Family-based HIV Prevention for Adolescent Girls

NCT00243126 | Completed

• 1 other identifier: ATN 012
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

HIV prevention; HIV Seronegativity; HIV negative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Conduct a preliminary efficacy test of the intervention

  32-36 Weeks

Study Arms (2)

Family-Based Risk Reduction Intervention

EXPERIMENTAL

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

No Treatment Control Group Condition

NO INTERVENTION

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.

Interventions

Family-Based Risk Reduction Intervention BEHAVIORAL

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.

Family-Based Risk Reduction Intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Adolescent is currently pregnant or has carried a pregnancy to term
• Adolescent self-reports as HIV positive

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

John H. Stroger Jr. Hospital and the Core Center

Chicago, Illinois, 60614, United States

Location

Mount Sinai Adolescent Health Center

New York, New York, 10128, United States

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Debra A Murphy, Ph.D.

  University of California, Los Angeles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 21, 2005
• Study Start: November 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 1, 2017

Record last verified: 2016-02

Locations

US (2)