Family-based HIV Prevention for Adolescent Girls

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.

Conditions

• HIV Infections

Interventions

BEHAVIORAL

Family-Based Risk Reduction Intervention

The intervention module topics include five modules and each module is 2 hours in length. The intervention will focus on the elements critical to HIV risk behavior change. These include: risk education (practical understanding of factors responsible for risk and behavior changes needed to reduce risk); threat personalization (accurate appraisal of personal risk based on behavior); self-efficacy (belief that one can implement risk reduction behavior changes and that if changes are made they will have protective value); skills acquisition (e.g., condom use, safer sex guidance, negotiation); cognitive problem-solving skills; and reinforcement.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Debra A Murphy, Ph.D. · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

19 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-11-30

Primary Completion

2006-12-31

Completion

2006-12-31

Countries

• United States

Study Locations