Family-based HIV Prevention for Adolescent Girls
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Family-based HIV Prevention for Adolescent Females|
- Test the feasibility of implementing intervention [ Time Frame: 32-26 Weeks ] [ Designated as safety issue: No ]The primary objective of this pilot study is to test the feasibility of implementing a mother-daughter HIV risk reduction intervention for at-risk female adolescents.
- Conduct a preliminary efficacy test of the intervention [ Time Frame: 32-36 Weeks ] [ Designated as safety issue: No ]The secondary objective of this pilot study is to conduct a preliminary efficacy test of the intervention to determine if trends towards significant effects for reducing unprotected sex and/or reducing substance use are found.
|Study Start Date:||November 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Experimental: Family-Based Risk Reduction Intervention
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.
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.
No Intervention: No Treatment Control Group Condition
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243126
|United States, Illinois|
|John H. Stroger Jr. Hospital and the Core Center|
|Chicago, Illinois, United States, 60614|
|United States, New York|
|Mount Sinai Adolescent Health Center|
|New York, New York, United States, 10128|
|Study Chair:||Debra A Murphy, Ph.D.||University of California, Los Angeles|