User-friendly HIV Testing and Counseling Services
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04585165|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : February 16, 2021
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.
- 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.
|Condition or disease|
|HIV Infections Sexually Transmitted Infection Hepatitis B, Chronic Hepatitis C|
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.
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Cohort of Individuals at Risk of HIV Infection Recruited in User-friendly HIV Testing and Counseling Services in Thailand Provinces|
|Actual Study Start Date :||October 19, 2020|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||December 2024|
Risk of HIV acquisition
Individuals reporting behavioral risk of HIV acquisition.
- HIV incidence [ Time Frame: Through study completion, an average of 3 years ]HIV incidence
- Participants initiating pre-exposure prophylaxis [ Time Frame: Through study completion, an average of 3 years ]Proportion of participants initiating pre-exposure prophylaxis among those at significant risk of HIV
- Retention [ Time Frame: Through study completion, an average of 3 years ]Cumulative probability of retest
- HIV knowledge [ Time Frame: Through study completion, an average of 3 years ]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.
Biospecimen Retention: Samples With DNA
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): NCT04585165
|Contact: Gonzague Jourdain, MD, PhD||+66 5324 0910||Gonzague.Jourdain@ird.fr|
|Contact: Nicolas Salvadori, PhD||+66 5324 0910||Nicolas.Salvadori@phpt.org|
|STIs Clinic of the Office of Disease Prevention and Control Region 1||Not yet recruiting|
|Chiang Mai, Thailand, 50100|
|Contact: Chonlatorn Boontan, MD +66 53 276364 firstname.lastname@example.org|
|Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University||Recruiting|
|Chiang Mai, Thailand, 50200|
|Contact: Phennapha Klangsinsirikul, PhD +66 53 949220 email@example.com|
|MAP Foundation||Not yet recruiting|
|Chiang Mai, Thailand|
|Contact: Brahm Press firstname.lastname@example.org|
|Chiang Rai Obstetrics Clinic||Recruiting|
|Chiang Rai, Thailand, 57000|
|Contact: Jullapong Achalapong, MD 66 53 711 300 email@example.com|
|Phayao Hospital||Not yet recruiting|
|Phayao, Thailand, 56000|
|Contact: Guttiga Halue, MD +66 54 431 209 firstname.lastname@example.org|
|University of Phayao Medical Center and Hospital||Not yet recruiting|
|Phayao, Thailand, 56000|
|Contact: Sawitree Nangola, PhD +66 54 466 666 email@example.com|
|Principal Investigator:||Gonzague Jourdain, MD, PhD||Institut de recherche pour le développement, and Chiang Mai University|