Piloting an STI POC test involves steps to setup the pilot, processes to manage the pilot and inbuilt measures to monitor and evaluate the pilot. The support of the Ministry of Health is critical to the success of piloting a POC test.

2.1 Establish or revitalise a technical working group

This task requires an understanding of the:

The process of introducing STI POC testing is likely to need the oversight of an interdisciplinary technical working group that includes members with a diverse range of experience in STI control and prevention, health communications and behaviour change, laboratory and essential drugs management, health worker training, monitoring and evaluation, finance and accounting, and procurement and logistics. The members of the technical working group may need to come from a range of different organisations.

Key questions include:

Key Questions Related Questions Why ask the Qs?
Is there an existing working group (e.g. an STI working group at national level) that could be responsible for leading and coordinating the pilot of the POC test? Do you have the requisite skills and experience available to form an interdisciplinary working group?
What is missing?

Who should be involved as core members? As associate members?

How will responsibilities be defined and assigned?

Can regional experts be drawn on to provide advice to the national technical working group?
Ensure that there the working group has sufficient breadth and depth of experience and technical know-how

Key activities in establishing a system of oversight for piloting an STI POC test:

Key sources of information include:

Local

Regional

Documents and materials

2.2 Align the design of the pilot with the policies & legislation

This task requires an understanding of:

STI testing is just one part of a comprehensive STI control strategy. Consequently, it is important that POC tests are integrated into existing PICT responses to STIs. This means that introduction of POC testing should happen with recognition of existing strategy documents, policies, protocols, legislation, guidelines and programs.

During the initial assessment, there should have been a review of the national policy and legislative context to understand the extent to which it will enable - or serve as a barrier to - the introduction of POC testing. For example, if nurses cannot legally prescribe drugs this could prevent the use of POC tests in remote services staffed only by nurses. The technical working group should lead efforts to amend policies or legislation as required. This will need to occur prior to the introduction of the POC test. Similarly, the working group should know about any local requirements for validation and accreditation of a new test.

Legislation regarding testing and treatment of young people

While legislation regarding the legal definition of an adult may vary among different Pacific Island Countries and Territories, the legal definition of an adult is usually between 16 and 18 years; people younger than that and above the age of 12 years are referred to as minors. Many STI testing strategies recommend that POC tests be used to test minors from the age of 15 years as young people are at highest risk of STIs in most places. This means that health workers will need to follow any existing legislation related to testing and treating minors for STIs. Where explicit legislation does not exist, consent to STI testing and treatment would usually be in line with consent to testing and treatment for other health issues.

In general, minors should be able to consent to STI testing and treatment without the consent of a parent or guardian if they are able to understand what they are being tested and treated for. Young people also have the right to confidentiality around testing and treatment except in circumstances where there is explicit legislation that may override that confidentiality e.g. mandatory reporting of sexual abuse. Health workers will need to be aware of any legislation or policies that are in place regarding how to manage young people if they disclose sexual abuse.

Key questions include:

Key Questions Related Questions Why ask the Qs?
Has an initial assessment been conducted? Can you describe why the POC test is needed, where it should be employed, and what difference it will make? Ensure that there is a sound case for introduction of the POC test
Are there aspects of policy, strategy or legislation that impact on POC testing for STIs? Is a broad range of practitioners able to offer STI testing and treatment? Can this be introduced through existing services such as antenatal clinics or other reproductive health services?

Do policies and guidelines support nurses and health workers in a range of health service settings to offer STI (or HIV) testing and treatment?

Are there specific national policies regarding procurement of test kits, related consumables and medications to treat STIs?

Are there any policies or legislation that will need to be amended to enable the introduction of POC testing?
Ensure that POC test piloting does not proceed without first addressing
Is there a need for advocacy before proceeding? Is there political and institutional support?

Do you know how much funding is needed to pilot the test? Are resources available to pilot the test and will resources be available to introduce it on a wider scale?

Whose support do you need? What messages will they listen to? How are these messages best delivered?

Have you gathered credible evidence and made a case for the introduction of a POC test? Is it cost-effective? Are clients informed and supportive? Has this been done in a sensitive, acceptable way?

Does the technical working group have the skills, experience and relationships to undertake advocacy?
Ensure that there is high level support

Key activities to ensure that the introduction of an STI POC test is aligned with national and where appropriate regional and international policies, strategies and legislation include:

Key sources of information include:

Local

Regional

Documents and materials

2.3 Identify stakeholders & establish coordination & governance mechanisms

This task requires an understanding of local:

The technical working group will need to consider the different groups who should be aware of the coming introduction of the STI POC test. The Ministry of Health will need to be informed of the reasons for introducing POC testing and the many implications. The support of political leaders, religious leaders, traditional leaders, managers of health facilities, professional and academic societies, and other stakeholders is important, and may be a necessary step to gaining the support of the community. Once the various stakeholders have been identified, it is important that the working group establishes ways to communicate progress and other information to stakeholders on a regular basis.

Key questions to ask:

Key activities

Key sources of information include:

Local

Regional

2.4 Define the population to be tested & the purpose for testing

This task requires an understanding of local:

The initial assessment will provide the technical working group with an idea of where the introduction of the STI POC test could improve outcomes for patients and for the health system. Based on this information, the technical working group will need to define who will be tested and why.

Key questions to ask:

Key activities

2.5 Decide on how the test will be implemented

This task requires an understanding of local:

Having decided on the population to be tested and the purpose for testing them (screening or diagnostic), decisions will need to be made about how the pilot test will be practically implemented.

Key questions:

An example of a partnership between clinical and non-clinical services

A youth service combines reproductive health services with 'drop-in' recreation activities. Large numbers of young women access the clinic for contraception and large numbers of young men access the service in the evening to use the DVD and pool table. Only some of the young people access HIV testing. The service employs peer educators who provide outreach education including education on STIs and HIV, and two nurses who have had training in reproductive health.

While POC testing could be easily added into routine reproductive health consultations, this will result in only a small number of youth being tested. Alternatively, nurses and peer educators could work together to engage young people to make better use of the existing service. The infrastructure and staff are in place to do this, and clinical and non-clinical staff could do the following to increase testing for STIs:

Increasing STI testing in Vanuatu

Wan Smolbag noted that fertility was very important to local people but few people were being tested for STIs. They developed a program to make people aware that STIs are a major cause of infertility. This led to more requests for STI testing by locals and it also improved the communication between health worker and clients when discussing this sensitive topic.

Key activities

Considering options for integrating POC tests into existing services

Mapping all the facilities and programs and the types of clinical and non-clinical services each provides can illuminate options for piloting an STI POC test. In this example, different providers offer a range of routine reproductive and primary health care services directed at different groups.

Any of these facilities could offer a ready avenue for integrating a new POC test because:

  1. Staff have training in STI and HIV management and often counselling as well
  2. The services are established
  3. A high proportion of women use the services including some women at risk of STIs.

The training needs of personnel would have to be assessed as personnel in different areas and in different facilities could have very different levels of skill and knowledge. For instance, primary health care staff may need additional training in the management of STIs.

While a high proportion of women may access the services listed here, most men would be missed and it is possible that women at highest risk of having an STI would also be missed. If it is important to ensure that these groups have access to testing, strategies will need to be developed to encourage them to attend these facilities (e.g. education and health promotion, opportunistic testing, transportation to facilities, increased opening hours, changing the way the service is delivered with longer opening hours or set days for seeing clients in these groups, provision of incentives to providers or clients etc.). Alternatively, other mechanisms would have to be considered if it was felt that no strategy would adequately overcome the barriers to testing at these facilities for these groups (e.g. set up a new facility specific for these groups, establish an outreach program, conduct mass testing in the community etc.).

2.6 Design a plan for implementing the pilot

This task requires an understanding of:

After selecting the most appropriate way to introduce the POC test into the health system, a formalised plan will need to be designed to ensure that the pilot can be successfully implemented. A project management framework can assist in developing a clear outline or summary that explains what you hope to achieve, how you are going to do it, who will be responsible for each component, and when each component needs to be completed.

Key questions to ask:

Key activities

Key sources of information include:

Local

Regional

Documents and materials

2.7 Develop tools for implementation

This task requires an understanding of:

Specific plans will need to be developed to guide staff in the implementation of the pilot of the STI POC test. Reference has already been made to writing a plan to guide the whole pilot project (Section 2.6), but multiple plans for smaller elements of the project can be written and referred to in the overarching plan. For example, specific plans for implementation should include a procedure manual documenting standard operating procedures and quality management strategies to make sure the test is introduced appropriately and the impact of the pilot can be properly assessed. Plans should detail all aspects of the relevant project element, they should specify milestones and the outcomes expected, as well as the timeframe in which they should be achieved and who is responsible for their completion. Specific project management tools can help ensure the pilot is well governed and runs according to schedule and budget.

Some of the things to consider when implementing the pilot are:

Procedure manual

To further guide staff in the implementation of the pilot of the STI POC test, a procedure manual should be developed. The procedure manual should consist of a number of standard operating procedures (SOPs) covering all essential aspects of the pilot. To ensure that the test is introduced in such a way as to produce consistent and reliable results, one or more of the SOPs should deal with quality assurance of the POC testing.

Standard Operating Procedures (SOPs)

As a general guide, SOPs should:

The list of SOPs that are required for the STI POC pilot will differ from one situation to another. However, in general the SOPs should describe the following:

Who should be offered testing and how often

How to explain the test to clients and how to obtain informed consent for testing

How to take sample(s) for testing

How to label specimens

How to perform the test

How to interpret the test result

How to manage positive & negative test results

Follow up and recall of people with positive test results

Quality assurance of testing

Infection control measures
How to safely dispose of waste

Algorithms for providing treatment

How to manage sexual partners of people with a positive test result

Documentation of clinical management and test results for STI surveillance as per national quidelines

Case management protocols for various possible scenarios such as ectopic pregnancy

Testing for other STIs in addition to the STI/s covered by the POC test

Appropriate referral practices

Procurement of test kits and stock management

For many of the things on this list there will be existing resources that can be adapted e.g. the Oceania Society for Sexual Health and HIV Medicine has published clinical management guidelines for STIs (OSSHM. Recommendations for HIV Medicine and Sexual Health Care in Pacific Small Island Countries and Territories Second Edition. September 2008. osshhm.org/).

Example of an SOP for handwashing procedures

Quality assurance of POC testing

The successful delivery of the POC testing itself depends on a number of factors including the quality of the tests selected for use, the development of the procedure manual and the SOPs that it contains, and effective training of staff. It is also essential to ensure that testing meets and maintains the required standard. This is achieved using quality assurance. The details of a program of quality assurance will vary from situation to situation. However, the main available elements of quality assurance are:

Quality control (QC)

QC is designed to ensure that the tests used perform correctly and consistently from day to day, and to detect any errors in test performance. Tests may not have been manufactured correctly, may have deteriorated in storage or transport, or the testing may not have been performed as specified by the manufacturer. The use of QC helps detect and minimise these problems.

Some POC tests come with built-in internal controls that can alert the person doing the test that the test has not performed as expected. These internal controls are valuable, but their use will not detect all testing problems.

It is also very important to regularly test external QC samples that are of a similar sample type to the patient samples that are usually tested. In countries with lots of resources, such external QC samples are tested daily or even more frequently. This is likely to be difficult in Pacific Island countries and territories but periodic testing of external QC samples is important. All results obtained with external QC samples should be recorded along with the date, the batch or lot number of the test, and the name of the person doing the test. The relevant SOP should define the range of external QC results that are acceptable and the steps to take if the results obtained fall outside this range. The summary of QC results should be periodically reviewed to identify any trends that might warn of developing testing problems.

