Sexually Transmitted DiseasesNCT00260780
An STD Prevention Intervention for Men Newly Released From Jail
A study testing The MISTERS Intervention for Post Jail Release Men in people with Sexually Transmitted Diseases and Risk Behavior, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Risk Behavior
- What is being tested?
- The MISTERS Intervention for Post Jail Release Men
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Jun 2004
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18 to 60, English speaking, not in jail for sexual offenses (rape or child molestation), reported risk behavior in two months prior to incarceration, weekday and evening availability, viable contact information, self-reported HIV negative status, released from jail no more than 45 days prior, and not visibly under the influence of drugs or alcohol at the time of eligibility determination
Who cannot join
- Opposite of the above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The MISTERS Project: An STD Prevention Intervention for Men Newly Released From Jail
Study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking activities, than the participants in the control group
Read the detailed description
The MISTERS study is a randomized control trial of a cognitive-behavioral skill building multi-session intervention that targets men who are newly released from jail and have a history of drug use. Men 45 days or less post release with self reported HIV negative and substance use histories were randomized into either a 5-session intervention or control group. Study participation included four time-sensitive interviews and STD testing at three time periods. The interview questions included demographics, STD history and knowledge, sexual risk behaviors, as well as an assessment of anger management, communication, and condom use skills.
- Conditions
- Sexually Transmitted Diseases, Risk Behavior
- Being tested
- The MISTERS Intervention for Post Jail Release Men
- Keywords
- sexually transmitted diseases, Risk Behavior
- Medical subject headings
- Sexually Transmitted Diseases, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MISTERS Intervention for Post Jail Release MenBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in risk behaviors
Secondary outcomes (1)
Reported STDs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startJun 2001
- Study completionJun 2004
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- STAND, Inc.
- Investigators
- Samantha P Williams, Ph.D., Study chair, CDC/NCHSTP/DSTDP/BIRBCharles Sperling, M.S., Principal investigator, STAND, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260780
- Sponsor's protocol ID
- CDC-NCHSTP-3728
- Other IDs
- U52/CCU422491, H25/CCH404332-11
- Status last verified
- Dec 2005
- First submitted
- 1 Dec 2005
- Last updated
- 2 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MISTERS Project: An STD Prevention Intervention for Men Newly Released From Jail
- ClinicalTrials.gov ID
- NCT00260780
- Acronym / sponsor ID
- CDC-NCHSTP-3728
- Conditions
- Sexually Transmitted Diseases, Risk Behavior
- Keywords
- sexually transmitted diseases, Risk Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- STAND, Inc.
- Study start
- Jun 2001
- Study completion
- Jun 2004
- First posted
- 2 Dec 2005 (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.
Study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking activities, than the participants in the control group
Detailed description
The MISTERS study is a randomized control trial of a cognitive-behavioral skill building multi-session intervention that targets men who are newly released from jail and have a history of drug use. Men 45 days or less post release with self reported HIV negative and substance use histories were randomized into either a 5-session intervention or control group. Study participation included four time-sensitive interviews and STD testing at three time periods. The interview questions included demographics, STD history and knowledge, sexual risk behaviors, as well as an assessment of anger management, communication, and condom use skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ages 18 to 60, English speaking, not in jail for sexual offenses (rape or child molestation), reported risk behavior in two months prior to incarceration, weekday and evening availability, viable contact information, self-reported HIV negative status, released from jail no more than 45 days prior, and not visibly under the influence of drugs or alcohol at the time of eligibility determination
Key exclusion criteria (1 listed)
- Opposite of the above
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 |
|---|---|---|
| The MISTERS Intervention for Post Jail Release Men | Behavioural | – |
Primary outcome
Change in risk behaviors
1 secondary outcome
Reported STDs
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 2 Dec 2005.
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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.
Samantha P Williams, Ph.D. study chair
CDC/NCHSTP/DSTDP/BIRB
Charles Sperling, M.S. principal investigator
STAND, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MISTERS Intervention for Post Jail Release Men in people with Sexually Transmitted Diseases and Risk Behavior, run by Centers for Disease Control and Prevention 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: finished, as of the sponsor's last update on 2 Dec 2005. 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 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?
Change in risk behaviors. 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 2 Dec 2005.