insights into packaging and labeling for hiv oral self-test kits in kenya preliminary results phase...
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Insights into Packaging and Labeling for HIV Oral Self-Test Kits in Kenya
Preliminary ResultsPhase 1
December 12, 2013
Ministry of Health
This study is funded by 3ie.
Outline of the presentation
1. Study Objectives2. Study design 3. Methods4. Preliminary results
Phase I5. Next steps
page 2
The primary aim of this study was to understand how HIV oral self-test kits should be packaged and labeled in the Kenyan context. – GoK regulations and consideration– Global HIV testing community – Manufacturer recommendations – User preferences – Cost implications
PAGE 3
About the Study
Literature Review & Formative
Data Collection
Formative Data
Analysis
Packaging Pro-Type
Packaging Pre-Test
Analysis of Pre-
Test Results
Final Guidanc
e
Study Design – Overview (1)
page 4
1 2 3
Study Design – Overview (2) Phase 1: Gather insights from stakeholders on what
information the packaging should include Phase 2: Prototype development Phase 3: Test the different packaging options developed
based on the insights from the first phase on the study.Phase 1: Study population
a. Key policy makers and regulatory officers of the GoKb. Oral HIV test kit manufacturersc. Packaging manufacturersd. Potential product distributors, particularly pharmacists
and health care providers e. Potential self-test kit users
page 5
Study Design – Overview (3)
2. Phase 2: Prototype package design– Using insights gained from Phase 1
3. Phase 3: Pre-testing of prototype package1. Potential self-test kit users2. Potential product distributors, particularly pharmacists
and health care providers
page 6
Methods (1)Phase 1: Qualitative interviews with: Relevant GoK regulatory officers (Nairobi) Oral HIV test kit manufacturers (US) Packaging experts, globally and within Kenya Potential users (Siaya and Mombasa)
– General Population– FSW– MSM
Potential distributors (pharmacists, providers and CHWs)
page 7
Methods (2) Phase II: Prototype Development
– PSI/Kenya is working with a design agency to develop a prototype of the self-test packaging, including instructions for use that employ preferred methodologies identified by potential test kit consumers and stakeholders.
– During prototype development, quotes for production of the packaging will be sourced from potential packaging/labeling manufactures to determine cost of prototype.
page 8
Methods (3)
Phase III: Pre-Testing of Prototypes In-depth interviews and observation will test the
packaging and labeling prototype Potential distributors Potential users (Siaya and Mombasa)
– General Population– FSW– MSM
page 9
Preliminary ResultsPhase 1
page 10
Phase I Study Respondents General Public In-Depth Interviews (IDIs)
– 8 Men (4 in Siaya, 4 in Mombasa)– 8 Women (4 in Siaya, 4 in Mombasa)– 10 Key Populations (5 FSW and 5 MSM)
Influencers Focus Group Discussions (FGDs)– Health Service Providers in Mombasa (1 triad)– Community Health Workers in Siaya (1 triad)– Pharmacists and Chemists in Mombasa (1 FGD Mombasa)
Stakeholders– Local: Kenya Bureau of Standards, NASCOP, Pharmacy and
Poison Board– International: FDA, WHO, PATH,
The AWARE kit was given to participants
They were asked to look at the kit and respond to certain prompts regarding:– Secondary (Outer) packaging– Outer information– Primary (Inner) packaging– Inner information
Participants shown AWARE to gain insight into packaging aesthetics
page 12
Packaging and labeling can ensure: Users are comfortable taking the HIV oral self-test HIV self-tests are used by appropriate individuals HIV self-tests are administered accurately HIV self-tests are interpreted accurately HIV self-tests remain stable Maintain confidentiality during testing Users know where to seek additional care
Main themes
page 13
Potential users interested, but skeptical of HIV oral testing Potential users were unfamiliar with
oral testing – Confusion about ORAL test for a virus not
transmitted orally Overcomes fear of needles and blood Stakeholders and influencers
concerned oral test will cause confusion about how HIV is transmitted – People might infer that HIV is transmitted
through saliva if the test is conducted orally
“There are people who
just have the phobia of the
blood and that’s why maybe VCT
was not doing very
well, now this is a swab of the saliva,
the gum and the teeth it
could be easy.”
Local Stakeholder
Concern about confusion over transmission routes
“…one of the fears, we have always said that you cannot get HIV from for example kissing so if the kit we introduce is oral based there will be fears
people will say if I can diagnose HIV from my mouth, what you have been telling me is a lie. So
there needs to be a lot of advocacy and a lot of information going out to the public, what are the facts,
what are the myths. So I think that needs to be very clear so that there are no misconceptions”
Potential User , MSM Mombasa
PAGE 16
Implications: Secondary Packaging Tightly sealed box will build user confidence in the
quality of the product– The test is quality – The user is the first to use the kit
Secondary packaging should state that this is the same test used by professionals
Users want labeling to convey that the test has been regulated and validated by appropriate bodies
Include diagram of contents of kit – Ensure less literate population know the test contents– User can confirm test was not tampered with
“…it is a bit hard to open
but that is good
because it is natural that way because it has to
be sealed”Potential
User, Female Siaya
Implications: Primary Packaging All audiences appreciate that the inner package is sealed.
– The sealed packaging conveys that the kit is safe, and unused.
Aware: Front side of the inner packaging
Package is sealed
Beware of too much technical information
Regulation should be balanced to ensure labeling does not make users uncomfortable about using the product.
The use of terms such as HIV 1/2, OMT, antibodies etc. were confusing for participants– Is the product half effective?
“[regarding HIV 1/2] According to me, this 1/2
shows that it is not 100% effective”Potential User, Female Siaya
Cost is a threat to use by appropriate individuals
Cost primary barrier to HIV testing for FSW and MSM; less prominent barrier for general population
Potential users gave acceptable price ranges from 50 shillings to maximum 300 shillings per kit.
Influencers/stakeholders emphasize test must reach low income quintiles. – Free distribution should be considered
“It should be average, like the price of bread, so that both the rich
and poor can afford to buy it.”
Potential User, MSM Mombasa
“Most people are poor, we are targeting the majority who
cannot afford so you should make it
free.”
Influencer
The price should be on the box so it cannot be marked up– Ensures access is not limited to the wealthy
Include information on who should /should not be taking the test– May be informed by results of question 3
Implications: Secondary Packaging
page 20
Confidentiality Key Perceived Benefit of HIV Oral Self Test People can control the environment in which they take the test:
– Prefer seeing the results before others Participants mentioned being uncomfortable about having to see
people they know when going to get tested in VCT centers.
"Personally it will make me
comfortable because it is easy to buy at the chemist then you get
home, lock the doors, test yourself
and know your status"
Potential User, MSM Mombasa
“It is good because many people shy of going to the VCT due to lack of privacy
and some VCT centers are located in the estates and
someone might feel that if they walk inside the center and see me
frowning they will start to assume that I am
positive.”Potential User, MSM Mombasa
Size of packaging– Able to fit into pocket or purse (size of phone/tape recorder)– Users want to conceal the kit when leaving a store/health center– Stakeholders report small size allows varied display sites in shops
Text should include emphasis on confidential use– State that test is only for use by the individual purchasing the test– Stakeholders emphasize need for language that testing is not coercive or
mandatory – Health workers recommend Including “dispose after use” to emphasize
confidentiality of results
Implications: Secondary Packaging
page 22
Secondary packaging should support confidentiality
page 23
“[the package]It can be the size of a phone but
not long like ruler...like the old
Nokia 1100”
Potential User, Female Siaya
"if you look at those ones they are normally very
small…if you have very big things they will be
things in the back room and people have got
stigma.“Local Stakeholder
“It should be written that it’s a self oral testing kit for the consumer to know. It’s his and he is supposed to
do it alone"Influencer
Potential users differ on influence of “HIV” on the package
Stakeholders want packaging to explicitly state it is an HIV test
Including “HIV” on the outer packaging
page 24
“This HIV should be in small font and kept in the insert and on the outside you just write Test kit so that the aspect of HIV is in the insert and cannot be
seen from outside”Potential User, Male Siaya
“…on top I think the most important thing is that this is a HIV kit”
Influencer
Stakeholders primary concern is accurate use
Stakeholders are worried about false positives and negatives Concern users will have challenges using the test
– Spilled buffer, use outside expiration date, inaccurate interpretation of results, in accurate storage of the product
Users also report some concern about accurate use
“When it comes to issues of self diagnostic we have a lot of problems because how do we trust that the result you get is going to be correct. There is what we call false positive and false negative:
false positive is when you are actually negative but the kit tells you that you are positive"
Influencer
Stakeholders/influencers want to ensure adherence to instructions
Healthcare workers and pharmacists want to control the process – See this as their role in society
Expect that instructions will not be read – Attributed to low levels of literacy
View human error as the primary issue in self-testing
Want HIV self-testing in a controlled environment – Allow demonstration before use– Allows access to counseling services
“People really don’t read
instructions; they want
graphics and maybe one line of written text
in local language or
English”International Stakeholder
Potential Users also concerned about testing instructions
User concern about accurate use also indicates additional support may be needed– Users report that chemists would be the
people to help users comprehend the instructions
Combined, data suggest there is a role for ensuring accurate use that reaches far beyond packaging and
labeling.
