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STI Care Model to Reduce Genital Inflammation and HIV Risk in South African Women

NCT03407586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2018-01-26

No results posted yet for this study

Summary

The goal of this prospective cohort study is to determine if a model of care including point-of-care testing, immediate therapy, expedited partner therapy and test of cure will result in a higher cure rate and a lower recurrence rate of sexually transmitted infections (STIs), with a subsequent reduction in genital inflammatory cytokines and hence HIV risk among young women in a high burden setting in KwaZulu-Natal, South Africa. The study will identify individuals with STIs using the GeneXpert system for the simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis, and Trichomonas vaginalis. Genital tract cytokines will be measured using Bio-Plex Pro Human Cytokine kits and a Bio-Plex MagPix Array Reader. Following point-of-care diagnosis, participants will be treated immediately with appropriate therapy under direct supervision, offering the participants expedited partner therapy for their partners. STI testing and cytokine assessments will be repeated after 6 and 12 weeks, to determine if these have decreased. Overall, this study will provide some evidence on whether this STI care model can have an impact on STI prevalence and genital tract inflammation, in a low- and middle-income country, where currently syndromic STI management is the standard of care.

Conditions

  • HIV Prevention
  • Sexually Transmitted Diseases

Interventions

DIAGNOSTIC_TEST

Point-of-care STI testing

All participants underwent point-of-care STI testing (GeneXpert), and if diagnosed with a STI were offered immediate therapy, and expedited therapy, if indicated.

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Centre for the AIDS Programme of Research in South Africa

    lead NETWORK

Principal Investigators

  • Nigel J Garrett, MBBS · Centre for the AIDS Programme of Research in South Africa

  • Anne Rompalo, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-15
Primary Completion
2017-02-01
Completion
2017-02-01

Countries

  • South Africa

Study Locations

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Entities

Companies

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 NCT03407586 on ClinicalTrials.gov