NCT02855606

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

April 22, 2016

Last Update Submit

July 20, 2022

Conditions

Patient Acceptance of Health Care

Keywords

Oral PrEPTGWThai MSM

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 year

Secondary Outcomes (2)

  • Adherence to PrEP by self-report

    1 year

  • Adherence to PrEP by pill count

    1 year

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Thai MSM and TGW

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piman Center

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Suwat Chariyalertsak, MD. DrPH.

    Research Institute for Health Sciences (RIHES)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., Dr.PH

Study Record Dates

First Submitted

April 22, 2016

First Posted

August 4, 2016

Study Start

December 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 30, 2019

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations

TH(1)