Abstract
Objective
To assess implementation of provider-initiated testing and counseling (PITC) for HIV in Malawi.
Methods
A review of PITC practices within 118 departments in 12 Ministry of Health (MoH) facilities across Malawi was conducted. Information on PITC practices was collected via a health facility survey. Data describing patient visits and HIV tests were abstracted from routinely collected program data.
Results
Reported PITC practices were highly variable. Most providers practiced symptom-based PITC. Antenatal clinics and maternity wards reported widespread use of routine opt-out PITC. In 2014, there was approximately 1 HIV test for every 15 clinic visits. HIV status was ascertained in 94.3% (5,293/5,615) of patients at tuberculosis clinics, 92.6% (30,675/33,142) of patients at antenatal clinics, and 49.4% (6,871/13,914) of patients at sexually transmitted infection clinics. Reported challenges to delivering PITC included test kit shortages (71/71 providers), insufficient physical space (58/71), and inadequate number of HIV counselors (32/71) while providers from inpatient units cited the inability to test on weekends.
Conclusions
Various models of PITC currently exist at MoH facilities in Malawi. Only antenatal and maternity clinics demonstrated high rates of routine opt-out PITC. The low ratio of facility visits to HIV tests suggests missed opportunities for HIV testing. However, the high proportion of patients at TB and antenatal clinics with known HIV status suggests routine PITC is feasible. These results underscore the need to develop clear, standardized PITC policy and protocols, and to address obstacles of limited health commodities, infrastructure, and human resources.
Keywords: provider-initiated testing and counseling, HIV, Malawi, HIV testing and counseling, register
Introduction
In 2014, UNAIDS announced their goal for 90% of people with HIV to know their status by the year 2020. This benchmark is particularly ambitious considering that in 2013 less than half of the 35 million people living with HIV globally were estimated to know their HIV-positive status [1]. To achieve the 90% target, access to and uptake of HIV testing and counseling (HTC) needs to dramatically increase. Provider-initiated testing and counseling (PITC) for HIV is believed to be a high yield strategy for identifying HIV-infected persons [2]. The WHO recommends that countries with generalized HIV epidemics routinely perform HIV testing on all patients presenting for medical care [3]. PITC has been successfully employed in clinical settings such as tuberculosis, antenatal, and sexually transmitted disease clinics with testing rates of 47–99% and HIV prevalence of 18.6–88% [4–9].
Despite the general consensus on the utility of PITC for HIV case finding, several different interpretations of how PITC should be implemented are commonly utilized (Figure 1). Symptom-based screening refers to a process where providers identify and offer testing to patients with a clinical presentation suggestive of HIV. Routine opt-in testing occurs when providers ask patients if they would like to be tested, regardless of their presenting symptoms. Routine opt-out testing (ROOT) occurs when all patients reporting to a health facility are tested for HIV unless they specifically decline testing.
Figure 1.
In Malawi, where the prevalence of HIV in adults is 10.8% [10], the Ministry of Health (MoH) recommends routine PITC, but does not specify which specific approach should be used to offer HIV testing [11]. There is a paucity of data about the current implementation of PITC in non-research settings [12]. As such, the objective of this assessment was to describe both how PITC is currently being implemented in MoH facilities in Malawi, as well as barriers to successful implementation.
Methods
Study Setting
The assessment was conducted at 12 health care facilities in central Malawi (six health centers, six hospitals) with a combined catchment area population of 904,000 [13]. Convenience sampling was used to guide site selection within an existing HIV community-based program [14,15]. Each of the facilities included in this assessment had at least one dedicated space for HTC.
HIV Testing Policy and Procedures
HIV testing is conducted in accordance with policy outlined in the National Guidelines for HIV Testing and Counseling [16]. Counselors are required to have completed at minimum a three-week standardized national training in HTC. Lay and volunteer counselors are permitted, as long as they have completed the required training. Testing is done via antibody-based rapid tests. In regards to PITC, the guidelines indicate that the “provider recommends test as standard practice for anyone coming to this clinic”, but guidance is not given on how this should be practically implemented or how the test should be recommended.
Assessment of PITC Practices
From June–July 2014, a structured survey was administered verbally to 71 providers of HIV testing and counseling. All respondents conducted HTC as part of their core responsibilities. Nurses were most frequently interviewed (35), followed by health surveillance assistants (14), HIV counselors (7), medical assistants (6), and clinical officers (5). Four respondents were in other cadres. The survey was designed to assess whether referral for HIV testing and counseling is symptom-based or routine, and if routine, is presented as an opt-in or opt-out service according to pre-defined standardized definitions (Figure 1). Providers were asked about their use of a PITC register, defined as any tool that recorded all patient encounters and included a field for patient HIV status. Finally, the survey assessed provider opinions of barriers to routinely offering HIV testing to all patients.
Facility Attendance and HIV Testing
Routinely collected data was abstracted from the Malawi Health Management Information System and MoH HIV Unit quarterly reports for January through December of 2014 [17–20]. Data from these reports was used to calculate total health center attendance, the ratio of HIV tests conducted compared to the total attendance, and the percentage of individuals tested for HIV in antenatal and sexually transmitted infection clinics. HIV prevalence estimates for each site were collected from 2014 MoH estimates, and catchment area population estimates were abstracted from government data. Data describing testing coverage at tuberculosis clinic was abstracted from tuberculosis treatment registers maintained by the MoH.
Statistical Analysis
Data was aggregated into a Microsoft Excel® database and imported into Stata® SE (version 14.0; StataCorp, College Station, TX) for analysis. Continuous variables were analyzed using two-tailed student’s t-tests. Odds ratios (OR) with 95% confidence intervals (95% CI) and robust standard errors were estimated using generalized estimating equations to account for correlation between observations at the same site. The study protocol was approved by the institutional review boards of the Malawi National Health Science Research Committee and the Baylor College of Medicine in Houston, TX in the United States of America.
Results
Facility characteristics
118 departments at 12 health care facilities were surveyed. Most facilities, and all hospitals, were in rural settings (Table 1). Estimated HIV prevalence was higher at health centers than at hospitals (8.8% vs 4.5%, p=0.037). The median number of HIV tests done per site in 2014 was 8,343 (IQR 4,279–11,168).
Table 1.
Characteristics of facilities surveyed
Total (N = 12) |
Health center (N = 6) |
Hospital (N = 6) |
|
---|---|---|---|
Facility setting—n (%) | |||
Urban | 3 | 3 | 0 |
Rural | 9 | 3 | 6 |
Catchment area population in thousands—median (IQR) |
57 (41–108) | 81 (31–121) | 54 (48–110) |
Catchment area estimated % HIV prevalence—median (IQR) |
6.4 (4.5–9.6) | 8.8 (5.3–10.4) | 4.5 (2.2–8.1) |
HIV tests done in 2014— median (IQR) |
8343 (4279– 11168) |
6225 (3512– 11940) |
9553 (5322– 10396) |
PITC model utilized
Variable models of PITC were reported across departments (Table 2). Symptom-based PITC was most commonly reported. Routine opt-out PITC was reported primarily at antenatal clinics (11/12) and maternity wards (8/12). Use of a PITC register varied significantly by department type and was associated with ROOT implementation (OR=11.2, 95%CI 3.7–33.9).
Table 2.
Reported provider initiated testing and counseling (PITC) model and use of PITC register according to department type
Type of PITC reported | ||||
---|---|---|---|---|
Department type (N) | Routine opt-out n (%) |
Routine opt-in n (%) |
Symptom- based n (%) |
PITC Register in use n (%) |
TB Clinic (12) | 6 (50) | 5 (42) | 1 (8) | 12 (100) |
Antenatal Clinic (12) | 11 (92) | 1 (8) | 0 (0) | 12 (100) |
Maternity Ward (12) | 8 (66) | 4 (33) | 0 (0) | 12 (100) |
Family Planning Clinic (11) | 1 (9) | 7 (64) | 3 (27) | 8 (73) |
STI Clinic (6) | 3 (50) | 2 (33) | 1 (17) | 6 (100) |
Outpatient Department (12) | 0 (0) | 1 (8) | 11 (92) | 0 (0) |
Under-5 Clinic (12) | 2 (17) | 1 (8) | 9 (75) | 5 (42) |
Malnutrition Clinic (10) | 8 (80) | 1 (10) | 1 (10) | 5 (50) |
Immunization Clinic (12) | 2 (17) | 2 (17) | 8 (67) | 4 (33) |
Adult Inpatient Ward (10) | 0 (0) | 2 (20) | 8 (80) | 1 (10) |
Pediatric Inpatient Ward (9) | 1 (11) | 1 (11) | 7 (78) | 2 (22) |
Total (118) | 42 (36) | 27 (23) | 49 (42) | 67 (57) |
Testing Coverage
Excluding two sites because of missing data, there were 1,063,526 patient visits in 2014 at the ten remaining facilities and 71,372 recorded HIV tests during this period, representing approximately 1 HIV test for every 15 clinic visits. Subgroup analysis demonstrated that HIV status was ascertained (i.e. HIV status was determined and those with unknown status were tested) in 94.3% (5,293/5,615) of patients at TB clinic, 92.6% (30,675/33,142) of patients at ANC clinic, and 49.4% (6,871/13,914) of patients at STI clinic. Data describing the HIV status of patients is not routinely recorded in other departments and was not available.
Barriers to Testing
Providers most commonly cited test kit shortages (71/71 providers), inadequate physical space (58/71), and inadequate number of HIV counselors (32/71) as challenges in PITC implementation. Providers from inpatient units cited the inability to perform HIV tests on weekends (8/16) as the largest impediment to PITC. Providers reported that the average length of HIV testing and counseling was 40 minutes and the average length of time to receive HIV results was 15 minutes, totaling an average of 55 minutes for patients to receive their results.
Discussion
Improving HIV case finding in high burden countries has profound potential benefits both for individual patients and society at large. WHO, UNAIDS, PEPFAR, and national MoH are placing increased emphasis on early HIV case detection, as mounting evidence has demonstrated that patients who are initiated on antiretroviral therapy early have fewer opportunistic infections, reduced morbidity from non-AIDS-related conditions, reduced risk of transmission, and improved survival [21–25]. Public health benefits of antiretroviral therapy—namely population-level reduction in risk of HIV acquisition—are most pronounced at higher levels of coverage [26]. Based on this evidence, Malawi has expanded eligibility for antiretroviral therapy [11] with potential plans for universal treatment in the coming years. Timely case finding is a clear prerequisite to realizing these benefits of early treatment and PITC is one effective approach to improve case finding.
Previous studies have detailed discrepant coverage rates after implementation of PITC, [27,28] however this study is the first we are aware of that documents variability of the specific interpretation of PITC in different health care settings. Understanding how PITC is implemented is critical as patient satisfaction and rates of testing uptake are strongly associated with the specific approach employed [29–34]. This evaluation demonstrates that variable interpretations of PITC have been implemented at the sample facilities in Malawi with ROOT adopted only in select departments, namely antenatal clinic and maternity ward.
That symptom-based PITC was most commonly reported is troubling. By targeting patients with clinical sequelae secondary to advanced disease, this testing modality only identifies those late in their disease course when mortality is high and the benefits of ART are attenuated [25]. Early initiation of ART in asymptomatic HIV-infected patients is associated with decreased all-cause mortality, however patients at this stage are missed with a symptom-based approach [25, 29].
ROOT offers an approach to maximize the benefits of ART by allowing early linkage to care for asymptomatic HIV-infected patients. Implementation of ROOT at ANC is associated with increased rates of testing coverage, higher numbers of HIV diagnoses, and greater retention across the antenatal care cascade [7]. Higher patient satisfaction, testing uptake, and number of tests done per counselor are all associated with ROOT compared to voluntary or symptom-based testing across various geographic and service delivery settings in sub-Saharan Africa [29–34]. In the present evaluation, an estimated greater than 90% of patient visits did not involve an HIV test. Adoption of ROOT across all health facility departments would likely have led to fewer missed opportunities for the diagnosis and treatment of HIV.
There are a number of potential barriers to optimal implementation of PITC in Malawi. First, the availability of a PITC register varied significantly by department with only 57% of surveyed facilities using a register to track HIV testing. Providers most commonly cited a shortage of test kits, which was also identified as a barrier in evaluations of PITC in in Uganda [35]. Providers also mentioned inadequate numbers of HIV counselors, limited physical space, lengthy counseling procedures, and the inability to perform HIV tests on weekends as impediments to routine PITC. Of note, while all facilities had at least one dedicated space for HTC, 82% of respondents reported lack of adequate physical space as a barrier to routine HIV testing. This finding suggests that one dedicated space for HTC is inadequate for the number of patients that require testing at the surveyed facilities. Expanding the available infrastructure for HTC will be critical in increasing HTC capacity and must be patient-centered in design—proximal to service delivery points, private, and non-stigmatizing. Overall, our results align with other studies reporting high patient volumes and limited health care staff are barriers to effective PITC implementation [36–38]. Our findings add to this literature by suggesting that wide-scale adoption of routine opt-out PITC will require a reliable supply of test kits, physical space for testing and counseling, streamlined procedures for pre- and post-test counseling, and a skilled cadre of dedicated HIV counselors.
Based on these baseline results, our program has been working with the Malawi MoH and other partners to address these requirements with improvements in supply chain management and distribution of test kits, improvements in physical infrastructure for testing combined with community based testing strategies, pilot testing of novel methods of pre-and post-test counseling using multimedia flipcharts and video, as well as development of a dedicated cadre of HIV counselors known as HIV Diagnostic Assistants (HDA). The framework for the HDA cadre was largely inspired by successful demonstration by our program and others that lay counselors can greatly expand HIV testing coverage [14,15, 39–41]. Most importantly, we are helping develop clear policy on how PITC should be implemented. Designing registers that clearly capture the HIV status of every health care facility attendee is a simple first step for ROOT implementation. We are piloting such registers at all of the facilities included in this baseline assessment. While some have argued that routine opt-out PITC can be an invasion of patient autonomy [42], the benefits of increased early diagnosis and referral into care and treatment are legion [21–25]. Further, a number of surveys have suggested that patients seeking health care may, in fact, favor making HIV testing a routine part of medical care as it helps to normalize and decrease the associated stigma [43–47].
There are several limitations to this evaluation. Our data sources for facility attendance did not indicate how many unique visits occurred, nor how many patients were already in HIV care and thus ineligible for testing. Therefore, our ratio of 1 HIV test to 15 facility visits is not an ideal proxy for testing coverage and underestimates this measure. Further, patients with a previous HIV-positive diagnosis on antiretroviral therapy who do not require testing contribute a comparatively large share of facility visits due to their regular visits to ART clinic. Though this ratio may therefore overestimate the gap in testing coverage, the magnitude of the ratio strongly suggests numerous missed opportunities and warrants discussion. Moreover, despite the diversity in size and patient population treated, our sample was not randomly collected and may not adequately represent the current state of PITC in facilities across Malawi. Finally, the use of a structured survey instead of direct observation introduces the possibility of response bias.
Conclusions
Various models of PITC currently exist at MoH facilities in Malawi. Only antenatal clinics and maternity clinics demonstrated high rates of the routine opt-out testing (ROOT) form of PITC as recommended by the WHO. The low ratio of facility visits that included an HIV test suggest missed opportunities for HIV testing. However, the high proportion of patients at TB and antenatal clinics with known HIV status suggest that routine testing is feasible. These results emphasize the need to develop clear, standardized PITC policy and protocols and to address the obstacles of limited health commodities, infrastructures, and human resources.
Acknowledgments
We thank the Malawi MoH staff that participated and assisted with this assessment. We are grateful to Dr. Elaine Abrams for critical review. This study was supported by the United States Agency for International Development (USAID) Cooperative Agreement number 674-A-00-10- 00093-00. MHK was supported by the Fogarty International Center of the National Institutes of Health under award number K01 TW009644. RF was supported by NIH Research Training Grant # R25 TW009340 funded by the Fogarty International Center. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Footnotes
POTENTIAL CONFLICTS OF INTEREST: The authors have no potential conflicts of interest.
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