Background
According to WHO the number of people accessing antiretroviral therapy (ART) has increased rapidly since 2005 from 2.2 to an estimated 21.7 million people globally and Sub-Saharan Africa achieved the greatest increase in ART coverage by reaching 9 million people, to about 37% coverage [
1‐
3]. Services for ART in Zambia have expanded rapidly in recent years such that at the end of 2018, it was estimated that more than 900,000 Human Immunodeficiency Virus (HIV) infected adults and children were currently receiving lifesaving Antiretroviral (ARVs) for HIV treatment [
4]. The increase in ART access has triggered the renewed interest in community health workers and community health Assistants, as they may play an important role in scaling-up antiretroviral treatment for HIV/AIDS by taking over a number of tasks from the health care workers.
The Ministry of Health (MoH) of the Republic of Zambia (GRZ) is committed to achieving the 90–90-90 United Nations Programme on HIV/AIDS
(UNAIDS) targets and is aware that the conventional human resources and physical infrastructure currently are not adequate to accommodate national scale up of ART. Hence, they have adapted the Differentiated service delivery (DSD) which is a client-centered approach that simplifies and adapts HIV services across the cascade in order to reflect the preference and expectations of various groups of people living with HIV (PLHIV) while also reducing unnecessary burdens on the health system. Community ART models are being implemented in Zambia to allow patients to administer the ARV from the community with only one person going to collect the drugs for others [
4‐
6].
The Community-based ART Model is a delivery model for antiretroviral therapy in which ART care is delivered at a community-based site. CAG model emanated from Mozambique in 2012 and this was prompted by the country’s high attrition rates, limited number of ART clinics, an influx of patients and longer distances covered to a health facility. This model constituted a group of six people and every month a different group representative was chosen and travelled to the clinic to collect drug at ART clinic on behalf of the other group members. The drugs were administered in the community and each member only visited the clinic twice in a year unless if they had complications. Hence the focus was on drug refill, adherence and support groups [
7].
The piloting of this model in Mozambique demonstrated that it had benefits on the patient, community and clinic. Hence it then spread to other countries such as Zambia, Zimbabwe, Malawi Uganda and South Africa and it’s been implemented in most countries within the sub-Saharan region. [
8‐
11]. The model reduced the financial and time costs associated with frequent clinic visits, promoted community-based peer support, improved adherence to treatment [
12,
13]. In addition, this package minimized clinic contact for clinically stable ART patients and redirected the limited resources towards managing unstable patients with complex clinical problems [
14].
However, in Zambia, studies have shown that community health workers (CHW) programs face additional challenges. These challenges included high turnover, low motivation, inadequate supervision, insufficient compensation or incentives, and low recognition [
15,
16]. These challenges may impede the integration of the community phlebotomy into the models if they are not holistically addressed.
Phlebotomy is the act or practice of drawing blood through venipuncture for the purpose of treatment and diagnosis and is a link between the laboratory and patient [
17,
18]. Phlebotomists in Africa are mainly responsible for collecting and properly packaging specimens such as blood, sputum, urine, other body fluids, tissues, etc. In addition, they are also responsible for ensuring that acceptance criteria for specimen is followed to the latter prior to testing and analysis and are often the only laboratory professionals who have direct contact with a patient during a clinical visit ([
19‐
21]. In many countries in Europe, phlebotomy is performed by doctors, nurses, laboratory staff and other healthcare professionals [
22‐
24]. Phlebotomy has been noted to have potential risks and has expose health workers and patients to bloodborne pathogens, such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and viral haemorrhagic fevers and dengue [
25]. Blood samples collected poorly or wrongly usually yields inaccurate results and misleads the clinicians, and in most cases, patients are either misdiagnosed or inconvenienced by repeat the testing [
26‐
29].
In Zambia collection of blood is done by the Medical Officers, Lay Counsellors, Nurses, Clinicians and Laboratory staffs and its used for testing and donation. This also shows that different cadres are capable of collecting bloods from either the community or bedside and guarantee a quality sample provided the cadre of interest is properly trained and certified. For instance, MoH Zambia has mandated the community health workers to collection specimens for EID tests and prepare the samples and store it for collection. [
29,
30].
Tenofovir Alafenamide (TAF) has been recommended in the Zambia Consolidated Treatment Guidelines for Prevention and Treatment of HIV as the alternative to Tenofovir Disoproxil Fumarate (TDF) since it has improved kidney and bone safety but similar efficacy when compared to TDF [
31]. The guidelines now recommend the combination of Tenofovir disoproxil fumarate, Lamivudine and Dolutegravir which is commonly referred to TLD whereas the Tenofovir alafenamide, Emtricitabine and Dolutegravir is referred to as TafED for patients on first line regimen. The guidelines recommend the use of viral loads to guide decision in switching from NNRTI to DTG-based first line ART regimens and now requires that all patients on NNRTI be switched to DTG based regimen. But the national viral load testing coverage stands at 37% and and falls short of meeting the global UNAIDS and MoH 90–90-90 goals deadline by 2020. This implies that about majority of patients (67%) on NNRTI based regimen do not have the viral load result and these patients cannot be switched to stronger and better drugs unless this test is done. In addition, more consented efforts are needed to improve the viral load testing coverage, and enable MoH switch patients to newer and better drugs [
32,
33].
However, the implementation of differentiated service delivery models in Zambia is decentralized half way (focus on drug refill), phlebotomy services are completely neglected in the model of delivery system [
7]. Hence, opportunity costs for blood draws are too high. On average, patients must travel long distances to the clinic with high transport costs to have blood draws and may lose an entire day of work productivity (arising from long waiting hours at the clinic). In addition, burnt out health care workers, poor relationships with health workers and clinic congestion can make a clinic environment unpalatable for patients [
9,
10].
The aim of this study was to determine stakeholder’s perceptions on the feasibility of incorporating the collection of blood samples for routine testing into the CAG model in Lusaka, Zambia. This was with the view to improving testing coverage in resource limited areas. The study proposed that the community health workers collect patients’ blood samples during the community monthly meeting and then sends samples for testing to the laboratory. Then only patients whose blood show virological failure, ARV drug toxicity, and intolerance or unresolved and prolonged side effects need to be referred to the facility [
9‐
11].
Discussions
Majority of participants perceived decentralizing the phlebotomy services within the community model as beneficial for the patients, health workers, community and health systems. The general feeling was that this had perceived benefits and all the cadres agreed that it was a progressive idea and would help in health system strengthening. However, the disagreements were on the modalities, such us where (designated localities within the communities) such interventions can be done and how do we ensure the safety of the patient and quality collection of the specimens. Generally speaking, there was consensus amongst the cadres interviewed (patients, CHW, HCW and policy-makers) that the idea was pragmatic and it must be piloted in Zambia.
The findings on perception of decentralizing community phlebotomy within the CAG model were similar to what other studies did in on GAG model even though in those studies the focus was on drug refill and retention rates [
7‐
10,
14,
37]. Decongesting the phlebotomy rooms (clinics) was the most talked about perception by almost all the participants; this was because it had perceived benefits at individual, clinic and community levels. At individual level the patients would spend less time during blood draws, less on transport money and in the process concentrate on other things such as working and improving on businesses. At the clinic level, the work load reduces such that now the clinicians would have enough time to focus on patients who were really sick (unstable). At the community level it helped in reducing stigma. These benefits however, were expected to continue happening when phlebotomy services are incorporated into the CAG model.
However, perceived threats were highlighted in this study. Some of the negative perception included the compromise on the quality of samples collected by community health workers [
38] and this is similar to studies done in POC testing. Most laboratory personnel were concerned on maintaining the sample integrity and ensure that the blood drawn was of good quality and that it should reach the laboratory within the recommended time frame. The other issues that was of great concern was avoiding clerical errors and usage of correct tubes for the correct tests and this was similar to what others have found [
26‐
28]. However, they mentioned that if the sample went beyond the stability time, had a lot of clerical errors and came into a wrong bottle, then that sample would be rejected and patient would be requested to submit a fresh sample. Hence there was need for the laboratory scientist to be proactive and disseminate standard operating procedures, laboratory hand book (summary of tests offered and requirements) and take a lead in training and sensitizing the phlebotomist. Also, refresher trainings must be mandated to phlebotomist and they must be accorded opportunities for exchange training programs.
Despite asserting that the decentralizing the phlebotomy services in the community models, there is need to also profusely consider the acceptability and feasibility of this intervention from the patients, health provider and community’s perspectives. However, it is known from literature that successful implementation and integration of intervention depends on the acceptability of service providers and beneficiaries of the that service [
39,
40]. Some essential elements for interventions’ acceptability are content, context and quality of service and if these elements are met for beneficiaries (patients and community), then they are more likely to adhere to recommendations and to benefit from such interventions [
41,
42]. In addition, from the health providers view (health professionals and researchers), the essential element for acceptability is on delivery of service. If an intervention has poor delivery services then that intervention may not be implemented as planned and consequently may have low acceptability [
43,
44]. This study has demonstrated and highlighted the greater need to conduct acceptability and feasibility studies on integrating phlebotomy services into the CAG model.
Studies in Zambia have shown that the WHO health building block’s specific weaknesses have a cross cutting effect in the health system. For instance, addressing challenges in key areas such as health work force, drug supply, health financing, and information systems does not guarantee success but rather addressing the these challenge with a health systems approach which considers all the six blocks (service delivery, health workforce, health information systems, access to essential medicines, financing, and governance) in applying the solution is what guarantees success. Health systems thinking approach espouses the necessity to use wider approaches in assessing the performance of health system interventions. Hence, it would be prudent for Government through the MoH policy-makers, and its partners to utterly consider system thinking approach when piloting the integration of phlebotomy into the DSD models. Health systems thinking approach will mitigate the perceived barriers and challenges [
45‐
47].
Community sensitization and health education campaigns (for both phlebotomist, health workers and communities) are key in the successful implementation and integration of the phlebotomy services with the community ART programs. A lot needs to be done to educate the community leaders, community and ensure that there is consensus and awareness of this program. The government through MoH needs to come with health promotion programs that would ensure that the community is adequately sensitized and reach levels where they also buy into the idea. Community-based studies have shown that lack of community sensitization, engagements and health education from the starting point leads to low outcomes of health implementation programs and in the process leads to low uptake of health care services [
48‐
50].
Integrating Phlebotomy services into the CAG model has financial implications and implementers of such interventions such as MoH would seriously need to consider the following areas for financial support; supplies, human resources and transportation costs.
Phlebotomy would require that all the materials such as gloves, cooler boxes, collection bottles (red, green and purple bottles), vacutainer holders and needles are readily available at any given time. Such materials are essential to the success of this program. But the great news is that MoH under Medical supplies Limited, is stocking all these materials and distributes such stock across the country upon requests from the local facilities. Hence, they would be need to adjust stock and monthly consumption, as these supplies would be projected to rise.
The other part that has cost implication is that of deploying the community phlebotomist to their respective places. A motivated and incentivized work force is crucial for the successful implementation and smooth running of this intervention. To try and address some of these challenges faced in health service delivery, the Zambian Ministry of Health (MoH) developed the National Community Health Assistant Strategy (MoH, 2010). This strategy has formalized and standardize the role of CHWs in the health system and has creating a health cadre called Community Heath Assistants (CHAs). CHAs undergo a one year’s standardized training programme, employed by government and registered with a general nursing council regulatory body. They are mentored and work under the supervision of nurses in delivering health services on a task-shifting basis. According to this strategy of 2010, the Ministry plans to train about 5000 CHAs by 2020 and by 2016 they were 1403 CHAs working at 789 facilities in every rural district. The CHAs are thus better suited and capable of handling the community phlebotomy because they have more intense training, are recognized by MoH, are enumerated, better supervised and additional training will be easier. It is for the above reasons CHAs have been recommended for the use of for community phlebotomy.
The other piece is that community phlebotomist would be very mobile as they would facilitate in collection of blood within the community and this would require that they have transport costs met from clinic to the community and back. So again, the Government through MoH should consider the use of either motor bikes or bicycles for phlebotomists or other means for specimens for transportation. The mode of transportation must be cost-effective and time sensitive so that it should preserve the sample integrity and must therefore, be reliable.
Hence the community phlebotomist must know exactly what testing bottles are needed for what test and the volume required for each test. For instance, purple is only for CD4 count, FBC and HIV viral load, green is for biochemistry and red is for RPR and hepatitis. The integrity of the specimen is key and of outmost importance [
31]. Failure to maintain the sample integrity would lead to wrong diagnosis and patient mismanagement. However, phlebotomy services would have to be regularly monitored and supervised by the laboratory staff for the purpose of quality assurance and quality control. This supervision would be needed and must be done very often to give confidence to the patients, health care workers and policy-makers.
Among some benefits mentioned in the study on inclusion of the phlebotomy services is that of improving the testing coverage for HIV viral load. Most of the participants especially the heath care workers and policy-makers feel that this would greatly improve in meeting the UN goals of 95% virologically suppressed patients. Most of the remote setting have little to no access to viral load and the inclusion of the lab services would imply that these services would be done elsewhere and improve patient treatment management. And if most patient are virologically suppressed the community would also benefit, in that the rate of transmission would also reduce and eventually reduce the rate of new infection [
31].
Some of the limitations of this study were that it focused on only the CAG model. But the current HIV guideline [
31] prescribes the usage of four community models to improve service delivery. The prescribed models include urban adherence group (UAG), out of facility managed individual, and in facility managed models and CAG. However, this study only focused on CAG and this was a weakness for this study. We hope future studies would look at all the four community models and provide further information to inform policy and add to the body of knowledge. In addition, all the four-model including CAG, only focus on the stable patients and neglect unstable patients and would like to see other studies explore the use of unstable patients in the community models.
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