Acceptability of HIV Oral PrEP Among MSM and TGW

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).

Study Overview

• Status: Completed
• Conditions: Patient Acceptance of Health Care

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Piman Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Thai MSM and TGW

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year
Adherence to PrEP by pill count	Among the participants who decide to take PrEP, the adherence will be evaluate by pill count.	1 year

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Suwat Chariyalertsak, MD. DrPH., Research Institute for Health Sciences (RIHES)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: TGW; Oral PrEP; Thai MSM
• Other Study ID Numbers: PrEP@PIMAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided