HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response (SHARP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of New Mexico.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01169922
First received: July 23, 2010
Last updated: August 5, 2011
Last verified: July 2011

July 23, 2010
August 5, 2011
October 2007
September 2012   (final data collection date for primary outcome measure)
  • Time-Line Follow-Back (TLFB) [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
  • Time-Line Follow-Back (TLFB) [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
  • Time-Line Follow-Back (TLFB) [ Time Frame: 9-months post-intervention ] [ Designated as safety issue: No ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
  • Time-Line Follow-Back (TLFB) [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
Time-Line Follow-Back (TLFB) [ Time Frame: used at baseline, and 3 months, 6 months, 9 months, and 12 months post-intervention ] [ Designated as safety issue: No ]
A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
Complete list of historical versions of study NCT01169922 on ClinicalTrials.gov Archive Site
  • Computer questionnaire [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
    Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes within past few months
  • Computer questionnaire [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes within past few months
  • Computer questionnaire [ Time Frame: 9 months post-intervention ] [ Designated as safety issue: No ]
    Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes within past few months
  • Computer questionnaire [ Time Frame: 12 months post-intervention ] [ Designated as safety issue: No ]
    Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes within past few months
Computer questionnaire [ Time Frame: used at baseline, and 3 months, 6 months, 9 months, and 12 months post-intervention ] [ Designated as safety issue: No ]
Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes within past few months
Not Provided
Not Provided
 
HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response
Not Provided

This research is examining how genetic and brain factors play a role in adolescents' health risk behavior as well as studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.

A baseline assessment is conducted, including a computer questionnaire assessing personality characteristics, attitudes toward and experiences with sex, alcohol, drugs, and cigarettes, among other things. The participant also meets with a therapist to conduct a brief motivational interview at this time. A "Time-Line Follow-Back" is conducted; this notes incidences of sexual intercourse, alcohol use, marijuana use, and cigarette use in a 30-day period. An fMRI is conducted, and a saliva sample is gathered. During the second session of the study, participants are randomly assigned to either a sex and alcohol risk reduction intervention, or a sex risk reduction intervention. After the intervention, participants are contacted at 3 month intervals (3 months later, 6 months later, 9 months later, and 12 months later) to meet. At these "follow-up" meetings, another Time-Line Follow-Back is conducted, along with another computer questionnaire (again assessing attitudes toward and experiences with sex, alcohol, drugs, and cigarettes).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Risk Reduction Behavior
  • Sexual Behavior
  • Health Behavior
  • Drinking Behavior
  • Adolescent Behavior
  • Behavioral: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION
    2 hour 50 minute long intervention; includes presentation of STD/HIV facts, activities/games regarding safe sex, condom demonstration, video about sexual decision making, video about alcohol/sexual decision making, alcohol-related risk-reduction motivational interview, group discussion
    Other Name: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION (SRRI+ETOH)
  • Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION
    1 hour 30 minute long intervention; includes presentation of STD/HIV facts, video about sexually transmitted diseases, review of STD/HIV facts
    Other Name: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)
  • Experimental: SEXUAL PLUS ALCOHOL RISK REDUCTION
    Intervention contains information geared toward sexual risk reduction as well as alcohol risk reduction.
    Intervention: Behavioral: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION
  • Active Comparator: INFORMATION-ONLY SEXUAL RISK REDUCTION
    Intervention contains information geared toward sexual risk reduction only.
    Intervention: Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
Not Provided
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adolescents age 14-18
  • Involved in Juvenile Justice System OR enrolled in a private school

Exclusion Criteria:

  • Currently taking anti-psychotics
  • Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
Both
14 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01169922
NIAAA RO1 AA017390-01
Not Provided
Dr. Angela Bryan, University of New Mexico
University of New Mexico
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Not Provided
University of New Mexico
July 2011

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