User-friendly HIV Testing and Counseling Services

Recruiting

• Conditions: Hepatitis C; HIV Infections; Sexually Transmitted Infection; Hepatitis B, Chronic

• Registration Number: NCT04585165
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Study Start: 2020-10-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV incidence	Through study completion, an average of 3 years	HIV incidence

Secondary Outcome Measures

Name	Time	Method
Participants initiating pre-exposure prophylaxis	Through study completion, an average of 3 years	Proportion of participants initiating pre-exposure prophylaxis among those at significant risk of HIV
Retention	Through study completion, an average of 3 years	Cumulative probability of retest
HIV knowledge	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.

Trial Locations

Locations (6)

Chiang Rai Obstetrics Clinic; 🇹🇭 Chiang Rai, Thailand

Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

Phayao Hospital; 🇹🇭 Phayao, Thailand

University of Phayao Medical Center and Hospital; 🇹🇭 Phayao, Thailand

STIs Clinic of the Office of Disease Prevention and Control Region 1; 🇹🇭 Chiang Mai, Thailand

MAP Foundation; 🇹🇭 Chiang Mai, Thailand