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Expedited Partner Therapy for MSM in Peru

This study has been completed.
Sponsor:
Collaborators:
Asociación Civil Impacta Salud y Educación, Peru
Information provided by (Responsible Party):
Jesse Clark, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01720654
First received: October 29, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention
Gonorrhea
Chlamydia
Behavioral: EPT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Expedited Partner Therapy as STI Control Among MSM in Peru

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Self-reported Partner Notification [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    Participant self-report of partner notification 14-21 days after randomization


Enrollment: 165
Study Start Date: August 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720654

Locations
Peru
Asociacion Civil Impacta Salud y Educacion
Lima, Peru
Sponsors and Collaborators
University of California, Los Angeles
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

No publications provided

Responsible Party: Jesse Clark, Assistant Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01720654     History of Changes
Other Study ID Numbers: R21 MH092232, IMP-478-2012, R21MH092232
Study First Received: October 29, 2012
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 24, 2014