Acceptability of HIV Oral PrEP Among MSM and TGW

Completed

• Conditions: Patient Acceptance of Health Care

• Registration Number: NCT02855606
• Lead Sponsor: Chiang Mai University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-04
• Primary Completion: 2018-05
• Study Completion: 2019-05-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability and factors affecting the decision to take oral PrEP	1 year	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).

Secondary Outcome Measures

Name	Time	Method
Adherence to PrEP by self-report	1 year	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).
Adherence to PrEP by pill count	1 year	Among the participants who decide to take PrEP, the adherence will be evaluate by pill count.

Trial Locations

Locations (1)

Piman Center; 🇹🇭 Chiang Mai, Thailand