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

Primary Purpose

Risk Reduction Behavior, Sexual Behavior, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION
INFORMATION-ONLY SEXUAL RISK REDUCTION
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Risk Reduction Behavior

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Diversion Meetings (Youth Services Center)
  • Youth Reporting Center (Youth Services Center)
  • Albuquerque Academy
  • Sandia Preparatory School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SEXUAL PLUS ALCOHOL RISK REDUCTION

INFORMATION-ONLY SEXUAL RISK REDUCTION

Arm Description

Intervention contains information geared toward sexual risk reduction as well as alcohol risk reduction.

Intervention contains information geared toward sexual risk reduction only.

Outcomes

Primary Outcome Measures

Time-Line Follow-Back (TLFB)
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)
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)
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)
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
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
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
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
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

Full Information

First Posted
July 23, 2010
Last Updated
September 11, 2017
Sponsor
University of New Mexico
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01169922
Brief Title
HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response
Acronym
SHARP
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (Actual)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk Reduction Behavior, Sexual Behavior, Health Behavior, Drinking Behavior, Adolescent Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEXUAL PLUS ALCOHOL RISK REDUCTION
Arm Type
Experimental
Arm Description
Intervention contains information geared toward sexual risk reduction as well as alcohol risk reduction.
Arm Title
INFORMATION-ONLY SEXUAL RISK REDUCTION
Arm Type
Active Comparator
Arm Description
Intervention contains information geared toward sexual risk reduction only.
Intervention Type
Behavioral
Intervention Name(s)
SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION
Other Intervention Name(s)
SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION (SRRI+ETOH)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
INFORMATION-ONLY SEXUAL RISK REDUCTION
Other Intervention Name(s)
INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)
Intervention Description
1 hour 30 minute long intervention; includes presentation of STD/HIV facts, video about sexually transmitted diseases, review of STD/HIV facts
Primary Outcome Measure Information:
Title
Time-Line Follow-Back (TLFB)
Description
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 Frame
3-months post-intervention
Title
Time-Line Follow-Back (TLFB)
Description
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 Frame
6-months post-intervention
Title
Time-Line Follow-Back (TLFB)
Description
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 Frame
9-months post-intervention
Title
Time-Line Follow-Back (TLFB)
Description
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 Frame
12-months post-intervention
Secondary Outcome Measure Information:
Title
Computer questionnaire
Description
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
Time Frame
3 months post-intervention
Title
Computer questionnaire
Description
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
Time Frame
6 months post-intervention
Title
Computer questionnaire
Description
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
Time Frame
9 months post-intervention
Title
Computer questionnaire
Description
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
Time Frame
12 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela D Bryan, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diversion Meetings (Youth Services Center)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87107
Country
United States
Facility Name
Youth Reporting Center (Youth Services Center)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87107
Country
United States
Facility Name
Albuquerque Academy
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Sandia Preparatory School
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87113
Country
United States

12. IPD Sharing Statement

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HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response

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