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

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ClinicalTrials.gov Identifier: NCT01169922
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Angela Bryan, University of New Mexico

Tracking Information
First Submitted Date  ICMJE July 23, 2010
First Posted Date  ICMJE July 26, 2010
Last Update Posted Date September 13, 2017
Actual Study Start Date  ICMJE October 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
  • Time-Line Follow-Back (TLFB) [ Time Frame: 3-months post-intervention ]
    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 ]
    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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
Time-Line Follow-Back (TLFB) [ Time Frame: used at baseline, and 3 months, 6 months, 9 months, and 12 months post-intervention ]
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.
Change History Complete list of historical versions of study NCT01169922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2011)
  • Computer questionnaire [ Time Frame: 3 months post-intervention ]
    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 ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
Computer questionnaire [ Time Frame: used at baseline, and 3 months, 6 months, 9 months, and 12 months post-intervention ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Risk Reduction Behavior
  • Sexual Behavior
  • Health Behavior
  • Drinking Behavior
  • Adolescent Behavior
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2017)
284
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2010)
250
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01169922
Other Study ID Numbers  ICMJE NIAAA RO1 AA017390-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angela Bryan, University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Angela D Bryan, PhD
PRS Account University of New Mexico
Verification Date September 2017

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