Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM
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ClinicalTrials.gov Identifier: NCT01637324 |
Recruitment Status
:
Completed
First Posted
: July 11, 2012
Last Update Posted
: May 9, 2017
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Objectives
- To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV voluntary counseling and testing (VCT)
- To determine the impact of MSM-targeted multidisciplinary services on the enrollment into care and retention of HIV-positive MSM
Subject population: HIV-negative and HIV-positive MSM clients, age ≥18 years old, of the Thai Red Cross Anonymous Clinic (TRC-AC) in Bangkok Thailand, the Cipto Mangunkusumo Hospital in Jakarta, and the Sanglah Hospital in Bali, Indonesia
Number of participants: 200 HIV-negative and 150 HIV-positive MSM participants
Condition or disease |
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HIV Testing Linkage to Care |
This is a prospective cohort study which will recruit 350 MSM clients within 3 months, and follow them for 12 months. MSM to be recruited will be first-time clients who come to the clinics for services other than VCT. These services may include but would not be limited to sexually transmitted infection (STI) diagnosis and treatment, anal dysplasia screening, nutritional counseling and non-occupational post-exposure prophylaxis (nPEP).
Approximately 250 MSM clients with unknown or previously negative HIV status will be offered HIV testing every 3 months (HIV-negative MSM cohort). MSM from the HIV-negative cohort who tested HIV-positive during the study (estimated 20%, 50 MSM) will be referred to the HIV-positive MSM cohort and will be followed up every 6 months. Additional clients who visit the clinic during the 3-month recruitment period with previously known HIV-positive status but have not been linked to HIV care (up to 100) will also be enrolled into HIV-positive MSM cohort. Therefore, there will be up to 150 HIV-positive subjects enrolled in this study. Each enrolled participant will have 12 months in the study.
This study will allow us to assess VCT and linkage into care, as well as HIV risk behavior and need for nPEP, and the incidence or prevalence of important morbidities in MSM such as STIs, anal dysplasia/cancer, hyperlipidemia, and diabetes.
Study Type : | Observational |
Actual Enrollment : | 350 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Thai Red Cross AIDS Research Centre |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2017 |


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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Male with history of anal sex with men
- Age 18 years old or older
- Thai or Indonesian citizen as identified by the Thai or Indonesian National Identification card
- Willing to provide location or contact information and allow contact
- Live in or near Bangkok, Jakarta, or Bali and is available for follow-up for the planned study duration
- Understand the study and sign informed consent form.
Exclusion Criteria:
1. 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637324
Thailand | |
The Thai Red Cross AIDS Research Centre | |
Pathumwan, Bangkok, Thailand, 10330 |
Responsible Party: | Thai Red Cross AIDS Research Centre |
ClinicalTrials.gov Identifier: | NCT01637324 History of Changes |
Other Study ID Numbers: |
MSM VCT |
First Posted: | July 11, 2012 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | May 2017 |
Keywords provided by Thai Red Cross AIDS Research Centre:
To assess VCT and linkage into care nPEP STIs anal dysplasia/cancer hyperlipidemia |
diabetes Proportion of first-time MSM clients attending multidisciplinary services who undergo HIV testing Proportion of MSM clients who have repeated HIV testing during the first six months after the first negative HIV test Proportion of HIV-positive MSM who receive HIV care within three months after HIV diagnosis or enrolment Proportion of HIV-positive MSM who still remain in HIV care at six months after enrollment |