Acceptability of HIV Oral PrEP Among MSM and TGW

Patient Acceptance of Health Care Clinical Trial

Official title:

Acceptability of HIV Oral Pre-Exposure Prophylaxis (PrEP) Among Men Have Sex With Men (MSM) and Transgender Women (TGW)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855606
• Other study ID #: PrEP@PIMAN
• Status: Completed
• Start date: December 2015
• Est. completion date: May 30, 2019

Study information

• Verified date: July 2022
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 30, 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Acceptance of Health Care

Locations

Country	Name	City	State
Thailand	Piman Center	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adherence to PrEP by pill count	Among the participants who decide to take PrEP, the adherence will be evaluate by pill count.	1 year