HIV InfectionsNCT03198962
Use of Amphetamine-type Stimulants & Its Relationship With HIV Incidence and Antiretroviral Adherence Among MSM and TG
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 510 participants
- Where
- 1 siteThailand
- Study dates
- 15 Nov 2016to 16 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is Thai MSM or TGW who present for HIV counseling and testing at one of the participating sites.
Who may be able to join
- 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
Show all 11Show fewer
- Consents to participate in the study
- 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
Who cannot join
- 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
- Indeterminate HIV test result
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- Group A: HIV negative, non-ATS user (n=275)
- Group B: HIV negative, ATS user (n=70)
- Group C: HIV positive, non-ATS user (n=130)
- Group D: HIV positive, ATS user (n=35)
- Conditions
- HIV Infections
- Keywords
- ATS, Thai MSM TG, Use of amphetamine-type stimulants, HIV, adherence
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start15 Nov 2016
- Primary completion15 Nov 2022
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, TREAT Asia
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD, PhD, Principal investigator, Thai Red Cross AIDS Research Centre (TRCARC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198962
- Sponsor's protocol ID
- Amphetamine-type stimulants
- Status last verified
- Apr 2022
- First submitted
- 22 Jun 2017
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03198962
- Acronym / sponsor ID
- Amphetamine-type stimulants
- Conditions
- HIV Infections
- Keywords
- ATS, Thai MSM TG, Use of amphetamine-type stimulants, HIV, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research, TREAT Asia
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Group A: HIV negative, non-ATS user (n=275)
- Group B: HIV negative, ATS user (n=70)
- Group C: HIV positive, non-ATS user (n=130)
- Group D: HIV positive, ATS user (n=35)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is Thai MSM or TGW who present for HIV counseling and testing at one of the participating sites.
Key inclusion criteria (11 listed)
- Age 18 years or above
- Born biological male
- Self-identifies as MSM or transgender woman
- Thai citizen
- Resident in Bangkok or surrounding suburb
Key exclusion criteria (4 listed)
- 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
- Indeterminate HIV test result
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nittaya Phanuphak, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre (TRCARC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amphetamine-type stimulants (ATS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.