HIV888/64NCT05195346
Undetectable = Untransmissible in Thailand (888/64)
An observational study of HIV, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site in Thailand.
Trial summary
This is a cross-sectional study to assess awareness, knowledge, and implementation of the concept of U=U among Thai PLHIV and Thai HIV healthcare providers, as well as associated factors. Data will be collected on an online survey platform called Alchemer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 770 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2021to 1 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include any HIV healthcare providers or Thai people living with HIV on antiretroviral therapy. All participants must be of Thai nationality and 18 or above years of age.
Who may be able to join
- Thai HIV healthcare providers or Thai PLHIV on ART medication
- ≥ 18 years of age
- Can read, understand, and write Thai
- Provide consent to participate in the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Institute of HIV Research and Innovation
Pathum Wan, Bangkok, 10330
About this study
Official title: A Cross-sectional Survey of HIV Healthcare Providers and People Living With HIV in Thailand, and Their Awareness, Knowledge, and Implementation of Undetectable = Untransmissible
This is a cross-sectional study to assess awareness, knowledge, and implementation of the concept of U=U among Thai PLHIV and Thai HIV healthcare providers, as well as associated factors. Data will be collected on an online survey platform called Alchemer. Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants, as well as collect sociodemographic information of participants.
Read the detailed description
Recruitment
Recruitment will start with the distribution of a brief description of the survey, along with the link to the questionnaire itself. This will be distributed systematically through the use of the snowball sampling method on popular social networking platforms (such as Line, Instagram, WhatsApp, Facebook and Twitter), where 'seed' distributors, who may be categorised into different groups (such as age, gender identity and treatment facility for PLHIV or healthcare facility and type of healthcare provider for HIV healthcare providers), will share out links to a number of friends. Participants will be enrolled into the study once they click on the link leading them to the survey and complete the questionnaire.
Informed consent process
Consent will be obtained by action. A brief description of the survey will be distributed, along with the online link to the survey, which will be on SurveyGizmo. All data will be collected anonymously. A digitalised consent form will be presented to participants before they start the survey, which will outline the potential risks and benefits. All participants will be equal to or over the age of 18; therefore, parental consent is not needed.
Questionnaires
The questionnaire should take no more than 15 minutes to complete. The survey will be completed on Alchemer (formerly SurveyGizmo), a flexible, cross platform online survey software, or other popular online survey platforms with similar features, with the participant giving consent through action. Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants, as well as collect sociodemographic information of participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. There will be two different questionnaires, one for PLHIV and one for HIV healthcare providers; each survey will be slightly altered to for the appropriate participant category. After the questionnaire is completed, participants can choose to be redirected to educational webpages with more information on U=U.
Data analysis
Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data
- Conditions
- HIV
- Keywords
- Undetectable = Untransmissible, Knowledge, Awareness, Implementation
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 |
|---|---|---|
| People Living with HIV (PLHIV) | Thai people living with HIV, aged 18 or above, who are on Antiretroviral Therapy (ART) | |
| HIV Healthcare Providers | Thai healthcare providers, including but not limited to doctors, nurses, counsellors, lay providers, pharmacists, lab technicians, etc., who take care of any persons living with HIV. All aged 18 or above |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study awareness, knowledge, and implementation of U=U concept among Thai HIV healthcare providers
Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data. We hypothesised that awareness will be low among Thai HIV healthcare providers (<50%), and thereby knowledge and implementation will be equal to or lower.
Measured: 12 months
To study awareness, knowledge, and implementation of U=U and its physical, mental, and sexual health impacts on Thai PLHIV.
Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data. We hypothesised that awareness will be relatively low among Thai PLHIV (~50%); therefore, knowledge and implementation will be equal to or lower.
Measured: 12 months
To explore factors associated with awareness, knowledge, and implementation of U=U concept among Thai HIV healthcare providers and Thai PLHIV.
Questions on the survey will also collect sociodemographic information of participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data. We hypothesised that factors most closely relative to awareness, knowledge, and implementation of U=U among PLHIV could be duration on ART, size of treatment facility, age, and gender identity. Among HIV healthcare providers, likely factors of influence will be size of healthcare facility and type of healthcare provider.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Cross-sectional
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD,Ph.D, Principal investigator, INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195346
- Sponsor's protocol ID
- IHRI012
- Acronym
- 888/64
- Status last verified
- Jan 2023
- First submitted
- 11 Dec 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Survey of HIV Healthcare Providers and People Living With HIV in Thailand, and Their Awareness, Knowledge, and Implementation of Undetectable = Untransmissible
- ClinicalTrials.gov ID
- NCT05195346
- Acronym / sponsor ID
- 888/64 / IHRI012
- Conditions
- HIV
- Keywords
- Undetectable = Untransmissible, Knowledge, Awareness, Implementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Jan 2022 (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.
