Family-based HIV Prevention for Adolescent Girls



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:15 - 19
Updated:4/21/2016
Start Date:November 2005
End Date:December 2006

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Family-based HIV Prevention for Adolescent Females

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.

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, sexually active female adolescents age 15 to 19 who are at
risk for HIV infection and their mother/guardian

The adolescent participant and her 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 24 participants from the intervention
condition (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.

Interviewers will collect participant data from the baseline and follow-up behavioral
interviews using a Computer Assisted Personal Interviewing (CAPI) method on a portable
computer.

Inclusion Criteria:

- 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 Criteria:

- Adolescent is currently pregnant or has carried a pregnancy to term

- Adolescent self-reports as HIV positive
We found this trial at
2
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New York, New York 10128
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