Study on Anal Human Papillomavirus Infection and Anal Intraepithelial Neoplasia Among Men Who Have Sex With Men in Indonesia, Malaysia, and Thailand

NCT02155231 | Completed

• 1 other identifier: Anal HPV and AIN among MSM
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES

1. 1.To determine the prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.
2. 2.To study the prevalence and incidence of HGAIN among these MSM.
3. 3.To evaluate risk factors, including HIV status, for anal high-risk HPV infection and HGAIN among these MSM.

Conditions

HPV Testing

Keywords

Male with history of anal sex with men or previous participants of the MSM VCT study

Outcome Measures

Primary Outcomes (1)

• prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.

  December 1,2014 (up to 2 years)

Study Arms (2)

previous enrolled

New Enrolled

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this study.

You may qualify if:

• Male with history of anal sex with men or previous participants of the MSM VCT study.
• Age 18 years old or older.
• Indonesian or Malaysian or Thai citizen as identified by the Indonesian or Malaysian or Thai National Identification card.
• Willing to provide location or contact information and allow contact.
• Available for follow-up for the planned study duration.
• Understand the study and sign informed consent form.

You may not qualify if:

• History of prior treatment for anal cancer OR had anal cytology or high-resolution anoscopy or infrared coagulation within 12 months prior to enrollment OR had trichloroacetic acid or podophyllin application of the intraanal area in the past month OR evidence of active concurrent intraanal or perianal bacterial or herpes simplex infection.
• Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with ability to give informed consent.

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• Verein Aids Life through TREAT Asia: collaborator

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 4, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

TH (1)