ClinicalTrials.gg
WithdrawnNCT01169922SHARPUpdated Jan 10, 2024

HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response

An interventional study of SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION and INFORMATION-ONLY SEXUAL RISK REDUCTION in Risk Reduction Behavior, Sexual Behavior and Health Behavior, sponsored by University of New Mexico. Withdrawn at 4 sites in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The study did not begin and is being terminated from the system.

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Oct 2007, registered Jul 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Risk Reduction Behavior
  • Sexual Behavior
  • Health Behavior
  • Drinking Behavior
  • Adolescent Behavior
03

In context

Risk Reduction Behavior

291 studies on the registry are indexed under Risk Reduction Behavior; 39 are open to participants now.

Browse Risk Reduction Behavior studies →

Lead sponsor

University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescents age 14-18
  • Involved in Juvenile Justice System OR enrolled in a private school

Exclusion criteria

Exclusion Criteria:

  • Currently taking anti-psychotics
  • Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • Active comparator
    INFORMATION-ONLY SEXUAL RISK REDUCTION

    Intervention contains information geared toward sexual risk reduction only.

    Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION

Interventions

  • BehavioralSEXUAL 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

    Also known as: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION (SRRI+ETOH)

  • BehavioralINFORMATION-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

    Also known as: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3-months post-intervention

  2. 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.

    Time frame: 6-months post-intervention

  3. 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.

    Time frame: 9-months post-intervention

  4. 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.

    Time frame: 12-months post-intervention

Secondary outcomes

  1. 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

    Time frame: 3 months post-intervention

  2. 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

    Time frame: 6 months post-intervention

  3. 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

    Time frame: 9 months post-intervention

  4. 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

    Time frame: 12 months post-intervention

07

Study locations

4 sites
  • Diversion Meetings (Youth Services Center)
    Albuquerque, New Mexico 87107, United States
  • Youth Reporting Center (Youth Services Center)
    Albuquerque, New Mexico 87107, United States
  • Albuquerque Academy
    Albuquerque, New Mexico 87109, United States
  • Sandia Preparatory School
    Albuquerque, New Mexico 87113, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2007 to primary completion in Oct 2007, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2010
First posted
Jul 26, 2010
StartActual
Oct 2007
Primary completionActual
Oct 2007
CompletionActual
Oct 2007
Last update
Jan 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01169922
Responsible party
Sponsor
First posted
Jul 26, 2010
Start date
Oct 2007
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Jan 10, 2024

Study contacts

Angela D Bryan, PhD
principal investigator
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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