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CompletedNCT01403298Project RAPUpdated May 12, 2020

Project RAP: Family-based HIV Prevention in the Juvenile Drug Court

An interventional study of Family-Based HIV prevention and Adolescent Only Health Promotion in HIV/AIDS, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-12.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
All
01

Study summary

The purpose of this project is to compare the effect of a family-based HIV prevention program to the effect of an adolescent-only health promotion program on adolescent HIV risk and marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island Family Court.

Read the detailed description

Adolescents and parents admitted to our study receive either an adolescent-only health education program that focuses on general health risk behaviors related to HIV/AIDS, smoking, diet and exercise or one that focuses on family-based HIV/AIDS education through safe decision-making and control of one's emotions as well as parent-child interactions that are associated with dysregulated affect, subsequent parenting deficits and adolescent HIV risk behaviors.

02

Conditions studied

  • HIV/AIDS

Keywords

  • Adolescent
  • HIV
  • AIDS
  • Sexual risk
  • Family
  • Prevention
  • Juvenile Drug Court
  • Juvenile Justice
  • Drug Use
  • Marijuana
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 120 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 13 to 18 years old;
  • male and female;
  • in Rhode Island Family Court - Intake and Juvenile Drug Court program;
  • English speaking

Exclusion criteria

Exclusion Criteria:

  • HIV infection (by self-report);
  • history of sex crimes,
  • current pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Adolescent Only Health Promotion

    An individual adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise

    Other: Adolescent Only Health Promotion

  • Experimental
    Family-Based HIV prevention

    This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.

    Behavioral: Family-Based HIV prevention

Interventions

  • BehavioralFamily-Based HIV prevention

    This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.

  • OtherAdolescent Only Health Promotion

    An individual, adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise

06

What researchers measure

Primary outcomes

  1. adolescent HIV/STD risk

    Adolescent self-report of rates of condom use, number of sex partners, number of unprotected vaginal and/or anal intercourse episodes, frequency of alcohol use during sexual activity, frequency of marijuana use during sexual activity, frequency of other drug use during sexual activity

    Time frame: 3 months post intervention

  2. adolescent substance use

    Adolescent self-report of quantity and frequency of marijuana use, alcohol use and other drug use over the past 3 months and over the past 30 days. Collateral urine toxicology screen data will also be available for analysis.

    Time frame: 3 months post-intervention

Secondary outcomes

  1. Scores on measures of parent-child communication (general and sex-specific),parental monitoring and family emotional environment

    Using well-established parenting and family-based measures, such as the Parental Knowledge scales (for monitoring), Parent-Child Communication Scales (general and sexually-specific), and the Family Assessment Device (FAD), we will be obtaining both parent and adolescent report of these constructs.

    Time frame: 3 months post intervention

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Study locations

1 site
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01403298
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Jul 27, 2011
Start date
Dec 2009
Primary completion
Jun 2013
Completion
Jun 2013
Last update
May 12, 2020

Study contacts

Marina Tolou-Shams, PhD
principal investigator · Rhode Island Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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