User-friendly HIV Testing and Counseling Services

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585165
• Other study ID #: Napneung-2
• Status: Recruiting
• Start date: October 19, 2020
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Institut de Recherche pour le Developpement
• Contact: Gonzague Jourdain, MD, PhD
• Phone: +66 5324 0910
• Email: Gonzague.Jourdain[@]phpt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis C
• HIV Infections
• Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Locations

Country	Name	City	State
Thailand	Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University	Chiang Mai
Thailand	MAP Foundation	Chiang Mai
Thailand	STIs Clinic of the Office of Disease Prevention and Control Region 1	Chiang Mai
Thailand	Chiang Rai Obstetrics Clinic	Chiang Rai
Thailand	Phayao Hospital	Phayao
Thailand	University of Phayao Medical Center and Hospital	Phayao

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Expertise France-L'Initiative, French National Research Institute for Sustainable Development (IRD)

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV incidence	HIV incidence	Through study completion, an average of 3 years
Secondary	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
Secondary	Retention	Cumulative probability of retest	Through study completion, an average of 3 years
Secondary	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

External Links

•   Presentation for potential participants