Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03778892
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2018-12-08
Brief Title:
Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
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:
YouthPrEP
Brief Summary:
A randomized controlled clinical trial looking at the effect of use of a mobile phone application in addition to standard care compared to standard care alone at a youth-friendly clinic in young men who have sex with men and transgender women aged between 15-19 years at risk of HIV on PrEP adherence
Detailed Description:
OBJECTIVES
Primary Objectives
To study PrEP adherence in adolescent MSM who are at high risk of HIV acquisition
Secondary Objectives
To study
1 Rates of HIV infection
2 Rates of sexually transmitted infections STIs
3 Sexual risk taking behaviours In adolescent MSM who are at high risk of HIV infection
HYPOTHESES
1 The investigators hypothesize that youth-focused interventions will produce superior adherence to PrEP from 50 with standard interventions to 70 with youth focused interventions
2 The investigators hypothesize that adherence to PrEP varies by the level of risk behavior one perceives Participants who take higher risk behaviors will be more likely to adhere to PrEP than participants who have lower risk behaviors STIs are expected to be more common among participants with higher levels of adherence if they are participants who have higher risk behaviors
RESEARCH DESIGN
Randomised control trial behavioural intervention
RESEARCH METHODOLOGY
1 Study population Volunteers aged 15 to under 20 years at high risk of HIV infection receiving PrEP under the Princess PrEP project
2 Inclusion Criteria
Adolescent men who have sex with men
At high risk of HIV infection have at least one of the following
More than 1 sexual partner in the last 6 months
Irregular condom use during sexual intercourse
HIV positive sexual partner
Age 15 to under 20 years old
A desire to take PrEP to prevent HIV infection
Tested HIV negative within 1 month of enrolment
Able to provide written consent or assent to take part in the clinical trial
3 Exclusion criteria Signs or symptoms of acute retroviral syndrome that cannot be confirmed to be due to alternate causes including unremitting fevers headaches myalgia fatigue and lymphadenopathy
4 Study recruitment
Eligible persons presenting to the Thai Red Cross Anonymous Clinic TRCARC or its affiliated community based organizations Rainbow Sky Association Thailand RSAT Ramkamhaeng Sex Workers in Action Group SWING Bangkok will be asked by counsellors on their interest to join the study
Number of participants to be studied 200
5 Informed consent process informed assent The research doctor will explain to potential participants about the purposes of the study and allow them to ask any questions they may have on it and will be given time to make their decision If a participant chooses to join the study they will be asked for their written consentassent and a copy of the informed consentassent form given to them
Participants aged between 15 and 18 will be asked for assent As this is a study on sexual health where disease prevention is of utmost concern parental consent will not be asked for
Participants aged 18 to 19 will be asked for consent
6 Study procedure After informed consent or assent all youth will commence once daily TFVFTC 200300mg Volunteers will be randomized into arms 1 standard intervention or 2 novel intervention strategy Both groups will receive youth-focused counselling by trained counsellors and have access to an adolescent-friendly sexual health promotion website and social media page where they can get in contact with counsellors doctors fellow adolescents and function as a platform through which they can learn about good sexual health practices Adolescents in arm 2 novel intervention strategy will also receive access to a mobile phone application
Youth-focused counselling Counsellors will provide counselling that is friendly non-judgmental and utilize motivational interviewing techniques where sessions are more collaborative rather than didactic
Mobile Phone Application
Password protection will ensure user privacy
Will allow users to input weekly data on their
Sexual risk eg no sexual activity sex with condoms sex without condoms
PrEP use eg whether or not participants take their PrEP
The application will calculate a percentage of protection users have based on their data entry
Points can be accumulated for application use data input to the application for attending appointments and also for normal STI and HIV screening results Points can be redeemed for cash
The overall goal of the application is to increase participant awareness of self-risk and motivation to protect themselves against HIV and STI infection
Participants will be followed up at months 1 3 and 6 At each visit participants will complete a questionnaire on drug adherence and sexual health risk behaviours
STI testing will be done as an indirect marker of condom use at visits 1 and 6 This will involve blood testing for syphilis serology and nucleic acid amplification testing for gonorrhea and chlamydia on swab samples
HIV testing will be done at all visits TFV-DP DBS will be done at months 1 3 and 6 to look at correlation of self-reported and actual measured PrEP compliance
Drug Concentrations will be measured using the TFV-DP DBS at the Program for HIV Prevention and Treatment PHPT Chiang Mai TFV-DP DBS levels 700 fmolpunch will be taken as adherence
Primary Objectives
To study PrEP adherence in adolescent MSM who are at high risk of HIV acquisition
Secondary Objectives
To study
1 Rates of HIV infection
2 Rates of sexually transmitted infections STIs
3 Sexual risk taking behaviours In adolescent MSM who are at high risk of HIV infection
HYPOTHESES
1 The investigators hypothesize that youth-focused interventions will produce superior adherence to PrEP from 50 with standard interventions to 70 with youth focused interventions
2 The investigators hypothesize that adherence to PrEP varies by the level of risk behavior one perceives Participants who take higher risk behaviors will be more likely to adhere to PrEP than participants who have lower risk behaviors STIs are expected to be more common among participants with higher levels of adherence if they are participants who have higher risk behaviors
RESEARCH DESIGN
Randomised control trial behavioural intervention
RESEARCH METHODOLOGY
1 Study population Volunteers aged 15 to under 20 years at high risk of HIV infection receiving PrEP under the Princess PrEP project
2 Inclusion Criteria
Adolescent men who have sex with men
At high risk of HIV infection have at least one of the following
More than 1 sexual partner in the last 6 months
Irregular condom use during sexual intercourse
HIV positive sexual partner
Age 15 to under 20 years old
A desire to take PrEP to prevent HIV infection
Tested HIV negative within 1 month of enrolment
Able to provide written consent or assent to take part in the clinical trial
3 Exclusion criteria Signs or symptoms of acute retroviral syndrome that cannot be confirmed to be due to alternate causes including unremitting fevers headaches myalgia fatigue and lymphadenopathy
4 Study recruitment
Eligible persons presenting to the Thai Red Cross Anonymous Clinic TRCARC or its affiliated community based organizations Rainbow Sky Association Thailand RSAT Ramkamhaeng Sex Workers in Action Group SWING Bangkok will be asked by counsellors on their interest to join the study
Number of participants to be studied 200
5 Informed consent process informed assent The research doctor will explain to potential participants about the purposes of the study and allow them to ask any questions they may have on it and will be given time to make their decision If a participant chooses to join the study they will be asked for their written consentassent and a copy of the informed consentassent form given to them
Participants aged between 15 and 18 will be asked for assent As this is a study on sexual health where disease prevention is of utmost concern parental consent will not be asked for
Participants aged 18 to 19 will be asked for consent
6 Study procedure After informed consent or assent all youth will commence once daily TFVFTC 200300mg Volunteers will be randomized into arms 1 standard intervention or 2 novel intervention strategy Both groups will receive youth-focused counselling by trained counsellors and have access to an adolescent-friendly sexual health promotion website and social media page where they can get in contact with counsellors doctors fellow adolescents and function as a platform through which they can learn about good sexual health practices Adolescents in arm 2 novel intervention strategy will also receive access to a mobile phone application
Youth-focused counselling Counsellors will provide counselling that is friendly non-judgmental and utilize motivational interviewing techniques where sessions are more collaborative rather than didactic
Mobile Phone Application
Password protection will ensure user privacy
Will allow users to input weekly data on their
Sexual risk eg no sexual activity sex with condoms sex without condoms
PrEP use eg whether or not participants take their PrEP
The application will calculate a percentage of protection users have based on their data entry
Points can be accumulated for application use data input to the application for attending appointments and also for normal STI and HIV screening results Points can be redeemed for cash
The overall goal of the application is to increase participant awareness of self-risk and motivation to protect themselves against HIV and STI infection
Participants will be followed up at months 1 3 and 6 At each visit participants will complete a questionnaire on drug adherence and sexual health risk behaviours
STI testing will be done as an indirect marker of condom use at visits 1 and 6 This will involve blood testing for syphilis serology and nucleic acid amplification testing for gonorrhea and chlamydia on swab samples
HIV testing will be done at all visits TFV-DP DBS will be done at months 1 3 and 6 to look at correlation of self-reported and actual measured PrEP compliance
Drug Concentrations will be measured using the TFV-DP DBS at the Program for HIV Prevention and Treatment PHPT Chiang Mai TFV-DP DBS levels 700 fmolpunch will be taken as adherence
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