STDsNCT02128594
Serosorting Intervention for HIV Negative MSM
A study testing Serosorting Intervention in people with STDs, run by University of Connecticut at 1 site in United States.
Trial summary
Men who have sex with men make up a majority of incident HIV infections, however few effective interventions to prevent HIV transmission among this group exist. African American men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is understood about how the role of stigma impacts… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- STDs
- What is being tested?
- Serosorting Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men who have sex with men
- Reside in study area (Atlanta, GA)
- At least 18 years of age
- Other criteria may apply
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Men who have sex with men make up a majority of incident HIV infections, however few effective interventions to prevent HIV transmission among this group exist. African American men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is understood about how the role of stigma impacts their linkage and retention to health care during treatment. Effective strategies for reducing HIV related risk taking are urgently needed to prevent further spread of the HIV epidemic. The proposed research will test a behavioral intervention, which can be used during routine public health services, designed to reduce HIV risks posed by sexual partner selection strategies. The proposed research will also identify treatment barriers among MSM who test HIV/STI positive. Effective strategies for reducing social barriers to health care treatment rely on a comprehensive and thorough investigation into social barriers that affect AAMSM to effectively engage in medical care. These areas of research will be focused on for the current trial.
Read the detailed description
Men who have sex with men continue to make up a majority of incident HIV infections. Despite alarmingly high rates of HIV infection, there are few effective interventions to prevent HIV transmission among these men. This five year study, proposed by a New/Early Stage Investigator, consists of a randomized controlled trial to test a behavioral intervention designed to reduce risks for HIV/AIDS posed by sexual partner selection strategies, specifically serosorting, among at-risk HIV negative men who have sex with men in Atlanta, GA. Serosorting - limiting unprotected sexual partners to those of the same HIV status- has emerged as a risk reduction strategy with little input from public health agencies. It is commonly practiced among men who have sex with men to avoid HIV infection. However, engaging in serosorting is a predictor of HIV transmission rather than a reliable form of prevention. Serosorting is ineffective due to several factors, including: multiple flaws in the ability to be certain of own or partner's HIV statuses, the failure of routine HIV tests to detect acute HIV infection, elevated infectiousness due to acute HIV infection, and increased risk for contracting other STIs that can facilitate HIV transmission. We are therefore proposing to test a brief, single-session, Conflict Theory of Decision Making based intervention for use in public health settings. This project uses a novel theory of informed decision making to guide an intervention designed for use in routine services, i.e., HIV post-test counseling. An intervention to address the needs of men who test HIV negative fits well with current efforts to scale up HIV testing, also referred to as seek, test and treat. The proposed research builds on the strengths of a pilot tested, behavioral intervention for addressing serosorting among men who have sex with men. Following screening, informed consent, baseline assessments, and HIV testing (we predict 70 men will test HIV positive), 600 HIV-negative participants will be randomly assigned to receive one of two intervention arms: (a) a serosorting, partner selection intervention, or (b) a time-match, CDC based, post-HIV test counseling, standard-of-care. Participants will be followed over 12-months and assessments will include measures of serosorting beliefs, decisional balance, knowledge of acute HIV infection, HIV status disclosure, and biological (incident STI) and behavioral outcomes (sexual behaviors). This study will test the hypotheses that a brief, single session, serosorting intervention will result in less risk-related serosorting beliefs, greater knowledge/awareness of HIV transmission risk taking, increased HIV status disclosure, reductions in number of sex partners, unprotected sex acts, and incident STIs among intervention participants more so than the control group participants. Moreover, we will test the hypothesis that the intervention will be cost saving when tested in cost-effectiveness analyses. If shown effective, the intervention model will be ready for immediate dissemination to HIV testing services. In a subset of participants, we will test how stigma affects linkage, engagement and retention in care for participants who test HIV/STI positive.
- Conditions
- STDs
- Being tested
- Serosorting Intervention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serosorting InterventionBehavioural
Single session, behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Experimental | Standard of care Receives: Behavioral: Serosorting Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexually Transmitted Disease
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2015
- Study completionApr 2015
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 STDsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Lisa A Eaton, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128594
- Sponsor's protocol ID
- H10-299
- Other IDs
- R01MH094230
- Status last verified
- May 2015
- First submitted
- 29 Apr 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eaton LA, Kalichman SC, Kalichman MO, Driffin DD, Baldwin R, Zohren L, Conway-Washington C. Randomised controlled trial of a sexual risk reduction intervention for STI prevention among men who have sex with men in the USA. Sex Transm Infect. 2018 Feb;94(1):40-45. doi: 10.1136/sextrans-2016-052835. Epub 2017 Apr 12.
PubMed 28404766
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serosorting Intervention for HIV Negative MSM
- ClinicalTrials.gov ID
- NCT02128594
- Acronym / sponsor ID
- H10-299
- Conditions
- STDs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 May 2014 (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.
Men who have sex with men make up a majority of incident HIV infections, however few effective interventions to prevent HIV transmission among this group exist. African American men who have sex with men (AAMSM) are disproportionately infected with STI/HIV and little is understood about how the role of stigma impacts their linkage and retention to health care during treatment. Effective strategies for reducing HIV related risk taking are urgently needed to prevent further spread of the HIV epidemic. The proposed research will test a behavioral intervention, which can be used during routine public health services, designed to reduce HIV risks posed by sexual partner selection strategies. The proposed research will also identify treatment barriers among MSM who test HIV/STI positive. Effective strategies for reducing social barriers to health care treatment rely on a comprehensive and thorough investigation into social barriers that affect AAMSM to effectively engage in medical care. These areas of research will be focused on for the current trial.
Detailed description
Men who have sex with men continue to make up a majority of incident HIV infections. Despite alarmingly high rates of HIV infection, there are few effective interventions to prevent HIV transmission among these men. This five year study, proposed by a New/Early Stage Investigator, consists of a randomized controlled trial to test a behavioral intervention designed to reduce risks for HIV/AIDS posed by sexual partner selection strategies, specifically serosorting, among at-risk HIV negative men who have sex with men in Atlanta, GA. Serosorting - limiting unprotected sexual partners to those of the same HIV status- has emerged as a risk reduction strategy with little input from public health agencies. It is commonly practiced among men who have sex with men to avoid HIV infection. However, engaging in serosorting is a predictor of HIV transmission rather than a reliable form of prevention. Serosorting is ineffective due to several factors, including: multiple flaws in the ability to be certain of own or partner's HIV statuses, the failure of routine HIV tests to detect acute HIV infection, elevated infectiousness due to acute HIV infection, and increased risk for contracting other STIs that can facilitate HIV transmission. We are therefore proposing to test a brief, single-session, Conflict Theory of Decision Making based intervention for use in public health settings. This project uses a novel theory of informed decision making to guide an intervention designed for use in routine services, i.e., HIV post-test counseling. An intervention to address the needs of men who test HIV negative fits well with current efforts to scale up HIV testing, also referred to as seek, test and treat. The proposed research builds on the strengths of a pilot tested, behavioral intervention for addressing serosorting among men who have sex with men. Following screening, informed consent, baseline assessments, and HIV testing (we predict 70 men will test HIV positive), 600 HIV-negative participants will be randomly assigned to receive one of two intervention arms: (a) a serosorting, partner selection intervention, or (b) a time-match, CDC based, post-HIV test counseling, standard-of-care. Participants will be followed over 12-months and assessments will include measures of serosorting beliefs, decisional balance, knowledge of acute HIV infection, HIV status disclosure, and biological (incident STI) and behavioral outcomes (sexual behaviors). This study will test the hypotheses that a brief, single session, serosorting intervention will result in less risk-related serosorting beliefs, greater knowledge/awareness of HIV transmission risk taking, increased HIV status disclosure, reductions in number of sex partners, unprotected sex acts, and incident STIs among intervention participants more so than the control group participants. Moreover, we will test the hypothesis that the intervention will be cost saving when tested in cost-effectiveness analyses. If shown effective, the intervention model will be ready for immediate dissemination to HIV testing services. In a subset of participants, we will test how stigma affects linkage, engagement and retention in care for participants who test HIV/STI positive.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Experimental | Behavioral: Serosorting InterventionStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men who have sex with men
- Reside in study area (Atlanta, GA)
- At least 18 years of age
- Other criteria may apply
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Serosorting InterventionSingle session, behavioral intervention | Behavioural | Standard of Care |
Primary outcome
Sexually Transmitted Disease
Time frame: 12 month
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 28 May 2015.
- Derived from this study: PubMed 28404766Eaton LA, Kalichman SC, Kalichman MO, Driffin DD, Baldwin R, Zohren L, Conway-Washington C. Randomised controlled trial of a sexual risk reduction intervention for STI prevention among men who have sex with men in the USA. Sex Transm Infect. 2018 Feb;94(1):40-45. doi: 10.1136/sextrans-2016-052835. Epub 2017 Apr 12.
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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.
Lisa A Eaton, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serosorting Intervention in people with STDs, run by University of Connecticut 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 4 inclusion and 0 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 28 May 2015. 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?
Sexually Transmitted Disease (time frame: 12 month). 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 NCT02128594, 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 28 May 2015.