HIV InfectionsPhase 1Project STARNCT00603369
HIV, Abuse, and Psychiatric Disorders Among Youth
A Phase 1 study testing group intervention in people with HIV Infections, run by Rhode Island Hospital at 1 site in United States.
Trial summary
One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Dec 2007
- Phase
- Phase 1
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent attending therapeutic school
Who cannot join
- Adolescent is HIV positive
- Adolescent is developmentally delayed
- Adolescent is pregnant
- Adolescent has a history of sexual crime
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. This study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. It is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest than peers in an information-based intervention.
- Conditions
- HIV Infections
- Being tested
- group intervention
- Keywords
- HIV prevention, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group interventionBehavioural
13-session intervention
group interventionBehavioural
2-session intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training. Receives: Behavioral: group intervention |
| 2 | Active comparator | 2 session group intervention including sexual health information training. Receives: Behavioral: group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
condom use
Measured: 1 year
Secondary outcomes (3)
scores on HIV knowledge questionnaire
Measured: 1 year
number of sexual partners
Measured: 1 year
scores on measure of attitudes toward condom use
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startSep 1999
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Larry K. Brown, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603369
- Sponsor's protocol ID
- R01MH061149
- Other IDs
- R01MH061149
- Acronym
- Project STAR
- Status last verified
- Feb 2009
- First submitted
- 16 Jan 2008
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. doi: 10.1016/j.jaac.2011.06.018. Epub 2011 Aug 27.
PubMed 21961780
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV, Abuse, and Psychiatric Disorders Among Youth
- ClinicalTrials.gov ID
- NCT00603369
- Acronym / sponsor ID
- Project STAR / R01MH061149
- Conditions
- HIV Infections
- Keywords
- HIV prevention, HIV seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Jan 2008 (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.
One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. This study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. It is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest than peers in an information-based intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: group intervention13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training. |
| 2 | Active comparator | Behavioral: group intervention2 session group intervention including sexual health information training. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent attending therapeutic school
Key exclusion criteria (4 listed)
- Adolescent is HIV positive
- Adolescent is developmentally delayed
- Adolescent is pregnant
- Adolescent has a history of sexual crime
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 |
|---|---|---|
| group intervention13-session intervention | Behavioural | 1 |
| group intervention2-session intervention | Behavioural | 2 |
Primary outcome
condom use
Time frame: 1 year
3 secondary outcomes
scores on HIV knowledge questionnaire
Time frame: 1 year
number of sexual partners
Time frame: 1 year
scores on measure of attitudes toward condom use
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
- Derived from this study: PubMed 21961780Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. doi: 10.1016/j.jaac.2011.06.018. Epub 2011 Aug 27.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Larry K. Brown, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing group intervention in people with HIV Infections, run by Rhode Island Hospital 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 4 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: finished, as of the sponsor's last update on 6 Feb 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 1 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 NCT00603369, which also lists 1 linked publication.
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 6 Feb 2009.