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Trial record 2 of 14 for:    gonorrhea combination

STI Screening as a Combined HIV Prevention Platform for MSM in Peru

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by University of California, Los Angeles
Sponsor:
Collaborators:
NGO Via Libre
University of California, San Francisco
Information provided by (Responsible Party):
Jesse Clark, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT03010020
First received: January 1, 2017
Last updated: January 3, 2017
Last verified: January 2017
  Purpose

The investigators propose to develop and pilot an HIV prevention intervention based on rectal STI testing, counseling, and treatment for MSM in Peru. The investigators will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. The intervention is based on three interrelated objectives: 1) To use periodic rectal STI nucleic acid testing to identify the members of the MSM population at greatest short-term risk for HIV infection; 2) To provide single-dose antibiotic treatment to control the immune activation and mucosal inflammation caused by rectal GC/CT infection that increase cellular risk for HIV transmission; and 3) To use Personal Cognitive Counseling (PCC) to understand and modify recent high-risk sexual practices that led to rectal STI acquisition and that increase future HIV risk.

The investigators propose to screen 750 behaviorally high-risk MSM for rectal GC/CT infection to enroll 100 GC/CT-positive individuals (using a conservative 15% prevalence estimate) and 50 GC/CT-negative controls (matched by age and baseline frequency of URAI). GC/CT-infected participants will be given single-dose antibiotic therapy and randomized to receive single-session PCC (n=50) or standard post-test counseling (n=50). The primary outcome will be the impact of PCC on self-reported sexual risk behavior (URAI). Secondary outcomes will assess: 1) Feasibility/Acceptability of the STI screening program; 2) Impact of GC/CT infection and treatment on levels of inflammatory cytokines (IL-6, IL-8, TNF-αand IL-1β) in rectal mucosa; 3) Prevalence of persistent/recurrent rectal GC/CT; and 4) HIV incidence in GC/CT-infected and -uninfected MSM.


Condition Intervention
Gonorrhoea of Rectum
Chlamydia of Rectum
HIV Infections
Behavioral: PCC
Behavioral: Traditional Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: STI Screening as a Combined HIV Prevention Platform for MSM in Peru

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Unprotected Receptive Anal Intercourse (URAI) with Serodiscordant or Unknown Serostatus Partner [ Time Frame: 6 Months ]
    prevalence of self-reported URAI with an HIV-infected or unknown serostatus partner at 6-month Follow-up


Secondary Outcome Measures:
  • Persistent or Recurrent Rectal GC/CT Infection [ Time Frame: 6 Months ]
    Effect of the intervention on the prevalence of persistent or recurrent rectal GC/CT infection will be assessed through repeat nucleic acid testing at 3- and 6-month Follow-up.

  • Inflammatory Cytokine Levels in Rectal Mucosa [ Time Frame: 6 Months ]
    Levels of IL-1β, IL-6, IL-8, and TNF-α in rectal mucosa will also be measured at Enrollment and 3- and 6-month Follow-up. Average levels of inflammatory cytokines in individuals with rectal GC/CT infection will be measured at time of diagnosis and after antibiotic treatment, and compared with GC/CT-negative controls.


Estimated Enrollment: 150
Study Start Date: February 2017
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STI-Positive: PCC
MSM diagnosed with rectal GC and/or CT infection counseled for HIV prevention using Personalized Cognitive Counseling (PCC) and treated with appropriate antibiotic therapy
Behavioral: PCC
Personalized Cognitive Counseling (PCC) sessions will be delivered as described above.
Placebo Comparator: STI-Positive: Traditional Counseling
MSM diagnosed with rectal GC and/or CT infection counseled for HIV prevention using traditional risk reduction counseling and treated with appropriate antibiotic therapy
Behavioral: Traditional Counseling
GC/CT-infected participants in the standard of care arm (and all GC/CT-negative participants screened for infection) will receive standard post-test counseling in accordance with Peruvian Ministry of Health guidelines.
No Intervention: STI-Negative
MSM without rectal GC and/or CT infection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Assigned male sex at birth
  • HIV-uninfected
  • Reports receptive anal intercourse with an HIV-infected or unknown serostatus partner within the previous 6 months
  • Diagnosed with rectal gonorrhea and/or chlamydia infection (not applicable to GC/CT-uninfected controls)

Exclusion Criteria:

  • Unable to complete informed consent procedures
  • HIV-infected (according to laboratory testing)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03010020

Contacts
Contact: Jesse L Clark, MD, MSc 1-310-825-3543 jlclark@mednet.ucla.edu
Contact: Eddy R Segura, MD, MPH 1-310-601-7798 eddysegura@gmail.com

Locations
Peru
Asociacion Civil Via Libre Not yet recruiting
Lima, Peru, 01
Contact: Williams Gonzales    (511) 203-9900 ext 153    wgonzales@vialibre.org.pe   
Principal Investigator: Robinson Cabello, MD         
Sponsors and Collaborators
University of California, Los Angeles
NGO Via Libre
University of California, San Francisco
  More Information

Responsible Party: Jesse Clark, Associate Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03010020     History of Changes
Other Study ID Numbers: R34MH105272 ( US NIH Grant/Contract Award Number )
Study First Received: January 1, 2017
Last Updated: January 3, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Due to restrictions on access to human subjects data, data will be made available to other researchers upon request and approval by the governing IRB/Ethics Committee.

Keywords provided by University of California, Los Angeles:
HIV Prevention
MSM
Rectal Gonorrhea
Rectal Chlamydia
Personalized Cognitive Counseling

Additional relevant MeSH terms:
Gonorrhea
HIV Infections
Chlamydia Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Infection
Genital Diseases, Male
Genital Diseases, Female
Chlamydiaceae Infections

ClinicalTrials.gov processed this record on March 22, 2017