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
|Condition or disease||Intervention/treatment||Phase|
|HIV Prevention Sexually Transmitted Diseases||Diagnostic Test: Point-of-care STI testing||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|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.|
|Official Title:||Changing the STI Care Model to Reduce Genital Inflammation and HIV Risk in South African Women|
|Actual Study Start Date :||May 15, 2016|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||February 1, 2017|
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407586
|Durban, KwaZulu-Natal, South Africa, 4001|
|Principal Investigator:||Nigel J Garrett, MBBS||Centre for the AIDS Programme of Research in South Africa|
|Principal Investigator:||Anne Rompalo, MD||Johns Hopkins University|