HIV Testing, MSMHIV-NAT 120NCT02161289
Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men
An observational study of HIV Testing, MSM, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
Objectives 1. To evaluate the acceptability and feasibility of "standard HIV prevention package" among Thai men who have sex with men (MSM) 2. To conduct a pilot study to demonstrate the acceptability and feasibility of internet-based social networking, asymptomatic sexually transmitted infection diagnosis and… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Testing, MSM
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2010to 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: men who have sex with men in Thailand
Who may be able to join
- Age 18 years old or older
- Have documented negative HIV EIA or CMIA test at screening
- Live in or near Bangkok
- Have a history of anal sex with men
- Understand the study and sign informed consent form.
Who cannot join
- 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
- Persons with history of urinary tract stone
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: Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men.
Objectives
- To evaluate the acceptability and feasibility of "standard HIV prevention package" among Thai men who have sex with men (MSM)
- To conduct a pilot study to demonstrate the acceptability and feasibility of internet-based social networking, asymptomatic sexually transmitted infection diagnosis and treatment and pre-exposure prophylaxis strategies as "potential HIV prevention methods" among Thai MSM
- To use mathematical modeling to identify the most effective HIV prevention package optimized for Thai MSM
Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic (TRC-AC), age ≥18 years old,Each participant will have a 12-month follow-up duration in the study.
Read the detailed description
Study design and methodology:
We will conduct a pilot study among 100 MSM participants who will be enrolled from the TRC-AC and will be followed up for 12 months. Participants will be followed at baseline, months 1 and 3, and then every 3 months. Interventions in the "standard HIV prevention package" to be provided at every clinic visit include anti-HIV testing, risk reduction counseling, provisions of free condoms and lubricants and diagnosis and treatment of symptomatic sexually transmitted infections (STI). All participants will also have access to non-occupational post-exposure prophylaxis (nPEP) without charge as part of the standard HIV prevention package. In addition, we will test for acceptability and feasibility of the "potential HIV prevention methods" which include:
- Internet-based social networking to distribute and stimulate discussion of HIV prevention information (2) Asymptomatic STI diagnosis and treatment for every participant at baseline visit and every 6 months (3) Oral and topical pre-exposure prophylaxis (PrEP) strategies using placebo tablet and gel.
The meta-analysis of various behavioral and biomedical HIV prevention studies among MSM will be done in parallel with the pilot study in order to gather information for mathematical modeling and finally to inform the design of a larger study. Data acquired from the pilot study will be used for mathematical modeling of HIV transmission among MSM. The output from the modeling will directly inform HIV preventative interventions to be evaluated empirically among MSM in Thailand.
- Conditions
- HIV Testing, MSM
- Keywords
- 100 HIV-negagtve MSM
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
An intervention will be defined as acceptable if the uptake is at least 60%.
Measured: 12 month
Feasibility
Feasibility endpoints will be a combination of the ability to recruit subjects, subjects' adherence to each HIV prevention methods, ability for staff to perform procedures according to the protocol and an overall lost to follow up rate of 5% or less per year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startSep 2010
- Primary completionSep 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 Testing, MSMStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The HIV Netherlands Australia Thailand Research Collaboration, Johns Hopkins University, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161289
- Sponsor's protocol ID
- HIV-NAT 120
- Acronym
- HIV-NAT 120
- Status last verified
- May 2017
- First submitted
- 28 May 2014
- 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
- Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men.
- ClinicalTrials.gov ID
- NCT02161289
- Acronym / sponsor ID
- HIV-NAT 120 / HIV-NAT 120
- Conditions
- HIV Testing, MSM
- Keywords
- 100 HIV-negagtve MSM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- The HIV Netherlands Australia Thailand Research Collaboration, Johns Hopkins University, Centers for Disease Control and Prevention
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 11 Jun 2014 (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 evaluate the acceptability and feasibility of "standard HIV prevention package" among Thai men who have sex with men (MSM)
- To conduct a pilot study to demonstrate the acceptability and feasibility of internet-based social networking, asymptomatic sexually transmitted infection diagnosis and treatment and pre-exposure prophylaxis strategies as "potential HIV prevention methods" among Thai MSM
- To use mathematical modeling to identify the most effective HIV prevention package optimized for Thai MSM
Subject population: HIV-negative MSM clients of the Thai Red Cross Anonymous Clinic (TRC-AC), age ≥18 years old,Each participant will have a 12-month follow-up duration in the study.
Detailed description
Study design and methodology:
We will conduct a pilot study among 100 MSM participants who will be enrolled from the TRC-AC and will be followed up for 12 months. Participants will be followed at baseline, months 1 and 3, and then every 3 months. Interventions in the "standard HIV prevention package" to be provided at every clinic visit include anti-HIV testing, risk reduction counseling, provisions of free condoms and lubricants and diagnosis and treatment of symptomatic sexually transmitted infections (STI). All participants will also have access to non-occupational post-exposure prophylaxis (nPEP) without charge as part of the standard HIV prevention package. In addition, we will test for acceptability and feasibility of the "potential HIV prevention methods" which include:
- Internet-based social networking to distribute and stimulate discussion of HIV prevention information (2) Asymptomatic STI diagnosis and treatment for every participant at baseline visit and every 6 months (3) Oral and topical pre-exposure prophylaxis (PrEP) strategies using placebo tablet and gel.
The meta-analysis of various behavioral and biomedical HIV prevention studies among MSM will be done in parallel with the pilot study in order to gather information for mathematical modeling and finally to inform the design of a larger study. Data acquired from the pilot study will be used for mathematical modeling of HIV transmission among MSM. The output from the modeling will directly inform HIV preventative interventions to be evaluated empirically among MSM in Thailand.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- men who have sex with men in Thailand
Key inclusion criteria (5 listed)
- Age 18 years old or older
- Have documented negative HIV EIA or CMIA test at screening
- Live in or near Bangkok
- Have a history of anal sex with men
- Understand the study and sign informed consent form.
Key exclusion criteria (2 listed)
- 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
- Persons with history of urinary tract stone
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
Acceptability
Time frame: 12 month
An intervention will be defined as acceptable if the uptake is at least 60%.
Feasibility
Time frame: 12 months
Feasibility endpoints will be a combination of the ability to recruit subjects, subjects' adherence to each HIV prevention methods, ability for staff to perform procedures according to the protocol and an overall lost to follow up rate of 5% or less per year.
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.
Related trials for HIV Testing, MSM
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa
HIV Infections, Mental Health
Active, not recruiting
Facilitating Routine HIV Testing Among MSM by a Subscription-based Self-test Distribution Model
Hiv
Enrolling by invitation
Getting to Zero Among HHI MSM in the American South
HIV Infections
Enrolling by invitationPhase 2
Peer Delivered HIV/Syphilis Self-Testing With Assisted Partner Notification Services
HIV, Syphilis
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, MSM, 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 5 inclusion and 2 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.
What does the primary outcome measure?
Acceptability (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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.