Exploration of the Neo-Vagina Study

NCT03049371 | Completed DMC

• 1 other identifier: The EN-V Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Transgender Women

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Other: No Intervention for both groups

Interventions

No Intervention for both groups OTHER

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

sample size 100

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• not TGW

Sponsors & Collaborators

• Thai Red Cross AIDS Research Centre: lead
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (1)

The Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Frits van Griensven, PhD, MPH

  The Thai Red Cross AIDS Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 10, 2017
• Study Start: January 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: November 1, 2022
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)