Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM

This study has been completed.

Sponsor:

Collaborators:

National Institutes of Health (NIH)

President's Emergency Fund for AIDS Relief (PEPFAR)

Information provided by (Responsible Party):

Thai Red Cross AIDS Research Centre

ClinicalTrials.gov Identifier:

NCT01637324

First received: July 6, 2012

Last updated: July 10, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 6, 2012
Last Updated Date	July 10, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01637324 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM
Official Title ^ICMJE	The Thai Red Cross AIDS Research Centre
Brief Summary	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
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 ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	MSM with HIV negative and positive MSM in Thai Red Cross Bangkok Thailand, the Cipto Mangunkusumo Hospital in Jakarta, and the Sanglah Hospital in Bali, Indonesia
Condition ^ICMJE	HIV Testing Linkage to Care
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	350
Completion Date	June 2012
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years to 90 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Thailand

Administrative Information
NCT Number ^ICMJE	NCT01637324
Other Study ID Numbers ^ICMJE	MSM VCT
Has Data Monitoring Committee	No
Responsible Party	Thai Red Cross AIDS Research Centre
Study Sponsor ^ICMJE	Thai Red Cross AIDS Research Centre
Collaborators ^ICMJE	National Institutes of Health (NIH) President's Emergency Fund for AIDS Relief (PEPFAR)
Investigators ^ICMJE	Not Provided
Information Provided By	Thai Red Cross AIDS Research Centre
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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