SYPHILIS POSES a significant risk to pregnancy and can result in a number of negative outcomes including spontaneous abortion, stillbirth, and perinatal death. The presence of syphilis can also facilitate the risk of HIV transmission. 1 Although syphilis has been well controlled in the developed world, it still remains a problem in Africa where the antenatal syphilis prevalence has been found to be in the range of 3% to 17%. 2–6 Some of these studies have identified the need for improvement in syphilis screening during antenatal care (ANC), 3–4,6 and a number of interventions have been successful in improving prenatal screening and treatment for positive cases. 2,6 In addition, screening for syphilis in pregnancy has been found to be a cost-effective intervention in a number of different settings. 6–7
South Africa has one of the most rapidly growing HIV and sexually transmitted infection (STI) epidemics in the world. Data from the 1999 national antenatal survey, 5 showed that on average 22.4% of women attending ANC clinics were infected with HIV and 7.3% with syphilis. Congenital syphilis is a major cause of perinatal mortality in South Africa. In one study 8 10% of stillbirths were found to be due to congenital syphilis.
The existing syphilis screening program has been funded and implemented by the National Department of Health who pay for all aspects of testing and treatment. The program has been available for approximately 20 years. At clinic level, professional nurses have routinely carried out the blood collection of first-time ANC clinic attenders and treatment of syphilis positive women. In the majority of cases, blood samples will be sent to a laboratory for analysis using the rapid plasma reagin (RPR) test. The treponemal tests are not routinely used in the public health services for ANC patients although these tests are used in some instances for STI patients. In most cases, serial dilutions are performed to quantify antibody titers on positive RPR tests. Standard treatment consists of three doses of 2.4 mil units benzathine penicillin at weekly intervals. This conservative approach is based on assumption that the majority of ANC attenders will have late latent syphilis.
The current program has been unable to routinely monitor compliance of testing and treatment because records are registered in client-retained cards. One study documented that at a rural mobile clinic site only half (49%) completed the full course of treatment. 9 There is limited information about partner notification and treatment.
With the high rates of syphilis and concerns over treatment completion, decentralized testing is proposed in new national guidelines to improve compliance. Feasibility studies of decentralized testing have been conducted in South Africa. 10–11 One study found that the clinic successfully identified 44 of the 48 positive tests identified by the laboratories. 10 The other study found that 75% of women completed their full treatment. 11
The case study reported here will be used to inform policy makers and managers of challenges in the existing program and also to look at the issues that will need to be addressed if decentralized testing is implemented.
Public sector sites included five urban and two rural clinics in the Umlazi and the Impendle-Polela-Underburg district in KwaZulu–Natal. The two referral hospitals of these clinics were also included. Although many private gynecologists were approached, all but one declined to take part. Data were collected between May 3 and July 28, 2000 using a number of data collection tools (Table 1). A comprehensive inventory was carried out in all the facilities excluding those of the private practitioner. Observation (inspection) of the clinic was conducted to collect data on the availability of information, education, and communication, to record the method and content of health education, to document procedures followed by first-visit ANC clients, to review existing guidelines, and to record equipment and supplies including drugs and logistics at each facility.
Key informant interviews were conducted with several categories of people including policy makers, clinic supervisors, laboratory staff, and one obstetrician.
Observations of client-provider consultations were conducted. Where possible, one provider was observed at least twice with one first-visit and one repeat-visit ANC client. Every fifth repeat client was sampled, as were consecutive first-time clients. Each observed client was then interviewed before leaving the facility using the client exit interview questionnaire. This was done in order to link the observation data with the client's perceptions of the service rendered. Postdelivery interviews were conducted in the two hospitals.
Focus group discussions were held with two groups of first-time pregnant women, to assess knowledge and perceptions of syphilis.
Client flow analysis was conducted using Client Observation Provider Efficiency (COPE) methodology. This tool assesses client contact time and waiting times. Data were entered and analyzed using Epi-Info 6.04 (Centers for Disease Control and Prevention, Atlanta, GA).
