AzTrials
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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • SHARE Project

    Atlanta, Georgia, 30308

Other trials in United States

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 groups in NCT02128594
Study groupRoleWhat they receive
Standard of CareExperimentalStandard of care
Receives: Behavioral: Serosorting Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted1 May 2014 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

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)
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

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.

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