Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
Condition: Adherence, Medication; Adolescent Behavior; HIV Prevention; Sexual Health; Mobile Health
Study type: Interventional

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
    

Intervention name(s): 'Project Raincoat' Mobile Phone Application
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: half of study participants will receive the intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP adherence; Youth; Adolescents; MSM; HIV Prevention; Mobile Health