Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand

Study Overview
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Brief Summary
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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
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OBJECTIVES Primary Objectives: To study PrEP adherence in adolescent MSM who are at high risk of HIV acquisition. Secondary Objectives: To study Rates of HIV infection Rates of sexually transmitted infections (STIs) Sexual risk taking behaviours In adolescent MSM who are at high risk of HIV infection. HYPOTHESES: The investigators hypothesize that youth-focused interventions will produce superior adherence to PrEP from 50% with standard interventions to 70% with youth focused interventions. 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 Study population Volunteers aged 15 to under 20 years at high risk of HIV infection receiving PrEP under the 'Princess PrEP' project 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 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 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 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. 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

Official Title
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Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand

Conditions
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Adherence, Medication, Adolescent Behavior, HIV Prevention, Sexual Health, Mobile Health

Intervention / Treatment
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* Behavioral: 'Project Raincoat' Mobile Phone Application


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: half of study participants will receive the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel Intervention<br>Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services | Behavioral: 'Project Raincoat' Mobile Phone Application<br>* Mobile phone application with weekly input channels for PrEP use, condom use, number of sex partners and sex acts and a calculation of self-HIV risk feedback scoring. Scoring system for attendance of visits, normal blood tests and use of application. Points redeemable for cash. Optional alarm system to remind to take medications and attend visits.<br>|
| No Intervention: Standard Intervention<br>Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Adherence | Self-Reported Adherence | Weekly self-reported adherence for a period of 6 months following randomization | 
| PrEP Adherence at 3 months | Measured Serum TDF-DP Level (from dried blood spots) | Measured at month 3 (measure of 17 day half life of TDF-DP) | 
| PrEP Adherence at 6 months | Measured Serum TDF-DP Level (from dried blood spots) | Measured at month 6 (measure of 17 day half life of TDF-DP) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV infection rates | seroconversion rates whilst on PrEP during study | duration of study (6 months) | 
| Rates of Urethral Neisseria gonorrhea | Rates of Urethral Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) urine testing | duration of study (6 months) | 
| Behaviour Risk-Taking | Composite calculated score of risk taking based on self-reported condom use, PrEP tablets taking, number of sexual partners in preceding one month. Scores will equate to risk levels of low, medium, high and very high. | duration of study (6 months) | 
| Rates of Anal Neisseria gonorrhea | Rates of Anal Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) from anal swab samples | duration of study (6 months) | 
| Rates of Urethral Chlamydia trachomatis | Rates of Urethral Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) urine testing | duration of study (6 months) | 
| Rates of Anal Chlamydia trachomatis | Rates of Anal Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) from anal swab samples | duration of study (6 months) | 
| Rates of Syphilis Infection | Rates of positive treponemal blood tests | duration of study (6 months) | 
| Rates of Hepatitis B infection | Rates of positive HbsAg blood tests | At initial project visit (month 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP adherence, Youth, Adolescents, MSM, HIV Prevention, Mobile Health