STI Screening as a Combined HIV Prevention Platform for MSM in Peru
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedStudy Start
First participant enrolled
July 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedAugust 7, 2018
August 1, 2018
11 months
January 1, 2017
August 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unprotected Receptive Anal Intercourse (URAI) with Serodiscordant or Unknown Serostatus Partner
prevalence of self-reported URAI with an HIV-infected or unknown serostatus partner at 6-month Follow-up
6 Months
Secondary Outcomes (2)
Persistent or Recurrent Rectal GC/CT Infection
6 Months
Inflammatory Cytokine Levels in Rectal Mucosa
6 Months
Study Arms (3)
STI-Positive: PCC
EXPERIMENTALMSM diagnosed with rectal GC and/or CT infection counseled for HIV prevention using Personalized Cognitive Counseling (PCC) and treated with appropriate antibiotic therapy
STI-Positive: Traditional Counseling
PLACEBO COMPARATORMSM diagnosed with rectal GC and/or CT infection counseled for HIV prevention using traditional risk reduction counseling and treated with appropriate antibiotic therapy
STI-Negative
NO INTERVENTIONMSM without rectal GC and/or CT infection
Interventions
Personalized Cognitive Counseling (PCC) sessions will be delivered as described above.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Unable to complete informed consent procedures
- HIV-infected (according to laboratory testing)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- NGO Via Librecollaborator
- University of California, San Franciscocollaborator
Study Sites (1)
Asociacion Civil Via Libre
Lima, 01, Peru
Related Publications (4)
Clark JL, Oldenburg CE, Passaro RC, Segura ER, Godwin W, Fulcher JA, Cabello R. Changes in Inflammatory Cytokine Levels in Rectal Mucosa Associated With Neisseria gonorrheae and/or Chlamydia trachomatis Infection and Treatment Among Men Who Have Sex With Men in Lima, Peru. J Infect Dis. 2024 Mar 14;229(3):845-854. doi: 10.1093/infdis/jiad349.
PMID: 37584273DERIVEDAyer A, Segura ER, Perez-Brumer A, Chavez-Gomez S, Fernandez R, Gutierrez J, Suarez K, Lake JE, Clark JL, Cabello R. Sexual health norms and communication patterns within the close social networks of men who have sex with men and transgender women in Lima, Peru: a 2017 cross-sectional study. BMC Public Health. 2021 Jun 7;21(1):1090. doi: 10.1186/s12889-021-11091-2.
PMID: 34098916DERIVEDBlair CS, Lake JE, Passaro RC, Chavez-Gomez S, Segura ER, Elliott J, Fulcher JA, Shoptaw S, Cabello R, Clark JL. Brief Report: HIV-1 Seroconversion Is Not Associated With Prolonged Rectal Mucosal Inflammation. J Acquir Immune Defic Syndr. 2021 Apr 15;86(5):e134-e138. doi: 10.1097/QAI.0000000000002601.
PMID: 33351532DERIVEDPassaro RC, Castaneda-Huaripata A, Gonzales-Saavedra W, Chavez-Gomez S, Segura ER, Lake JE, Cabello R, Clark JL. Contextualizing condoms: a cross-sectional study mapping intersections of locations of sexual contact, partner type, and substance use as contexts for sexual risk behavior among MSM in Peru. BMC Infect Dis. 2019 Nov 11;19(1):958. doi: 10.1186/s12879-019-4517-y.
PMID: 31711433DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesse L Clark, MD, MSc
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor-in-Residence
Study Record Dates
First Submitted
January 1, 2017
First Posted
January 4, 2017
Study Start
July 15, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
August 7, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
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.