Family-based HIV Prevention for Adolescent Girls

HIV Infections Clinical Trial

Official title:

Family-based HIV Prevention for Adolescent Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243126
• Other study ID #: ATN 012
• Status: Completed
• Phase: N/A
• First received: October 19, 2005
• Last updated: February 27, 2017
• Start date: November 2005
• Est. completion date: December 2006

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	John H. Stroger Jr. Hospital and the Core Center	Chicago	Illinois
United States	Mount Sinai Adolescent Health Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test the feasibility of implementing intervention	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.	32-26 Weeks
Secondary	Conduct a preliminary efficacy test of the intervention	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.	32-36 Weeks

External Links

•   Website for the Adolescent Trials Network for HIV/AIDS Interventions