Sexually Transmitted InfectionsNCT01198418
A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)
A study testing Experimental in people with Sexually Transmitted Infections and HIV Infections, run by University of California, San Diego at 3 sites in United States.
Trial summary
This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sexually Transmitted Infections, HIV Infections
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jul 2010to 9 Nov 2017
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western Blot are not available, HIV infection may be documented by two HIV RNA values > 2000 copies/mL, drawn at least 24 hours apart. The HIV RNA assays should have been run at a CLIA approved laboratory or equivalent.
- 18 years of age or older.
- Male.
- At least one of the following:
- An HIV negative or unknown status sexual partner in the past three months.
- A sexually transmitted disease in the past 1 year (other than HIV).
Show all 11Show fewer
- More than 2 male partners in past year.
- Unprotected anal sex in past 3 month.
- Capable of signing written informed consent.
- Read and comprehend English
- Adequate computer skills for study.
Who cannot join
- Uncontrolled psychiatric condition.
- Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Southern California
Los Angeles, California, 90033
University of California, San Diego
San Diego, California, 92103
University of California, Los Angeles (Harbor)
Torrance, California, 90502
About this study
Official title: A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM
This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate contact (sexually transmitted infection (STI)). STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop methods that will allow someone who is living with HIV an easy way that they can get information and learn of ways on their own that can decrease their chances of getting sexually transmitted infections and ways that they can reduce the chance that they may transmit HIV to others.
Read the detailed description
Design: CCTG 592 is a randomized, controlled study that will compare the efficacy of web-based intervention to reduce high-risk sexual behavior by persons living with HIV AIDS (PLWH).
Duration: 48 weeks
Sample Size: 200 subjects (100 per arm) that will be randomized
Study Population: HIV-1-infected men who have sex with men (MSM) at least 18 years of age who have a recent history of transmission risk behavior.
Stratification: Subjects will be stratified based upon their baseline antiretroviral use, whether they have a home computer and by site.
- Conditions
- Sexually Transmitted Infections, HIV Infections
- Being tested
- Experimental
- Keywords
- STI, MSM, HIV, Prevention, Men having sex with men
- Medical subject headings
- Sexually Transmitted Diseases, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
Internet-based intervention that assesses transmission risk and provides prevention messages
| Study group | Role | What they receive |
|---|---|---|
| Internet-based counseling | Experimental | Completes surveys monthly about their sexual and drug use behaviors as well as receives information designed to help reduce the chances of getting an STI. Receives: Behavioral: Experimental |
| Survey Alone | No intervention | Completes surveys monthly about their sexual and drug use behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
STI incidence
- To compare the composite STI incidence of syphilis or Chlamydia trachomatis (CT) or Neisseria gonorrhea (GC) at any mucosal site among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.
- To compare the incidence of nonspecific urethritis by urinalysis and testing for Mycoplasma genitalum and trichomonas sp. among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.
Measured: Baseline and follow-up visits every 3 months
Secondary outcomes (1)
Evaluate risk factors of STIs
- Compare:a)self reported levels of unsafe sex among HIV-infected men b)intention to start ARV among HIV-infected men not currently on ARV will increase during 12 mos. participation in an internet risk reduction intervention compared to survey instrument alone
- Compare self-reported among HIV-infected men during 12 mos. participation as measured by those reporting 100% disclosure in an internet risk reduction intervention compared to survey instrument alone
- Collect genital tract secretions of semen for future study
Measured: Baseline, follow-up visits every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study start9 Jul 2010
- Primary completion18 Oct 2017
- Study completion9 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Southern California, California HIV/AIDS Research Program
- Responsible party
- Principal investigator, Sheldon Morris, University of California, San Diego
- Investigators
- Sheldon Morris, MD, MPh, Principal investigator, UC San Diego AntiViral Research Center (AVRC)Joel Milam, PhD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198418
- Sponsor's protocol ID
- CCTG 592
- Status last verified
- May 2020
- First submitted
- 8 Sep 2010
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM
- ClinicalTrials.gov ID
- NCT01198418
- Acronym / sponsor ID
- CCTG 592
- Conditions
- Sexually Transmitted Infections, HIV Infections
- Keywords
- STI, MSM, HIV, Prevention, Men having sex with men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Southern California, California HIV/AIDS Research Program
- Study start
- 9 Jul 2010 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 10 Sep 2010 (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 is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate contact (sexually transmitted infection (STI)). STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop methods that will allow someone who is living with HIV an easy way that they can get information and learn of ways on their own that can decrease their chances of getting sexually transmitted infections and ways that they can reduce the chance that they may transmit HIV to others.
Detailed description
Design: CCTG 592 is a randomized, controlled study that will compare the efficacy of web-based intervention to reduce high-risk sexual behavior by persons living with HIV AIDS (PLWH).
Duration: 48 weeks
Sample Size: 200 subjects (100 per arm) that will be randomized
Study Population: HIV-1-infected men who have sex with men (MSM) at least 18 years of age who have a recent history of transmission risk behavior.
Stratification: Subjects will be stratified based upon their baseline antiretroviral use, whether they have a home computer and by site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based counseling | Experimental | Behavioral: ExperimentalCompletes surveys monthly about their sexual and drug use behaviors as well as receives information designed to help reduce the chances of getting an STI. |
| Survey Alone | No intervention | –Completes surveys monthly about their sexual and drug use behaviors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western Blot are not available, HIV infection may be documented by two HIV RNA values > 2000 copies/mL, drawn at least 24 hours apart. The HIV RNA assays should have been run at a CLIA approved laboratory or equivalent.
- 18 years of age or older.
- Male.
- At least one of the following:
- An HIV negative or unknown status sexual partner in the past three months.
Key exclusion criteria (2 listed)
- Uncontrolled psychiatric condition.
- Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent
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 |
|---|---|---|
| ExperimentalInternet-based intervention that assesses transmission risk and provides prevention messages | Behavioural | Internet-based counseling |
Primary outcome
STI incidence
Time frame: Baseline and follow-up visits every 3 months
* To compare the composite STI incidence of syphilis or Chlamydia trachomatis (CT) or Neisseria gonorrhea (GC) at any mucosal site among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone. * To compare the incidence of nonspecific urethritis by urinalysis and testing for Mycoplasma genitalum and trichomonas sp. among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.
1 secondary outcome
Evaluate risk factors of STIs
Time frame: Baseline, follow-up visits every 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 12 May 2020.
- (organization's website)Link provided by the sponsor.
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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.
Sheldon Morris, MD, MPh principal investigator
UC San Diego AntiViral Research Center (AVRC)
Joel Milam, PhD study chair
University of California, San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Sexually Transmitted Infections and HIV Infections, run by University of California, San Diego at 3 sites 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 11 inclusion and 2 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
STI incidence (time frame: Baseline and follow-up visits every 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 12 May 2020.