User-friendly HIV Testing and Counseling Services

October 29, 2023 updated by: GONZAGUE JOURDAIN, Institut de Recherche pour le Developpement

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University
        • Contact:
      • Chiang Mai, Thailand, 50100
        • Recruiting
        • STIs Clinic of the Office of Disease Prevention and Control Region 1
        • Contact:
      • Chiang Mai, Thailand
      • Chiang Rai, Thailand, 57000
      • Phayao, Thailand, 56000
        • Not yet recruiting
        • Phayao Hospital
        • Contact:
      • Phayao, Thailand, 56000
        • Recruiting
        • University of Phayao Medical Center and Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals requesting a test for HIV and sexually transmitted infections

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV incidence
Time Frame: Through study completion, an average of 3 years
HIV incidence
Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 3 years
Retention
Time Frame: Through study completion, an average of 3 years
Cumulative probability of retest
Through study completion, an average of 3 years
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.
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche pour le Developpement

Collaborators

Expertise France-L'Initiative
French National Research Institute for Sustainable Development (IRD)

Investigators

  • Principal Investigator: Gonzague Jourdain, MD, PhD, Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2020

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

October 12, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 29, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Napneung-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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