Clinical trial NCT00243126: Family-based HIV Prevention for Adolescent Girls
Official title: Family-based HIV Prevention for Adolescent Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV prevention
HIV Seronegativity
HIV negative
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-10-21
Enrollment: 168
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Test the feasibility of implementing intervention
timeFrame: 32-26 Weeks
Secondary outcomes:
measure: Conduct a preliminary efficacy test of the intervention
timeFrame: 32-36 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital and the Core Center
state: Illinois
city: New York
country: United States
facility: Mount Sinai Adolescent Health Center
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Debra A Murphy, Ph.D.
role: STUDY_CHAIR
References: