Clinical Trials

MainTitle

Use of Amphetamine-type Stimulants & Its Relationship With HIV Incidence and Antiretroviral Adherence Among MSM and TG

This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2017 by Thai Red Cross AIDS Research Centre

Sponsor
Thai Red Cross AIDS Research Centre

Collaborator
amfAR, The Foundation for AIDS Research
TREAT Asia

Information provided by (Responsible Party)
Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier
NCT03198962

First received: June 22, 2017
Last updated: July 16, 2017
Last Verified: June 2017
History of Changes
Purpose

Purpose

There are two stages in the study. In Stage 1, 2000 Thai MSM, MSW and TGW/TGSW will be screened at the Thai Red Cross Anonymous Clinic (TRCAC) or Besides walk-in clients of TRCAC, potential participants could be referred to TRCAC by Rainbow Sky Association of Thailand (RSAT), Service Workers In Group (SWING) Foundation and Sisters Foundation. Each participant will complete a short standardized questionnaire on risk behavior, including use of amphetamine-type stimulants (ATS) and other drugs. HIV testing will be done following usual HIV testing and counseling (HTC) guidelines. Stage 1 will collect data on ATS use in the community. The results from stage 1 will also be used to stratify participants for inclusion in stage 2 of the study.

Participants from the screening will be invited to participate in stage 2 of the study, which is the longitudinal cohort study. Recruitment will be stratified by HIV status and ATS use as listed in to ensure an adequate number of ATS users for data analysis. Participants in stage 2 will follow-up every 6 months for 18 months.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Amphetamine-type Stimulants and Its Relationship With HIV Incidence and Antiretroviral Adherence Among Thai Men Who Have Sex With Men and Transgender Women

Further study details as provided by Thai Red Cross AIDS Research Centre:

Primary Outcome Measures

  • amphetamine-type stimulants (ATS) [ Time Frame: 5 years ]
    The study of amphetamine-type stimulants (ATS) use among HIV-negative and HIV-positive Thai MSM, MSW, TGW and TGSW in Bangkok. Pattern of ATS use over the study period and by HIV status will be described along with its associated demographic and behavioral risk characteristics. The effect of ATS use on HIV and STI incidence among HIV-negative participants and ART adherence and virologic suppression among HIV-positive participants will also be studied.

Estimated Enrollment: 510
Study Start Date: November 15, 2016
Estimated Study Completion Date: December 20, 2022
Estimated Primary Completion Date: November 15, 2020 (Final data collection date for primary outcome measure)

Arms
Groups A
At each visit, a series of self-administered questionnaires will be used to collect demographic, sexual behavioral risk and drug use data. HIV testing, risk reduction counseling, condoms & lubricants will also be provided at these visits. Syphilis serology, Chlamydia trachomatis/Neisseria gonorrhea testing from anal and urethral compartments will be performed at baseline, month 6,12,18. HIV-negative participants will be actively offered to visit the clinic for pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP) or STI services and encouraged to visit the clinic outside of the scheduled visits for these services whenever they feel needed. Adherence to PrEP, PEP, STI treatment will be evaluated in those who are prescribed these medications. Among HIV seroconverters, drug use patterns will be longitudinally monitored prior to and after HIV diagnosis. HIV seroconverters at month 6 or month 12 will be transferred to groups C, D dependent on drug use history.
Groups C
At each visit, a series of self-administered questionnaires will be used to collect demographic, behavioral risk and drug use data. In addition, data on adherence to antiretroviral therapy (ART) will be collected. Risk reduction counseling, adherence counseling, condoms & lubricants will also be provided at these visits. Syphilis serology, Chlamydia trachomatis/Neisseria gonorrhea testing from anal and urethral compartments will be performed at baseline, month 6,12,18.
Group B
At each visit, a series of self-administered questionnaires will be used to collect demographic, sexual behavioral risk and drug use data. HIV testing, risk reduction counseling, condoms & lubricants will also be provided at these visits. Syphilis serology, Chlamydia trachomatis/Neisseria gonorrhea testing from anal and urethral compartments will be performed at baseline, month 6,12,18.
Group D
At each visit, a series of self-administered questionnaires will be used to collect demographic, behavioral risk and drug use data. In addition, data on adherence to antiretroviral therapy (ART) will be collected. Risk reduction counseling, adherence counseling, condoms & lubricants will also be provided at these visits. Syphilis serology, Chlamydia trachomatis/Neisseria gonorrhea testing from anal and urethral compartments will be performed at baseline, month 6,12,18. HIV-positive participants, if they have not yet started ART, will be referred to preferred hospitals to receive ART regardless of CD4 count according to the 2014 National Guidelines. Drug use patterns will be longitudinally monitored prior to and after ART initiation.

