Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02161289
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2014-05-28
Brief Title:
Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men
Sponsor:
Thai Red Cross AIDS Research Centre
Organization:
Thai Red Cross AIDS Research Centre
Study Overview
Official Title:
Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIV-NAT 120
Brief 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 treatment and pre-exposure prophylaxis strategies as potential HIV prevention methods among Thai MSM
3 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 oldEach participant will have a 12-month follow-up duration in the study
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 treatment and pre-exposure prophylaxis strategies as potential HIV prevention methods among Thai MSM
3 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 oldEach 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
1 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
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
1 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None