Exploration of the Neo-Vagina Study

Not Applicable

Completed

• Conditions: Transgender Women; HIV Infections
• Interventions: Other: No Intervention for both groups

• Registration Number: NCT03049371
• Lead Sponsor: Thai Red Cross AIDS Research Centre

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-10
• Primary Completion: 2019-05
• Study Completion: 2022-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sample size 100	No Intervention for both groups	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

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

The Thai Red Cross AIDS Research Centre; 🇹🇭 Pathum Wan, Bangkok, Thailand