Expedited Partner Therapy and the HIV Prevention Cascade

NCT04553211 | Completed DMC

• 1 other identifier: R01MH118973
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection; Gonorrhea Male; Chlamydia; Partner Communication

Keywords

Expedited Partner Therapy; MSM; Transgender women; HIV prevention; Peru

Outcome Measures

Primary Outcomes (2)

• Self-reported partner notification

  Participant self-report of notification of one or more sexual partners at 21-days Follow-up

  21 Days

• Partner-confirmed notification

  Confirmation by named partners following notification of STI exposure by the index participant

  60 Days

Secondary Outcomes (4)

• Self-reported partner treatment

  21 Days

• Self-reported partner HIV/STI testing

  21 Days

• Partner confirmed treatment

  60 Days

• Partner confirmed HIV/STI testing

  60 Days

Study Arms (2)

Expedited Partner Therapy (EPT)

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

EPT BEHAVIORAL

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.

Expedited Partner Therapy (EPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) Inability to understand the study procedures or to provide informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Asociación Civil Via Libre, Peru: collaborator
• University of California, San Francisco: collaborator
• Emory University: collaborator

Study Sites (1)

Asociacion Civil Via Libre

Lima, 01, Peru

Location

MeSH Terms

Conditions

Chlamydia Infections

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Jesse L Clark, MD, MSc

  Associate Professor-in-Residence

  PRINCIPAL INVESTIGATOR

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: Associate Professor-in-Residence

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 17, 2020
• Study Start: April 25, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)