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
  Purpose

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.


Condition Intervention
Risk Reduction Behavior
Sexual Behavior
Health Behavior
Drinking Behavior
Adolescent Behavior
Behavioral: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION
Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 250
Study Start Date: October 2007
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEXUAL PLUS ALCOHOL RISK REDUCTION
Intervention contains information geared toward sexual risk reduction as well as alcohol risk reduction.
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)
Active Comparator: INFORMATION-ONLY SEXUAL RISK REDUCTION
Intervention contains information geared toward sexual risk reduction only.
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)

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).

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169922

Locations
United States, New Mexico
Youth Reporting Center (Youth Services Center)
Albuquerque, New Mexico, United States, 87107
Sandia Preparatory School
Albuquerque, New Mexico, United States, 87113
Albuquerque Academy
Albuquerque, New Mexico, United States, 87109
Diversion Meetings (Youth Services Center)
Albuquerque, New Mexico, United States, 87107
Sponsors and Collaborators
University of New Mexico
  More Information

No publications provided

Responsible Party: Dr. Angela Bryan, University of New Mexico
ClinicalTrials.gov Identifier: NCT01169922     History of Changes
Other Study ID Numbers: NIAAA RO1 AA017390-01
Study First Received: July 23, 2010
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014