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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 23, 2010
Last Updated Date	August 5, 2011
Start Date ^ICMJE	October 2007
Estimated 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 ] [ 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.
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 ] [ 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.
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 ] [ 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
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 ] [ 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
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (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 Arm (s)	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	Active, not recruiting
Estimated Enrollment ^ICMJE	250
Completion Date	Not Provided
Estimated 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)
Gender	Both
Ages	14 Years to 18 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01169922
Other Study ID Numbers ^ICMJE	NIAAA RO1 AA017390-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Dr. 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	Not Provided
Information Provided By	University of New Mexico
Verification Date	July 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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