Does a waiting room increase same-day treatment for sexually transmitted infections among pregnant women? A quality improvement study at South African primary healthcare facilities
1Research Unit, Foundation for Professional Development, East London, South Africa
2Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
3CTU Bern, Department of Clinical Research, University of Bern, Bern, Switzerland
4Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, California, USA
5Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
6Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, Alabama, USA
7Department of Microbiology, Immunology, and Parasitology, Louisiana State University Health Sciences, New Orleans, LA
8Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
9Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa
#Corresponding author: Prof. Nicola Low (nicola.low@unibe.ch)Abstract
Background
Same-day testing and treatment of curable sexually transmitted infections (STI) is a strategy to reduce infection duration and onward transmission. South African primary healthcare facilities often lack sufficient waiting spaces. This study aimed to assess the proportion of, and factors influencing, pregnant women waiting for on-site STI test results before and after the installation of clinic-based waiting rooms.
Methods
We conducted an observational quality improvement study at 5 public primary healthcare facilities in South Africa from March 2021 to May 2023. The intervention was the installation of a waiting room in two clinics. Three clinics were used as comparators: two already had a waiting room in an existing building and one had access to a shared waiting area. The outcome was the percentage of women who waited for their STI test results. We conducted univariable and multivariable analyses and report marginal risk differences (with 95% confidence intervals, CI) of the proportions of women who waited for results. A subset of women answered structured questions about factors influencing their decision to wait for results.
Results
We analysed data from 624 women across the 5 facilities. Overall, 36% (95% CI 31, 40) waited for their test results (range 7% to 89%). In the two intervention clinics, 17% (95% CI 11, 24) waited for results before the introduction of a waiting room and 10% (95% CI 5, 18) after (crude absolute difference -7% (95% CI -16, +3), adjusted difference, -6% (95% CI -17, +5)). The percentages of pregnant women waiting for sexually transmitted infection test results were higher throughout the study period in 2 clinics which always had a dedicated waiting room than in 2 clinics where a waiting room was installed, or in 1 clinic, which only had access to a shared waiting area. Most women reported before testing that they did not intend to wait and none of the suggested factors would change their decision.
Conclusions
Introduction of a waiting room did not increase the proportion of women who waited for their results in this observational study. Future studies should investigate infrastructure, individual and test-based factors that affect same-day STI testing and treatment.
Article notes
Competing Interest Statement
The authors have declared no competing interest.
Clinical Protocols
Funding Statement
This study was supported by the US National Institutes of Health (grant number R01AI149339 to JDK and AMM) and the Swiss National Science Foundation (grant numbers 197831 to NL and 191225 to RMSG).
Introduction
Antenatal clinic services should provide timely treatment for women with newly diagnosed conditions in pregnancy. In South Africa, approximately one-third of women attending antenatal clinics have been found to have at least one curable sexually transmitted infection, including Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis [1, 2]. In settings lacking laboratory STI diagnostic testing, women with vaginal discharge often receive syndromic management - an empiric approach in which people are treated for the most common potential causes [3]. Clinical management of STIs in pregnancy with rapid accurate diagnostic tests at the point of care would allow same-day targeted treatment [4], reduce overtreatment of symptomatic women without infection and detect asymptomatic infections [5, 6]. The GeneXpert platform (Cepheid, Sunnyvale, California) uses highly sensitive and specific nucleic amplification technology, which can detect C. trachomatis, N. gonorrhoeae and T. vaginalis within 60 to 90 minutes but requires an electricity supply.
The proportion of women who wait for results or receive same-day treatment for STIs detected on the GeneXpert platform in community or primary care settings in resource-limited settings, including sub-Saharan Africa has varied from 2% to 92% [7-12]. In a study in Zimbabwe, researchers investigated why only 2% (1/61) of adolescents received results on the same day after being tested in non-clinical community settings. Clinic staff reported delays resulting from workflow difficulties and power cuts, and that patients could not wait 90 minutes for results [7]. In our South African research project, called “Philani Ndiphile”, 39% of 125 pregnant women who tested positive for STIs using GeneXpert between March 2021 and March 2022, received same-day treatment. This percentage varied from 26% to 96% among the four clinics [13]. We observed that the clinic where most women waited for results had a comfortable designated waiting room.
