Risk Reduction BehaviorSHARPNCT01169922
HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response
A study testing SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION and INFORMATION-ONLY SEXUAL RISK REDUCTION in people with Risk Reduction Behavior and Sexual Behavior, run by University of New Mexico at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior, Sexual Behavior, Health Behavior
- What is being tested?
- SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION and INFORMATION-ONLY SEXUAL RISK REDUCTION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2007to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents age 14-18
- Involved in Juvenile Justice System OR enrolled in a private school
Who cannot join
- Currently taking anti-psychotics
- Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Diversion Meetings (Youth Services Center)
Albuquerque, New Mexico, 87107
Youth Reporting Center (Youth Services Center)
Albuquerque, New Mexico, 87107
Albuquerque Academy
Albuquerque, New Mexico, 87109
Sandia Preparatory School
Albuquerque, New Mexico, 87113
About this study
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).
- Conditions
- Risk Reduction Behavior, Sexual Behavior, Health Behavior, Drinking Behavior, Adolescent Behavior
- Being tested
- SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION, INFORMATION-ONLY SEXUAL RISK REDUCTION
- Medical subject headings
- Risk Reduction Behavior, Sexual Behavior, Health Behavior, Drinking Behavior, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTIONBehavioural
Also called SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION (SRRI+ETOH)
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
INFORMATION-ONLY SEXUAL RISK REDUCTIONBehavioural
Also called INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)
1 hour 30 minute long intervention; includes presentation of STD/HIV facts, video about sexually transmitted diseases, review of STD/HIV facts
| Study group | Role | What they receive |
|---|---|---|
| SEXUAL PLUS ALCOHOL RISK REDUCTION | Experimental | Intervention contains information geared toward sexual risk reduction as well as alcohol risk reduction. Receives: Behavioral: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION |
| INFORMATION-ONLY SEXUAL RISK REDUCTION | Active comparator | Intervention contains information geared toward sexual risk reduction only. Receives: Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months post-intervention
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.
Measured: 6-months post-intervention
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.
Measured: 9-months post-intervention
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.
Measured: 12-months post-intervention
Secondary outcomes (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
Measured: 3 months post-intervention
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
Measured: 6 months post-intervention
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
Measured: 9 months post-intervention
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
Measured: 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startOct 2007
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: The study did not begin and is being terminated from the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Angela D Bryan, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169922
- Sponsor's protocol ID
- NIAAA RO1 AA017390-01
- Acronym
- SHARP
- Status last verified
- Jan 2024
- First submitted
- 23 Jul 2010
- Last updated
- 10 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response
- ClinicalTrials.gov ID
- NCT01169922
- Acronym / sponsor ID
- SHARP / NIAAA RO1 AA017390-01
- Conditions
- Risk Reduction Behavior, Sexual Behavior, Health Behavior, Drinking Behavior, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not begin and is being terminated from the system.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2007 (actual)
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEXUAL PLUS ALCOHOL RISK REDUCTION | Experimental | Behavioral: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTIONIntervention contains information geared toward sexual risk reduction as well as alcohol risk reduction. |
| INFORMATION-ONLY SEXUAL RISK REDUCTION | Active comparator | Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTIONIntervention contains information geared toward sexual risk reduction only. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents age 14-18
- Involved in Juvenile Justice System OR enrolled in a private school
Key exclusion criteria (2 listed)
- Currently taking anti-psychotics
- Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTIONAlso: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION (SRRI+ETOH)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 | Behavioural | SEXUAL PLUS ALCOHOL RISK REDUCTION |
| INFORMATION-ONLY SEXUAL RISK REDUCTIONAlso: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)1 hour 30 minute long intervention; includes presentation of STD/HIV facts, video about sexually transmitted diseases, review of STD/HIV facts | Behavioural | INFORMATION-ONLY SEXUAL RISK REDUCTION |
Primary outcome
Time-Line Follow-Back (TLFB)
Time frame: 3-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.
Time-Line Follow-Back (TLFB)
Time frame: 6-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.
Time-Line Follow-Back (TLFB)
Time frame: 9-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.
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.
4 secondary outcomes
Computer questionnaire
Time frame: 3 months post-intervention
Computer questionnaire
Time frame: 6 months post-intervention
Computer questionnaire
Time frame: 9 months post-intervention
Computer questionnaire
Time frame: 12 months post-intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela D Bryan, PhD principal investigator
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION and INFORMATION-ONLY SEXUAL RISK REDUCTION in people with Risk Reduction Behavior and Sexual Behavior, run by University of New Mexico at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-Line Follow-Back (TLFB) (time frame: 3-months post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.