Men or Transgender Women Who Have Sex With MenNCT03745495
HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW
An observational study of Men or Transgender Women Who Have Sex With Men, run by Thai Red Cross AIDS Research Centre at 7 sites in Thailand.
Trial summary
This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla. Read more about this study
- Who is it for?
- Ages 15 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Men or Transgender Women Who Have Sex With Men
- How many people
- 600 participants
- Where
- 7 sitesThailand
- Study dates
- 15 Oct 2018to 26 Oct 2021
- 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 15 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Approximately 600 older adolescent MSM and TGW
Who may be able to join
- Thai nationality
- Age 15-19 years old
- Men or transgender women who have sex with men
- HIV-negative at the time of screening
- Have at least one of the following risks for HIV acquisition in the past 6 months:
- Any unprotected receptive anal sex with a male partner
Show all 12Show fewer
- More than 5 male partners, regardless of condom use and serostatus
- Has had a bacterial sexually transmitted infection (STI)
- Any injected drug use
- Calculated creatinine clearance (CrCl) ≥ 75 mL/min, as estimated by the Cockcroft- Gault equation
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Have signed the informed consent form
Who cannot join
- HIV-positive
- Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening
- Known allergy/sensitivity to tenofovir or emtricitabine
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Thailand7 sites
1.Swing Dic,
Bangkok
2. Rsat Dic,
Bangkok
5. Caremat DIC,
Chiang Mai
6. MPlus DIC,
Chiang Mai
3. Swing Dic,
Chon Buri
4. Sister DIC,
Chon Buri
7. Rsat Dic,
Songkhla
About this study
Official title: Study to Determine the Effect of HIV Self-testing on the Uptake of and Retention in Pre-exposure Prophylaxis Service Among Older Adolescent Men Who Have Sex With Men and Transgender Women
This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
Read the detailed description
All eligible participants will be followed up at month 3, 6, 9, and 12; month 6 and 12 will be mandatory clinic visits, while month 3 and 9 will be either clinic or a virtual visits. For participants accepting PrEP, additional follow-up visit at month 1, 2, 4, and 5 will be appointed; all visits will be either clinic or virtual visits.
Study Sites
The study will take place at the following community-based clinics:
- SWING DIC, Bangkok, Thailand
- RSAT DIC, Bangkok, Thailand
- SWING DIC, Chonburi, Thailand
- Sister DIC, Chonburi, Thailand
- Caremat DIC, Chiang Mai, Thailand
- MPlus DIC, Chiang Mai, Thailand
- RSAT DIC, Songkhla, Thailand
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
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 |
|---|---|---|
| Group 1 | 300 To determine the effect of HIVST on PrEP uptake among older adolescent MSM and TGW | |
| Group 2 | 300 To determine the effect of HIVST on retention of older adolescent MSM and TGW in HIV service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants starting PrEP among those who use and do not use HIVST
Measured: 3 years
Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start15 Oct 2018
- Primary completion15 Dec 2020
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Men or Transgender Women Who Have Sex With MenStudies 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Red Cross AIDS Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745495
- Sponsor's protocol ID
- STANDUP-TEEN
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2018
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Effect of HIV Self-testing on the Uptake of and Retention in Pre-exposure Prophylaxis Service Among Older Adolescent Men Who Have Sex With Men and Transgender Women
- ClinicalTrials.gov ID
- NCT03745495
- Acronym / sponsor ID
- STANDUP-TEEN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 19 Nov 2018 (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.
This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
Detailed description
All eligible participants will be followed up at month 3, 6, 9, and 12; month 6 and 12 will be mandatory clinic visits, while month 3 and 9 will be either clinic or a virtual visits. For participants accepting PrEP, additional follow-up visit at month 1, 2, 4, and 5 will be appointed; all visits will be either clinic or virtual visits.
Study Sites
The study will take place at the following community-based clinics:
- SWING DIC, Bangkok, Thailand
- RSAT DIC, Bangkok, Thailand
- SWING DIC, Chonburi, Thailand
- Sister DIC, Chonburi, Thailand
- Caremat DIC, Chiang Mai, Thailand
- MPlus DIC, Chiang Mai, Thailand
- RSAT DIC, Songkhla, Thailand
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –300 To determine the effect of HIVST on PrEP uptake among older adolescent MSM and TGW |
| Group 2 | – | –300 To determine the effect of HIVST on retention of older adolescent MSM and TGW in HIV service |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Approximately 600 older adolescent MSM and TGW
Key inclusion criteria (12 listed)
- Thai nationality
- Age 15-19 years old
- Men or transgender women who have sex with men
- HIV-negative at the time of screening
- Have at least one of the following risks for HIV acquisition in the past 6 months:
Key exclusion criteria (3 listed)
- HIV-positive
- Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening
- Known allergy/sensitivity to tenofovir or emtricitabine
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
Proportion of participants starting PrEP among those who use and do not use HIVST
Time frame: 3 years
Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST
Time frame: 3 years
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 26 Nov 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Men or Transgender Women Who Have Sex With Men, run by Thai Red Cross AIDS Research Centre at 7 sites 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 12 inclusion and 3 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Proportion of participants starting PrEP among those who use and do not use HIVST (time frame: 3 years). The study lists 2 primary outcomes in all. 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 26 Nov 2024.