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NCT01454921 · ClinicalTrials.gov registry record · Phase 2
Development of an Empowerment Intervention for Young Women Living With HIV
A Phase 2 study of HIV, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 3
- Study locations
NCT01454921: Completed Phase 2 study of HIV, sponsored by University of North Carolina, Chapel Hill.
NCT01454921 is a Phase 2 study of HIV that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 43 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01454921, a Phase 2 study of HIV, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will develop/adapt a culturally appropriate secondary prevention intervention for young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups, evaluate its acceptability and feasibility, make appropriate modifications, and manualize the intervention in preparation for a full-scale randomized trial. Once the intervention is developed/adapted, the sites will pilot the interventions twice to enable modifications. The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease (STD). Data will be collected to assess the feasibility and acceptability of the newly developed intervention using both quantitative and qualitative methods at each iteration.
Primary Outcome
Compare pre-intervention ACASI scores on Sexual Activity and Sexual Risk and Psychological Empowerment Questionnaires with those collected immediately post-intervention and 3 months after intervention to determine effect of intervention on sexual risk and psychological empowerment.
Conditions Studied
Interventions
- BEHAVIORAL Evolution: Young Women Taking Charge and Growing Stronger
Study Locations (3)
Florida
- USF College of Medicine - Tampa
Illinois
- Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital - Chicago
Maryland
- University of Maryland Medical School - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT01454921 record still lists
NCT01454921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Evolution: Young Women Taking Charge and Growing Stronger is the first listed.
NCT01454921 reports a single indexed study location in Florida, Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT01454921 about?
NCT01454921 is a clinical study titled "Development of an Empowerment Intervention for Young Women Living With HIV". This study will develop/adapt a culturally appropriate secondary prevention intervention for young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups, evaluate its acceptability and feasibility, make appropriate modifications, and manualize the intervention in preparation...
What is the current status of trial NCT01454921?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2010-02. Estimated completion is 2011-10.
What conditions does trial NCT01454921 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01454921?
The interventions under investigation include: Evolution: Young Women Taking Charge and Growing Stronger (BEHAVIORAL).
Who is sponsoring clinical trial NCT01454921?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01454921 being conducted?
This trial has 3 study locations across Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01454921's enrollment target sits among peer trials
43 239th of 303 higher than 64 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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