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

HIV Testing, MSM Clinical Trial

— HIV-NAT 120  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161289
• Other study ID #: HIV-NAT 120
• Status: Completed
• Phase: N/A
• First received: May 28, 2014
• Last updated: May 8, 2017
• Start date: September 2010
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Testing, MSM

Locations

Country	Name	City	State
Thailand	The Thai Red Cross AIDS Research Centre	Pathumwan,	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	Centers for Disease Control and Prevention, Johns Hopkins University, The HIV Netherlands Australia Thailand Research Collaboration

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	An intervention will be defined as acceptable if the uptake is at least 60%.	12 month
Primary	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.	12 months