Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03778892
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : January 23, 2020
Sponsor:
Collaborators:
Thai Red Cross AIDS Research Centre
International AIDS Society
Information provided by (Responsible Party):
Wipaporn Natalie Songtaweesin, MD., Chulalongkorn University

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 Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: half 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 : March 1, 2018
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



Primary Outcome Measures :
  1. PrEP Adherence [ Time Frame: Weekly self-reported adherence for a period of 6 months following randomization ]
    Self-Reported Adherence

  2. PrEP Adherence at 3 months [ Time Frame: Measured at month 3 (measure of 17 day half life of TDF-DP) ]
    Measured Serum TDF-DP Level (from dried blood spots)

  3. PrEP Adherence at 6 months [ Time Frame: 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 :
  1. HIV infection rates [ Time Frame: duration of study (6 months) ]
    seroconversion rates whilst on PrEP during study

  2. Rates of Urethral Neisseria gonorrhea [ Time Frame: duration of study (6 months) ]
    Rates of Urethral Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) urine testing

  3. Behaviour Risk-Taking [ Time Frame: 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.

  4. Rates of Anal Neisseria gonorrhea [ Time Frame: duration of study (6 months) ]
    Rates of Anal Neisseria gonorrhea via Nucleic Acid Amplification Screening (NAAT) from anal swab samples

  5. Rates of Urethral Chlamydia trachomatis [ Time Frame: duration of study (6 months) ]
    Rates of Urethral Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) urine testing

  6. Rates of Anal Chlamydia trachomatis [ Time Frame: duration of study (6 months) ]
    Rates of Anal Chlamydia trachomatis via Nucleic Acid Amplification Screening (NAAT) from anal swab samples

  7. Rates of Syphilis Infection [ Time Frame: duration of study (6 months) ]
    Rates of positive treponemal blood tests

  8. Rates of Hepatitis B infection [ Time Frame: At initial project visit (month 0) ]
    Rates of positive HbsAg blood tests



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   men who have sex with men or transgender women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778892


Locations
Layout table for location information
Thailand
Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Thai Red Cross AIDS Research Centre
International AIDS Society

Layout table for additonal information
Responsible Party: Wipaporn Natalie Songtaweesin, MD., Principal Investigator, Clinical Researcher, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03778892    
Other Study ID Numbers: 2017/472-SON
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wipaporn Natalie Songtaweesin, MD., Chulalongkorn University:
PrEP adherence
Youth
Adolescents
MSM
HIV Prevention
Mobile Health