HivNCT05774548
LA PrEP Impact and Cost-effectiveness (TEAMS)
A study testing In-depth interviews (IDI) and Focus group discussion (FGD) in people with Hiv, run by Institute of HIV Research and Innovation Foundation, Thailand at 12 sites in Thailand.
Trial summary
This study will have three components: 1. Discrete choice experiments 2. Analysis of routine service data 3. Impact and cost-effectiveness analyses using results from 1 and 2 Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- In-depth interviews (IDI) and Focus group discussion (FGD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,720 participants
- Where
- 12 sitesThailand
- Study dates
- 15 Mar 2022to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age of 18 years
- Individual assigned male at birth reporting sex with men in the past 12 months
- Self-reported HIV-negative MSM and TGW who either report interest in PrEP use, current PrEP use, or past PrEP use
- Permit audio recording during the interview and/or discussion.
Who cannot join
- Not willing to participate in the study
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Thailand12 sites, 12 recruiting
- Recruiting
The Service Workers In Group Foundation (SWING)
Bang Lamung, Changwat Chon Buri, 20150
Surang Janyam, 038 412 297, surang.jan@swingthailand.org
- Recruiting
Rainbow Sky Association of Thailand (RSAT)
Bangkok, Bangkapi, 10240
Tanachai Chaisalee, 6683 897 1691, tanachai@rsat.info
- Recruiting
The Service Workers In Group Foundation (SWING)
Bangkok, Building 3, Patpong, Surawong Road, 10500
Surang Janyam, 081 626 6538, surang.jan@swingthailand.org
- Recruiting
Tangerine Clinic
Bangkok, Pathumwan, 10330
Nittaya Phanuphak, MD,PhD, 02 160 5372, nittaya.p@ihri.org
- Recruiting
The Service Workers In Group Foundation (SWING)
Bangkok, Phay Thai, 10400
Surang Janyam, 02 115 0251, surang.jan@swingthailand.org
- Recruiting
CAREMAT
Chiang Mai, 50200
Satayu Sittikarn, 052 005 458, satayu.lapter@gmail.com
- Recruiting
Mplus Foundation
Chiang Mai, 50200
Pongpeera Patpeerapong, 053 283 108, clash.ae@gmail.com
- Recruiting
Mplus Foundation
Chiang Rai, 57000
Pongpeera Patpeerapong, 052 026 357, clash.ae@gmail.com
- Recruiting
Rainbow Sky Association of Thailand (RSAT)
Chon Buri, Changwat Chon Buri, 20000
Tanachai Chaisalee, 038 455 508, tanachai@rsat.info
- Recruiting
Rainbow Sky Association of Thailand (RSAT)
Hat Yai, Changwat Songkhla, 90110
Tanachai Chaisalee, 074 232 101, tanachai@rsat.info
- Recruiting
Mplus Foundation
Phitsanulok, 65000
Pongpeera Patpeerapong, 055 002 309, clash.ae@gmail.com
- Recruiting
Rainbow Sky Association of Thailand (RSAT)
Ubon Ratchathani, 34000
Tanachai Chaisalee, 045 957 007, tanachai@rsat.info
About this study
Official title: Epidemiological Impact and Cost-effectiveness of Long-acting Antiretrovirals for Pre-exposure Prophylaxis Among Key Populations in Thailand
This study will have three components:
- Discrete choice experiments
- Analysis of routine service data
- Impact and cost-effectiveness analyses using results from 1 and 2
Read the detailed description
Discrete choice experiments (DCE) will be part of a survey, assessing sociodemographic characteristics, risk behavior, PrEP related information. Two separate surveys and DCEs will be designed, one for MSM, and one for TGW. Information collected through DCEs will allow us to estimate user values in the absence of observations or readily available data, and use these preferences to inform mathematical modeling on the impact and cost-effectiveness of long-acting PrEP. DCEs will be designed as per best-practice guidance by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). To maximize statistical and response efficiency, the number of attributes selected for evaluation must be restricted, i.e. the most important attributes must be known prior to construction. Therefore, the DCE design and implementation of the survey will be conducted in different phases:
PHASE I - Identification of attributes In-depth interviews (IDIs) with up to 40 potential, current, previous PrEP users (20 MSM,20 TGW) will assess which attributes are most relevant among each population. Posters will be used to recruit participants for IDIs. Self-reported HIV-negative MSM, TGW who either report interest in PrEP use, current PrEP use, or past PrEP use, will be eligible to participate in the IDIs. IDIs will be conducted by the study staff by in-person or on-line interviews. Focus group discussion (FGD) will prepare to discuss the interested information from IDIs. Following IDIs, participants will be informed and invited to the focus group discussion. A FGD will recruit 6-10 IDI participants from each MSM, TGW group. A list of 10 random numbers will be generated using statistical software if more than 10 individuals show interest in participating in the FGD. If there are less than 6 accepted participants for the FGD, the backup list or a new participant will be invited. The study staff will perform FGD by in-person or on-line conference. Data obtained during this process will be used to create a final list of attributes for each population and their levels to include in the choice tasks, ensuring that the choices are plausible and exchangeable. The number of DCE choice sets will be about 6 per person.
