Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
YouthPrEP
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 8, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedJanuary 23, 2020
January 1, 2020
1.8 years
December 8, 2018
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
HIV infection rates
duration of study (6 months)
Rates of Urethral Neisseria gonorrhea
duration of study (6 months)
Behaviour Risk-Taking
duration of study (6 months)
Rates of Anal Neisseria gonorrhea
duration of study (6 months)
Rates of Urethral Chlamydia trachomatis
duration of study (6 months)
- +3 more secondary outcomes
Study Arms (2)
Novel Intervention
EXPERIMENTALUse of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services
Standard Intervention
NO INTERVENTIONUse of a mobile phone application to support PrEP adherence in addition to youth-friendly counselling and services
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chulalongkorn Universitylead
- Thai Red Cross AIDS Research Centrecollaborator
- International AIDS Societycollaborator
Study Sites (1)
Thai Red Cross AIDS Research Center
Bangkok, 10330, Thailand
Related Publications (2)
Kawichai S, Songtaweesin WN, Wongharn P, Phanuphak N, Cressey TR, Moonwong J, Vasinonta A, Saisaengjan C, Chinbunchorn T, Puthanakit T. A Mobile Phone App to Support Adherence to Daily HIV Pre-exposure Prophylaxis Engagement Among Young Men Who Have Sex With Men and Transgender Women Aged 15 to 19 Years in Thailand: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Apr 21;10(4):e25561. doi: 10.2196/25561.
PMID: 35451976DERIVEDSongtaweesin WN, Kawichai S, Phanuphak N, Cressey TR, Wongharn P, Saisaengjan C, Chinbunchorn T, Janyam S, Linjongrat D, Puthanakit T; CE-PID - TRC Adolescent Study Team. Youth-friendly services and a mobile phone application to promote adherence to pre-exposure prophylaxis among adolescent men who have sex with men and transgender women at-risk for HIV in Thailand: a randomized control trial. J Int AIDS Soc. 2020 Sep;23 Suppl 5(Suppl 5):e25564. doi: 10.1002/jia2.25564.
PMID: 32869511DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Researcher
Study Record Dates
First Submitted
December 8, 2018
First Posted
December 19, 2018
Study Start
March 1, 2018
Primary Completion
December 15, 2019
Study Completion
December 15, 2019
Last Updated
January 23, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share