Sexual Risk BehaviorNCT00914719
Alcohol Use and Sexual Risk: An Intervention
A study testing Information only, Sexual risk reduction intervention and sexual risk reduction + alcohol risk reduction component in people with Sexual Risk Behavior and Alcohol Use, run by University of New Mexico at 1 site in United States.
Trial summary
Adolescents are at great risk for sexually transmitted diseases (STDs) including the human immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo \& Whaley, 1999). Though the CDC (2000b) reports that overall AIDS incidence is on the decline, there has been no comparable decline in the number of newly diagnosed HIV cases… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Risk Behavior, Alcohol Use, Drug Use
- What is being tested?
- Information only, Sexual risk reduction intervention and sexual risk reduction + alcohol risk reduction component
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2002
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All young people between the ages of 14 and 17 who were in the detention centers at which recruitment took place.
Who cannot join
- Age less than 14 or non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Adolescents are at great risk for sexually transmitted diseases (STDs) including the human immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo \& Whaley, 1999). Though the CDC (2000b) reports that overall AIDS incidence is on the decline, there has been no comparable decline in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of color are particularly at risk. Compared to the general adolescent population, adolescents involved with the criminal justice system are younger at first intercourse, have a greater number of sex partners, and lower rates of condom use, resulting in higher rates of unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly cited as a reason for lack of condom use among high-risk adolescents such as those involved in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research suggests that it is heavy alcohol use in concert with sexual activity that is most strongly related to lack of condom use (Bryan, Rocheleau, \& Robbins, 2002a). The goal of this research is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction intervention that is theory-based, empirically targeted to adolescents, and articulated to a criminal justice setting. The study compares a sexual risk reduction intervention with a group motivational interviewing alcohol component to a standard sexual risk reduction intervention and a no treatment control condition. The investigators hope to show that: 1) A three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol risk reduction intervention will result in larger decreases in sexual risk behavior than a sexual risk reduction alone, 3) The interventions will exert their effects through changes in mediators derived from a theoretically-based model of condom use intentions and behaviors, and 4) A sexual risk reduction intervention including an alcohol component will be especially effective for those adolescents with higher levels of existing alcohol problems. Finally, given proven efficacy, the intervention curricula and materials will be disseminated for use in adolescent detention facilities throughout the state.
- Conditions
- Sexual Risk Behavior, Alcohol Use, Drug Use
- Being tested
- Information only, Sexual risk reduction intervention, sexual risk reduction + alcohol risk reduction component
- Keywords
- sexual risk behavior among adolescents, alcohol and drug use among adolescents
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information onlyBehavioural
Sexual risk reduction interventionBehavioural
sexual risk reduction + alcohol risk reduction componentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Information only | Active comparator | Not described Receives: Behavioral: Information only |
| sexual risk reduction intervention | Active comparator | Not described Receives: Behavioral: Sexual risk reduction intervention |
| SRRI+ETOH | Experimental | Not described Receives: Behavioral: sexual risk reduction + alcohol risk reduction component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom use
Measured: one year
Secondary outcomes (1)
alcohol use
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startSep 2002
- Primary completionSep 2002
- Study completionSep 2002
Why it stopped: PI left the institution and no subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual Risk 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
- Prevention
- Intervention model
- Factorial
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914719
- Sponsor's protocol ID
- R01AA013844-01
- Status last verified
- Jan 2024
- First submitted
- 3 Jun 2009
- Last updated
- 11 Jan 2024
- Results posted
- No
Publications
Bryan A, Schmiege SJ, Broaddus MR. Mediational analysis in HIV/AIDS research: estimating multivariate path analytic models in a structural equation modeling framework. AIDS Behav. 2007 May;11(3):365-83. doi: 10.1007/s10461-006-9150-2.
PubMed 16917669Schmiege SJ, Broaddus MR, Levin M, Bryan AD. Randomized trial of group interventions to reduce HIV/STD risk and change theoretical mediators among detained adolescents. J Consult Clin Psychol. 2009 Feb;77(1):38-50. doi: 10.1037/a0014513.
PubMed 19170452Bryan AD, Schmiege SJ, Broaddus MR. HIV risk reduction among detained adolescents: a randomized, controlled trial. Pediatrics. 2009 Dec;124(6):e1180-8. doi: 10.1542/peds.2009-0679. Epub 2009 Nov 9.