“You can get the instructions
from the pharmacist, they will tell
you what to do and give
instructions on what to do.”
Potential User, Male Siaya
Text should urge users to read instructions within the box
Implications: Secondary Packaging
page 28
“I think a lot of emphasis should be put on as you guys should label the outer package,
indicate that the consumers should read the leaflet before using the kit. It is very
important for them to read the leaflet and understand before using the kit”
Influencer
Implications: Primary Packaging Among the general public there were questions on when exactly they
should take the test– What to do if their gums were bleeding– How long to wait after eating
Stakeholders and influencers mention that the instructions should clarify that people should take the test at least 30mins after eating.
“He should clean the mouth first or the food particles might interfere with the results…Like
when someone has taken alcohol, alcohol will interfere with the results”
Influencer
Implications: Primary Packaging
Ensure self-tests are administered accurately All audiences agreed on the fact that both text and picture
instructions should be included in the inner packaging. – Stakeholders provided details regarding instructions
• Limit clutter and unnecessary information (e.g. some self-tests have never removed language meant for lab personnel)
• Use drawings instead of photos (more easily manipulated)• Graphics should include people that resemble the intended users • Colors should be used to support instructions: color of item should match
color in drawings within instructions• Instructions for use should be read in a stepwise fashion. Packaging
should facilitate reading of each instruction, in order to ensure that the user follows every step.
page 31
Pictures and words are wanted for instructions on
the package
Aware: Back side of the inner packaging
Implications: Primary Packaging Potential users and influencers report that Instructions should be in two
languages to maximize potential for accurate use
“Both if it is too complicated; you can put the pictures and words in English or Kiswahili…Africa is not like Europe we need more of the instruction clearly written in English and
illustrated for those who don’t know how to read and write”
Influencer
Stakeholders reported a number of HIV self-test challenges that packaging (beyond instructions) can help address– Users open the test on the correct end– Users grab the wrong end of the swab and use incorrectly– Users often don’t know how hard to press the swab during
specimen collection– The buffer spill during vial opening or when in use– Expiration date is not checked before use – Tests are read outside the 20-45 minute window
Implications: Primary Packaging
page 33
Stakeholder report concern that:– Users may administer the test correctly, but interpret results wrong– Users will read test outside the 20-45 minute window – Users will not seek a confirmatory test to rule out false positive results
Potential users differ on confirmatory testing behavior – Some focus on getting a confirmatory test in case of positive result– Others want information on treatment
Confirmatory testing
page 34
“If you turn positive you should go to the established clinics and see the doctor and inform
the doctor that I did a self test at home and I got these results and I have come for the last
confirmation”Potential User, MSM Mombasa
Implications: Secondary and Primary Packaging
Instructions need to indicate if the results are positive, negative or invalid
Packaging itself can be used to support interpretation (e.g. Aware)
Aware: Back side of the outer packaging
Negative Result
Positive Result
Missing: Invalid Result
Implications: Primary Packaging Packaging can support accurate timing for test administration Potential users mention using watches or cell phones in order to keep
accurate time Participants mention doing other things during the test like chores
– This suggests potential for distraction that results in a test read after the appropriate window
“It is instant, though it takes that twenty minutes but it is less time consuming you
could go about your chores like wash, as you wait for the results.”
Potential User, FSW Mombasa
Implications: Primary Packaging Stakeholders report that a list of facilities that offer confirmatory testing
needs to be provided – Some emphasized this is an additional insert that does not originate with the
manufacturer, given the logistical challenges of such an approach Information about the window period and when to retest should be
included
"If you put right information in the insert can also say: if positive go for confirmatory test and then
you say that for confirmatory test visit any established health facility. This way people will go to the health facility and say can I confirm my status. This instruction is going to be a very important tool
within the insert.Influencer
Stakeholders report that bulky tertiary and secondary packaging may be an issue for public sector central medical storage facilities with limited space
A tightly sealed box will protect the product during shipment and storage
Diagrams of test kit on secondary packaging will indicate test was not tampered with
Implications: Secondary Packaging
page 38
“A good package is one that
protects the integrity of
what’s inside the kit”
Local Stakeholder
The lot number must be printed on the box – In case of potential recall
The expiry and manufacturing dates should be printed on box – Users pointed out that expiry date was not clear on Aware
packaging– Stakeholders emphasize stickers with expiry date
unacceptable The storage information should be on the box
– 3-30 degrees can be read as 3 to negative 30 degrees This information key to ensure regulatory compliance
Implications: Secondary Packaging
page 39
Implication: Primary Packaging Users and influencers see seal at
means to prevent “leakage and contamination”
Expiry date must be printed on all components of primary packaging
Instructions for use must include:– Test should not be used beyond
expiration date– Not to use the test if components
missing or seal is not present
Aware: Front side of the inner packaging
Package is sealed
Influencers and Stakeholders are concerned about counseling Both audiences noted that the reaction people have after getting their
results needs to be controlled– Counseling and health centers are the medium in which this can be
done; hence desire for distribution through these centers Participants note that some people might fall into depression, or
worse commit suicide if they do not get counseled. Community health workers primary concern with self-testing is the
inability to know who tests and thus inability to provide adequate follow-up counseling
Concerns about counseling
page 42
“Previously they didn’t know about their status,
they don’t want to disclose to anyone
about this test and so they will suffer from depression and they end up losing weight.
But we will be around to encourage them that if they were not
satisfied with the results of the oral test, they can
try the blood test.”Influencer
“You have to introduce
counseling. Maybe from where they are buying from either from the pharmacy
there should be someone to counsel that person. If you
are buying from the hospital also
someone has to counsel them before
they test themselves.“
Influencer
Implications: Primary Packaging Counseling by healthcare workers/distribution was reported as the main
method for providing information of HIV care services/living with HIV A call center number on the box was suggested
– This would also help users stay anonymous while trying to process their results.
“…in the instructions you need to state clearly the expected results and what next after each result so this person can go for further discussion. Either a
phone number or an address whatever is visible should be present. Something very specific for
this client so that they know where they need to go, the number to call. You know that sort of
information, it needs to be very clear as part of the information”
Local Stakeholder
Implications: Primary Packaging All interviewees focus on the need for information that discourages
risk behavior and informs individuals when to be re-tested
“We should also include when the
patient test again - you should include
after how long should the testing
be done again.”Potential User, Female
Mombasa
“Maybe on how you can keep that status of yours of being negative....You will always ask yourself the precautions you should take so that you don’t
acquire the disease, the virus.”Influencer
PAGE 45
Summary and Conclusions
Lack of familiarity with HIV self-testing will require packaging to increase trust in product quality
Packaging must support confidentiality of testing because this is seen as a key benefit of the test and data indicates it may be an area of misuse
There is a tension between increasing access and ensuring accurate use. Packaging and labeling can help to address this, but is not the sole solution
Summary (1)
Instructions for use are a key component for ensuring accurate use
Most aspects of product stability are addressed by manufacturers (e.g. ensuring buffer does not evaporate). Packaging supports product stability by ensuring use within expiration date and under proper storage conditions.
Once identified, methods for ensuring linkage to care need to be integrated into packaging and labeling to address participant concerns regarding counseling
Summary (2)
page 47
PAGE 48
Next Steps
Phase II: Developing a creative brief for proto-type design agency
Phase III: Pre-test the prototypes among:– Potential Users– Potential product distributors, particularly
pharmacists and health care providers
Phase II and III
page 49
Study TimelinesMilestonesDevelopment of the study protocol, IRB and data collection process
Done
Training/sensitization of study personnel on study protocol and process
Done
Development of packaging/labeling prototype
On-going
Recruitment of participants for second round of self-test kit user interviews (with prototype)
Data Analysis On-goingQualitative Data Thematic Coding for FGDs and IDIs to inform prototype development
Qualitative Data Thematic Coding for IDIs testing prototype
Data Reporting and Dissemination
page 50
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