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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01170260
Other study ID # NIAAA RO1 AA013844-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2010
Est. completion date June 2014

Study information

Verified date April 2024
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is 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:

During baseline assessment, a computer questionnaire is administered, including questions about participants' attitudes, beliefs, and behaviors regarding sexual behavior, condom use, and drug use. A saliva sample is provided as well. A "Time-Line Follow-Back" is conducted, noting on which days certain activities occurred, such as sexual intercourse, alcohol use, marijuana use, and cigarette use. A urine sample is also collected in order to test for the STD's chlamydia and gonorrhea (if results are positive, we schedule a meeting with the participant to administer medication to treat the STD). In the second session, a 3-hour interventional health class is held with groups of same-gender participants. There are 3 different health classes (one focusing just on sex risk reduction, one focusing on sex and alcohol risk reduction, and one focusing on sex, alcohol, and marijuana risk reduction); participants are randomly assigned to one. Participants are contacted 3 months after the intervention, 6 months after, 9 months after, and 12 months after, in order to meet. These meetings entail completing another Time-Line Follow-Back and completing another questionnaire. At the final 12 month meeting, we collect another urine sample to again test for chlamydia and gonorrhea. As before, if results are positive, we schedule a meeting with the participant to administer medical treatment.


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - Ages 14-18 - Involved in Juvenile Justice System (living in the Detention Center when recruited) Exclusion Criteria: - Currently taking anti-psychotics - Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)

Study Design


Intervention

Behavioral:
INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)
Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion
SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)
Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion
SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION
Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion

Locations

Country Name City State
United States Juvenile Detention Center (JDC) 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 Number of Participants With Risky Sexual Behavior Measured for 1 Year 1 year
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