HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response (SHARP)
This study is ongoing, but not recruiting participants.
Sponsor:
University of New Mexico
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
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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
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 June 17, 2013