HIV TestingNCT01637324
Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM
An observational study of HIV Testing and Linkage to Care, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Testing, Linkage to Care
- How many people
- 350 participants
- Where
- 1 siteThailand
- Study dates
- May 2011to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Pathumwan, Bangkok, 10330
About this study
Official title: 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
Read the 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.
- Conditions
- HIV Testing, Linkage to Care
- Keywords
- 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
- Medical subject headings
- Sexually Transmitted Diseases, Neoplasms, Hyperlipidemias, Diabetes Mellitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), United States President's Emergency Plan for AIDS Relief
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637324
- Sponsor's protocol ID
- MSM VCT
- Status last verified
- May 2017
- First submitted
- 6 Jul 2012
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thai Red Cross AIDS Research Centre
- ClinicalTrials.gov ID
- NCT01637324
- Acronym / sponsor ID
- MSM VCT
- Conditions
- HIV Testing, Linkage to Care
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), United States President's Emergency Plan for AIDS Relief
- Study start
- May 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Testing and Linkage to Care, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.