Improving Syphilis Screening and Treatment in Mozambique

Improving Syphilis Screening and Treatment in Mozambique Health Alliance International Ministry of Health Beira and Chimoio, Mozambique University of Washington, Seattle Syphilis: The „ideal‟ public health screening candidate: • Availability of cheap and highly sensitive diagnostic tests. • Very effective and affordable treatment (Penicillin). • Cost-effectiveness of syphilis screening and treatment in antenatal care compares well with pMTCT, EPI and ORT Maternal syphilis in sub-Saharan Africa: Est. 1.6 million pregnant women with undiagnosed syphilis annually in sub-Saharan Africa, including over one million women who attend antenatal care. MOZAMBIQUE: syphilis prevalence in pregnancy is ~10%-15% Prenatal care attendance rate of ~95% in urban and ~50% in rural settings. Sofala Province: pop. 1,550,000 • Pregnancy rate ~5%, • 77,500 deliveries/year • At a syphilis prevalence of 15.1% : 11,325 pregnancies in syphilis infected women – 20% spontaneous abortions ( 2200) – 26% stillbirths (3000) – 13% preterm delivery (1400) – 15% congenital syphilis (1700) – 26% healthy (3000) Early HAI efforts to improve prenatal syphilis screening: 1993 “Feasibility Study” • Beginning at ~5% antenatal patients screened, gradually increased number of health facilities participating in prenatal syphilis screening by refresher training, awareness-raising at district and provincial MOH levels • Increased total screening rate of pregnant women to 5060% in health facilities with laboratories by 1995 • BUT, difficult to increase the screening to >60%; only around half of the women screened returned for results) Next steps: health system initiatives to improve patient flow and efficiency • Blood draw by MCH nurses (rather than referral to laboratory) – Batch testing of samples – Same day results – Treatment by MCH nurses (rather than sending to STD clinics) Results: antenatal patients screened for syphilis per month in health facilities with access to laboratories % Attendees Screened per month 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Syringe stockout National RPR stockout Blood draw, treatment in PNC Nov Nov Nov Julho Julho Julho Jan-97 Jan-98 Jan-99 Jan-00 Mar Mar Mar Maio Maio Maio Set Set Set Manica Sofala Julho Nov Jan-01 Mar Maio Mar Set Further advances in prenatal screening for syphilis in Mozambique limited by: - Absence of testing in facilities without a lab. - Questions about test accuracy in facilities with labs in settings with high prevalence of HIV and malaria - Late attendance at ANC - Reagent shortages A Solution? A new inexpensive rapid Immunochromatographic Strip test (ICS): • provides the possibility of testing in sites without labs • improves accuracy of testing in facilities with labs. Evaluation of the ICS – Objectives: 1) Determine the sensitivity, specificity and predictive values of the ICS compared with the standard Rapid Plasma Reagin (RPR) test Determine the test’s performance in women with and without HIV or malaria Compare reference laboratory vs. field results, determining operational issues associated with the performance of the tests in the study setting 2) 3) Methods Study population: • Pregnant women in their first antenatal visit. • Pregnant women presenting for follow up visits without a previous syphilis test during that pregnancy. • Male partners of the women who had positive syphilis test results. 6 health facilities from the Sofala province (4 in Beira). August 2003 to January 2004 Procedures: QUESTIONNAIRE Information about previous pregnancies, syphilis history and treatment. BASIC PHYSICAL EXAM Routine examination expanded to include a specific search for mucocutaneous (skin) lesions suggestive of syphilis. SPECIMEN COLLECTION AND LAB TESTS - Finger prick (capillary blood): ICS at the antenatal care office, malaria thick blood smear. - Venipuncture (serum): ICS, RPR, and TPHA. - Swab/imprint of mucocutaneous lesions: Fluorescence Stain for T.pallidum. Training: • Nurses and lab technicians received theoretical and practical training. • Pilot study to adjust questionnaires and standardize procedures. Two-week ~50 patients per facility. Results GOLD STANDARD FOR DIAGNOSIS OF SYPHILIS Combination of results of TPHA and RPR SYPHILIS STAGE No Syphilis Active Syphilis Past or treated Syphilis Biological False Positive (BFP) TPHA inconclusive All Syphilis BLOOD TEST RESULTS RPRRPR+ RPRRPR + TPHATPHA+ TPHA + TPHA- Indeterminate or Invalid RPR+ /TPHA+ and RPR- /TPHA+ Study results by probable stage of disease: SEROLOGIC STATUS (Probable Syphilis Stage) TPHA-/RPR(No Syphilis) TPHA+/RPR+ (Active syphilis) TOTAL CASES n (%) 3877 (86.7) 381 (8.5) TPHA+/RPR(Old or treated syphilis) TPHA-/RPR+ (Biologic False Positive) 151 (3.4) 45 (1.0) Comparison of the Sensitivity and Specificity of the ICS and RPR performed at Beira’s Reference Lab (REF) and at the Health Facilities (HF); "All syphilis" (TPHA+) vs. "Active syphilis" (TPHA+/RPR-) cases 99.4% 95.3% 96.5% 98.8% 96.7% 96.9% 100% 90% 80% 70% 90.6% 77.2% 84.1% PERFORMANCE 60% 50% 40% 30% 20% 10% 0% TPHA+ TPHA+/RPR+ ICS REF TPHA+ TPHA+/RPR+ ICS HF 55.9% 70.7% 96.4% Sensitivity Specificity TPHA+ TPHA+/RPR+ RPR HF TEST/SYPHILIS REFERENCE GROUP Test performance: • The performance of the ICS in pregnant women was superior to the RPR at identifying women with active or past syphilis: – Better in the reference laboratory than HF (weak positives difficult to interpret at HFs) – Better independently of women’s HIV or malaria status Satisfaction by Health Workers • Both lab technicians and MCH nurses preferred rapid test, because it: – “Takes less time to perform” – “ Is easy to read” – “Doesn’t require much blood” – “Reduces the waiting time of the mothers” – “The result is more precise” Discussion and Conclusions Conclusions: • The interpretation of the ICS is easier, and the reproducibility significantly higher, than that of the RPR in our study setting. • The ICS makes it possible to: – easily diagnose syphilis in facilities without labs – improve syphilis diagnosis in facilities with labs • ICS cost per test administration is $0.96-0.98 compared to RPR cost of $0.85 Concerns: Using a treponemal test as only test has clinical and social implications: • Approximately 20% of the pregnant women having positive ICS were TPHA+/RPR- (old syphilis) – Some cases would be unnecessarily treated – Partners would be unnecessarily notified • Discussion needed as to whether a proportion of TPHA+/RPR- cases would benefit from treatment (i.e. represent patients with late untreated syphilis at risk of developing neurosyphilis especially if HIV positive). Further research needed: • Define the effects of HIV infection on the performance of the ICS controlling for CD4 count • Determine the rate of conversion of ICS from positive to negative in syphilis infected patients after receiving appropriate treatment Policy recommendation: The use of the ICS in Mozambique and comparable settings would result in a significant improvement of the ANC syphilis screening and treatment program, thus reducing maternal, perinatal and infant mortality and morbidity in the region. Thank you!