NCT05774548

Brief Summary

This study will have three components:

  1. 1.Discrete choice experiments
  2. 2.Analysis of routine service data
  3. 3.Impact and cost-effectiveness analyses using results from 1 and 2

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,720

participants targeted

Target at P75+ for not_applicable hiv

Timeline
33mo left

Started Mar 2022

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2022Dec 2028

Study Start

First participant enrolled

March 15, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

February 22, 2023

Last Update Submit

March 16, 2026

Conditions

Keywords

HIV, PrEP

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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

    18 months

  • Preferred PrEP modalities among Thai MSM and TGW, trade-off of different PrEP attributes

    18 months

  • Patterns of PrEP use

    18 months

Study Arms (1)

(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

Other: In-depth interviews (IDI)Other: Focus group discussion (FGD)

Interventions

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.

(PHASE I) Attributes identification

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.

(PHASE I) Attributes identification

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Rainbow Sky Association of Thailand (RSAT)

Bangkok, Bangkapi, 10240, Thailand

RECRUITING

The Service Workers In Group Foundation (SWING)

Bangkok, Building 3, Patpong, Surawong Road, 10500, Thailand

RECRUITING

The Service Workers In Group Foundation (SWING)

Bang Lamung, Changwat Chon Buri, 20150, Thailand

RECRUITING

Rainbow Sky Association of Thailand (RSAT)

Chon Buri, Changwat Chon Buri, 20000, Thailand

RECRUITING

Rainbow Sky Association of Thailand (RSAT)

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Tangerine Clinic

Bangkok, Pathumwan, 10330, Thailand

RECRUITING

The Service Workers In Group Foundation (SWING)

Bangkok, Phay Thai, 10400, Thailand

RECRUITING

CAREMAT

Chiang Mai, 50200, Thailand

RECRUITING

Mplus Foundation

Chiang Mai, 50200, Thailand

RECRUITING

Mplus Foundation

Chiang Rai, 57000, Thailand

RECRUITING

Mplus Foundation

Phitsanulok, 65000, Thailand

RECRUITING

Rainbow Sky Association of Thailand (RSAT)

Ubon Ratchathani, 34000, Thailand

RECRUITING

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Nittaya Phanuphak, MD,PhD.

    INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nittaya Phanuphak, MD,PhD.

CONTACT

Rena Janamnuaysook, MBA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 17, 2023

Study Start

March 15, 2022

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations