Expedited Partner Therapy for MSM in Peru
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|ClinicalTrials.gov Identifier: NCT01720654|
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : August 6, 2014
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||Phase|
|Gonorrhea Chlamydia||Behavioral: EPT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Expedited Partner Therapy as STI Control Among MSM in Peru|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
No Intervention: Control
Standardized partner notification counseling.
Standardized partner notification counseling and provision of 5 partner treatment (EPT) packets.
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.
- Self-reported Partner Notification [ Time Frame: 21 Days ]Participant self-report of partner notification 14-21 days after randomization
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
|Asociacion Civil Impacta Salud y Educacion|
|Principal Investigator:||Jesse L Clark, MD, MSc||University of California, Los Angeles|
|Principal Investigator:||Thomas J Coates, PhD||University of California, Los Angeles|