Abstract
In 2008, HIV rapid testing (HIV RT) was only minimally used in the Caribbean region. Collaboration with countries and international partners since then has resulted in greater availability and use of HIV RT services. Surveys were conducted in 2012 and 2014 among 11 selected Caribbean countries to inform stakeholders of progress made since 2008 and to identify strategies to further improve access and uptake of high-quality HIV RT in community- and facility-based settings in support of the UNAIDS 90-90-90 targets. Key accomplishments during this period include (1) presence of in-country national HIV RT algorithms, (2) use of the dried tube specimen (DTS) as an external quality assessment (EQA) program, (3) use of standardized logbooks for data collection and monitoring, and (4) use of oral fluid for HIV RT, particularly for key population surveys. Although progress has been made since 2008 to increase access and improve the quality of HIV RT among countries in the Caribbean, some work remains to be done. This includes the development of new policies and implementation of existing ones, task shifting, quality and access to testing, testing strategies, and integration of HIV RT into HIV Testing Services.
Introduction
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Over 70% of the total number of people living with HIV/AIDS are in developing countries. 4 Despite significant scale-up of HIV testing services (HTS), recent UNAIDS data show that 55% of HIV-infected persons in developing countries are unaware of their status. 5 At the current rate, it will not be possible to reach the proposed UNAIDS 90% diagnostic target by 2020. This underscores the need to increase HIV testing uptake, expand testing, and ensure improved antiretroviral treatment coverage to meet these targets.
Recent changes in the global HIV and AIDS response emphasize early diagnosis and immediate initiation of antiretroviral therapy (ART). Data from the recent Strategic Timing of Antiretroviral Therapy (START) trial demonstrate the benefits of initiating ART in HIV-positive adults when CD4 cell counts are above 500 cells/mm3. 6 In October 2015, the WHO revised its treatment guidelines recommending immediate initiation of ART for all individuals living with HIV, irrespective of age and CD4 cell counts. 7 To meet these guidelines, testing needs to be accessible and results must be accurate, as in some instances there may not be another opportunity for retesting before initiating ART as recommended by WHO. 8
The Caribbean region is made up of an archipelago of developing island nations, characterized by interdependency, population mobility, geographical proximity, and cultural similarities. As a result of this, countries in the region face similar health system challenges. The HIV prevalence among countries in the Caribbean is generally estimated to be 1.10%. 9 Specific country demographic data are summarized in Table 1. 10
PLHIV, people living with HIV.
In the past, laboratory services to support HIV diagnosis in some Caribbean countries faced multiple challenges. This included lack of testing policies, approved algorithms, quality assurance systems, supply chain management, and training/human capacity. 11 For example, Trinidad and Tobago only affected policy change and full implementation of same-visit HIV testing and reporting of results between 2006 and 2007. 12 In addition, despite evaluation of HIV rapid test kits in Jamaica in 2000, 13 there were still reported cases of late stage disease diagnosis in 2010, partly due to limited access to testing services. 14 Data from other Caribbean countries show similar trends. 11 Point of care (POC) HIV diagnosis as recommended by WHO 15 was not well understood and essentially not used in the majority of these countries.
Since 2008, multiple regional efforts coordinated by governments and international partners have supported countries in strengthening laboratory services and systems for improved access to and quality of HIV POC testing. In January 2012, a survey was conducted among 11 countries 10 in the region to (1) provide a situational analysis of HIV RT and (2) identify strategies and make recommendations for expanding access to and coverage of high-quality HIV RT in community- and facility-based settings. Results from the survey were shared during a joint CDC/PEPFAR and PAHO/WHO meeting of Latin America and Caribbean countries in Panama in April 2012.
Action plans were created, and technical assistance was provided to countries to address gaps identified in the survey. In August 2014, the same survey was conducted among the same countries. The aim of the survey was to identify progress in addressing gaps identified in the earlier survey and to make further recommendations for improvement.
This article is an analysis of the current use of HIV RT in the Caribbean region following progressive program implementation. It also offers recommendations to ensure improved access and uptake of quality HIV RT to meet the UNAIDS treatment targets.
Methodology
Survey region and approach
Two surveys using the same questionnaire were conducted. The first survey was conducted in January 2012 and the second one in August 2014. The surveys targeted 11 Caribbean countries (Antigua and Barbuda, Bahamas, Barbados, Dominica, Grenada, Jamaica, St Kitts and Nevis, St Lucia, St Vincent and the Grenadines, Suriname, and Trinidad and Tobago). The questionnaires were designed based on a literature review of norms, expectations, and practices in the use of HIV RT in the region. Table 1 summarizes the questions asked in the survey. Laboratory managers and directors were the primary recipients of the survey questionnaires.
Data collected from the survey were entered and analyzed using Microsoft Excel (Microsoft Corporation, Redmond, WA). Frequency distribution, including proportions, percentages, and tabulations, was used to describe the data. The data sets were compared to identify trends and improvements over the survey periods.
Results
Tables 2 and 3 summarize and compare the findings. Results of both surveys showed that 8 of the 11 countries surveyed reported having policies for HIV RT (Table 2). All countries reported having an approved national HIV RT algorithm and were using HIV RT at least at the central or national reference laboratory (Table 2). In the 2014 survey, four countries reported using a serial testing algorithm compared to two in 2012 (Table 2). Use of standardized HIV testing logbooks also showed improvements over the previous survey. In 2012, seven countries reported having logbooks in use, whereas all 11 countries reported its availability and use in 2014 (Table 2). Results for dried tube specimen (DTS) proficiency testing and use of oral fluid (OF) are shown in Table 2 as well. Same day reporting of positive HIV RT results also showed improvement: eight countries reported positive RT results on the same day of testing in 2014, compared to six in 2012 (Table 2). The number of countries reporting using HIV RT in various HTS settings showed a general improvement from 2012 survey levels (Table 3). Similar improvements were seen in approved HIV RT locations and task shifting over the 2-year period (Table 3).
DTS, dried tube specimen; EQA, external quality assessment; HIV RT, HIV rapid testing.
ANC, antenatal care; HTC, HIV testing and counseling; PITC, provider-initiated testing and counseling; PMTCT, prevention of mother to child transmission; VCT, voluntary counseling and testing.
Discussion
Data from the 2012 and 2014 surveys show that there have been improvements in addressing issues associated with HIV RT rollout and integration into existing HTS among countries in the region compared to the situation described in 2008. 11 Some achievements, challenges, and recommendations are discussed below.
Policy issues and task shifting
Although 8 of the 11 countries that participated in the survey had HIV RT policies in place (Table 2), it is not clear if these policies are being implemented or if they adequately address current recommendations for scaling up HIV RT. 16,17 One example of these recommendations is task shifting that allows nonlaboratory professionals, including doctors, nurses, and lay counselors, to perform HIV RT. 17 Although the second survey conducted in 2014 showed more countries are authorizing nonlaboratory professionals to perform RT compared to 2012 (Table 3), it appears there is still a need for dialogue on policy change in favor of task shifting, especially with countries that are not using this approach. Enhancing access to HIV RT requires rolling it out to nonlaboratory settings such as community-based and hot spot locations where key populations congregate. This approach requires task shifting, which allows well-trained lay persons to perform RT in an environment where there is a shortage of trained laboratory staff. 18,19 The task-shifting approach when adequately designed has been shown to be an effective strategy to increase HIV testing uptake, meet prevention combination targets, and resolve the shortage of laboratory staff for HIV RT needs. 20,21 For example, a baseline survey conducted in Zambia reports that more than 40% of HIV testing at the district voluntary counseling and testing sites was done by trained lay counselors and this led to marked improvement in access to diagnosis and treatment. 21 Follow-up review of existing policies in the Caribbean region to determine how they address WHO guidelines for scaling up of HIV RT, including task shifting, will be critical to expansion and testing uptake efforts. 15 HIV RT is easy to perform; however, studies have shown that the interpretation of its results is sometimes subjective. 22 To ensure quality testing and consistency as nonlaboratorians become more involved in the exercise, countries may benefit by developing and approving training and certification packages customized to their needs.
Confirmation of positive POC test results with enzyme immunoassay
In 2008, HIV POC HIV diagnosis was not well understood and essentially not used in the majority of countries in the region. 11 The 2014 survey data show an increase in the number of countries (from six to eight) using HIV POC testing and reporting positive results on the same day of testing (Table 2). Although this is an improvement, three countries are withholding positive RT results pending confirmation by EIA or other confirmatory testing, which may result in increased turnaround time for final results. Several comparative studies on HIV RT, including ones in which nonlaboratorians were used as testers, have shown high concordance rates between the test performed at the community level using HIV RT and the confirmatory testing done at the national or reference laboratories using EIA. 23,24 Studies have shown that because of limited access to HTS and delays in the release of test results, many people either do not know their HIV status or, if tested, do not return for their test results. 25,26 Based on the above challenges, it is suggested that Caribbean countries select and validate test kits in-country to finalize the selection of appropriate tests and to develop suitable testing algorithms and training materials for the local context. RT kits with a minimum sensitivity of 99% and specificity of 98% are recommended for use in testing and release of concordant results at the community level without further confirmation at the central or national laboratory. 15,27 It is important that this approach be captured and well articulated in the in-country HIV RT policy document to ensure compliance. To further avoid misdiagnosis that might have occurred and to minimize placing HIV-negative persons on ART, the WHO has recommended retesting and confirmation of all persons diagnosed HIV positive before commencement of ART. 8 Countries in the Caribbean should also consider this recommendation.
HIV testing strategies and algorithms
The World Health Organization (WHO) recommends a serial testing strategy for countries with low HIV prevalence. 15 Although the number of countries using serial testing increased from two to four in 2014, seven countries are still using parallel testing. This strategy is considered less cost effective since all client samples are tested by two tests concurrently. The Caribbean region has an average HIV prevalence of 1%. 9 This is considered low prevalence; hence, more countries should consider switching from a parallel to serial testing strategy in keeping with WHO recommendations. 15 The use of a parallel testing strategy is recommended, however, in emergency situations when an urgent conclusive result is needed and may include (1) pregnant women presenting in labor with unknown HIV status at prenatal clinics, (2) sexual violence, (3) occupational exposure, and (4) during HIV testing among discordant couples. 15
Use of standardized logbooks
Good record keeping is important to monitor the performance of testing sites, personnel, and the validity of testing algorithms through the collection and analysis of routine HIV testing data. To facilitate data collection and analysis, WHO 28 and Parekh et al. 29 recommend that standardized paper-based logbooks for HIV testing sites be used as ongoing quality monitoring tools, particularly in resource-limited settings. The 2014 survey showed that all 11 countries were using the standardized paper-based logbooks for their HIV testing activities. This is a tremendous improvement in HIV RT data collection from 2008. Using electronic laboratory information systems has been challenging in most resource-limited settings, including the Caribbean region, because of the cost and sophistication of the technology. Simple paper-based systems such as the HIV standardized testing logbooks have been shown to be well adapted in these settings. 29 This tool could be helpful in collecting and analyzing data needed to answer some unresolved programmatic questions. For example, it has been difficult to clearly characterize the HIV epidemic in the Caribbean region and to map the locations or hotspots of key populations because of a lack of data. This could be improved by using simple paper-based laboratory data collection tools such as the HIV logbooks. The absence of such information affects key decision-making as well as the design and implementation of HIV prevention intervention programs. Proper collection and analysis and use of HTS site data could fill this programmatic gap.
Participation in external quality assessment programs
The implementation of external quality assessment (EQA) activities to monitor the quality of HIV RT is key to ensuring that all nonconformances, logistics, and operational challenges are identified and corrected as they occur. The rollout of these activities has been challenging in most resource-limited settings because of the cost and complexities associated with the procurement, shipment, and delivery of panels for EQA programs. 30 In a majority of developing countries, panels for EQA schemes are commercially acquired through international proficiency testing providers. This approach incurs additional cost for transport, maintaining cold chain storage, custom clearance, repackaging, and temporary storage at the national reference laboratories before distribution. To alleviate these challenges, a more user-friendly technology known as DTS that is suitable for resource-limited countries has been developed and validated. 31 The DTS panels are very easy to prepare in-country. They are stable at room temperature and therefore do not require special cold chain storage conditions. This technology is currently being used as EQA panels to monitor the quality of HIV RT in several developing countries. 31,32
Following deficiencies identified in 2008 regarding the participation in HIV RT EQA programs, 11 staff from all 11 countries surveyed were trained by the CDC/PEPFAR program and in-country capacity strengthened to support the integration of DTS into HTS activities as they were being scaled up (Table 3). Survey data from 2014 showed that 8 of the 11 of countries reported using DTS either as an internal quality control material at the national reference laboratory or have integrated it into an EQA program for their community HTS activities (Table 2). More efforts are needed to encourage the use of DTS in the three remaining countries. Neither surveys asked about in-country engagement of private laboratories in the rollout of HIV RT and their participation in HIV RT EQA programs. It is recommended that where such laboratories are involved, their participation in EQA be supported and encouraged to ensure the generation of quality HIV test results at all levels of the health system.
The use of OF POC HIV RT
In general, the use of OF POC HIV RT has been shown to be well accepted and beneficial during epidemiologic surveys and special studies, including key population surveys. 33,34 The performance of the OF POC test in different settings is comparable to that of blood-based RT. 34,35 Data from the 2014 survey indicate a decline in the use of OF diagnostic tests (Table 2). This corresponds to a decline in the number of key population surveillance studies conducted between 2012 and 2014, in which OF technologies were used. Such studies among key populations have shown the feasibility of using OF technology to access these hard to reach groups. Because of the importance of these survey data and the complexities of conducting surveys using blood-based tests, more effort should be made to support the use OF HIV RT, particularly during surveys, as such results will help characterize the epidemic, especially among key populations.
Integration of HIV RT into HTS settings
A recent UNAIDS report shows that 55% of HIV-infected persons in developing countries are unaware of their status. 5 This is partly due to limited access to centralized testing venues, high levels of stigma and discrimination, and perceived lack of confidentiality at testing sites. 3 To alleviate this, there has been a rapid scale-up of HTS through different channels such as client-initiated testing and counseling (CITC), and provider-initiated testing and counseling (PITC). 36 This could be delivered through health facilities, community-based settings, outreach testing, and the use of mobile testing units. Findings from the current survey show progress in the integration of HIV RT into existing HTS units at various levels (Table 2). This is commendable and further confirms current regional advanced effort in the complete elimination of mother-to-child transmission of HIV. 37 Moving forward, more emphasis should be placed on ensuring effective integration of these services. For example, to increase uptake of HTS, CITC services should be combined with PITC, community outreach testing, and mobile testing units, in line with WHO/UNAIDS recommendations. 36 Outlets for referral and follow-up of people who are diagnosed HIV-positive should be an integral part of this initiative. Finally, systems to evaluate the implementation of these approaches should be designed and implemented to ensure effective linkages and integration of current efforts into other health systems support activities.
Key Recommendations
(a) A review of existing HIV RT policies and regulations in the Caribbean countries is needed to ensure that they adequately address the requirements of POC testing.
(b) Since most countries in the region are considered low prevalence, countries should consider adopting a serial algorithm for routine testing, while using parallel testing for emergency situations.
(c) Adequate training and participation in DTS-based EQA programs to monitor the accuracy of HIV RT should be implemented for both public and private laboratories and be captured in HIV testing policy documents.
(d) Promoting uptake of the standardized HIV testing logbook will help identify issues and address them in a timely manner.
(e) The use of innovative tools, such as the HIV RT Quality Improvement Initiative (HIVRTQII) and the Stepwise Process for Improving HIV Rapid Testing (SPI-RT) checklist, can help site supervisors identify systemic problems and inform program managers for decision-making.
(f) Integration of HIV RT into HTS activities should be strengthened to ensure improved access, quick diagnosis, linkages, and referral for care and treatment.
Conclusion
Improving access to quality HIV testing and its integration into HTS is critical to ensuring that individuals being tested receive appropriate care. Collaborative efforts in the region have led to an increase in awareness of the efficacy, usefulness, and reliability of HIV RT. This has led to the scale-up of HIV RT across the Caribbean Region, where lack of access to testing has been a significant barrier. More efforts are needed to ensure consistent quality during program expansion and sustainability of current activities. To achieve this, national governments should take the lead in rolling out POC HIV RT. This approach may include the development and implementation of detailed national policies on HIV RT with clear linkages to prevention, treatment, care, and guidance on access for key populations.
Footnotes
Acknowledgments
This research has been supported by the President's Emergency Plan for AIDS Relief (PEPFAR) through the Centers for Disease Control and Prevention (CDC). The authors would also like to acknowledge staff from various Ministries of Health in the region who participated in this survey.
Disclaimer
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry.
Author Disclosure Statement
No competing financial interests exist.
