STI Screening as a Combined HIV Prevention Platform for MSM in Peru
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.
Gonorrhoea of Rectum
Chlamydia of Rectum
Behavioral: Traditional Counseling
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
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|
- Unprotected Receptive Anal Intercourse (URAI) with Serodiscordant or Unknown Serostatus Partner [ Time Frame: 6 Months ] [ Designated as safety issue: No ]prevalence of self-reported URAI with an HIV-infected or unknown serostatus partner at 6-month Follow-up
- Persistent or Recurrent Rectal GC/CT Infection [ Time Frame: 6 Months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|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)|
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT03010020
|Contact: Jesse L Clark, MD, MScemail@example.com|
|Contact: Eddy R Segura, MD, MPHfirstname.lastname@example.org|
|Asociacion Civil Via Libre||Not yet recruiting|
|Lima, Peru, 01|
|Contact: Williams Gonzales (511) 203-9900 ext 153 email@example.com|
|Principal Investigator: Robinson Cabello, MD|