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

Last updated: November 22, 2024
Sponsor: Thai Red Cross AIDS Research Centre
Overall Status: Completed

Phase

N/A

Condition

Human Papilloma Virus (Hpv)

Treatment

N/A

Clinical Study ID

NCT02155231
Anal HPV and AIN among MSM
  • Ages 18-90
  • Male
  • Accepts Healthy Volunteers

Study Summary

OBJECTIVES

  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. To study the prevalence and incidence of HGAIN among these MSM.

  3. To evaluate risk factors, including HIV status, for anal high-risk HPV infection and HGAIN among these MSM.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male with history of anal sex with men or previous participants of the MSM VCTstudy.

  2. Age 18 years old or older.

  3. Indonesian or Malaysian or Thai citizen as identified by the Indonesian or Malaysianor Thai National Identification card.

  4. Willing to provide location or contact information and allow contact.

  5. Available for follow-up for the planned study duration.

  6. Understand the study and sign informed consent form.

Exclusion

Exclusion Criteria:

  1. History of prior treatment for anal cancer OR had anal cytology or high-resolutionanoscopy or infrared coagulation within 12 months prior to enrollment OR hadtrichloroacetic acid or podophyllin application of the intraanal area in the pastmonth OR evidence of active concurrent intraanal or perianal bacterial or herpessimplex infection.

  2. Persons who have a history of a medical or psychiatric disorder by investigator'sinterview and physical examination according to standard practices, that in thejudgment of the investigator(s), would interfere with ability to give informedconsent.

Study Design

Total Participants: 430
Study Start date:
February 01, 2013
Estimated Completion Date:
December 31, 2022

Study Description

This is a prospective cohort study that will newly enroll approximately 150 MSM in Kuala Lumpur, Jakarta, and Bangkok and follow them prospectively with a group of 280 MSM who are previous participants of a study entitled "Multidisciplinary services to enhance HIV testing and linkage to care among MSM" (MSM VCT study) in Jakarta, Bali, and Bangkok. Newly enrolled MSM will have three study visits at baseline, month 6, and at month 12. MSM who are previous participants of the MSM VCT study will only have one study visit.

Connect with a study center

  • The Thai Red Cross AIDS Research Centre

    Pathum Wan, Bangkok 10330
    Thailand

    Site Not Available

  • The Thai Red Cross AIDS Research Centre

    Pathumwan,, Bangkok 10330
    Thailand

    Site Not Available

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