- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637324
Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM
The Thai Red Cross AIDS Research Centre
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
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok
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Pathumwan, Bangkok, Thailand, 10330
- The Thai Red Cross AIDS Research Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- diabetes
- STIs
- hyperlipidemia
- nPEP
- To assess VCT and linkage into care
- anal dysplasia/cancer
- 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
Other Study ID Numbers
- MSM VCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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