The ‘Ideal Clinic’ initiative of the South African National Department of Health aims to create healthcare facilities with good infrastructure, including adequate waiting space and waiting times [14]. However, most healthcare facilities in South Africa need renovation and extension [14, 15]. In addition, the increasing frequency of planned power cuts (known as ‘load shedding’) could increase the turnaround time, from arrival at the clinic to receiving of test results [4, 16], in research settings where the GeneXpert test platform is available. In September 2022, the Philani Ndiphile project investigators planned to upgrade the physical conditions in two clinics by installing a waiting room. This decision provided an opportunity to observe whether there were differences in the percentages of pregnant women waiting for GeneXpert STI test results, according to the presence of a dedicated waiting room. The objectives of this study were to: 1) observe the percentage of women waiting for STI test results before and after installing a dedicated waiting room in two clinics; 2) compare percentages of women waiting for results in clinics with and without a waiting room; and 3) describe reasons why pregnant women did not intend to wait for results.
Methods
We used the Standards for Quality Improvement Reporting Excellence (version 2.0) guidelines [17] to report this study. The statistical analysis plan is at: https://osf.io/zk4xd/.
Study design and setting
This healthcare quality improvement study used an observational design. It was nested within the Philani Ndiphile research project, which aims to evaluate different screening strategies to decrease the burden of STIs among pregnant women and reduce adverse birth outcomes in Buffalo City Metropolitan Health District, Eastern Cape Province, South Africa [18, 19]. Enrolment into Philani Ndiphile commenced in the antenatal clinics of four public healthcare facilities between March and May 2021, with a fifth clinic starting in June 2022 [13]. We used study data collected from Philani Ndiphile participants from 29 March 2021 to 12 May 2023.
Clinics A, B and E are community healthcare centres, and Clinics C and D primary healthcare facilities, with the former being larger and offering more services than the latter (Table 1).1 Clinics A and E are in peri-urban townships. Clinic A is in a more densely populated area with mainly informal dwellings than Clinic E with a mix of formal and informal dwellings. Clinic B is in a larger peri-urban township with mainly formal dwellings. Clinic D is in a semi-rural area with formal dwellings. Clinic C is in a sparsely populated peri-urban town with formal dwellings.
The installation of a dedicated waiting room (described as the intervention) was implemented at Clinics A and B (Table 1, Figure 1). At these clinics, the Philani Ndiphile research procedures were initially conducted out of 14m2 (approximately 5.9m x 2.3m) metal freight containers on the community healthcare centre grounds and participants had to wait outside in an uncovered area. At Clinics C and D, research procedures were conducted in multiple rooms inside the clinic building. Only study participants could use these dedicated comfortable waiting rooms. At Clinic E, research study staff shared a small room with other antenatal care services inside the clinic building. Participants used the same waiting area, which was a corridor, as the regular antenatal clinic attendees. We judged this facility to be sub-optimal for an ‘Ideal Clinic’ [14]. Since no upgrade was planned, we considered it separately as having ‘no dedicated waiting area’.
Study population
At their enrolment visit, Philani Ndiphile study participants who received same-day STI testing according to the study protocol in the clinics, were included in this study. Participants were aged ≥18 years and <27 weeks of gestation at enrolment. A research nurse conducted a physical examination and collected vaginal swabs as early as possible during the enrolment visit in all clinics. One swab was tested on-site on the GeneXpert machine. The processing time for the combined assay for C. trachomatis and N. gonorrhoeae is 90 minutes and for the assay for T. vaginalis 60 minutes; the tests run in parallel on the same machine. Times from arrival at the clinic until testing and from the end of processing until receipt of results were not measured.
Intervention
Clinics A and B were provided with a new air-conditioned 18m2 (approximately 5.9m x 3.0m) container, with one room furnished as a waiting room with seating space, a water dispenser, and a separate bathroom (Table 1, Figure 1). At Clinic A, the original 14m2 freight container was also replaced. A newly installed roof between the two new containers could also be used as an additional outside covered waiting area. At Clinic B, the 14m2 freight container remained. The intervention, introduction of the new waiting rooms, started operating on 14th December 2022 (Figure 2).
Outcomes
The primary outcome was the percentage of participants who waited to receive their STI test results on the same day. The secondary outcome was the response to structured questions about reasons for waiting for same-day STI test results.
Sample size
We used study data about all STI tests and the proportions of participants waiting for results in the Clinics A and B before the intervention (26%, 17/65 and 10%, 8/84). Guided by the proportion of participants waiting in Clinic C (94%, 77/82) which always had a waiting room, we considered a conservative increase to 45%. Based on 26% of participants waiting and 147 participants with complete pre-intervention data, a total of 220 participants would result in more than 0.8 power to detect an improvement to 45% at an alpha of 0.05, based on a chi-squared test. We aimed to observe at least 80 participants post-intervention in Clinics A and B combined.
Data collection
We recorded data in a Research Electronic Data Capture software (REDCap, Vanderbilt University, Tennessee, USA) project database [21]. From 29 March 2021 to 6 November 2022, we only collected the dates of testing and treatment for participants with a positive STI result (Figure 2). We classified the participant as having waited for her result if the dates of testing and treatment were identical. From 7 November 2022, we captured data from all participants, irrespective of their STI test result. The first month after the waiting rooms were installed on 14 December 2022 coincided with a holiday period. We considered this a ‘settling in’ period for the intervention and did not analyse data for this period (Figure 2). From 14 September 2022 onwards, all participants from all clinics were asked structured questions about their intention to wait, what would make them wait and, for participants who did not intend to wait but actually received same-day results, what were their reasons. We obtained national-level data about load shedding from the national power supplier. We applied the national level of load shedding that was in operation at midday of each day in the observation period to each clinic. We defined three groups: no load shedding, stages 1-3 (3-6 hours of power outage per day), and stages 4-6 (6-12 hours of power outage per day) and added this information to the database at the participant level.
Statistical analysis
We summarised continuous baseline characteristics using means and standard deviations, or medians and interquartile ranges, and categorical variables as frequencies. We compared baseline characteristics of participants included in the analyses with all those eligible for same-day STI testing, using Mann-Whitney or chi-square tests.
Objective 1: we calculated the percentages (with 95% confidence intervals, CI) of women who waited for results (number who waited for their results divided by number tested), by clinic and intervention group. We made run charts, which display monthly aggregated percentages, by clinic and intervention status [22]. Objective 2: To analyse the primary outcome for each woman (waited for results, yes/no), we used binomial generalised estimating equations, with an independence correlation structure and the clinic as a cluster variable. We pre-specified 6 explanatory variables, which could have influenced waiting. Participant factors were employment status, symptom status and STI test positivity. Although the result is not known at the time of testing, women who are aware of sexual practices that increase STI acquisition risk or women who have symptoms might be more likely to wait for results under any circumstances [7, 23]. Clinic setting factors were the distance to the nearest food shop, which was a proxy for clinic location and ability to buy food whilst waiting, years of clinical experience of the research nurse and level of electrical load shedding. The primary analysis model compared data for women attending post-intervention (waiting room available) vs. pre-intervention (no waiting room) for Clinics A and B only. We conducted two secondary analyses, using data for all clinics. In the first model, waiting room was a binary variable with each woman categorised as attending a clinic in which a waiting room was available vs. not available. In the second model, waiting room was a categorical variable: never available, available from the beginning, and waiting room introduced. We conducted multivariable analyses and planned to adjust for all pre-specified explanatory variables in each model. We also conducted a subgroup analysis using data from Clinics A and B, according to the STI test, to investigate whether women who might have thought they had an STI were more likely to wait for their results under any circumstances. The model included an interaction term for STI and the intervention as additional covariates. We report results from each statistical model as the marginal risk difference (with 95% CI). Objective 3: we tabulated responses to structured questions about factors that might make the participant wait or change her mind and report these as frequencies and percentages.
Ethical considerations
All participants provide written informed consent to participate in the Philani Ndiphile study. The Philani Ndiphile study received approval from the University of Cape Town’s Human Research Ethics Committee (Reference: 676/2019) and from the local Department of Health (Reference: EC_202010_017). The study reported here is a healthcare quality improvement study, which did not require ethical committee review. Authorisation to analyse de-identified data at the University of Bern has been granted by the Canton of Bern Ethics Committee (Reference 2021-01209).
Results
From 29 March 2021 to 12 May 2023, a total of 1986 participants were enrolled into the Philani Ndiphile study and 1500 participants received same-day testing, according to study protocol (Figure 3). We excluded data from 822 participants enrolled before 7 November 2022, because we did not initially collect data about waiting for those with a negative STI test result, and from 54 participants during the settling in (no observation) period. Our final dataset included 624 participants: 257 in the period during which we only collected waiting data on participants with a positive STI test and 367 in the period during which we collected waiting data on all participants (Figure 2). Of these, 99 participants were enrolled post-intervention in Clinics A and B combined. There were no substantial differences in socio-economic and health characteristics of included and excluded participants (Additional File 1).
The characteristics of included participants in each clinic are shown in Table 2. Across the 5 clinics, the median age was 27 years, and 31% of women were living with HIV. Participants reported waiting from around half an hour to two hours to see a public health nurse or a doctor. Research nurses in Clinics A, B and E had the same level of clinical experience. For these clinics, the population density and distance to the nearest shop were also very similar (Table 1).
The monthly run chart (Figure 4) shows that the percentages of women waiting for their test results before and after the intervention did not change substantially and that the percentage waiting in Clinics C and D, which always had dedicated waiting room, remained higher throughout the study period than in the intervention Clinics A and B and in Clinic E, which never had a dedicated waiting room. Summary data for each clinic separately are shown in Additional File 2.
In the primary analysis, for the intervention clinics, Clinics A and B combined, 17% (CI 11 to 24) of participants waited for their result before the intervention and 10% (CI 5 to 18) after the addition of a waiting room (absolute difference, -7% (CI -16 to +3) (Table 3). After adjustment for employment status, STI test positivity, symptoms, load shedding and distance to the nearest shop, the absolute adjusted percentage waiting was 6% (CI -16 to +2) lower after the intervention (Table 3). The years of research nurse experience could not be included in the model because the values of the variable were identical in both clinics.
For the secondary analysis, with waiting room as a binary variable, 58% (CI 53, 65) of participants waited for their result when a waiting room was available and 19% (CI 15 to 23) when there was no waiting room (absolute difference 39%, CI 31 to 47). After adjustment for employment status, STI test positivity, symptoms, load shedding and distance to the nearest shop, the adjusted percentage difference was +7% (CI –4 to +18) when a waiting room was available (Table 3). When the clinical experience of the nurse was added to the model, the adjusted percentage difference was –8% (CI –15 to –0.3) (Additional File 3).
With waiting room as a 3-level categorical variable, the percentages of participants waiting were: no dedicated waiting room ever 19% (CI 15 to 23), waiting room available from the beginning 83% (CI 77 to 88), and dedicated waiting room introduced 10% (CI 5, to18). Compared with no dedicated waiting room ever, the absolute percentage difference was +65% (CI +58 to +72) when a waiting room was available from the beginning and –9% (CI – 16 to –1) when a waiting room was introduced. In the multivariable model, distance to the nearest shop and clinical experience of the research nurse were highly correlated and could not both be included. After adjustment for employment status of participants, STI positivity, symptoms, load shedding, and distance to the nearest shop, the adjusted percentage differences waiting were similar to the univariable analysis (Table 3).
In the subgroup analysis, according to the presence of an STI, we used data for Clinics A and B. We did not find evidence for an interaction of the STI status and waiting (p-value for interaction unadjusted = 0.79, p-value for interaction adjusted = 0.76, Additional File 4).
Three hundred and ninety-two of 624 (63%) participants provided data about intentions and reasons for not waiting for results (Table 4). Responses did not differ substantially by clinic (Additional File 5) and 136/392 (35%) were collected before the intervention. Of these, 55% (217/392) reported that they did not intend to wait for their results. The main reasons were family (30%, 66/217) or work/school (28%, 60/217) commitments. When we asked these 217 participants what would change their mind about waiting, 72% (157/217) reported that nothing would change their mind. Of 11 participants who did not intend to wait but who received same-day results, 7 said that they were still waiting for other procedures at the clinic, for example for medication from the pharmacy (Table 4). Of 175 participants who intended to wait for their results, 77% (103/175) waited.
Discussion
The absolute difference in Clinics A and B after the introduction of a waiting room was –7% (–16 to +3) in univariable analysis and –6% (–16 to +2) in multivariable analysis. The percentages of pregnant women waiting for STI test results were higher throughout the study period in Clinics C and D, which always had a dedicated waiting room, than in intervention Clinics A and B, and in Clinic E, which never had a dedicated waiting room. Most participants overall (217/392, 55%) said that they were not willing to wait for their results and of those not intending to wait, 72% (157/217) stated that nothing would change their mind.
Strengths and limitations of the study methods
The main strength of this healthcare improvement study is the real-world setting in multiple primary care clinics, which allowed comparisons both pre- and post-intervention and between clinics in which the availability of a waiting room differed. The study setting and observational design are methodological limitations because the number of clinics was limited and a randomised or crossover design were not possible. Whilst we pre-specified factors that could have affected the tendency to wait for STI test results, the measured variables might not have fully captured the reasons for differences between the study clinics. Measurement error, for example, resulting from applying national-level data to each clinic, could have resulted in a non-differential error, biasing any effect towards the null. In addition, the multivariable analyses aimed to adjust for differences between clinics, but some variables could not be included because the values were identical between clinics or were highly correlated. We collected data about intentions and reasons for waiting for test results after deciding to evaluate the intervention, so these questions were only presented to a subset of participants, and potentially important reasons might have been missed because the responses were pre-defined.
Interpretation of the study findings
Following installation of a dedicated waiting room, water dispenser and bathroom in two community health facilities, the percentage of pregnant women waiting for the results of on-site GeneXpert tests for STIs did not increase. It was plausible that upgrading the physical infrastructure of research study clinics could have made it more comfortable for women to wait for their results because we had observed much higher percentages of women waiting for results in a healthcare facility with a dedicated waiting room than in clinics without [13]. There are several possible reasons for the primary findings observed in our study. First, the presence or absence of a waiting room in itself might not be a decisive factor influencing decisions about waiting for results. Responses from a subset of participants in this study (Table 4) support this, as very few women said that the absence of a waiting room was the main reason for not waiting and availability of a waiting room would not have changed the decision. This information was only obtained, however, after the decision to install dedicated waiting rooms had been made. Second, an increase in load shedding during the study period might have masked any possible effect of the new waiting rooms. The percentage of women waiting was lower after the intervention than before; power cuts would have decreased the capacity of the GeneXpert machines, made the clinic environment less conducive to waiting and further prolonged clinic visits. Third, there is imprecision in the estimates, which are compatible with both a reduction and a small increase in the percentage of participants waiting.
In other research studies in resource-limited settings, 90% or more of pregnant women have been reported to wait for same-day results and/or treatment following GeneXpert STI testing [9-12]. In our study, similar percentages of women waited for results in some clinics. The large differences between clinics likely reflect a mix of setting-related factors, which we could not entirely disentangle. These clinics differed in other ways from the clinics at which few women waited; locations were in less densely populated areas and closer to the nearest shop, and research nurses were more experienced. In our secondary analysis, the crude percentage difference was 39% (95% CI 31 to 47) higher when a waiting room was available than when it was not available (Table 3). This difference was reduced to +7% (95% CI –4 to +18) after adjusting for factors, including the distance to the nearest shop. This variable may represent other unmeasured community-related characteristics associated with ability to wait for test results. Additional adjustment for the experience of the research nurse reduced this difference further to –8% (95% CI –15 to –0.3) (Additional File 3). The duration of clinical experience of research nurses might therefore also influence outcomes or might represent other unmeasured factors, which could be investigated in future qualitative studies. It is also possible that the physical environment of freight containers and their placement away from the main clinic building (Figure 1) was less attractive than fixed integrated spaces within a healthcare facility.
Implications for research and policy
This healthcare improvement study shows both the importance and the challenges of evaluating the outcomes of changing physical conditions in the healthcare setting. The goal of improving healthcare infrastructure through initiatives such as the ‘Ideal Clinic’ is clearly important [14] but understanding the impact on process and outcome indicators is also needed. Relevant modifiable factors include clinic workflow, staff training, clinic infrastructure and the turnaround time of test technology. Point-of-care tests that allow treatment decisions to be made at the initial clinical encounter and are rapid, affordable, electricity-independent are particularly important in settings with limited healthcare infrastructure [4-6, 24]. Currently licensed platforms, such as GeneXpert, for on-site C. trachomatis, N. gonorrhoeae and T. vaginalis detection, remain restricted to research studies in most settings. Long waiting times for GeneXpert STI test results have been reported as a major reason for not waiting, in a study amongst youth in Zimbabwe [7] and interruptions to the supply of electricity also reduce efficiency and limit the ability to reduce overall turnaround times. Both qualitative and quantitative studies will be needed to evaluate reasons for differences in, and the implementation of interventions to improve the probability of, waiting for STI results.
Conclusion
Changing only the physical infrastructure by introducing a dedicated and comfortable waiting room to primary healthcare facilities did not overcome the challenges of providing same-day treatment among pregnant women in our study setting. Future studies should investigate how infrastructure, individual and test-based factors, including other methods of results notification or point-of-care tests with faster turnaround times can improve the uptake of same-day STI testing and treatment.
Supporting information
Data Availability
All data produced in the present study are available upon reasonable request to the authors
List of abbreviations
- CI
- confidence interval
- REDCap
- Research Electronic Data Capture
- STI
- sexually transmitted infections
List of additional files
Additional file 1: Additional file 1.docx, Socio-economic and health characteristics of included and excluded participants.
Additional file 2: Additional file 2.docx, Percentage of women who waited for results by clinic and intervention date (14 December 2023).
Additional file 3: Additional file 3.docx, Secondary analysis 1: All clinics, grouped by waiting room availability.
Additional file 4: Additional file 4.docx, Additional file 4 – Sub-group analysis: Clinics A and B combined, grouped by presence of a sexually transmitted infection.
Declarations
Consent for publication
Not applicable
Availability of data and materials
The datasets analysed for this study are part of ongoing studies, which have not yet been completed. Data used in these analyses are available from the corresponding author on reasonable request.
Competing interests
All authors declare that they have no competing interests.
Funding
This study was supported by the US National Institutes of Health (grant number R01AI149339 to JDK and AMM) and the Swiss National Science Foundation (grant numbers 197831 to NL and 191225 to RMSG).
Acknowledgements
The authors thank all the participants and our field staff.