HIV InfectionsNCT04585165
User-friendly HIV Testing and Counseling Services
An observational study of HIV Infections and Sexually Transmitted Infection, run by Institut de Recherche pour le Developpement at 6 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Infection, Hepatitis B, Chronic
- How many people
- 3,000 participants
- Where
- 6 sitesThailand
- Study dates
- 19 Oct 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals requesting a test for HIV and sexually transmitted infections
Who may be able to join
- Aged 15 years or more
- Willing to be tested for HIV and other sexually transmitted infections
- Able to understand the study and its procedures
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Thailand6 sites, 6 recruiting
- Recruiting
STIs Clinic of the Office of Disease Prevention and Control Region 1
Chiang Mai, 50100
Chonlatorn Boontan, MD, +66 53 276364, firstboontan@gmail.com
- Recruiting
Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, 50200
Phennapha Klangsinsirikul, PhD, +66 53 949220, phennapha.k@cmu.ac.th
- Recruiting
MAP Foundation
Chiang Mai
Brahm Press, brahm.press@gmail.com
- Recruiting
Chiang Rai Obstetrics Clinic
Chiang Rai, 57000
Jullapong Achalapong, MD, 66 53 711 300, jullapongachalapong@gmail.com
- Not yet recruiting
Phayao Hospital
Phayao, 56000
Guttiga Halue, MD, +66 54 431 209, drgutti@gmail.com
- Recruiting
University of Phayao Medical Center and Hospital
Phayao, 56000
Sawitree Nangola, PhD, +66 54 466 666, sawitree.na@up.ac.th
About this study
Official title: 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.
Read more
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.
- Keywords
- HIV, Testing, Self-testing, Retesting, Early diagnosis, Counseling, Computer, Reminder, Short message service, Pre-exposure prophylaxis
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Hepatitis B, Chronic, Hepatitis C, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Risk of HIV acquisition | Individuals reporting behavioral risk of HIV acquisition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV incidence
HIV incidence
Measured: Through study completion, an average of 3 years
Secondary outcomes (3)
Participants initiating pre-exposure prophylaxis
Proportion of participants initiating pre-exposure prophylaxis among those at significant risk of HIV
Measured: Through study completion, an average of 3 years
Retention
Cumulative probability of retest
Measured: Through study completion, an average of 3 years
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.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start19 Oct 2020
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Expertise France, French National Research Institute for Sustainable Development (IRD)
- Responsible party
- Principal investigator, GONZAGUE JOURDAIN, Chiang Mai University
- Investigators
- Gonzague Jourdain, MD, PhD, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585165
- Sponsor's protocol ID
- Napneung-2
- Status last verified
- Oct 2023
- First submitted
- 27 Apr 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 31605294Salvadori 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Individuals at Risk of HIV Infection Recruited in User-friendly HIV Testing and Counseling Services in Thailand Provinces
- ClinicalTrials.gov ID
- NCT04585165
- Acronym / sponsor ID
- Napneung-2
- Keywords
- HIV, Testing, Self-testing, Retesting, Early diagnosis, Counseling, Computer, Reminder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Expertise France, French National Research Institute for Sustainable Development (IRD)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk of HIV acquisition | – | –Individuals reporting behavioral risk of HIV acquisition. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals requesting a test for HIV and sexually transmitted infections
Key inclusion criteria (3 listed)
- Aged 15 years or more
- Willing to be tested for HIV and other sexually transmitted infections
- Able to understand the study and its procedures
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIV incidence
Time frame: Through study completion, an average of 3 years
HIV incidence
3 secondary outcomes
Participants initiating pre-exposure prophylaxis
Time frame: Through study completion, an average of 3 years
Retention
Time frame: Through study completion, an average of 3 years
HIV knowledge
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 31605294Salvadori 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.
- Background: PubMed 32294318Salvadori 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.
- Presentation for potential participantsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzague Jourdain, MD, PhD principal investigator
Chiang Mai University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Sexually Transmitted Infection, run by Institut de Recherche pour le Developpement at 6 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonzague Jourdain, MD, PhD (+66 5324 0910, Gonzague.Jourdain@phpt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV incidence (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585165, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.