Family-based HIV Prevention for Adolescent Girls

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00243126
First received: October 19, 2005
Last updated: June 23, 2014
Last verified: April 2014

October 19, 2005
June 23, 2014
November 2005
December 2006   (final data collection date for primary outcome measure)
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.
  • 1. decreased sexual risk behavior and decreased substance use;
  • 2. higher reports of self-efficacy for sexual communication with both their mothers/guardians and with sexual partners;
  • 3. increased intention to use effective contraception to prevent unplanned pregnancies and transmission of HIV/STDs; and
  • 4. improved scores on family functioning measures.
  • 1. improved scores on measures of affective status and;
  • 2. improved scores on measures of mental health indicators.
  • -It will be feasible to engage adolescents and mothers/guardians in a five session family-based mother-daughter HIV risk reduction intervention.
  • -It is anticipated that in comparison to adolescents in the control condition, adolescents receiving the pilot intervention will show (by self-report):
  • -It is anticipated that in comparison to adolescents and mothers/guardians in the control condition, adolescents and mothers/guardians receiving the pilot intervention will show:
Complete list of historical versions of study NCT00243126 on ClinicalTrials.gov Archive Site
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.
  • -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.
  • -To utilize data from this pilot to further develop and refine a theoretically driven, developmentally appropriate family-based intervention to reduce risk of HIV transmission among disadvantaged, minority adolescent females.
Not Provided
Not Provided
 
Family-based HIV Prevention for Adolescent Girls
Family-based HIV Prevention for Adolescent Females

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
HIV Infections
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.
  • 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.
    Intervention: Behavioral: Family-Based Risk Reduction Intervention
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Female
15 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00243126
ATN 012
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Chair: Debra A Murphy, Ph.D. University of California, Los Angeles
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP