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

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT03778892

Collaborator

Thai Red Cross AIDS Research Centre (Other), International AIDS Society (Other)

200

Enrollment

Location

Arms

21.5

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adherence, Medication Adolescent Behavior HIV Prevention Sexual Health Mobile Health	Behavioral: 'Project Raincoat' Mobile Phone Application	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

half of study participants will receive the interventionhalf of study participants will receive the intervention

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Dec 15, 2019

Actual Study Completion Date :

Dec 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Novel Intervention Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services	Behavioral: 'Project Raincoat' Mobile Phone Application 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.
No Intervention: Standard Intervention Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services

Arm

Intervention/Treatment

Experimental: Novel Intervention

Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services

Behavioral: 'Project Raincoat' Mobile Phone Application

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.

No Intervention: Standard Intervention

Use of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

HIV infection rates [duration of study (6 months)]
seroconversion rates whilst on PrEP during study
Rates of Urethral Neisseria gonorrhea [duration of study (6 months)]
Rates of Urethral Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) urine testing
Behaviour Risk-Taking [duration of study (6 months)]
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.
Rates of Anal Neisseria gonorrhea [duration of study (6 months)]
Rates of Anal Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) from anal swab samples
Rates of Urethral Chlamydia trachomatis [duration of study (6 months)]
Rates of Urethral Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) urine testing
Rates of Anal Chlamydia trachomatis [duration of study (6 months)]
Rates of Anal Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) from anal swab samples
Rates of Syphilis Infection [duration of study (6 months)]
Rates of positive treponemal blood tests
Rates of Hepatitis B infection [At initial project visit (month 0)]
Rates of positive HbsAg blood tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 19 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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