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

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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

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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)

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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

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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

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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)

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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.

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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

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Preliminary ResultsPhase 1

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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

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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

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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

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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

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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

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Secondary packaging should support confidentiality

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“[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

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“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

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“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.

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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

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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

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 “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

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“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

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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

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“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

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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)

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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

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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

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