PubMed 19901006
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Use and Sexual Risk: An Intervention
- ClinicalTrials.gov ID
- NCT00914719
- Acronym / sponsor ID
- R01AA013844-01
- Conditions
- Sexual Risk Behavior, Alcohol Use, Drug Use
- Keywords
- sexual risk behavior among adolescents, alcohol and drug use among adolescents
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution and no subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Sep 2002 (actual)
- Primary completion
- Sep 2002 (actual)
- Study completion
- Sep 2002 (actual)
- First posted
- 5 Jun 2009 (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.
Adolescents are at great risk for sexually transmitted diseases (STDs) including the human immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo \& Whaley, 1999). Though the CDC (2000b) reports that overall AIDS incidence is on the decline, there has been no comparable decline in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of color are particularly at risk. Compared to the general adolescent population, adolescents involved with the criminal justice system are younger at first intercourse, have a greater number of sex partners, and lower rates of condom use, resulting in higher rates of unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly cited as a reason for lack of condom use among high-risk adolescents such as those involved in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research suggests that it is heavy alcohol use in concert with sexual activity that is most strongly related to lack of condom use (Bryan, Rocheleau, \& Robbins, 2002a). The goal of this research is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction intervention that is theory-based, empirically targeted to adolescents, and articulated to a criminal justice setting. The study compares a sexual risk reduction intervention with a group motivational interviewing alcohol component to a standard sexual risk reduction intervention and a no treatment control condition. The investigators hope to show that: 1) A three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol risk reduction intervention will result in larger decreases in sexual risk behavior than a sexual risk reduction alone, 3) The interventions will exert their effects through changes in mediators derived from a theoretically-based model of condom use intentions and behaviors, and 4) A sexual risk reduction intervention including an alcohol component will be especially effective for those adolescents with higher levels of existing alcohol problems. Finally, given proven efficacy, the intervention curricula and materials will be disseminated for use in adolescent detention facilities throughout the state.
Study design
- Primary purpose
- Prevention
- Intervention model
- Factorial
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Information only | Active comparator | Behavioral: Information only |
| sexual risk reduction intervention | Active comparator | Behavioral: Sexual risk reduction intervention |
| SRRI+ETOH | Experimental | Behavioral: sexual risk reduction + alcohol risk reduction component |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All young people between the ages of 14 and 17 who were in the detention centers at which recruitment took place.
Key exclusion criteria (1 listed)
- Age less than 14 or non-English speaking
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 |
|---|---|---|
| Information only | Behavioural | Information only |
| Sexual risk reduction intervention | Behavioural | sexual risk reduction intervention |
| sexual risk reduction + alcohol risk reduction component | Behavioural | SRRI+ETOH |
Primary outcome
Condom use
Time frame: one year
1 secondary outcome
alcohol use
Time frame: one year
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 11 Jan 2024.
- Background: PubMed 16917669Bryan A, Schmiege SJ, Broaddus MR. Mediational analysis in HIV/AIDS research: estimating multivariate path analytic models in a structural equation modeling framework. AIDS Behav. 2007 May;11(3):365-83. doi: 10.1007/s10461-006-9150-2.
- Results publication: PubMed 19170452Schmiege SJ, Broaddus MR, Levin M, Bryan AD. Randomized trial of group interventions to reduce HIV/STD risk and change theoretical mediators among detained adolescents. J Consult Clin Psychol. 2009 Feb;77(1):38-50. doi: 10.1037/a0014513.
- Derived from this study: PubMed 19901006Bryan AD, Schmiege SJ, Broaddus MR. HIV risk reduction among detained adolescents: a randomized, controlled trial. Pediatrics. 2009 Dec;124(6):e1180-8. doi: 10.1542/peds.2009-0679. Epub 2009 Nov 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information only, Sexual risk reduction intervention and sexual risk reduction + alcohol risk reduction component in people with Sexual Risk Behavior and Alcohol Use, run by University of New Mexico at 1 site 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 1 inclusion and 1 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 11 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 1 site 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?
Condom use (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00914719, which also lists 3 linked publications.
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 11 Jan 2024.