This is a cross-sectional study to assess awareness, knowledge, and implementation of the concept of U=U among Thai PLHIV and Thai HIV healthcare providers, as well as associated factors. Data will be collected on an online survey platform called Alchemer. Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants, as well as collect sociodemographic information of participants.
Detailed description
Recruitment
Recruitment will start with the distribution of a brief description of the survey, along with the link to the questionnaire itself. This will be distributed systematically through the use of the snowball sampling method on popular social networking platforms (such as Line, Instagram, WhatsApp, Facebook and Twitter), where 'seed' distributors, who may be categorised into different groups (such as age, gender identity and treatment facility for PLHIV or healthcare facility and type of healthcare provider for HIV healthcare providers), will share out links to a number of friends. Participants will be enrolled into the study once they click on the link leading them to the survey and complete the questionnaire.
Informed consent process
Consent will be obtained by action. A brief description of the survey will be distributed, along with the online link to the survey, which will be on SurveyGizmo. All data will be collected anonymously. A digitalised consent form will be presented to participants before they start the survey, which will outline the potential risks and benefits. All participants will be equal to or over the age of 18; therefore, parental consent is not needed.
Questionnaires
The questionnaire should take no more than 15 minutes to complete. The survey will be completed on Alchemer (formerly SurveyGizmo), a flexible, cross platform online survey software, or other popular online survey platforms with similar features, with the participant giving consent through action. Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants, as well as collect sociodemographic information of participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. There will be two different questionnaires, one for PLHIV and one for HIV healthcare providers; each survey will be slightly altered to for the appropriate participant category. After the questionnaire is completed, participants can choose to be redirected to educational webpages with more information on U=U.
Data analysis
Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People Living with HIV (PLHIV) | – | –Thai people living with HIV, aged 18 or above, who are on Antiretroviral Therapy (ART) |
| HIV Healthcare Providers | – | –Thai healthcare providers, including but not limited to doctors, nurses, counsellors, lay providers, pharmacists, lab technicians, etc., who take care of any persons living with HIV. All aged 18 or above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include any HIV healthcare providers or Thai people living with HIV on antiretroviral therapy. All participants must be of Thai nationality and 18 or above years of age.
Key inclusion criteria (4 listed)
- Thai HIV healthcare providers or Thai PLHIV on ART medication
- ≥ 18 years of age
- Can read, understand, and write Thai
- Provide consent to participate in the study
Key exclusion criteria (1 listed)
- None
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
To study awareness, knowledge, and implementation of U=U concept among Thai HIV healthcare providers
Time frame: 12 months
Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data. We hypothesised that awareness will be low among Thai HIV healthcare providers (<50%), and thereby knowledge and implementation will be equal to or lower.
To study awareness, knowledge, and implementation of U=U and its physical, mental, and sexual health impacts on Thai PLHIV.
Time frame: 12 months
Questions on the survey will evaluate awareness, knowledge, and implementation of U=U among participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data. We hypothesised that awareness will be relatively low among Thai PLHIV (~50%); therefore, knowledge and implementation will be equal to or lower.
To explore factors associated with awareness, knowledge, and implementation of U=U concept among Thai HIV healthcare providers and Thai PLHIV.
Time frame: 12 months
Questions on the survey will also collect sociodemographic information of participants. All the information collected will be kept confidential and anonymous, and participants cannot be identified in any way. Data used for analysis will only include data that is submitted through the online portal. It will be analysed using descriptive statistics including percentage, mean and standard deviations, as well as inferential statistics such as Chi Square test or t-test depending on the characteristics of data. We hypothesised that factors most closely relative to awareness, knowledge, and implementation of U=U among PLHIV could be duration on ART, size of treatment facility, age, and gender identity. Among HIV healthcare providers, likely factors of influence will be size of healthcare facility and type of healthcare provider.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
Nittaya Phanuphak, MD,Ph.D principal investigator
INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Institute of HIV Research and Innovation Foundation, Thailand at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study awareness, knowledge, and implementation of U=U concept among Thai HIV healthcare providers (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.