Expedited Partner Therapy for MSM in Peru
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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 |
- Self-reported Partner Notification [ Time Frame: 21 Days ] [ Designated as safety issue: No ]Participant self-report of partner notification 14-21 days after randomization
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | July 2013 (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 |
Inclusion Criteria:
- Biologically male at birth
- 18 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)
Exclusion Criteria:
- Under 18 years of age
- Anatomically female at birth
- Unable to understand study procedures or provide informed consent
Contacts and Locations| Contact: Jesse L Clark, MD, MSc | 3106017798 | jlclark@mednet.ucla.edu |
| Contact: Eddy R Segura, MD, MPH | 3106017798 | eddysegura@gmail.com |
| Peru | |
| Asociacion Civil Impacta Salud y Educacion | Recruiting |
| Lima, Peru | |
| Contact: Jesica Rios 562 1600 | |
| Principal Investigator: Javier R Lama, MD, MPH | |
| 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: | October 31, 2012 |
| 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 Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Neisseriaceae Infections |
ClinicalTrials.gov processed this record on May 19, 2013