In total, 112 ANC clients were interviewed across all nine facilities. Almost half (46%) were attending for their first ANC consultation and 54% had already had at least one ANC visit during the current pregnancy. In addition 22 postnatal clients were interviewed after delivery at the two referral hospitals. The mean age of all women interviewed was 25 years (range 12–42 years) and the majority of them (79%) were educated to the secondary school level with over half completing their secondary education. Mean gestation at first ANC visit was 5 1/2 months. Late presenters included adolescents and women from very remote areas who moved to the vicinity of the health facility for their delivery.
Syphilis Screening at Clinic Level
All nurses reported syphilis testing for first-time ANC attenders as an essential part of this first visit. All available guidelines that were reviewed stipulated testing for syphilis and mentioned conditions for retesting. Provincial guidelines stated women should return after 2 weeks for their test results. There was some confusion between existing syndromic management guidelines for STIs and syphilis screening guidelines in pregnancy. Current policy for notification of syphilis was not familiar to all informants and the Health Informatics department that collects and reports on notifiable conditions reported a very low level of syphilis notification from facilities.
Of the 51 first-visit ANC clients who were observed, all had blood taken for a syphilis test. Daily health talks were identified by clinics as the medium used mainly for informing clients about syphilis. However one half (50%) of the women received no information on why the test was taken. Some health talks emphasized that blood tests were not being taken for HIV, but did not mention syphilis. Although 86% of women interviewed reported that HIV could be transmitted through unprotected sexual intercourse, less (63%) mentioned that syphilis could be sexually transmitted. Only a small number (3%) knew it could be transmitted from mother to child. Both history taking and examination showed minimal verbal screening for signs and symptoms of STIs generally.
Women were not told to return specifically for the test results. It was standard practice in all the facilities observed to give results at the next ANC visit. While clinics kept records of syphilis test results returned from laboratories, there were no records for treatment of clients with RPR-positive test results, or their partners. The test results and treatment were recorded on the client-retained card only.
Transportation of Specimens and Results
All facilities sent blood samples to a laboratory for testing. The laboratories were situated in the same facility for the two hospital-based ANC clinics with the greatest distance between laboratory and clinic being 70 km. There was no dedicated transport for blood specimen collection. All specimens were transported by the existing government transport/ambulance service. All key informants indicated their concern that drivers were not trained or aware of the need to deliver the specimens promptly and stated this as a major cause of delay. Samples were kept under refrigeration at each facility for up to 1 week before collection. Between 1% and 5% of specimens arrived at the laboratories mislabeled or unsuitable for analysis. When this occurred, the relevant facility was notified immediately by telephone. Mean turnaround for the results was 4 weeks (range 3 days to 6 weeks). Laboratories mainly used government transport to get results back to clinics, this being the same transport that took samples to the laboratory. One clinic collected their results from the laboratory. Some clinics located in the same facility used the hospital porter system to take the results from the laboratory across to the clinics.
All laboratories reported that specimen analysis was done within 1 day unless samples arrived in the afternoon in which case they were tested the following day. If confirmatory tests were requested the results could also be available on the next day. There were no reported staff shortages for analysis of samples but unreliable transport to dispatch the results. The level of dilution of the RPR test considered a positive result differed between laboratories and ranged between 1:2 and 1:8.
Management of Syphilis Screening Results at Facilities
Some providers in clinics suggested syphilis prevalence of 1% to 2% in their clients. However one laboratory indicated that 20% of the specimens they received from ANC clinics in their area were positive. An obstetrician quoted a similar figure.
There were 61 repeat clients in total. Most of these women (n = 56) had previously attended the same clinic while five had changed clinics since their first ANC visit. Not all of these clients had received their results or knew their syphilis status (Table 2).
One woman incorrectly reported that she was seropositive for syphilis, having misread her card and confused her syphilis test results with Rhesus test results. In almost all cases the available results were written on the client card. All 22 postnatal women reported that they were tested for syphilis but only 15 women had the test recorded on their cards.
Management of Positive Clients
Of the antenatal women sampled who had received test results for syphilis, 18% (n = 8) had been told they were positive. These women were asked what information/counseling the provider had given to them in addition to the treatment they received. Of the eight women, fewer than one half reported having been given information on a range of issues (Table 3). Two postnatal clients (9%) tested positive for syphilis and both received full treatment. Dates of the treatment were recorded on the client carrier card. Women with positive test results were retested at delivery at one facility. Syringes and needles for blood collection and administration of the injection were available at all facilities. Although the hospital-based facilities reported consistent drug supplies, the nonhospital ANC sites reported that it was not uncommon to run short of drugs such as penicillin and erythromycin. When these drugs were out of stock three facilities said they advised the client to go to another nearby facility and three others said the client would be advised to return 1 week later to check whether that particular treatment had arrived.
Administration of Treatment
Of the nine facilities, six provided syphilis treatment on a daily basis, and three treated on repeat ANC days only. Syphilis treatment was identical across all facilities—penicillin 2.4 mil inits, at weekly intervals for 3 weeks. All providers reported prescribing erythromycin for clients allergic to penicillin, however, the dosage, frequency, and duration of treatment was often incorrect. It was further stated that if the woman defaulted from treatment, it should be started again. Women who delivered without completing the treatment were expected to do so postdelivery. Tests were occasionally repeated to monitor response to treatment.
Most facilities indicated that partner notification cards were used to contact partners for treatment. In three facilities these cards had been out of stock for over 3 months. There were no protocols for follow-up of clients or partners of clients with positive test results who failed to return for their results or treatment. The importance of bringing partners for testing was not stressed by providers. All nine facilities treated the presenting partner on the basis of the pregnant women's results. One facility reported taking a blood specimen for an RPR test simultaneously with administering treatment. Only one dose of penicillin was given to partners. Facilities were unable to comment on partner return as there were no records of partner treatment.
Clients were asked a number of questions regarding their general treatment at the facility. The majority of women reported positively about their consultation. Some women (21%), however, did felt that their consultation was rushed, and 10% said their provider made them feel uncomfortable. Overall, women (84%) expressed satisfaction with their visit and reported that they received the information and treatment they needed.
The mean duration of client-provider interaction was 20 minutes (range 13–28 min) for a first-time antenatal client. Repeat clients had a much shorter appointment with a mean time of 10 minutes (range 1–32 min). The average time for completion of the whole ANC procedure by a first-time or repeat client, including waiting and interaction time, was 4 hours and 7 minutes (range 30 min–8 hours).
Human Resources and Availability of Services
Facilities differed in the number of nurses who had received specialist training. Overall, only one fifth (21%) of staff were trained in STI management and less (10%) of staff had been trained in STI/HIV counseling. No HIV testing or perinatal prophylaxis programs were available in any of the clinics. Women were referred for HIV testing. Although HIV referral numbers were not collected as part of this study few women were referred for testing. The high crime rates resulted in the reluctance of external supervisors and doctors visiting some facilities.
In South Africa the majority (94%) of women seek clinic-based antenatal care, 12 therefore, the syphilis screening program has potential for reaching almost all ANC attenders. This service is free, and testing and treatment should be available at clinic level. Clients and their partners do not have to attend a dedicated STI clinic and are therefore not stigmatized as “STI” clients. Patient-held cards (carrier cards) allow continuity of treatment at any facility.
In this study all women had blood taken for the RPR test. In comparison, in Kenya, 79% of women attending antenatal clinics participating in a decentralized syphilis control program were screened. This figure was 56% in the nonintervention clinics. 2 Although not all women were screened in the Nairobi study, almost all (97%) of the women with positive RPR test results were treated and, in addition, 75% of the partners were treated. In South Africa the routine clinic data collection has not documented compliance to treatment for the women with positive test results, or their partners. From a limited number of research studies 4,9 compliance to treatment was found to be low.
This study identified a combination of factors that reduced the effectiveness of the program after initial screening. One of the main problems encountered was the lack of a reliable, dedicated means of transporting samples and results between laboratory and clinic. Samples were at risk of damage in transit or by prolonged or incorrect storage at clinics before collection. As a result of this delay, providers did not tell clients to come back after 2 weeks as stated in guidelines, and routinely gave results at the next scheduled ANC appointment. Similar transport problems were found in Kenya 13 where unreliable transport remained a problem even after the centralized system was strengthened. The delay in test results coupled with the late presentation of women for the first ANC visit meant that women received treatment mainly in the third trimester and approximately 15% of women in this study would not have been able to complete treatment before delivery. Late presentation for ANC was also found to be a problem in other African countries. 2,3,6 In Kenya 2 one third of women were treated after 29 weeks of pregnancy. In the Zambian syphilis intervention 6 health education materials had to be developed specifically to encourage early ANC attendance.
Drugs, notification cards, and consumables were found to be out of stock on occasion, and providers felt frustrated because they received no information as to why these shortages had occurred. Health providers at the clinic level felt there was little support and supervision from management and were consequently demotivated. Many of these issues have also been identified in other studies. 6,13
Treatment was often administered with minimal discussion of transmission, prevention, importance of treatment compliance, and partner notification. No systems were available to track women or their partners who did not complete treatment.
The provincial STI training program had not cascaded adequately down to clinic level, and the majority of staff had not attended a course on syndromic management of STIs. There was minimal attention paid to STIs other than syphilis during the prenatal period. There was a low awareness of the magnitude of the syphilis problem with nurses quoting rates much lower than those reported by laboratories.
The following recommendations were made for improving the current program:
- Transport issues addressed that could guarantee the return of RPR-test results to clinics within 2 weeks.
- Providers should be trained to counsel women around testing and results, including standard counseling for all women with positive test results.
- Records of client treatment should be kept at the clinic to monitor general compliance, and clinics should report levels of compliance to health informatics for monitoring purposes.
- Notification cards should be supported by letters to explain to partners the importance of treatment in pregnancy.
- Strategies should be explored for active partner follow-up, and partner treatment should be indicated on index client card.
- Women with early syphilis (less than 2 years) should be given the option of single-dose treatment with penicillin 2.4 mil units (injection) following WHO treatment guidelines.
- Clients should be encouraged to start ANC as early as possible.
- Dilution levels should be standardized to indicate cases for treatment.
The majority of the proposed recommendations could be carried out with resources already available to the services in question. The transport issue would be one of the greatest challenges because there is no possibility of dedicated transport for the samples to laboratories. This issue has been raised with the management of the referral hospital, and discussions are underway for devising methods of obtaining results in less than two weeks.
Potential of Upscaling the Current Program to Decentralized Testing
Evidence from the client flow analysis indicated that nurses would have time to manage on-site testing at all sites included in this case study. Most clinics were moving towards an integrated service and lifting restrictions that permitted first-time clients to attend clinics only on certain days, thus more evenly distributing the volume of first-time clients throughout the week. New national guidelines propose on-site (decentralized) testing, however, the services have not been assessed on their preparedness for implementing such a program. On-site testing will only improve the current status quo if it can be shown to be at least as accurate as the current laboratory system. A detailed clinic-level protocol for on-site testing needs to be developed for facilities with support for implementation. The results of this study have been used within the Province of KwaZulu–Natal to identify clinics which are committed to introducing decentralized testing—a number of clinic sites have already been identified in two regions. In addition to training in conducting the RPR test, this pilot project will address the whole area of improving the quality of ANC with a particular focus on STIs. This comprehensive package aims to ensure that the decentralized testing will not only be of good quality but also will be sustainable in the long run. The process will be documented and what is learned will be used to inform the expansion of decentralized testing to other parts of the province.
The study concluded that although the syphilis screening program was well established, a lack of clear guidelines had led to facilities interpreting on their own how the screening should be carried out. The program has not been thoroughly evaluated at the national level, and implementation at the facility level has been limited by local resources and individual commitment to the program. The syphilis epidemic has not been given adequate attention in the light of the HIV/AIDS situation even though the screening program has potential to have considerable impact on syphilis rates. There are policy, guideline, and training issues that need to be addressed to improve syphilis screening and management in ANC. STI and ANC services are not well integrated and this needs urgent attention in the light of the South African HIV epidemic. There are plans to make HIV voluntary counseling and testing (VCT) services more widely available in public sector clinics in South Africa. One of the sites in this study has been identified as a potential VCT site. Strategies to conduct both HIV and syphilis testing at clinic level should be explored.
The program has potential to implement on-site testing because core components are in place. Plans should be developed at the provincial level to assess the existing screening program and to detail proposed changes.