Patient Acceptance of Health CareNCT02855606
Acceptability of HIV Oral PrEP Among MSM and TGW
An observational study of Patient Acceptance of Health Care, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Patient Acceptance of Health Care
- How many people
- 105 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2015to 30 May 2019
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Thai MSM and TGW
Who may be able to join
- MSM or TGW at age18 years or older at enrollment
- Able to read and write effectively in Thai language
- Negative HIV testing (by assigned rapid tests) at enrollment
- Available to return for the study visits and willing to comply with study requirements
- Willing to provide reachable contact numbers and address
- Creatinine clearance ≥ 60 mL/min
- Negative urine protein
- Negative HBs Ag
Who cannot join
- Symptoms suggestive for acute HIV seroconversion
- Participating in any interventional HIV research
- Has any physical or mental condition(s) that, in the opinion of the investigator(s), complicate interpretation of study outcome data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability of HIV Oral Pre-Exposure Prophylaxis (PrEP) Among Men Have Sex With Men (MSM) and Transgender Women (TGW)
The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW).
- Conditions
- Patient Acceptance of Health Care
- Keywords
- Oral PrEP, TGW, Thai MSM
- Medical subject headings
- Patient Acceptance of Health Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and factors affecting the decision to take oral PrEP
After receiving information about PrEP, the participants will have a chance to decide whether they want to take PrEP or not. The set of questions asking about reason(s) for taking (or not taking) PrEP are used to evaluated the acceptability. The questions will evaluate multiple aspects such as knowledge about PrEP (efficacy and medications side effect), personal belief about PrEP, sexual practice, social stigmata, and concern for HIV resistance. The participants will answer these questions via Computer-Assisted Self Interviewing (CASI).
Measured: 1 year
Secondary outcomes (2)
Adherence to PrEP by self-report
Among the participants who decide to take PrEP, the adherence will be evaluate by self-report (directly to medical staff and via Computer-Assisted Self Interviewing).
Measured: 1 year
Adherence to PrEP by pill count
Among the participants who decide to take PrEP, the adherence will be evaluate by pill count.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Acceptance of Health CareStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwat Chariyalertsak, Chiang Mai University
- Investigators
- Suwat Chariyalertsak, MD. DrPH., Principal investigator, Research Institute for Health Sciences (RIHES)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855606
- Sponsor's protocol ID
- PrEP@PIMAN
- Status last verified
- Jul 2022
- First submitted
- 22 Apr 2016
- Last updated
- 22 Jul 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of HIV Oral Pre-Exposure Prophylaxis (PrEP) Among Men Have Sex With Men (MSM) and Transgender Women (TGW)
- ClinicalTrials.gov ID
- NCT02855606
- Acronym / sponsor ID
- PrEP@PIMAN
- Conditions
- Patient Acceptance of Health Care
- Keywords
- Oral PrEP, TGW, Thai MSM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 4 Aug 2016 (estimated)
- 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.
The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thai MSM and TGW
Key inclusion criteria (8 listed)
- MSM or TGW at age18 years or older at enrollment
- Able to read and write effectively in Thai language
- Negative HIV testing (by assigned rapid tests) at enrollment
- Available to return for the study visits and willing to comply with study requirements
- Willing to provide reachable contact numbers and address
Key exclusion criteria (3 listed)
- Symptoms suggestive for acute HIV seroconversion
- Participating in any interventional HIV research
- Has any physical or mental condition(s) that, in the opinion of the investigator(s), complicate interpretation of study outcome data
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
Acceptability and factors affecting the decision to take oral PrEP
Time frame: 1 year
After receiving information about PrEP, the participants will have a chance to decide whether they want to take PrEP or not. The set of questions asking about reason(s) for taking (or not taking) PrEP are used to evaluated the acceptability. The questions will evaluate multiple aspects such as knowledge about PrEP (efficacy and medications side effect), personal belief about PrEP, sexual practice, social stigmata, and concern for HIV resistance. The participants will answer these questions via Computer-Assisted Self Interviewing (CASI).
2 secondary outcomes
Adherence to PrEP by self-report
Time frame: 1 year
Adherence to PrEP by pill count
Time frame: 1 year
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 22 Jul 2022.
- 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.
Suwat Chariyalertsak, MD. DrPH. principal investigator
Research Institute for Health Sciences (RIHES)
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 Patient Acceptance of Health Care, run by Chiang Mai University 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 8 inclusion and 3 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 22 Jul 2022. 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?
Acceptability and factors affecting the decision to take oral PrEP (time frame: 1 year). 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 22 Jul 2022.