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Completed

NCT Number: NCT02161289

Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men

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 old,Each participant will have a 12-month follow-up duration in the study.

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Key information

Conditions

HIV Testing, MSM

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

The Thai Red Cross AIDS Research Centre

Pathumwan,, Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Acceptability

    Time frame: 12 month

    An intervention will be defined as acceptable if the uptake is at least 60%.

  2. 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.

Sponsors and collaborators

Lead sponsor

Thai Red Cross AIDS Research Centre

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Johns Hopkins University
  • The HIV Netherlands Australia Thailand Research Collaboration

Registry information

Official study title

Behavioral and Biomedical HIV Prevention Interventions for Thai Men Who Have Sex With Men.

Acronym: HIV-NAT 120

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Jun 11, 2014
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.