NCT02128594

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

April 29, 2014

Last Update Submit

May 27, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sexually Transmitted Disease

    12 month

Study Arms (1)

Standard of Care

EXPERIMENTAL

Standard of care

Behavioral: Serosorting Intervention

Interventions

Single session, behavioral intervention

Standard of Care

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men who have sex with men
  • Reside in study area (Atlanta, GA)
  • At least 18 years of age
  • Other criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SHARE Project

Atlanta, Georgia, 30308, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa A Eaton, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 1, 2014

Study Start

January 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations