Expedited Partner Therapy for MSM in Peru
Expedited Partner Therapy as STI Control Among MSM in Peru
2 other identifiers
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
November 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 6, 2014
August 1, 2014
2 years
October 29, 2012
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-reported Partner Notification
Participant self-report of partner notification 14-21 days after randomization
21 Days
Study Arms (2)
Control
NO INTERVENTIONStandardized partner notification counseling.
EPT
EXPERIMENTALStandardized partner notification counseling and provision of 5 partner treatment (EPT) packets.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Biologically male at birth
- years of age or older
- Sexual contact (oral or anal intercourse) with a male or male-to-female transgender person within the past 12 months.
- Clinical Urethritis or proctitis OR Laboratory-diagnosed gonorrhea and/or chlamydia in any anatomic site (urethra, rectum, or oropharynx)
You may not qualify if:
- Under 18 years of age
- Anatomically female at birth
- Unable to understand study procedures or provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asociacion Civil Impacta Salud y Educacion
Lima, Peru
Related Publications (2)
Braun HM, Segura ER, Lake JE, Gandhi M, Rios J, Villaran MV, Sanchez J, Lama JR, Clark JL. Individual and partnership factors associated with anticipated versus actual partner notification following STI diagnosis among men who have sex with men and/or with transgender women in Lima, Peru. Sex Transm Infect. 2018 Dec;94(8):607-610. doi: 10.1136/sextrans-2017-053292. Epub 2017 Nov 30.
PMID: 29191814DERIVEDClark JL, Segura ER, Oldenburg CE, Rios J, Montano SM, Perez-Brumer A, Villaran M, Sanchez J, Coates TJ, Lama JR. Expedited Partner Therapy (EPT) increases the frequency of partner notification among MSM in Lima, Peru: a pilot randomized controlled trial. BMC Med. 2017 May 4;15(1):94. doi: 10.1186/s12916-017-0858-9.
PMID: 28468648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesse L Clark, MD, MSc
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Thomas J Coates, PhD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor-in-Residence
Study Record Dates
First Submitted
October 29, 2012
First Posted
November 2, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 6, 2014
Record last verified: 2014-08