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Exploration of the Neo-Vagina Study

NCT03049371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • amfAR, The Foundation for AIDS Research

    collaborator OTHER

  • Thai Red Cross AIDS Research Centre

    lead OTHER

Principal Investigators

  • Frits van Griensven, PhD, MPH · The Thai Red Cross AIDS Research Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-05-31
Completion
2022-11-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049371 on ClinicalTrials.gov