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OpenTrials
Completed

NCT Number: NCT02155231

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

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: December 1,2014 (up to 2 years)

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

  • Verein Aids Life through TREAT Asia

Registry information

Official study title

The Thai Red Cross AIDS Research Centre

Important dates

Study start
2013
Primary completion
2020
Study completion
2022
First posted
Jun 4, 2014
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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