PHASE II - Pilot testing of DCE (The result from Phase I will be used for finalize an initial draft in this part) Initial drafts of the choice tasks (one draft for MSM and one draft for TGW) will be administered to convenience samples of 30 MSM, 30 TGW (10% of phase III sample size), respectively, to obtain feedback about difficulty of tasks, plausibility of levels, length, wording and clarity using a survey form. Final DCEs for each population will be agreed upon by consensus, and incorporated in the surveys.
PHASE III - Survey implementation (The result from Phase II will be used for finalize a survey in this part).
Two final surveys will be launched:1 survey for MSM, 1 survey for TGW. Both surveys will collect data on:
- Participant information, including:
- Sociodemographic information
- Risk behavior
- HIV testing
- STI testing and diagnoses
- PrEP knowledge and use
- Awareness of different PrEP modalities
- Interest in different PrEP modalities
- Preferences for different PrEP modalities
- Current and past use
- DCE of different PrEP options. Although the final list of attributes will be based on literature review and interviews, potential attributes of interest and their levels are:
- Product form (oral, injectable)
- Dosing frequency (daily, once every 2 months, once every 6 months, once every 12 months)
- Type of facility (hospital, CBO, primary care center, pharmacy, home)
- Type of provider preference (KP lay provider, doctor, nurse, pharmacist, self)
- Monthly cost out of pocket (free, up to 500 THB, up to 1000 THB)
- Side effects (mild, moderate)
Data from these surveys will be analyzed to identify the most important drivers for PrEP preference. This will allow us to analyze the trade-offs that respondents make, to quantitatively explore what drives individual decision making and the relative strength of preferences. These findings will be used to project the hypothetical uptake of long acting antiretrovirals with different characteristics, the impact of this formulation on the uptake of oral PrEP, and how certain long acting antiretroviral characteristics will affect the uptake. Findings generated will be used to conduct epidemiological impact and cost-effectiveness analyses. Uptake projections will be determined for those never using PrEP before, for those having used oral PrEP before and stopped, and for those currently using oral PrEP.
- Conditions
- Hiv
- Being tested
- In-depth interviews (IDI), Focus group discussion (FGD)
- Keywords
- HIV, PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-depth interviews (IDI)Other
In-depth interviews (IDI) 20 MSM,20 TGW, current, previous PrEP users will assess which attributes are relevant each population. Posters will be used to recruit for IDIs. Self-reported HIV-negative who either report interest in current or past PrEP use will be eligible to participate in IDI. IDI will be conducted by a study by in-person, on-line interviews.
Focus group discussion (FGD)Other
Focus group discussion (FGD) will discuss a interested information from IDIs. IDIs will be informed, invited to a FGD. FGD recruit 6-10 IDI. 10 random number will be generated using statistical if more 10 individuals show interest in participating in a FGD. If there are less than 6 accepted participants for a FGD, the backup list or new participant will be invited. Study will perform FGD by in-person, on-line conference. Data obtained during a process will be used to create a list of attributes for each population, their levels to include in the choice tasks, ensuring that a choices are plausible, exchangeable.
| Study group | Role | What they receive |
|---|---|---|
| (PHASE I) Attributes identification | Experimental | To identify attributes of importance for our research question and assign possible levels to these attributes, a combination of literature review and qualitative approaches will be conducted Receives: Other: In-depth interviews (IDI); Other: Focus group discussion (FGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The epidemiological impact of long-acting antiretrovirals for HIV prevention among Thai MSM and TGW at risk of HIV infection
Epidemiological impact analyses will compare a current scenario in which PrEP is only available as an oral formulation to a scenario in which long-acting PrEP is also available.
