We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expedited Partner Therapy for MSM in Peru

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01720654
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : August 6, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner management with heterosexual patients, but note the absence of evidence necessary to make an equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess the impact of EPT on partner notification, treatment, and STI re-infection among MSM are critical to the development of evidence-based partner management guidelines.

Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may be a factor contributing to the persistently high incidence of HIV infection among MSM in the region. The investigators propose a pilot evaluation of the effect of EPT on partner notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any anatomic site.

Specific Aim 1: To explore the social norms and structural factors influencing partner notification and treatment among MSM in Peru.

Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification among MSM diagnosed with gonorrhea or chlamydia infection.

Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial re-infection among MSM randomized to receive EPT compared with standard partner notification counseling.

The proposed study will provide pilot data on the use of EPT with MSM diagnosed with gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as an STI control method among MSM in Latin America.


Condition or disease Intervention/treatment
Gonorrhea Chlamydia Behavioral: EPT

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Expedited Partner Therapy as STI Control Among MSM in Peru
Study Start Date : August 2012
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
Standardized partner notification counseling.
Experimental: EPT
Standardized partner notification counseling and provision of 5 partner treatment (EPT) packets.
Behavioral: EPT
Standardized partner notification counseling and provision of 5 partner treatment packets containing: Printed information on signs, symptoms, diagnosis, and treatment of gonorrhea and chlamydia as well as information on local testing/treatment resources; 400 mg Cefixime and 1g Azithromycin.


Outcome Measures

Primary Outcome Measures :
  1. Self-reported Partner Notification [ Time Frame: 21 Days ]
    Participant self-report of partner notification 14-21 days after randomization


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biologically male at birth
  2. 18 years of age or older
  3. Sexual contact (oral or anal intercourse) with a male or male-to-female transgender person within the past 12 months.
  4. Clinical Urethritis or proctitis OR Laboratory-diagnosed gonorrhea and/or chlamydia in any anatomic site (urethra, rectum, or oropharynx)

Exclusion Criteria:

  1. Under 18 years of age
  2. Anatomically female at birth
  3. Unable to understand study procedures or provide informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720654


Locations
Peru
Asociacion Civil Impacta Salud y Educacion
Lima, Peru
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Asociación Civil Impacta Salud y Educación, Peru
Investigators
Principal Investigator: Jesse L Clark, MD, MSc University of California, Los Angeles
Principal Investigator: Thomas J Coates, PhD University of California, Los Angeles
More Information

Responsible Party: Jesse Clark, Assistant Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01720654     History of Changes
Other Study ID Numbers: R21MH092232 ( U.S. NIH Grant/Contract )
IMP-478-2012 ( Other Identifier: Instituto Nacional de Salud del Peru )
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

Keywords provided by Jesse Clark, University of California, Los Angeles:
Expedited Partner Therapy
MSM
Peru
Gonorrhea
Chlamydia

Additional relevant MeSH terms:
Chlamydia Infections
Gonorrhea
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections