Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
10720 participants
INTERVENTIONAL
2022-03-15
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Discrete choice experiments
2. Analysis of routine service data
3. Impact and cost-effectiveness analyses using results from 1 and 2
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of PrEP-30: a Demonstration Project of Pre-exposure Prophylaxis for MSM and Other High-risk Group Clients at the Thai Red Cross Anonymous Clinic
NCT02437981
Same-Day Antiretroviral Therapy Initiation
NCT04032028
Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand
NCT00433030
Preliminary Study of Early, Primary HIV Infection in a High Risk Cohort
NCT00989144
Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression
NCT03251690
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. Participant information, including:
1. Sociodemographic information
2. Risk behavior
3. HIV testing
4. STI testing and diagnoses
2. PrEP knowledge and use
1. Awareness of different PrEP modalities
2. Interest in different PrEP modalities
3. Preferences for different PrEP modalities
4. Current and past use
3. 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:
1. Product form (oral, injectable)
2. Dosing frequency (daily, once every 2 months, once every 6 months, once every 12 months)
3. Type of facility (hospital, CBO, primary care center, pharmacy, home)
4. Type of provider preference (KP lay provider, doctor, nurse, pharmacist, self)
5. Monthly cost out of pocket (free, up to 500 THB, up to 1000 THB)
6. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
(PHASE I) Attributes identification
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
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasmus Medical Center
OTHER
Institute of HIV Research and Innovation Foundation, Thailand
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nittaya Phanuphak, MD,PhD.
Role: PRINCIPAL_INVESTIGATOR
INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rainbow Sky Association of Thailand (RSAT)
Bangkok, Bangkapi, Thailand
The Service Workers In Group Foundation (SWING)
Bangkok, Building 3, Patpong, Surawong Road, Thailand
The Service Workers In Group Foundation (SWING)
Bang Lamung, Changwat Chon Buri, Thailand
Rainbow Sky Association of Thailand (RSAT)
Chon Buri, Changwat Chon Buri, Thailand
Rainbow Sky Association of Thailand (RSAT)
Hat Yai, Changwat Songkhla, Thailand
Tangerine Clinic
Bangkok, Pathumwan, Thailand
The Service Workers In Group Foundation (SWING)
Bangkok, Phay Thai, Thailand
CAREMAT
Chiang Mai, , Thailand
Mplus Foundation
Chiang Mai, , Thailand
Mplus Foundation
Chiang Rai, , Thailand
Mplus Foundation
Phitsanulok, , Thailand
Rainbow Sky Association of Thailand (RSAT)
Ubon Ratchathani, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
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 study
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IHRI019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.