Family-based HIV Prevention for Adolescent Girls

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Family-Based Risk Reduction Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00243126

ATN 012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: Female

Ages: 15 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 2 patient groups

Family-Based Risk Reduction Intervention

Experimental group

Description:

The intervention will be delivered in five, two-hour, small group sessions, across five weeks (group will meet once per week). Each of the 5 modules consists of 3 sessions: a one-hour session for the daughters meeting together with each other, a one-hour session for the mothers meeting together with each other; and a one-hour session in which the daughters and mothers meet together. Therefore, each week, the daughters will meet as a group for one hour of each module, while the mothers meet as a group for one hour, and for one hour the mothers and daughters will all meet together.

Treatment:

Behavioral: Family-Based Risk Reduction Intervention

No Treatment Control Group Condition

No Intervention group

Description:

A no treatment control group condition will be utilized for this preliminary feasibility study. Participants in this condition, both mothers and adolescents will be assessed at baseline, immediate post-intervention, at 3-month follow-up and at 6-month follow-up.