Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
Study NCT ID:
NCT03778892
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2018-12-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
Sponsor:
Chulalongkorn University
Organization:
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 consent/assent and a copy of the informed consent/assent 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 TFV/FTC 200/300mg. 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 e.g. no sexual activity, sex with condoms, sex without condoms
* PrEP use e.g. 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 fmol/punch 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 consent/assent and a copy of the informed consent/assent 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 TFV/FTC 200/300mg. 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 e.g. no sexual activity, sex with condoms, sex without condoms
* PrEP use e.g. 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 fmol/punch will be taken as adherence
Study Oversight
Has Oversight DMC:
False
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?: