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User-friendly HIV Testing and Counseling Services

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ClinicalTrials.gov Identifier: NCT04585165
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : February 16, 2021
Sponsor:
Collaborators:
Expertise France
Chiang Mai University
Information provided by (Responsible Party):
GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement

Brief Summary:

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.

Condition or disease
HIV Infections Sexually Transmitted Infection Hepatitis B, Chronic Hepatitis C

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Risk of HIV acquisition
Individuals reporting behavioral risk of HIV acquisition.



Primary Outcome Measures :
  1. HIV incidence [ Time Frame: Through study completion, an average of 3 years ]
    HIV incidence


Secondary Outcome Measures :
  1. 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

  2. Retention [ Time Frame: Through study completion, an average of 3 years ]
    Cumulative probability of retest

  3. 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
Plasma from remaining blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals requesting a test for HIV and sexually transmitted infections
Criteria

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


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): NCT04585165


Contacts
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Contact: Gonzague Jourdain, MD, PhD +66 5324 0910 Gonzague.Jourdain@ird.fr
Contact: Nicolas Salvadori, PhD +66 5324 0910 Nicolas.Salvadori@phpt.org

Locations
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Thailand
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    firstboontan@gmail.com   
Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50200
Contact: Phennapha Klangsinsirikul, PhD    +66 53 949220    phennapha.k@cmu.ac.th   
MAP Foundation Not yet recruiting
Chiang Mai, Thailand
Contact: Brahm Press       brahm.press@gmail.com   
Chiang Rai Obstetrics Clinic Recruiting
Chiang Rai, Thailand, 57000
Contact: Jullapong Achalapong, MD    66 53 711 300    jullapongachalapong@gmail.com   
Phayao Hospital Not yet recruiting
Phayao, Thailand, 56000
Contact: Guttiga Halue, MD    +66 54 431 209    drgutti@gmail.com   
University of Phayao Medical Center and Hospital Not yet recruiting
Phayao, Thailand, 56000
Contact: Sawitree Nangola, PhD    +66 54 466 666    sawitree.na@up.ac.th   
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Expertise France
Chiang Mai University
Investigators
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Principal Investigator: Gonzague Jourdain, MD, PhD Institut de recherche pour le développement, and Chiang Mai University
Additional Information:
Publications:
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Responsible Party: GONZAGUE JOURDAIN, PHPT Research Team, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT04585165    
Other Study ID Numbers: Napneung-2
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement:
HIV
Testing
Self-testing
Retesting
Early diagnosis
Counseling
Computer
Reminder
Short message service
Pre-exposure prophylaxis
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis C
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis B
Sexually Transmitted Diseases
Hepatitis B, Chronic
Hepatitis
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Sexually Transmitted Diseases, Viral
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic