Development of an Empowerment Intervention for Young Women Living With HIV

Completed · Phase 2

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT01454921

Run by

University of North Carolina, Chapel Hill

People needed

43

Starts

2010-02-01

Expected to finish

2011-10-01

Last updated by the study team

2017-02-28

Who can join

Age: 16 and older, up to 24. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• USF College of Medicine — Tampa, Florida, United States
• Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital — Chicago, Illinois, United States
• University of Maryland Medical School — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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