HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response (SHARP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of New Mexico.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of New Mexico
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 (Child, Adult) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169922
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169922
Locations
| United States, New Mexico | |
| Diversion Meetings (Youth Services Center) | |
| Albuquerque, New Mexico, United States, 87107 | |
| Youth Reporting Center (Youth Services Center) | |
| Albuquerque, New Mexico, United States, 87107 | |
| Albuquerque Academy | |
| Albuquerque, New Mexico, United States, 87109 | |
| Sandia Preparatory School | |
| Albuquerque, New Mexico, United States, 87113 | |
Sponsors and Collaborators
University of New Mexico
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
More Information
| 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 Central Nervous System Depressants Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016