Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men (HIV-NAT 120)
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|ClinicalTrials.gov Identifier: NCT02161289|
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : May 9, 2017
- 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.
|Condition or disease|
|HIV Testing, MSM|
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.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men.|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||May 2017|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161289
|The Thai Red Cross AIDS Research Centre|
|Pathumwan,, Bangkok, Thailand, 10330|