willing to be randomized

Exclusion Criteria:

* Current major psychiatric illness including mood, psychotic or anxiety disorder
* History of major medical illnesses including asthma, chronic obstructive lung disease, gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances
* Use of medications including beta blockers and NASAIDs
* Known allergy to Galantamine
C: 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
D: Inclusion Criteria: McKinney Act criteria for homelessness; DSM IV diagnosis for Cocaine Dependence; self-reported use within the last 2 weeks; psychological distress indicated by score of 70 on 1 or more Brief Symptom Inventory scales; willingness to participate; no plans to move from Birmingham area for 18 months;

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Exclusion Criteria: cognitive impariment precluding informed consent; requiring immediate inpatient medical treatment

Answer: C