Status:
COMPLETED
Family-based HIV Prevention for Adolescent Girls
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Eligibility:
FEMALE
15-19 years
Phase:
NA
Brief Summary
This is an exploratory/developmental study to support the early phases of development and evaluation of a family-based HIV prevention program for adolescent girls prior to a full-scale trial. Research...
Detailed Description
Participants will be involved with the study and follow up for a total of 32 to 36 weeks. 68-84 female adolescents and their mother/guardian (total N = 136-168). African American or mixed race, sexu...
Eligibility Criteria
Inclusion
- Female
- Between the age of 15 years and 0 days and 19 years and 364 days at the time of initial eligibility screening.
- Born in the United States
- Self identifies as all or part African American.
- Sexually active, defined as having had vaginal or anal intercourse
- Has engaged in unprotected sex during the past 3 months
- Is willing to invite and participate with her mother/guardian in the intervention
- Has either a biological mother or a guardian who is willing to participate in the study and meets the eligibility criteria
- For the purposes of this pilot study, biological mothers are eligible, as are non-biological primary caretakers serving as mother/guardians who have guardianship of the adolescent and with whom the adolescent is living.
- Able to understand spoken and written English sufficiently to provide assent/consent and to be interviewed and participate in the study intervention.
- Not intending to relocate out of the current geographical area for the duration of study participation.
- Provides informed assent or consent
- Mother or Mother/guardian
- Has legal guardianship; and
- Currently resides with the adolescent.
- Self identifies as all or part African American.
- Born in the United States
- Able to understand spoken and written English sufficiently to provide consent and to be interviewed and participate in the study intervention.
- Not intending to relocate out of the current geographical area for the duration of study participation.
- Provides informed consent
Exclusion
- Adolescent is currently pregnant or has carried a pregnancy to term
- Adolescent self-reports as HIV positive
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00243126
Start Date
November 1 2005
End Date
December 1 2006
Last Update
March 1 2017
Active Locations (2)
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1
John H. Stroger Jr. Hospital and the Core Center
Chicago, Illinois, United States, 60614
2
Mount Sinai Adolescent Health Center
New York, New York, United States, 10128