Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
  Purpose

Objectives

  1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV voluntary counseling and testing (VCT)
  2. 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
HIV Testing
Linkage to Care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Red Cross AIDS Research Centre

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Thai Red Cross AIDS Research Centre:
Enrollment: 350
Study Start Date: May 2011
Study Completion Date: June 2012
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.

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  1. Male with history of anal sex with men
  2. Age 18 years old or older
  3. Thai or Indonesian citizen as identified by the Thai or Indonesian National Identification card
  4. Willing to provide location or contact information and allow contact
  5. Live in or near Bangkok, Jakarta, or Bali and is available for follow-up for the planned study duration
  6. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637324

Locations
Thailand
The Thai Red Cross AIDS Research Centre
Pathumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
National Institutes of Health (NIH)
President's Emergency Fund for AIDS Relief (PEPFAR)
  More Information

No publications provided

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT01637324     History of Changes
Other Study ID Numbers: MSM VCT
Study First Received: July 6, 2012
Last Updated: July 10, 2012
Health Authority: Thailand: Ethical Committee
Cipto Mangunkusumo Hospital: University of Indonesia
Sanglah Hospital: Kerti Praja Foundation

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

ClinicalTrials.gov processed this record on March 03, 2015