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

NCT03198962 | Completed DMC

• 1 other identifier: Amphetamine-type stimulants
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• amphetamine-type stimulants (ATS)

  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.

  5 years

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Indeterminate HIV test result

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• amfAR, The Foundation for AIDS Research: collaborator
• TREAT Asia: collaborator

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nittaya Phanuphak, MD, PhD

  Thai Red Cross AIDS Research Centre (TRCARC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 26, 2017
• Study Start: November 15, 2016
• Primary Completion: November 15, 2022
• Study Completion: February 16, 2023
• Last Updated: February 17, 2023

Record last verified: 2022-04

Locations

TH (1)