Clinical trial NCT04585165: User-friendly HIV Testing and Counseling Services
Official title: Cohort of Individuals at Risk of HIV Infection Recruited in User-friendly HIV Testing and Counseling Services in Thailand Provinces
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Sexually Transmitted Infection
Hepatitis B, Chronic
Hepatitis C
Keywords: HIV
Testing
Self-testing
Retesting
Early diagnosis
Counseling
Computer
Reminder
Short message service
Pre-exposure prophylaxis
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Expertise France-L'Initiative
name: French National Research Institute for Sustainable Development (IRD)
First posted: 2020-10-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals requesting a test for HIV and sexually transmitted infections

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.

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.

Eligibility 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

Primary outcomes:
measure: HIV incidence
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Participants initiating pre-exposure prophylaxis
timeFrame: Through study completion, an average of 3 years
measure: Retention
timeFrame: Through study completion, an average of 3 years
measure: HIV knowledge
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: STIs Clinic of the Office of Disease Prevention and Control Region 1
city: Chiang Mai
country: Thailand
facility: Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University
city: Chiang Mai
country: Thailand
facility: MAP Foundation
city: Chiang Rai
country: Thailand
facility: Chiang Rai Obstetrics Clinic
city: Phayao
country: Thailand
facility: Phayao Hospital
city: Phayao
country: Thailand
facility: University of Phayao Medical Center and Hospital
Study officials:
affiliation: Chiang Mai University
name: Gonzague Jourdain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salvadori N, Decker L, Ngo-Giang-Huong N, Mary JY, Chevret S, Arunothong S, Adam P, Khamduang W, Samleerat T, Luangsook P, Suksa-Ardphasu V, Achalapong J, Rouzioux C, Sirirungsi W, Jourdain G. Impact of Counseling Methods on HIV Retesting Uptake in At-Risk Individuals: A Randomized Controlled Study. AIDS Behav. 2020 May;24(5):1505-1516. doi: 10.1007/s10461-019-02695-2.
citation: Salvadori N, Adam P, Mary JY, Decker L, Sabin L, Chevret S, Arunothong S, Khamduang W, Luangsook P, Suksa-Ardphasu V, Achalapong J, Rouzioux C, Sirirungsi W, Ngo-Giang-Huong N, Jourdain G. Appointment reminders to increase uptake of HIV retesting by at-risk individuals: a randomized controlled study in Thailand. J Int AIDS Soc. 2020 Apr;23(4):e25478. doi: 10.1002/jia2.25478.