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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
Sponsor:
Collaborators:
The HIV Netherlands Australia Thailand Research Collaboration
Johns Hopkins University
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Thai Red Cross AIDS Research Centre

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


Condition or disease
HIV Testing, MSM

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
men who have sex with men in Thailand
Criteria

Inclusion Criteria:

  1. Age 18 years old or older
  2. Have documented negative HIV EIA or CMIA test at screening
  3. Live in or near Bangkok
  4. Have a history of anal sex with men
  5. Understand the study and sign informed consent form.

Exclusion Criteria:

  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
  2. Persons with history of urinary tract stone

Information from the National Library of Medicine

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


Locations
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Thailand
The Thai Red Cross AIDS Research Centre
Pathumwan,, Bangkok, Thailand, 10330
Sponsors and Collaborators
Thai Red Cross AIDS Research Centre
The HIV Netherlands Australia Thailand Research Collaboration
Johns Hopkins University
Centers for Disease Control and Prevention
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Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT02161289    
Other Study ID Numbers: HIV-NAT 120
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by Thai Red Cross AIDS Research Centre:
100 HIV-negagtve MSM