Status:

COMPLETED

Development of an Empowerment Intervention for Young Women Living With HIV

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Conditions:

HIV

Eligibility:

FEMALE

16-24 years

Phase:

PHASE2

Brief 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 acceptab...

Eligibility Criteria

Inclusion

  • Female at birth and currently female;
  • Receives services at one of the selected ATN sites or their community partners
  • HIV-infected as documented by medical record review or verbal verification with referring professional
  • Between the ages of 16-24 years (inclusive) at the time of informed consent/assent
  • Ability to understand both written and spoken English
  • Gives informed consent/assent for study participation

Exclusion

  • Presence of active, serious psychiatric symptoms (e.g., hallucinations, thought disorder) that would impair a participant's ability to meet the study requirements
  • Visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior)
  • Intoxicated or under the influence of alcohol or other substances at the time of study enrollment\*.
  • Intoxication at the time of visit will exclude participation at that time. Participants cannot be visibly under the influence of substances at the time of enrollment or consent. If a participant returns to enroll while sober, enrollment can occur. Similarly, if a participant arrives to an intervention group visibly intoxicated, then she will be asked to leave. However, prior intoxication does not eliminate future participation. Thus, those who are dismissed from a session due to intoxication can return to a subsequent session as long as they are sober.

Key Trial Info

Start Date :

February 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2011

Estimated Enrollment :

43 Patients enrolled

Trial Details

Trial ID

NCT01454921

Start Date

February 1 2010

End Date

October 1 2011

Last Update

February 28 2017

Active Locations (3)

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Page 1 of 1 (3 locations)

1

USF College of Medicine

Tampa, Florida, United States, 33606

2

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, United States, 60612

3

University of Maryland Medical School

Baltimore, Maryland, United States, 20723