NCT03049371

Exploration of the Neo-Vagina Study

Thai Red Cross AIDS Research Center

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Thai Red Cross AIDS Research Centre · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• HIV Infections
• Transgender Women

Interventions

Type	Name	Description
OTHER	No Intervention for both groups	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

Timeline

• Start date: 2013-01-01
• Primary completion: 2019-05-01
• Completion: 2022-11-01
• First posted: 2017-02-10
• Last updated: 2024-11-25

Locations

1 site across 1 country: Thailand