Measured: 12 months
The cost-effectiveness of long-acting antiretrovirals for HIV prevention among Thai MSM and TGW at risk of HIV infection
The cost-effectiveness analysis will be based on previous HIV transmission models published by the Erasmus Medical Centre
Measured: 12 months
Secondary outcomes (3)
Proportion of MSM and TGW indicating uptake of PrEP in hypothetic scenarios, impact of sociodemographic and behavioral characteristics on projected uptake
The uptake of different PrEP modalities will be measured via a discrete choice experiment survey with clients in KP-led PrEP clinic
Measured: 18 months
Preferred PrEP modalities among Thai MSM and TGW, trade-off of different PrEP attributes
To quantify preference for long-acting antiretrovirals as PrEP in Thai MSM and TGW using discrete choice experiments
Measured: 18 months
Patterns of PrEP use
Patterns of PrEP use will analyze from the data such as discontinuation rates and restarts of oral PrEP in KP-led PrEP program
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start15 Mar 2022
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD,PhD., Principal investigator, INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774548
- Sponsor's protocol ID
- IHRI019
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2023
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Impact and Cost-effectiveness of Long-acting Antiretrovirals for Pre-exposure Prophylaxis Among Key Populations in Thailand
- ClinicalTrials.gov ID
- NCT05774548
- Acronym / sponsor ID
- IHRI019
- Conditions
- Hiv
- Keywords
- HIV, PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,720 participants (estimated)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Mar 2023 (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 study will have three components:
- Discrete choice experiments
- Analysis of routine service data
- Impact and cost-effectiveness analyses using results from 1 and 2
Detailed description
Discrete choice experiments (DCE) will be part of a survey, assessing sociodemographic characteristics, risk behavior, PrEP related information. Two separate surveys and DCEs will be designed, one for MSM, and one for TGW. Information collected through DCEs will allow us to estimate user values in the absence of observations or readily available data, and use these preferences to inform mathematical modeling on the impact and cost-effectiveness of long-acting PrEP. DCEs will be designed as per best-practice guidance by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). To maximize statistical and response efficiency, the number of attributes selected for evaluation must be restricted, i.e. the most important attributes must be known prior to construction. Therefore, the DCE design and implementation of the survey will be conducted in different phases:
PHASE I - Identification of attributes In-depth interviews (IDIs) with up to 40 potential, current, previous PrEP users (20 MSM,20 TGW) will assess which attributes are most relevant among each population. Posters will be used to recruit participants for IDIs. Self-reported HIV-negative MSM, TGW who either report interest in PrEP use, current PrEP use, or past PrEP use, will be eligible to participate in the IDIs. IDIs will be conducted by the study staff by in-person or on-line interviews. Focus group discussion (FGD) will prepare to discuss the interested information from IDIs. Following IDIs, participants will be informed and invited to the focus group discussion. A FGD will recruit 6-10 IDI participants from each MSM, TGW group. A list of 10 random numbers will be generated using statistical software if more than 10 individuals show interest in participating in the FGD. If there are less than 6 accepted participants for the FGD, the backup list or a new participant will be invited. The study staff will perform FGD by in-person or on-line conference. Data obtained during this process will be used to create a final list of attributes for each population and their levels to include in the choice tasks, ensuring that the choices are plausible and exchangeable. The number of DCE choice sets will be about 6 per person.
PHASE II - Pilot testing of DCE (The result from Phase I will be used for finalize an initial draft in this part) Initial drafts of the choice tasks (one draft for MSM and one draft for TGW) will be administered to convenience samples of 30 MSM, 30 TGW (10% of phase III sample size), respectively, to obtain feedback about difficulty of tasks, plausibility of levels, length, wording and clarity using a survey form. Final DCEs for each population will be agreed upon by consensus, and incorporated in the surveys.
PHASE III - Survey implementation (The result from Phase II will be used for finalize a survey in this part).
Two final surveys will be launched:1 survey for MSM, 1 survey for TGW. Both surveys will collect data on:
- Participant information, including:
- Sociodemographic information
- Risk behavior
- HIV testing
- STI testing and diagnoses
- PrEP knowledge and use
- Awareness of different PrEP modalities
- Interest in different PrEP modalities
- Preferences for different PrEP modalities
- Current and past use
- DCE of different PrEP options. Although the final list of attributes will be based on literature review and interviews, potential attributes of interest and their levels are:
- Product form (oral, injectable)
- Dosing frequency (daily, once every 2 months, once every 6 months, once every 12 months)
- Type of facility (hospital, CBO, primary care center, pharmacy, home)
- Type of provider preference (KP lay provider, doctor, nurse, pharmacist, self)
- Monthly cost out of pocket (free, up to 500 THB, up to 1000 THB)
- Side effects (mild, moderate)
Data from these surveys will be analyzed to identify the most important drivers for PrEP preference. This will allow us to analyze the trade-offs that respondents make, to quantitatively explore what drives individual decision making and the relative strength of preferences. These findings will be used to project the hypothetical uptake of long acting antiretrovirals with different characteristics, the impact of this formulation on the uptake of oral PrEP, and how certain long acting antiretroviral characteristics will affect the uptake. Findings generated will be used to conduct epidemiological impact and cost-effectiveness analyses. Uptake projections will be determined for those never using PrEP before, for those having used oral PrEP before and stopped, and for those currently using oral PrEP.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (PHASE I) Attributes identification | Experimental | Other: In-depth interviews (IDI), Other: Focus group discussion (FGD)To identify attributes of importance for our research question and assign possible levels to these attributes, a combination of literature review and qualitative approaches will be conducted |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum age of 18 years
- Individual assigned male at birth reporting sex with men in the past 12 months
- Self-reported HIV-negative MSM and TGW who either report interest in PrEP use, current PrEP use, or past PrEP use
- Permit audio recording during the interview and/or discussion.
Key exclusion criteria (1 listed)
- Not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-depth interviews (IDI)In-depth interviews (IDI) 20 MSM,20 TGW, current, previous PrEP users will assess which attributes are relevant each population. Posters will be used to recruit for IDIs. Self-reported HIV-negative who either report interest in current or past PrEP use will be eligible to participate in IDI. IDI will be conducted by a study by in-person, on-line interviews. | Other | (PHASE I) Attributes identification |
| Focus group discussion (FGD)Focus group discussion (FGD) will discuss a interested information from IDIs. IDIs will be informed, invited to a FGD. FGD recruit 6-10 IDI. 10 random number will be generated using statistical if more 10 individuals show interest in participating in a FGD. If there are less than 6 accepted participants for a FGD, the backup list or new participant will be invited. Study will perform FGD by in-person, on-line conference. Data obtained during a process will be used to create a list of attributes for each population, their levels to include in the choice tasks, ensuring that a choices are plausible, exchangeable. | Other | (PHASE I) Attributes identification |
Primary outcome
The epidemiological impact of long-acting antiretrovirals for HIV prevention among Thai MSM and TGW at risk of HIV infection
Time frame: 12 months
Epidemiological impact analyses will compare a current scenario in which PrEP is only available as an oral formulation to a scenario in which long-acting PrEP is also available.
The cost-effectiveness of long-acting antiretrovirals for HIV prevention among Thai MSM and TGW at risk of HIV infection
Time frame: 12 months
The cost-effectiveness analysis will be based on previous HIV transmission models published by the Erasmus Medical Centre
3 secondary outcomes
Proportion of MSM and TGW indicating uptake of PrEP in hypothetic scenarios, impact of sociodemographic and behavioral characteristics on projected uptake
Time frame: 18 months
Preferred PrEP modalities among Thai MSM and TGW, trade-off of different PrEP attributes
Time frame: 18 months
Patterns of PrEP use
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- The epidemiological impact and cost-effectiveness of key population-led PrEP delivery to prevent HIV among men who have sex with men in Thailand: A modelling studyLink provided by the sponsor.
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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.
Nittaya Phanuphak, MD,PhD. principal investigator
INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-depth interviews (IDI) and Focus group discussion (FGD) in people with Hiv, run by Institute of HIV Research and Innovation Foundation, Thailand at 12 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 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nittaya Phanuphak, MD,PhD. (6681 825 3544, nittaya.p@ihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The epidemiological impact of long-acting antiretrovirals for HIV prevention among Thai MSM and TGW at risk of HIV infection (time frame: 12 months). The study lists 2 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 18 Mar 2026.