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

NCT03407586 | Completed

• 2 other identifiers: CAPRISA 083R21AI116759
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention; Sexually Transmitted Diseases

Keywords

point-of-care testing; sexually transmitted infections; expedited partner therapy; genital inflammation

Outcome Measures

Primary Outcomes (1)

• Changes in genital inflammation in women diagnosed with STIs after a diagnostic care intervention

  Genital cytokine measurements before and after the intervention

  Baseline and 6 and 12 weeks after the intervention

Secondary Outcomes (3)

• Prevalence of laboratory-diagnosed STIs in women presenting to the Prince Cyril Zulu Communicable Diseases Clinic, Durban, South Africa

  Baseline

• Validation of GeneXpert technology for STI testing against laboratory-based STI assays

  Baseline

• Acceptability of implementing expedited partner therapy among patients

  6 weeks and 3 months after intervention

Study Arms (1)

Diagnostic STI care

OTHER

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

Interventions

Point-of-care STI testing DIAGNOSTIC_TEST

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

Diagnostic STI care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• HIV positive women
• Pregnant women
• Women who have had antibiotic treatment within the last 7 days
• Women who disclose any form of sex work

Sponsors & Collaborators

• Centre for the AIDS Programme of Research in South Africa: lead
• Johns Hopkins University: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

CAPRISA

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (1)

• 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.

  PMID: 30782948 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nigel J Garrett, MBBS

  Centre for the AIDS Programme of Research in South Africa

  PRINCIPAL INVESTIGATOR

• Anne Rompalo, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants provided written informed consent to join the intervention of diagnostic rather than syndromic management.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pathogenesis and Vaccine Research

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 23, 2018
• Study Start: May 15, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

ZA (1)