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RecruitingNCT04585165Updated Oct 31, 2023

User-friendly HIV Testing and Counseling Services

An observational study in HIV Infections, Sexually Transmitted Infection and Hepatitis B, Chronic, sponsored by Institut de Recherche pour le Developpement. Recruiting at 6 sites in Thailand. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Institut de Recherche pour le Developpement · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
15 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals requesting a test for HIV and sexually transmitted infections

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Risk of HIV acquisition

    Individuals reporting behavioral risk of HIV acquisition.

05

What researchers measure

Primary outcomes

  1. HIV incidence

    HIV incidence

    Time frame: Through study completion, an average of 3 years

Secondary outcomes

  1. Participants initiating pre-exposure prophylaxis

    Proportion of participants initiating pre-exposure prophylaxis among those at significant risk of HIV

    Time frame: Through study completion, an average of 3 years

  2. Retention

    Cumulative probability of retest

    Time frame: Through study completion, an average of 3 years

  3. 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.

    Time frame: Through study completion, an average of 3 years

06

Study locations

5 of 6 sites recruiting
  • STIs Clinic of the Office of Disease Prevention and Control Region 1
    Chiang Mai, 50100, Thailand
    Recruiting
  • Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University
    Chiang Mai, 50200, Thailand
    Recruiting
  • MAP Foundation
    Chiang Mai, Thailand
    Recruiting
  • Chiang Rai Obstetrics Clinic
    Chiang Rai, 57000, Thailand
    Recruiting
  • Phayao Hospital
    Phayao, 56000, Thailand
    Not yet recruiting
  • University of Phayao Medical Center and Hospital
    Phayao, 56000, Thailand
    Recruiting
07

References and documents

Publications

  • 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. PubMed 31605294 ↗
  • 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. PubMed 32294318 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT04585165
Lead sponsor
Institut de Recherche pour le Developpement
Collaborators
Expertise France-L'Initiative, French National Research Institute for Sustainable Development (IRD)
Responsible party
GONZAGUE JOURDAIN (Researcher, Chiang Mai University) — Principal investigator
First posted
Oct 14, 2020
Start date
Oct 19, 2020
Primary completion
Sep 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 31, 2023

Study contacts

Gonzague Jourdain, MD, PhD
Contact
Gonzague.Jourdain@phpt.org
+66 5324 0910
Nicolas Salvadori, PhD
Contact
Nicolas.Salvadori@phpt.org
+66 5324 0910
Gonzague Jourdain, MD, PhD
principal investigator · Chiang Mai University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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