HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response

Health Behavior Clinical Trial

— SHARP  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01169922
• Other study ID #: NIAAA RO1 AA017390-01
• Status: Withdrawn
• Phase: N/A
• Start date: October 2007
• Est. completion date: October 2007

Study information

• Verified date: January 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adolescent Behavior
• Drinking Behavior
• Health Behavior
• Risk Reduction Behavior
• Sexual Behavior

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Albuquerque Academy	Albuquerque	New Mexico
United States	Diversion Meetings (Youth Services Center)	Albuquerque	New Mexico
United States	Sandia Preparatory School	Albuquerque	New Mexico
United States	Youth Reporting Center (Youth Services Center)	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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