Family-based HIV Prevention for Adolescent Girls
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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 on the new intervention will include evaluating the feasibility, tolerability, and acceptability of the intervention, and allow us to obtain the preliminary data needed as a pre-requisite to a larger-scale intervention study. Adolescent females and their mother/guardian will be randomized to either: a family-based risk reduction intervention; or a no-treatment control group condition. Participants in both conditions will be assessed at baseline, immediate post-intervention, and at 3- and 6-month follow-ups. A subset of families (12 adolescents and 12 mothers) will participate in a qualitative interview following the 6-month follow-up, in which information will be obtained on participant perception of procedures and intervention content, and whether they have utilized skills taught following the end of the project.
Key facts
- Study ID
- NCT00243126
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 168
- Starts
- 2005-11-01
- Expected to finish
- 2006-12-01
- Last updated by the study team
- 2017-03-01
Who can join
Age: 15 and older, up to 19. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Adolescent is currently pregnant or has carried a pregnancy to term
- Adolescent self-reports as HIV positive
Where it is running
- John H. Stroger Jr. Hospital and the Core Center — Chicago, Illinois, United States
- Mount Sinai Adolescent Health Center — New York, New York, United States
Full record on ClinicalTrials.gov
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