Anal HPV Infection and Risk for Anal High-grade Squamous Intraepithelial Lesion Among Thai MSM With Acute HIV Infection

NCT03032575 | Completed DMC

• 1 other identifier: HPV in MSM with AHI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1\. To determine the prevalence and incidence of anal HSIL and associated risk factors among MSM who initiate ART during AHI.

Conditions

Human Papillomavirus Infection

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• The prevalence and incidence of anal HSIL among MSM who initiate ART during AHI will be lower than among chronically-infected HIV-positive MSM, Anal HSIL is diagnosed based on histology specimen and cytology (2001 Bethesda system)

  The prevalence of anal HSIL and the incidence of anal HSIL during the follow-up period. Anal HSIL is diagnosed based on histology specimen. A composite anal HSIL outcome (including both cytologic HSIL/ASC-H and histologic HSIL) will also be used. Incidence of HSIL during the follow-up period will be calculated as the number of new diagnoses per person time at risk. 95% confidence intervals (CI) will be calculated assuming a Poisson distribution. Cox proportional hazards regression will be used to identify factors associated with incident HSIL.

  12 months

Study Arms (1)

sample size 100

OTHER

Study Design: This is a prospective observational cohort of Thai MSM who initiated ART at the time of AHI, defined as the first 30 days after HIV acquisition (Fiebig stages 1 through 5). Volunteers will be examined at baseline to determine the prevalence of HPV infection and HSIL at HIV diagnosis. They will then be followed longitudinally for new incidence of HPV and HSIL, as well as progression or regression of existing lesions.

Behavioral: SEARCH010/RV254

Interventions

SEARCH010/RV254 BEHAVIORAL

sample size 100

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above.
• Born biological male.
• Self-identifies as MSM or transgender woman.
• Enrolled in the SEARCH010/RV254 cohort.
• In the stage of acute HIV infection diagnosed within 7 days (Fiebig I-V).
• Agrees to start ART during acute HIV infection.
• Had sex with a male partner at least once in the previous 3 months
• Consents to participate in the study

You may not qualify if:

• \. Any history of previous HSIL diagnosis or treatment.

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• SEARCH Research Foundation: collaborator
• amfAR, The Foundation for AIDS Research: collaborator
• TREAT Asia: collaborator

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (1)

• Thitipatarakorn S, Teeratakulpisarn N, Nonenoy S, Klinsukontakul A, Suriwong S, Makphol J, Hongchookiat P, Chaya-Ananchot T, Chinlaertworasiri N, Mingkwanrungruang P, Sacdalan C, Poltavee K, Pankam T, Kerr SJ, Ramautarsing R, Colby D, Phanuphak N. Prevalence and incidence of anal high-grade squamous intraepithelial lesions in a cohort of cisgender men and transgender women who have sex with men diagnosed and treated during acute HIV acquisition in Bangkok, Thailand. J Int AIDS Soc. 2024 May;27(5):e26242. doi: 10.1002/jia2.26242.

  PMID: 38695517 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nittaya Phanuphak, M.D.,Ph.D.

  The Thai Red Cross AIDS Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 26, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: October 1, 2023
• Last Updated: November 25, 2024

Record last verified: 2024-04

Locations

TH (1)