External quality assessment

External quality assessment schemes (EQAS) for medical testing are often known as quality assurance programs (QAP) or Proficiency Testing. The provider of an EQAS periodically sends identical panels of positive and negative samples to a number of participating testing services for testing. Staff at the testing services do not know the true results of each sample. Participants return their results to the coordinator of the scheme who reports the results. In this way, EQAS monitors the complete testing process from sample preparation to result reporting at one point in time, and the EQAS report allows participants to assess their own test performance and make improvements as required.

EQAS provides information that is complementary to the day-to-day use of external QC, and participation in an appropriate scheme is highly desirable. In cases where a relevant EQAS may not be available, different testing organisations or testing sites should periodically exchange samples so they can compare their results. In cases where sending actual samples for EQAS is too difficult or expensive, it may be possible for photos representing different levels of POC test reactivity to be sent to health facilities for review - this approach assesses the health worker’s ability to read and interpret POC test results but does not assess how they perform the test.

Sample referral

Another way to assure the quality of testing is to send a random subset of samples to a central testing facility for confirmation of the POC test results. The central testing facility can use the same or different tests to confirm the results. This approach, however, may not always be practical e.g. if the sample is capillary blood obtained from a finger prick at the point-of-care.

Batch release of tests

In some situations, each new batch of POC tests is tested at a central location against a panel of samples having known reactivity and the results are compared to pre-defined acceptance criteria. This process is known as batch release and is performed prior to the new batch being used to test patient samples. If the new batch fails to meet the pre-defined criteria, the manufacturer should be informed and the tests may be replaced. Batch release has the benefit of ensuring that the lot-to-lot variability of the POC test is minimised to an acceptable level. However, batch release testing does not detect problems with testing as a result of transport, poor storage or incorrect use of the tests.

Key questions to ask:

Key activities

There is a lot of work involved in preparing a procedure manual and establishing quality assurance processes. It might be helpful for the local Technical Working Group to commit time to working on this together and to consider adapting tools that have already been developed in the Pacific rather than starting from scratch. The following will need to be detailed and explained in the procedure manual:

Key sources of information include:

Regional

Documents and materials

Communication strategy

Earlier identification of stakeholders and advocacy with them will help pave the way for POC test introduction. The next step is to take this communication down to the community level- to the people that you ultimately want to access with POC testing.

There are many specific resources that can guide you in developing a communication strategy. There is one manual that has been specifically developed for the Pacific region. This is highly recommended and listed under the reference tab in this section.

The following steps are similar to the communication strategy development process described in detail in this recommended manual. Please refer to the manual for further information.

Key questions to ask:

Key activities

Key sources of information include:

Documents and materials

Health worker training and supervision

All staff expected to provide POC testing will need to be trained to use the test.

Key questions to ask:

Key activities

Key sources of information include:

Documents and materials

Procurement & logisitics

Procurement, supply and stock management can be challenging for many countries but are essential components of a functioning health system. It is important to develop standard operating procedures that are harmonised with national guidelines and to integrate the supply chain into the existing system.

Key questions include:

Key activities

Key sources of information include:

Local

Regional

Documents and materials

Other standard project management tools

Experience project managers will consider the following aspects of managing the pilot of the STI POC test:

Key sources of information include:

Documents and materials

2.8 Implement, monitor & evaluate pilot

This task requires an understanding of local:

There are several reasons why monitoring and evaluation (M&E) is important for an STI POC test pilot. As well as documenting progress and enabling reporting on activities, M&E can help us to understand:

There are many resources that deal with M&E in more depth than this toolkit. However, the principles of implementing an M&E plan for an STI POC test pilot are the same as for any project:

Key questions

Key activities

There are many resources that deal with the important topic of monitoring and evaluation in more depth than we are able to in this toolkit. Please see Key References in this section for some examples. The idea of thinking about how to monitor and evaluate POC testing might seem a bit daunting. But, it doesn't need to be too complicated. Try and think about the process of developing an M&E plan by working through the following steps:

Key sources of information include:

Local

Regional

Documents and materials

Next: 3.0 Scale Up

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