HIV InfectionsPhase 2/3NCT00183573
HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic
A Phase 2/3 study testing Brief Motivational Intervention, Brief Informational Intervention and Intensive Informational Intervention in people with HIV Infections and Sexually Transmitted Diseases, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Brief Motivational Intervention, Brief Informational Intervention and Intensive Informational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,554 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2007
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug-using partner, or a partner with an STD
- Able to understand English
Who cannot join
- Psychosis or impaired mental status that would prevent participant from providing informed consent
- Have been tested for HIV within 3 months prior to study entry
- HIV infected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIV Prevention for STD Clinic Patients
This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).
Read the detailed description
Numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. Data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. This study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for HIV prevention.
At study entry, participants will undergo a physical exam, various STD tests, and a rapid HIV test, which can provide test results within several hours. While waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. Participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a DVD on safer sex. After receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention.
Two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. These participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. Participants who choose not to participate in the workshop will complete the study after receiving their STD and HIV test results. Participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for STD testing.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Brief Motivational Intervention, Brief Informational Intervention, Intensive Informational Intervention, Intensive Info-Motivation-Behavioral Skills Intervention
- Keywords
- STDs, Sexual Behavior, Health Behavior, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Sexual Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterventionBehavioural
15-20 minute, motivational one-on-one counseling
Brief Informational InterventionBehavioural
15 minute informational DVD on safer sex
Intensive Informational InterventionBehavioural
4-hour, information-only intensive group workshop
Intensive Info-Motivation-Behavioral Skills InterventionBehavioural
4-hour, intensive group workshop with emphasis on motivation and skills
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Brief Motivational Intervention only Receives: Behavioral: Brief Motivational Intervention |
| 2 | Experimental | Brief Informational Intervention only Receives: Behavioral: Brief Informational Intervention |
| 3 | Experimental | Brief Motivational Intervention + Intensive Informational Intervention Receives: Behavioral: Brief Motivational Intervention; Behavioral: Intensive Informational Intervention |
| 4 | Experimental | Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention Receives: Behavioral: Brief Motivational Intervention; Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention |
| 5 | Experimental | Brief Informational Intervention + Intensive Informational Intervention Receives: Behavioral: Brief Informational Intervention; Behavioral: Intensive Informational Intervention |
| 6 | Experimental | Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention Receives: Behavioral: Brief Informational Intervention; Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual behavior
Measured: 12 months
Secondary outcomes (1)
STD incidence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,554 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Rochester, Syracuse University
- Responsible party
- Principal investigator, Michael P. Carey, The Miriam Hospital
- Investigators
- Michael P. Carey, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183573
- Sponsor's protocol ID
- R01MH068171
- Other IDs
- R01MH068171
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention for STD Clinic Patients
- ClinicalTrials.gov ID
- NCT00183573
- Acronym / sponsor ID
- R01MH068171
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- STDs, Sexual Behavior, Health Behavior, HIV Seronegativity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,554 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Rochester, Syracuse University
- Study start
- Mar 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Sep 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.
This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).
Detailed description
Numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. Data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. This study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for HIV prevention.
At study entry, participants will undergo a physical exam, various STD tests, and a rapid HIV test, which can provide test results within several hours. While waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. Participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a DVD on safer sex. After receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention.
Two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. These participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. Participants who choose not to participate in the workshop will complete the study after receiving their STD and HIV test results. Participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for STD testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief Motivational InterventionBrief Motivational Intervention only |
| 2 | Experimental | Behavioral: Brief Informational InterventionBrief Informational Intervention only |
| 3 | Experimental | Behavioral: Brief Motivational Intervention, Behavioral: Intensive Informational InterventionBrief Motivational Intervention + Intensive Informational Intervention |
| 4 | Experimental | Behavioral: Brief Motivational Intervention, Behavioral: Intensive Info-Motivation-Behavioral Skills InterventionBrief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention |
| 5 | Experimental | Behavioral: Brief Informational Intervention, Behavioral: Intensive Informational InterventionBrief Informational Intervention + Intensive Informational Intervention |
| 6 | Experimental | Behavioral: Brief Informational Intervention, Behavioral: Intensive Info-Motivation-Behavioral Skills InterventionBrief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug-using partner, or a partner with an STD
- Able to understand English
Key exclusion criteria (3 listed)
- Psychosis or impaired mental status that would prevent participant from providing informed consent
- Have been tested for HIV within 3 months prior to study entry
- HIV infected
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 |
|---|---|---|
| Brief Motivational Intervention15-20 minute, motivational one-on-one counseling | Behavioural | 1, 3, 4 |
| Brief Informational Intervention15 minute informational DVD on safer sex | Behavioural | 2, 5, 6 |
| Intensive Informational Intervention4-hour, information-only intensive group workshop | Behavioural | 3, 5 |
| Intensive Info-Motivation-Behavioral Skills Intervention4-hour, intensive group workshop with emphasis on motivation and skills | Behavioural | 4, 6 |
Primary outcome
Sexual behavior
Time frame: 12 months
1 secondary outcome
STD incidence
Time frame: 12 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 7 Jun 2013.
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.
Michael P. Carey, PhD principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Brief Motivational Intervention, Brief Informational Intervention and Intensive Informational Intervention in people with HIV Infections and Sexually Transmitted Diseases, run by The Miriam 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 2 inclusion and 3 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 7 Jun 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Sexual behavior (time frame: 12 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 7 Jun 2013.