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

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ClinicalTrials.gov Identifier: NCT03407586
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Dr Nigel Garrett, Centre for the AIDS Programme of Research in South Africa

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 23, 2018
Last Update Posted Date January 26, 2018
Actual Study Start Date  ICMJE May 15, 2016
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
Changes in genital inflammation in women diagnosed with STIs after a diagnostic care intervention [ Time Frame: Baseline and 6 and 12 weeks after the intervention ]
Genital cytokine measurements before and after the intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03407586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
  • Prevalence of laboratory-diagnosed STIs in women presenting to the Prince Cyril Zulu Communicable Diseases Clinic, Durban, South Africa [ Time Frame: Baseline ]
    Prevalence of chlamydia, gonorrhoea and trichomoniasis in young women presenting for syndromic STI care
  • Validation of GeneXpert technology for STI testing against laboratory-based STI assays [ Time Frame: Baseline ]
    GeneXpert validation
  • Acceptability of implementing expedited partner therapy among patients [ Time Frame: 6 weeks and 3 months after intervention ]
    Proportion of patients taking up expedited partner therapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STI Care Model to Reduce Genital Inflammation and HIV Risk in South African Women
Official Title  ICMJE Changing the STI Care Model to Reduce Genital Inflammation and HIV Risk in South African Women
Brief 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.
Detailed Description

Sexually transmitted infections (STIs) are strongly associated with HIV risk. However, population based studies to manage STIs as a way of reducing HIV risk have had limited success. Recent studies show that elevated genital tract inflammatory cytokines are strongly associated with an increased risk of HIV acquisition, and STIs are one of the commonest causes of elevated genital tract cytokines. This interest in the role of cytokines in HIV acquisition has reinvigorated interest in STIs and whether better management strategies can have a role to play in HIV risk reduction.

HIV and STIs are extremely common in the South African province of KwaZulu-Natal, where there are many challenges with STI diagnosis and treatment, including the reliance on syndromic management, an approach based on the recognition of STI syndromes (vaginal discharge, urethral discharge and genital ulceration), followed by treatment targeting the common causes of the syndrome. This syndromic management approach has a low sensitivity and specificity for detecting the most common curable STIs, such as chlamydia, gonorrhoea, trichomoniasis and syphilis. Studies have shown that only 13% of symptomatic STI infections are cured with the STI treatment services currently offered in KwaZulu-Natal. This low cure rate for symptomatic STIs is compounded by the fact that up to 80% of STIs are asymptomatic, which results in a majority of STIs remaining undiagnosed and untreated. Other challenges with current STI management include limited partner notification and treatment, resulting in high levels of reinfection. At a population level, the result is that most STIs remain untreated and the burden of STIs within the community remains unchecked.

The goal of the study is to determine if an innovative, enhanced programme of STI management will result in a higher cure rate and a lower recurrence rate, with a subsequent reduction in genital inflammatory cytokines and hence HIV risk. This proof-of-concept cohort study will identify individuals with STIs using an innovative, point-of-care diagnostic test, an automated, cartridge-based nucleic amplification assay (GeneXpert) for the simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis, and Trichomonas vaginalis. This technology has been introduced on a large scale across South Africa to detect tuberculosis (TB) and TB drug resistance, thereby accelerating diagnosis, treatment and enhancing public health initiatives to control TB. 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, giving the participants the same treatment to take home for their sexual partners (expedited partner therapy) and asking them to return after six weeks and three months for a test of cure and additional cytokine assessments, to determine if these have decreased.

Overall, this innovative enhanced management package for targeted STI care, offers the best opportunity to reduce STIs, by ensuring that the individual is cured and by reducing the risk of reinfection using expedited partner therapy. This will allow the investigators to determine whether genital inflammation can be reduced after effective targeted STI treatment, and ultimately reduce the risk of HIV acquisition in South Africa.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective cohort study
Masking: None (Open Label)
Masking Description:
All participants provided written informed consent to join the intervention of diagnostic rather than syndromic management.
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Prevention
  • Sexually Transmitted Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE Diagnostic STI care
All participants underwent point-of-care STI testing, and if diagnosed with a STI were offered immediate therapy, and expedited therapy if indicated.
Intervention: Diagnostic Test: Point-of-care STI testing
Publications * Garrett N, Mitchev N, Osman F, Naidoo J, Dorward J, Singh R, Ngobese H, Rompalo A, Mlisana K, Mindel A. Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study. BMJ Open. 2019 Feb 19;9(2):e026888. doi: 10.1136/bmjopen-2018-026888.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2018)
267
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 - 40 years
  • Female gender
  • HIV negative antibody test at enrollment

Exclusion Criteria:

  • HIV positive women
  • Pregnant women
  • Women who have had antibiotic treatment within the last 7 days
  • Women who disclose any form of sex work
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03407586
Other Study ID Numbers  ICMJE CAPRISA 083
R21AI116759 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be published in open access journal together with manuscript, and will thereby be shared with other researchers.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: The manuscript and supporting information are currently under review at PLOS ONE journal and are expected to be published indefinitely by 31 January 2018.
Responsible Party Dr Nigel Garrett, Centre for the AIDS Programme of Research in South Africa
Study Sponsor  ICMJE Centre for the AIDS Programme of Research in South Africa
Collaborators  ICMJE
  • Johns Hopkins University
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Nigel J Garrett, MBBS Centre for the AIDS Programme of Research in South Africa
Principal Investigator: Anne Rompalo, MD Johns Hopkins University
PRS Account Centre for the AIDS Programme of Research in South Africa
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP