User-friendly HIV Testing and Counseling Services

Study Overview
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Brief Summary
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Multicenter cohort study of individuals reporting behavioral risks of HIV acquisition, recruited among those presenting for testing for HIV and other sexually transmitted infections. Overarching goal: to study factors associated with uptake of HIV prevention and (re)testing services in medium-sized cities in Thailand. Primary objective: To estimate the incidence of HIV and other sexually transmitted infections (syphilis, chronic hepatitis B and C) among individuals presenting for retesting. Secondary objectives: To evaluate the uptake of pre-exposure prophylaxis To assess retention in the study To evaluate client HIV knowledge To describe HIV prevalence and characteristics of individuals newly diagnosed with HIV To describe characteristics of individuals at risk of HIV infection To assess the quality of the testing and referral services.

Detailed Description
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Testing and counseling for HIV, syphilis and other sexually transmitted infections is provided to consenting individuals. Components: interactive counseling program, self sampling (finger prick) under supervision, questionnaire (on a tablet computer) to assess risks of HIV acquisition, understanding of HIV transmission routes and pre-exposure prophylaxis, willingness to take pre-exposure prophylaxis if at risk of HIV, and satisfaction with regard to services provided. Referral to appropriate care facility of participants diagnosed with infection. HIV negative participants with significant risk of HIV are advised to come back for HIV retesting within 3 to 6 months and informed about pre-exposure prophylaxis.

Official Title
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Cohort of Individuals at Risk of HIV Infection Recruited in User-friendly HIV Testing and Counseling Services in Thailand Provinces

Conditions
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HIV Infections, Sexually Transmitted Infection, Hepatitis B, Chronic, Hepatitis C

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 15 years or more Willing to be tested for HIV and other sexually transmitted infections Able to understand the study and its procedures Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Risk of HIV acquisition<br>Individuals reporting behavioral risk of HIV acquisition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV incidence | HIV incidence | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants initiating pre-exposure prophylaxis | Proportion of participants initiating pre-exposure prophylaxis among those at significant risk of HIV | Through study completion, an average of 3 years | 
| Retention | Cumulative probability of retest | Through study completion, an average of 3 years | 
| HIV knowledge | Answers to a self-constructed questionnaire assessing participants' knowledge of HIV transmission routes and pre-exposure prophylaxis, following counseling. The questionnaire is composed of one multiple-choice question on HIV transmission routes and three True/False questions on pre-exposure prophylaxis. The results will be reported item by item. Exploratory data analyses may be conducted using, for example, principal component analysis. | Through study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Testing, Self-testing, Retesting, Early diagnosis, Counseling, Computer, Reminder, Short message service, Pre-exposure prophylaxis