STI Care Model to Reduce Genital Inflammation and HIV Risk in South African Women
Condition: HIV Prevention; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases; Inflammation
Study type: Interventional

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.
    

Intervention name(s): Point-of-care STI testing
Intervention type(s): Diagnostic Test
Intervention description(s): All participants underwent point-of-care STI testing (GeneXpert), and if diagnosed with a STI were offered immediate therapy, and expedited therapy, if indicated.
Intervention model: Single Group Assignment
Intervention model description: Prospective cohort study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: point-of-care testing; sexually transmitted infections; expedited partner therapy; genital inflammation