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Expedited Partner Therapy and the HIV Prevention Cascade (EPT and MSM)

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ClinicalTrials.gov Identifier: NCT04553211
Recruitment Status : Not yet recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
Asociacion Civil Via Libre
Francis I. Proctor Foundation
Emory University
Information provided by (Responsible Party):
Jesse Clark, University of California, Los Angeles

Brief Summary:

The HIV epidemic in Peru remains concentrated in the subpopulation of men who have sex with men (MSM), where the prevalence of disease has been estimated between 10-22% in recent epidemiologic surveys. Partner-based methods to limit the spread of HIV and STI co-infection, including partner notification and partner treatment, provide an important new strategy for HIV control in the region.

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 fully 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.

As a theoretical model, EPT integrates behavioral, social, and biomedical approaches to HIV/STI control in a comprehensive prevention intervention. Our proposed exploration of the social and behavioral dimensions of partner notification and treatment will provide a methodological structure for understanding the influence of EPT on behavioral decision-making processes, interpersonal factors that influence partner notification, and network patterns of STI transmission within MSM populations in Peru.

The proposed study includes a screening protocol to identify eligible MSM subjects for participation in our planned study of the effect of EPT on partner notification, treatment, and linkage to HIV prevention and care services. Potential participants will complete a behavioral survey and undergo physical examination and testing for HIV, syphilis, gonorrhea, and chlamydia. Participants diagnosed with Gonorrhea and/or Chlamydia (at any anatomic site) will be eligible for enrollment in our Partner Management study of EPT and the HIV prevention cascade among MSM in Peru.

Participants in the Partner Management study will be randomly assigned to receive either standard of care partner notification counseling or standard counseling along with a maximum of five antibiotic treatment packets to deliver to their recent sexual partners. Participants will be asked to return to the site after 21 days to report on their actual partner notification behavior, with differences in notification evaluated between the two groups. Participants will then work with a study counselor to identify their recent partners and, if the participant agrees, to provide contact information so that the study team can contact these partners. Study staff will either confirm that the partner has already been notified, or provide notification of their likely STI exposure. After informing partners of their STI exposure, staff will ask partners to provide verbal consent to a single question evaluation (whether or not the partner had previously been informed of their exposure) to verify participant-reported behavior. Partners will also be asked to visit the study site to complete a brief survey of their sexual practices and treatment-seeking behavior, as well as to undergo testing for HIV and STIs. All of the above data will be used to construct models of the spread of HIV and STIs in local MSM networks, and the potential effect of EPT on controlling the spread of STIs in this population.


Condition or disease Intervention/treatment Phase
HIV-1-infection Gonorrhea Male Chlamydia Partner Communication Behavioral: EPT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Expedited Partner Therapy and the HIV Prevention Cascade for MSM in Peru
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Expedited Partner Therapy (EPT)
Participants in the EPT arm will receive up to five partner antibiotic treatment packets to deliver to their recent sexual partners following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The intervention will be repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.
Behavioral: EPT
Expedited Partner Therapy (EPT) involves provision of empiric oral antibiotic therapy to the recent sexual partners of an individual diagnosed with gonorrhea and/or chlamydia infection.

No Intervention: Control
Participants in the control arm will receive standard-of-care counseling on partner notification following a diagnosis of gonorrhea (GC) and/or chlamydia (CT). The same counseling will be repeated with all subsequent episodes of GC and/or CT infection during the 12-month follow-up period.



Primary Outcome Measures :
  1. Self-reported partner notification [ Time Frame: 21 Days ]
    Participant self-report of notification of one or more sexual partners at 21-days Follow-up

  2. Partner-confirmed notification [ Time Frame: 60 Days ]
    Confirmation by named partners following notification of STI exposure by the index participant


Secondary Outcome Measures :
  1. Self-reported partner treatment [ Time Frame: 21 Days ]
    Participant self-report of antibiotic treatment of one or more sexual partners at 21-days

  2. Self-reported partner HIV/STI testing [ Time Frame: 21 Days ]
    Participant self-report of HIV/STI testing by one or more sexual partners at 21-days

  3. Partner confirmed treatment [ Time Frame: 60 Days ]
    Partner confirmation of antibiotic treatment following notification of STI exposure by the index participant

  4. Partner confirmed HIV/STI testing [ Time Frame: 60 Days ]
    Partner confirmation of HIV/STI testing following notification of STI exposure by the index participant



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Anatomically male at birth
  2. Condomless anal intercourse with an HIV serodiscordant or unknown serostatus male or transgender female partner in the previous 6 months
  3. 18 years of age or older
  4. Diagnosis of Gonorrhea and/or Chlamydia infection at any anatomic site at the Screening visit

Exclusion Criteria:

1) Inability to understand the study procedures or to provide informed consent


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): NCT04553211


Contacts
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Contact: Jesse L Clark, MD, MSc 310 825-3543 jlclark@mednet.ucla.edu

Locations
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Peru
Asociacion Civil Via Libre
Lima, Peru, 01
Contact: Karla Suarez    (511) 203-9900 ext 153    ksuarez@vialibre.org.pe   
Principal Investigator: Robinson Cabello, MD         
Sponsors and Collaborators
University of California, Los Angeles
Asociacion Civil Via Libre
Francis I. Proctor Foundation
Emory University
Investigators
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Principal Investigator: Jesse L Clark, MD, MSc Associate Professor-in-Residence
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Responsible Party: Jesse Clark, Associate Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04553211    
Other Study ID Numbers: R01MH118973 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesse Clark, University of California, Los Angeles:
Expedited Partner Therapy
MSM
Transgender women
HIV prevention
Peru
Additional relevant MeSH terms:
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Gonorrhea
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Neisseriaceae Infections