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

January 24, 2018 updated by: Dr Nigel Garrett, Centre for the AIDS Programme of Research in South Africa

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
267

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • CAPRISA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 6 and 12 weeks after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline
Validation of GeneXpert technology for STI testing against laboratory-based STI assays
Time Frame: Baseline
GeneXpert validation
Baseline
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
6 weeks and 3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for the AIDS Programme of Research in South Africa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nigel J Garrett, MBBS, Centre for the AIDS Programme of Research in South Africa
  • Principal Investigator: Anne Rompalo, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAPRISA 083
  • R21AI116759 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be published in open access journal together with manuscript, and will thereby be shared with other researchers.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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