Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583267
Status:
UNKNOWN
Last Update Posted:
2020-10-12
First Post:
2020-09-18
Brief Title:
HIV Pre-exposure Prophylaxis Implementation Study in South Korea
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
HIV Pre-exposure Prophylaxis Implementation Study in South Korea
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to examine acceptability patterns of use rates of adherence safety and measured levels of drug when high risk men who have sex with men MSM are provided open-label tenofoviremtricitabine TDFFTC for PrEP in South Korea Secondary objectives are 1 to evaluate HIV incidence among study participants 2 to evaluate risk behavior and risk compensation among study participants and 3 to identify barriers and facilitators of PrEP among study participants The design of this study is a prospective open-label cohort study assessing PrEP implementation in tertiary hospital infectious diseases clinics in South Korea for 1 year Baseline data will be collected 1 months before initiation of PrEP and the date of initiation of PrEP All persons receiving PrEP should be seen at 1 month since PrEP initiation and at least every 3 months to assess side effects adherence and HIV acquisition risk behaviors Drug concentration will be measured every 6 months It is anticipated that approximately 100 Korean MSM will be enrolled in this study
Detailed Description:
1 Primary Objectives
To examine acceptability patterns of use rates of adherence safety and measured levels of drug when high risk MSM are provided open-label TDFFTC for PrEP in South Korea
2 Secondary Objectives
To evaluate HIV incidence among study participants
To evaluate risk behavior and risk compensation among study participants
To identify barriers and facilitators of PrEP among study participants
3 Study design Prospective open-label cohort study assessing PrEP delivery in tertiary hospital infectious diseases clinics in South Korea for 1 year
4 Evaluation
Baseline evaluation
1 HIV testing and the documentation of results are required to confirm that patients do not have HIV infection when they start taking PrEP medications HIV Aganti HIV Ab combo assay should be performed before starting PrEP Negative result of HIV Aganti HIV Ab combo assay within 1 week should be ascertained before PrEP initiation Results from rapid test with oral specimen or unreliable testing results cannot be acknowledged
2 Renal function with estimated creatinine clearance eCrCl should be evaluated before starting TDFFTC TDFFTC can be prescribed for persons with eCrCl 60 mlmin Any person with an eCrCl of 60 mlmin should not be prescribed PrEP with TDFFTC
3 Testing for hepatitis B virus HBsAg HBsAb and hepatitis C virus HCV Ab should be performed before starting PrEP Hepatitis B virus vaccination is recommended for MSM without HBsAb
4 Acute HIV infection must be excluded by symptom history physical examinations and appropriate HIV testing before PrEP is prescribed
5 If HIV testing shows intermediate results clinician should hold PrEP initiation make efforts to identify symptoms and signs of acute viral infections and do follow up HIV testing
Follow up and monitoring during PrEP
1 All persons receiving PrEP should be seen at 1 month since PrEP initiation and at least every 3 months to assess side effects adherence and HIV acquisition risk behaviors
2 All persons receiving PrEP should be seen at least every 3 months to assess for signs or symptoms of acute infection and repeat HIV testing HIV Aganti HIV Ab combo assay If acute infection is suspected HIV RNA testing should be performed
3 Confirmative HIV testing western blot assay and HIV RNA testing should be performed for persons with positive results of screening assay HIV Aganti HIV Ab assay Resistance testing should be performed for persons with confirmed HIV infection during PrEP
4 If acute HIV infection is suspected during PrEP PrEP should be stopped combination antiretroviral therapy with TDFFTCboosted protease inhibitor darunavirritonavir or TDFFTC dolutegravir should be prescribed
5 All persons receiving PrEP should be seen at least every 3 months to monitor eCrCl
6 Sexually active persons receiving PrEP should be seen at least every 6 months to conduct tests for sexually transmitted infections ie syphilis gonorrhea chlamydia
7 Assessments of bone health are not routinely recommended before the initiation of PrEP or for the monitoring of persons while taking PrEP However assessment for bone health can be considered for any person who has a history of pathologic fractures or who has significant risk factors for osteoporosis mineral density PrEP
8 All persons receiving PrEP should be seen at least 12 months to evaluate the need to continue PrEP as a component of HIV prevention considering HIV acquisition risk behavior adherence and so on
5 Measurement Baseline data will be collected 1 months before initiation of PrEP and the date of initiation of PrEP
All persons receiving PrEP should be seen at 1 month since PrEP initiation and at least every 3 months to assess side effects adherence and HIV acquisition risk behaviors During every visits including screening visit below measures are assessed
Diagnostic testing HIV testing with a fourth generation HIV AgAb test HIV RNA assay serologic test for syphilis using VDRL or RPR screening for gonorrhoea and chlamydia using nucleic acid amplification test
Sociodemographics and sexual behaviors demographic and sexual behavioral data are collected by trained interviewers using standardized questionnaires including residence living situation employment insurance status income housingfood instability drug use number of anal sex partners episodes in the past 3 months condom use partner HIV serostatus sexual position etc
To examine acceptability patterns of use rates of adherence safety and measured levels of drug when high risk MSM are provided open-label TDFFTC for PrEP in South Korea
2 Secondary Objectives
To evaluate HIV incidence among study participants
To evaluate risk behavior and risk compensation among study participants
To identify barriers and facilitators of PrEP among study participants
3 Study design Prospective open-label cohort study assessing PrEP delivery in tertiary hospital infectious diseases clinics in South Korea for 1 year
4 Evaluation
Baseline evaluation
1 HIV testing and the documentation of results are required to confirm that patients do not have HIV infection when they start taking PrEP medications HIV Aganti HIV Ab combo assay should be performed before starting PrEP Negative result of HIV Aganti HIV Ab combo assay within 1 week should be ascertained before PrEP initiation Results from rapid test with oral specimen or unreliable testing results cannot be acknowledged
2 Renal function with estimated creatinine clearance eCrCl should be evaluated before starting TDFFTC TDFFTC can be prescribed for persons with eCrCl 60 mlmin Any person with an eCrCl of 60 mlmin should not be prescribed PrEP with TDFFTC
3 Testing for hepatitis B virus HBsAg HBsAb and hepatitis C virus HCV Ab should be performed before starting PrEP Hepatitis B virus vaccination is recommended for MSM without HBsAb
4 Acute HIV infection must be excluded by symptom history physical examinations and appropriate HIV testing before PrEP is prescribed
5 If HIV testing shows intermediate results clinician should hold PrEP initiation make efforts to identify symptoms and signs of acute viral infections and do follow up HIV testing
Follow up and monitoring during PrEP
1 All persons receiving PrEP should be seen at 1 month since PrEP initiation and at least every 3 months to assess side effects adherence and HIV acquisition risk behaviors
2 All persons receiving PrEP should be seen at least every 3 months to assess for signs or symptoms of acute infection and repeat HIV testing HIV Aganti HIV Ab combo assay If acute infection is suspected HIV RNA testing should be performed
3 Confirmative HIV testing western blot assay and HIV RNA testing should be performed for persons with positive results of screening assay HIV Aganti HIV Ab assay Resistance testing should be performed for persons with confirmed HIV infection during PrEP
4 If acute HIV infection is suspected during PrEP PrEP should be stopped combination antiretroviral therapy with TDFFTCboosted protease inhibitor darunavirritonavir or TDFFTC dolutegravir should be prescribed
5 All persons receiving PrEP should be seen at least every 3 months to monitor eCrCl
6 Sexually active persons receiving PrEP should be seen at least every 6 months to conduct tests for sexually transmitted infections ie syphilis gonorrhea chlamydia
7 Assessments of bone health are not routinely recommended before the initiation of PrEP or for the monitoring of persons while taking PrEP However assessment for bone health can be considered for any person who has a history of pathologic fractures or who has significant risk factors for osteoporosis mineral density PrEP
8 All persons receiving PrEP should be seen at least 12 months to evaluate the need to continue PrEP as a component of HIV prevention considering HIV acquisition risk behavior adherence and so on
5 Measurement Baseline data will be collected 1 months before initiation of PrEP and the date of initiation of PrEP
All persons receiving PrEP should be seen at 1 month since PrEP initiation and at least every 3 months to assess side effects adherence and HIV acquisition risk behaviors During every visits including screening visit below measures are assessed
Diagnostic testing HIV testing with a fourth generation HIV AgAb test HIV RNA assay serologic test for syphilis using VDRL or RPR screening for gonorrhoea and chlamydia using nucleic acid amplification test
Sociodemographics and sexual behaviors demographic and sexual behavioral data are collected by trained interviewers using standardized questionnaires including residence living situation employment insurance status income housingfood instability drug use number of anal sex partners episodes in the past 3 months condom use partner HIV serostatus sexual position etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None