Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03198962 |
| Other study ID # |
Amphetamine-type stimulants |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2016 |
| Est. completion date |
February 16, 2023 |
Study information
| Verified date |
April 2022 |
| Source |
Thai Red Cross AIDS Research Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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) 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.
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)
4. Group D: HIV positive, ATS user (n=35)
