Sexually Transmitted DiseasesGET UPNCT00831883
Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents
A study testing Partner-Specific IMB-based HIV risk reduction intervention and Healthy Lifestyle in people with Sexually Transmitted Diseases and Substance-Related Disorders, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Sexually Transmitted Diseases, Substance-Related Disorders
- What is being tested?
- Partner-Specific IMB-based HIV risk reduction intervention and Healthy Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2011
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English-speaking ability
- unprotected vaginal, anal, or oral intercourse at least once in the 6 months prior to incarceration or placement
- marijuana use disorders, other non-injection drug use disorders, or substance use by a sexual partner during a sexual episode in the six months prior to incarceration or placement
- sentence or placement length between 2 and 12 months
- must plan to remain in the area for the 6 months following their release from the facility
- must be willing to provide two pieces of contact information for follow-up
Who cannot join
- signs of psychosis (assessed through clinical assessment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: Partner-Specific HIV Risk Reduction Intervention for Drug-Using Incarcerated Adolescents
The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use.
Read the detailed description
Incarcerated adolescents represent a group at high risk for health consequences associated with risky sexual behaviors. Condom use is more common with non-main than main sex partners and substance use in conjunction with sexual risk also appears to vary by partner type. The research team will conduct a small randomized trial to pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use. Participants will be randomized to a 5 session HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model, or a 5 session healthy lifestyles psychoeducation intervention, and then reassessed 3 months after their access to the general community is reinstated. The main hypothesis is that participants in the HIV risk reduction intervention condition will have lower levels of sex-related HIV risk behavior and of substance use in conjunction with sexual risk, relative to those in a healthy lifestyles psychoeducation intervention.
- Being tested
- Partner-Specific IMB-based HIV risk reduction intervention, Healthy Lifestyle
- Keywords
- Adolescent, Adolescent behavior, Health behavior, Sexual Behavior, Incarceration, Behavioral Intervention, Risk Reduction Behavior
- Medical subject headings
- Sexually Transmitted Diseases, Substance-Related Disorders, Adolescent Behavior, Health Behavior, Sexual Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner-Specific IMB-based HIV risk reduction interventionBehavioural
5 session partner-specific HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model.
Healthy LifestyleBehavioural
5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills.
| Study group | Role | What they receive |
|---|---|---|
| Partner Specific IMB | Experimental | partner-specific HIV risk reduction intervention Receives: Behavioral: Partner-Specific IMB-based HIV risk reduction intervention |
| HLS | Placebo comparator | 5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills. Receives: Behavioral: Healthy Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower levels of sex-related HIV risk behavior
Measured: 3 months
Secondary outcomes (4)
knowledge about STI transmission
Measured: 3 months
partner-specific perceptions of STI risks
Measured: 3 months
social norms, expectations and personal attitudes regarding partner-specific sexual behavior
Measured: 3 months
partner-specific behavioral and communication skills
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rhode Island
- Responsible party
- Principal investigator, Cynthia Rosengard, Women and Infants Hospital of Rhode Island
- Investigators
- Cynthia Rosengard, PhD, MPH, Principal investigator, Women & Infants of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831883
- Sponsor's protocol ID
- 08-0128
- Other IDs
- R01DA022921-03
- Acronym
- GET UP
- Status last verified
- Dec 2012
- First submitted
- 28 Jan 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partner-Specific HIV Risk Reduction Intervention for Drug-Using Incarcerated Adolescents
- ClinicalTrials.gov ID
- NCT00831883
- Acronym / sponsor ID
- GET UP / 08-0128
- Keywords
- Adolescent, Adolescent behavior, Health behavior, Sexual Behavior, Incarceration, Behavioral Intervention, Risk Reduction Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- University of Rhode Island
- Study start
- Feb 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Jan 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.
The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use.
Detailed description
Incarcerated adolescents represent a group at high risk for health consequences associated with risky sexual behaviors. Condom use is more common with non-main than main sex partners and substance use in conjunction with sexual risk also appears to vary by partner type. The research team will conduct a small randomized trial to pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use. Participants will be randomized to a 5 session HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model, or a 5 session healthy lifestyles psychoeducation intervention, and then reassessed 3 months after their access to the general community is reinstated. The main hypothesis is that participants in the HIV risk reduction intervention condition will have lower levels of sex-related HIV risk behavior and of substance use in conjunction with sexual risk, relative to those in a healthy lifestyles psychoeducation intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partner Specific IMB | Experimental | Behavioral: Partner-Specific IMB-based HIV risk reduction interventionpartner-specific HIV risk reduction intervention |
| HLS | Placebo comparator | Behavioral: Healthy Lifestyle5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- English-speaking ability
- unprotected vaginal, anal, or oral intercourse at least once in the 6 months prior to incarceration or placement
- marijuana use disorders, other non-injection drug use disorders, or substance use by a sexual partner during a sexual episode in the six months prior to incarceration or placement
- sentence or placement length between 2 and 12 months
- must plan to remain in the area for the 6 months following their release from the facility
Key exclusion criteria (1 listed)
- signs of psychosis (assessed through clinical assessment)
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 |
|---|---|---|
| Partner-Specific IMB-based HIV risk reduction intervention5 session partner-specific HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model. | Behavioural | Partner Specific IMB |
| Healthy Lifestyle5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills. | Behavioural | HLS |
Primary outcome
lower levels of sex-related HIV risk behavior
Time frame: 3 months
4 secondary outcomes
knowledge about STI transmission
Time frame: 3 months
partner-specific perceptions of STI risks
Time frame: 3 months
social norms, expectations and personal attitudes regarding partner-specific sexual behavior
Time frame: 3 months
partner-specific behavioral and communication skills
Time frame: 3 months
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 5 Dec 2012.
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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.
Cynthia Rosengard, PhD, MPH principal investigator
Women & Infants of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner-Specific IMB-based HIV risk reduction intervention and Healthy Lifestyle in people with Sexually Transmitted Diseases and Substance-Related Disorders, run by Women and Infants Hospital of Rhode Island 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 6 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: finished, as of the sponsor's last update on 5 Dec 2012. 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. Some participants in this study may receive a placebo. 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 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?
lower levels of sex-related HIV risk behavior (time frame: 3 months). 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 5 Dec 2012.