Exploration of the Neo-Vagina Study

Thai Red Cross AIDS Research Centre

Status: Completed

Conditions: Transgender Women; HIV Infections

Treatments: Other: No Intervention for both groups

Study type: Interventional

Funder types: Other

Identifiers

NCT03049371

The EN-V Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

not TGW

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

sample size 100

Other group

Description:

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

Treatment:

Other: No Intervention for both groups