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COMPLETED Phase 2

HIV Prevention Intervention for Couples

NCT00325585 · View on ClinicalTrials.gov ↗

Study Summary

Recent studies have shown that many drug-using minority women are vulnerable to HIV infection from their husbands or other intimate male partners. The goal of this study is to develop and evaluate two new HIV counseling and testing programs designed for drug-using women at risk for HIV from a primary male partner. It is predicted that HIV counseling and testing programs administered to couples rather than to women only, and programs that focus on intimate relationships in the context of HIV risk, will result in a reduction of risky sexual and drug-related behavior among drug-using women and their primary male partners. This four-year study employs a randomized clinical trial (RCT) design to test the effectiveness of two new HIV counseling and testing programs for women drug-users in Harlem and the South Bronx in New York City.

Interventions

  • BEHAVIORAL Couples HIV counseling and testing
  • BEHAVIORAL Women's relationship-focused HIV counseling and testing

Study Locations (1)

New York

  • NDRI South Bronx Field Office — The Bronx

Trial Details

FieldValue
Enrollment Target 780 participants
Start Date 2005-04
Est. Completion 2008-06
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00325585

The ClinicalTrials.gov registry entry for NCT00325585 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 780 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Development and Research Institutes, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acquired Immunodeficiency Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Couples HIV counseling and testing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00325585 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00325585 about?

NCT00325585 is a clinical study titled "HIV Prevention Intervention for Couples". Recent studies have shown that many drug-using minority women are vulnerable to HIV infection from their husbands or other intimate male partners. The goal of this study is to develop and evaluate two new HIV counseling and testing programs designed for drug-using women at risk for HIV from a primar...

What is the current status of trial NCT00325585?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 780 participants. The study started on 2005-04. Estimated completion is 2008-06.

What conditions does trial NCT00325585 study?

This clinical trial studies the following conditions: Acquired Immunodeficiency Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00325585?

The interventions under investigation include: Couples HIV counseling and testing (BEHAVIORAL), Women's relationship-focused HIV counseling and testing (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00325585?

This trial is sponsored by National Development and Research Institutes, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00325585 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial