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P3.109 Point-of-care testing for sexually transmitted infections in hiv prevention trials
  1. J Naidoo1,
  2. N Samsunder1,
  3. K Govender1,
  4. R Noble1,
  5. N Ngubane1,
  6. N Naicker1,
  7. A Mindel1,
  8. A Rompalo2,
  9. K Mngadi1,
  10. L Mansoor1,
  11. N Garrett1
  1. 1Centre for the AIDS Programme of Research in South Africa (CAPRISA), Durban, South Africa
  2. 2Johns Hopkins University, Baltimore, USA

Abstract

Introduction Accurate HIV risk assessment is essential when screening volunteers for HIV prevention studies. STI testing plays a key role, but has traditionally been conducted in central laboratories resulting in reporting delays, which can impact on screening and enrolment decisions, and on participant care during follow-up. Here, we outline the implementation of a 2 hour point-of-care (POC) STI care model for clinical trial participants.

Methods As part of a Phase I/IIa vaccine study, CAPRISA implemented POC STI testing for chlamydia, gonorrhoea (Xpert CT/NG, 90 min) and trichomonas (OSOM, 15 min) at a site laboratory of a research clinic in Durban, South Africa, in July 2015. Since then, the POC model has been adopted by 5 other prevention studies, becoming the main STI testing model at CAPRISA.

Results A total of 1426 Xpert CT/NG assays were run on two 4-module Genexpert machines between July 2015 and November 2016. Chlamydia was detected in 206 (14.4%), gonorrhoea in 79 (5.5%) samples, and 52 (3.6%) samples showed both infections. No infection was detected in 1070 (75.0%) samples. 143 (8.6%) samples showed either an error message (5.0%), an invalid result (3.0%) or no result (0.6%) requiring repeat testing, either on the same or next convenient visit. Trichomonas testing was conducted simultaneously on all female participants (n=1093, prevalence 2.7%). Gram staining to diagnose bacterial vaginosis and candida infection was performed on-site in one of the studies. Implementation of this model allowed early detection of screen failures for Phase I/IIa vaccine studies. During follow-up, participants with STIs received enhanced risk reduction counselling and immediate treatment on the day of sample collection. This resulted in improved care, early partner notification, and cost-savings by avoiding unnecessary screening procedures and repeat visits.

Conclusion A 2 hour POC STI testing model can streamline screening and follow-up of participants in HIV prevention studies, and should be considered for implementation by other research sites.

Support: Cepheid loaned two 4-module Genexpert machines to the study team free-of-charge, but did not contribute to the preparation of this abstract

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