Clinical trial NCT02155231: Study on Anal Human Papillomavirus Infection and Anal Intraepithelial Neoplasia Among Men Who Have Sex With Men in Indonesia, Malaysia, and Thailand
Official title: The Thai Red Cross AIDS Research Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Testing
Keywords: Male with history of anal sex with men or previous participants of the MSM VCT study
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: Verein Aids Life through TREAT Asia
First posted: 2014-06-04
Enrollment: 430
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Male with history of anal sex with men or previous participants of the MSM VCT study.
2. Age 18 years old or older.
3. Indonesian or Malaysian or Thai citizen as identified by the Indonesian or Malaysian or 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 Criteria:

1. 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.
2. 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.

Primary outcomes:
measure: prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.
timeFrame: December 1,2014 (up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
state: Bangkok
Study officials:
References: