HIV InfectionsNCT03049371
Exploration of the Neo-Vagina Study
A study of HIV Infections and Transgender Women, run by Thai Red Cross AIDS Research Centre at 1 site in Thailand.
Trial summary
The current study will explore behavioral, surgical and biological neovaginal and rectal HIV transmission risks and feasibility of collection of blood and ano-genital samples (rectal, genital and neo-vaginal, including urine) for microbiological, immunological and cytological characterization in the context of… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Transgender Women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2013to Nov 2022
- Phase
- Interventional
- 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 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be recruited through existing social networks among TGW and from the Thai Red Cross Anonymous and Tangerine Clinics providing HIV testing, care and treatment services. TGW attending clinic services will be offered enrollment in the study. Particular attention will be paid to offering enrollment to those attending HIV treatment and care services. The current study offers medical evaluation and a range of laboratory testing specific to the health of TGW, which may be of interest and beneficial to them. At the same time, the study may benefit from their participation.
Who cannot join
- not TGW
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330
About this study
Official title: Thai Red Cross AIDS Research Center
The current study will explore behavioral, surgical and biological neovaginal and rectal HIV transmission risks and feasibility of collection of blood and ano-genital samples (rectal, genital and neo-vaginal, including urine) for microbiological, immunological and cytological characterization in the context of antiretroviral chemoprophylaxis for the prevention of HIV infection in TGW. This includes the feasibility of home self-collection of ano-genital samples prior to habitual cleansing of the anatomical collection site.
Read the detailed description
A computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neovaginal health, neovaginal practices, and sexual behavior including neovaginal intercourse and drug use history from each participant. The questionnaire can be completed online from any location or at the study clinic and will take about 15-20 minutes.
- Conditions
- HIV Infections, Transgender Women
- Being tested
- No Intervention for both groups
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention for both groupsOther
No Intervention for both groups However, computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neovaginal health, neovaginal practices, and sexual behavior including neovaginal intercourse and drug use history from each participant
| Study group | Role | What they receive |
|---|---|---|
| sample size 100 | Other | 24 post-op and 100 pre- non- and post-op TGW Study participants need to be of Thai nationality, at least 18 years old, male at birth and self-identify as post-op TGW for participation in study. Signed informed consent is required for study participation Receives: Other: No Intervention for both groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
important information regarding the willingness and obstacles for TGW to come forward for neo-vaginal and rectal HIV and STI evaluation, a computer-administered questionnaire.
A computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neo-vaginal health, neo vaginal practices, and sexual behavior including neo-vaginal intercourse and drug use history from each participant. The questionnaire can be completed online from any location or at the study clinic and will take 15-20 minutes.
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 posted10 Feb 2017
- Study startJan 2013
- Primary completionMay 2019
- Study completionNov 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- Responsible party
- Sponsor
- Investigators
- Frits van Griensven, PhD, MPH, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049371
- Sponsor's protocol ID
- The EN-V Study
- Status last verified
- Nov 2024
- First submitted
- 24 Jan 2017
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thai Red Cross AIDS Research Center
- ClinicalTrials.gov ID
- NCT03049371
- Acronym / sponsor ID
- The EN-V Study
- Conditions
- HIV Infections, Transgender Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Thai Red Cross AIDS Research CentreUniversity, hospital or other
- Collaborators
- amfAR, The Foundation for AIDS Research
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Nov 2022 (actual)
- First posted
- 10 Feb 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.
The current study will explore behavioral, surgical and biological neovaginal and rectal HIV transmission risks and feasibility of collection of blood and ano-genital samples (rectal, genital and neo-vaginal, including urine) for microbiological, immunological and cytological characterization in the context of antiretroviral chemoprophylaxis for the prevention of HIV infection in TGW. This includes the feasibility of home self-collection of ano-genital samples prior to habitual cleansing of the anatomical collection site.
Detailed description
A computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neovaginal health, neovaginal practices, and sexual behavior including neovaginal intercourse and drug use history from each participant. The questionnaire can be completed online from any location or at the study clinic and will take about 15-20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sample size 100 | Other | Other: No Intervention for both groups24 post-op and 100 pre- non- and post-op TGW Study participants need to be of Thai nationality, at least 18 years old, male at birth and self-identify as post-op TGW for participation in study. Signed informed consent is required for study participation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be recruited through existing social networks among TGW and from the Thai Red Cross Anonymous and Tangerine Clinics providing HIV testing, care and treatment services. TGW attending clinic services will be offered enrollment in the study. Particular attention will be paid to offering enrollment to those attending HIV treatment and care services. The current study offers medical evaluation and a range of laboratory testing specific to the health of TGW, which may be of interest and beneficial to them. At the same time, the study may benefit from their participation.
Key exclusion criteria (1 listed)
- not TGW
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention for both groupsNo Intervention for both groups However, computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neovaginal health, neovaginal practices, and sexual behavior including neovaginal intercourse and drug use history from each participant | Other | sample size 100 |
Primary outcome
important information regarding the willingness and obstacles for TGW to come forward for neo-vaginal and rectal HIV and STI evaluation, a computer-administered questionnaire.
Time frame: 5 years
A computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neo-vaginal health, neo vaginal practices, and sexual behavior including neo-vaginal intercourse and drug use history from each participant. The questionnaire can be completed online from any location or at the study clinic and will take 15-20 minutes.
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 25 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Frits van Griensven, PhD, MPH principal investigator
Thai Red Cross AIDS Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of HIV Infections and Transgender Women, 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 1 inclusion and 1 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 25 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 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?
important information regarding the willingness and obstacles for TGW to come forward for neo-vaginal and rectal HIV and STI evaluation, a computer-administered questionnaire. (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 25 Nov 2024.