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Acceptability of HIV Oral PrEP Among MSM and TGW

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ClinicalTrials.gov Identifier: NCT02855606
Recruitment Status : Unknown
Verified January 2017 by Suwat Chariyalertsak, Chiang Mai University.
Recruitment status was:  Recruiting
First Posted : August 4, 2016
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Suwat Chariyalertsak, 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).

Condition or disease
Patient Acceptance of Health Care

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Acceptability of HIV Oral Pre-Exposure Prophylaxis (PrEP) Among Men Have Sex With Men (MSM) and Transgender Women (TGW)
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Acceptability and factors affecting the decision to take oral PrEP [ Time Frame: 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 :
  1. Adherence to PrEP by self-report [ Time Frame: 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).

  2. Adherence to PrEP by pill count [ Time Frame: 1 year ]
    Among the participants who decide to take PrEP, the adherence will be evaluate by pill count.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Thai MSM and TGW
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855606


Contacts
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Contact: Suwat Chariyalertsak, MD. DrPH. 66-53-936148 ext 109 suwat@rihes.org

Locations
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Thailand
Piman Center Recruiting
Chiang Mai, Thailand, 50200
Contact: Radhcanok Songsupa    6653211 363      
Contact: Pongpun Saokhieo         
Sub-Investigator: Quanhathai Kaewpoowat, MD         
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Suwat Chariyalertsak, MD. DrPH. Research Institute for Health Sciences (RIHES)
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Responsible Party: Suwat Chariyalertsak, MD., Dr.PH, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02855606    
Other Study ID Numbers: PrEP@PIMAN
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Keywords provided by Suwat Chariyalertsak, Chiang Mai University:
Oral PrEP
TGW
Thai MSM