Detailed Description:

Stage 1 Stage one includes recruitment, the informed consent process, enrollment into the study, completion of the stage 1 questionnaire, and HIV counseling and testing. MSM/TG who present for routine HTC will be pre-screened for inclusion and exclusion criteria by the HTC counseling staff. MSM/TG who meet the inclusion criteria will be informed about the study and if interested will complete the informed consent process. After providing consent, participants will fill out the stage 1 questionnaire before receiving the HIV test result.
After the HIV test result is known to be positive or negative, the research staff will assign the participant to a study group (A,B,C,D) based on the HIV and ATS use status, as defined in section 3.2.3. If the study group has not yet filled to maximum size, then the participant will be offered participation in Stage 2 though another informed consent process. If the participant agrees, then the research staff will confirm contact information and will inform the participant that they will receive a reminder before the next visit in 6 months by their method of choice (telephone, SMS, email, Line, Facebook, etc).
If the study group has reached its maximum size, then the participant will be informed that their involvement in the study is finished and will be thanked for their contribution.
Stage 2 Stage 2 is the longitudinal follow-up of participants over 18 months. All study groups will follow the same schedule of follow-up visits one time every 6 months for 3 visits. At each visit, participants will complete a follow-up questionnaire and have a blood test. There will be no differences in procedures based on ATS use. Follow-up procedures will be divided by HIV status.
The four groups and sample sizes are:

  1. Group A: HIV negative, non-ATS user (n=275)
  2. Group B: HIV negative, ATS user (n=70)
  3. Group C: HIV positive, non-ATS user (n=130)
D: HIV positive, ATS user (n=35)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

The study population is Thai MSM or TGW who present for HIV counseling and testing at one of the participating sites.

Criteria

Stage 1
Inclusion Criteria:

  • Age 18 years or above
  • Born biological male
  • Self-identifies as MSM or transgender woman
  • Thai citizen
  • Resident in Bangkok or surrounding suburb
  • Had sex with a male partner at least once in the previous 12 months
  • Consents to participate in the study


Exclusion Criteria:
  • Unable to perform any study procedures, or unable to commit to attend all study visits.
  • Has a serious medical, psychological, or substance use problem that, in the opinion of the study staff, would prevent appropriate participation or adequate follow-up in the trial

  • Criteria: Stage 2
    Inclusion Criteria:
  • Must meet all of the criteria in stage 1, plus:
  • Completed HIV test with result determined to be positive or negative
  • Agrees to return for follow-up visits with testing per protocol every 6 months for 18 months
  • Consents to participate in the study


Exclusion Criteria:
  • Indeterminate HIV test result

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03198962

Contacts

Contact:   Siriporn Nonenoy, MPH +662 253 0996 siriporn.n@trcarc.org
Contact:   Napasawan Chinlaertworasiri +6661 439 5287 napasawan@trcarc.org

Locations

Thailand
The Thai Red Cross AIDS Research Centre Recruiting
Bangkok, Thailand, 10330
Contact: Siriporn Nonenoy, RN    +662 253 0996    siriporn.n@trcarc.org

Sponsors and Collaborators

Thai Red Cross AIDS Research Centre
amfAR, The Foundation for AIDS Research
TREAT Asia

Investigators

Principal Investigator: Nittaya Phanuphak, MD, PhD Thai Red Cross AIDS Research Centre (TRCARC)
More Information

More Information


Responsible Party: Thai Red Cross AIDS Research Centre  
ClinicalTrials.gov Identifier: NCT03198962   History of Changes  
Other Study ID Numbers: Amphetamine-type stimulants  
Study First Received: June 22, 2017  
Last Updated: July 16, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Thai Red Cross AIDS Research Centre:

ATS, Thai MSM TG, Use of amphetamine-type stimulants, HIV, adherence

Additional relevant MeSH terms:
HIV Infections
Amphetamine
Central Nervous System Stimulants

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.