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Family-based HIV Prevention for Adolescent Girls

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Based Risk Reduction Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV prevention, HIV Seronegativity, HIV negative

Eligibility Criteria

15 Years - 19 Years (Child, Adult)FemaleAccepts 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

Sites / Locations

  • John H. Stroger Jr. Hospital and the Core Center
  • Mount Sinai Adolescent Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family-Based Risk Reduction Intervention

No Treatment Control Group Condition

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 19, 2005
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00243126
Brief Title
Family-based HIV Prevention for Adolescent Girls
Official Title
Family-based HIV Prevention for Adolescent Females
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV prevention, HIV Seronegativity, HIV negative

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family-Based Risk Reduction Intervention
Arm Type
Experimental
Arm 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.
Arm Title
No Treatment Control Group Condition
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Risk Reduction Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test the feasibility of implementing intervention
Description
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.
Time Frame
32-26 Weeks
Secondary Outcome Measure Information:
Title
Conduct a preliminary efficacy test of the intervention
Description
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.
Time Frame
32-36 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra A Murphy, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
John H. Stroger Jr. Hospital and the Core Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Mount Sinai Adolescent Health Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States

12. IPD Sharing Statement

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Family-based HIV Prevention for Adolescent Girls

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