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Clinical Trials/NCT01169922
NCT01169922WithdrawnNot Applicable

HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response

University of New Mexico8 sites in 1 countryStarted: October 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
8
Primary Endpoint
Time-Line Follow-Back (TLFB)

Study Overview

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 Design

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

Eligibility Criteria

Ages
14 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

Time-Line Follow-Back (TLFB)

Time Frame: 12-months post-intervention

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 Outcomes

  • Computer questionnaire(12 months post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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