Exploration of the Neo-Vagina Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections; Transgender Women
• Intervention / Treatment: Other: No Intervention for both groups

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nittaya Phanuphak, M.D.,Ph.D.; Phone Number: +662 253 0996; Email: nittaya.p@trcarc.org
• Study Contact Backup: Name: Siriporn Nonenoy, MPH; Phone Number: +662 253 0996; Email: siriporn.n@trcarc.org

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • The Thai Red Cross AIDS Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: sample size 100; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Thai Red Cross AIDS Research Centre
• Collaborators: amfAR, The Foundation for AIDS Research
• Investigators: Principal Investigator: Frits van Griensven, PhD, MPH, The Thai Red Cross AIDS Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: The EN-V Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No