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

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.

Study Overview

• Status: Withdrawn
• Conditions: Drinking Behavior; Sexual Behavior; Health Behavior; Adolescent Behavior; Risk Reduction Behavior
• Intervention / Treatment: Behavioral: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION; Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • Diversion Meetings (Youth Services Center)
    • Albuquerque, New Mexico, United States, 87107
      • Youth Reporting Center (Youth Services Center)
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Academy
    • Albuquerque, New Mexico, United States, 87113
      • Sandia Preparatory School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-months post-intervention
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.	6-months post-intervention
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.	9-months post-intervention
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.	12-months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months post-intervention
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	6 months post-intervention
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	9 months post-intervention
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	12 months post-intervention

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Angela D Bryan, PhD

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: July 23, 2010
• First Submitted That Met QC Criteria: July 23, 2010
• First Posted (Estimated): July 26, 2010

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: NIAAA RO1 AA017390-01