The Risk of HIV Acquisition Among Traditional Healers in South Africa: Implementing Novel Strategies to Improve Protective Behaviors
Phase: NA
Conditions: HIV Infections
Sponsor: Vanderbilt University Medical Center

 
 
 
 
 
 
The Risk of HIV Acquisition among Traditional Healers in South Africa: Implementing Novel 
Strategies to Improve Protective Behaviors 
Carolyn M. Audet, PhD, MSc 
Assistant Professor 
Department of Health Policy 
Institute for Global Health 
Vanderbilt University, Nashville USA 
 
Ryan G. Wagner, PhD, MSc(Med) 
Research Fellow & Trials Manager 
MRC/Wits-Agincourt Research Unit 
University of the Witwatersrand, Johannesburg 
 
 
May 28, 2021 
NCT Number: NCT04440813 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. 
Introduction 
In rural South Africa, traditional healers provide physical and psychological services to >80% of 
the population.1 There are more than 200,000 traditional healers in South Africa and 2 million in 
all of SSA.2-6 A patient often first seeks a healer for their health needs, receiving herbal remedies 
(“injected” and ingested) to prevent and cure ailments. While substantial research efforts have 
been expended on understanding the positive7-16 and negative4,17,18 impact that healers can have 
on the health of their patients, occupational hazards associated with traditional healer practices 
in SSA have attracted scant attention.18 Allopathic health care workers (HCWs) are recognized to 
be at risk for HIV, HBV, HCV, and other bloodborne infections through occupational exposure to 
blood and body fluids.19-23 Similar to allopathic HCWs, healers are also exposed to patients’ blood 
and body fluids. A widespread practice is the traditional “injection,” in which the healer performs 
dozens of subcutaneous incisions in order to rub herbs directly into the bloodied skin.24-26 In South 
Africa, 98% of healers report conducting “injections”, resulting in an estimated 1,500 blood 
exposures over the course of their lifetime.27 Despite pressure to eliminate the practice of 
“injections,” these treatments have been used for centuries and are often the preferred treatment 
delivery method by patients.28,29 Like clean needle exchange programs, the provision of personal 
protective equipment (PPE) does not enable traditional “injection” behavior. Instead it bridges the 
divide between these two systems and reduces healers’ occupational hazard.  
Traditional healers face a risk of acquiring bloodborne pathogens from contaminated blood and 
body fluids. While most exposures for unbroken skin do not result in infection, risk of infection 
varies by the pathogen involved, the type of exposure, the amount of blood involved, and the 
amount of virus in the patient’s blood at the time of exposure.30 The average risk of HIV infection 
after a needlestick or cut exposure to HIV-infected blood is 0.3%, and after exposure to eye, nose, 
or mouth is estimated to be 0.1%.30 “Injections” result in substantial blood exposure- 
approximately 2 mL of blood per injection, which is in contact with a healer’s bare skin (primarily 
hands and arms- we find blood under healer fingernails after treatments- but as people touch their 
faces 23 times per hour, exposure to the mucus membranes is possible).31 Healers are often 
subsistence farmers (resulting in small cuts and abrasions on their hands from planting and 
harvesting, as well as from regular household activities, including preparing food and washing 
clothes). Furthermore, they have limiting access to potable water in their homes (thus, limited 
hand washing opportunities post-“injection”) exacerbating their risk of acquisition. In the Agincourt 
area (Figure 1), healers have an overall HIV prevalence of 30% (CI: 23%-37%) vs. 19% in the 
general population;32 in our previous study, healers who reported exposure to patient blood had 
2.4-fold higher risk of being HIV-positive than those with no reported blood exposure (59% vs. 
25%, respectively).27 
Low rates of PPE training and use can place healers at risk. PPE is defined as equipment or 
instruments (gloves, safety glasses, facemasks, respirators, etc.33) worn to avoid and/or minimize 
exposure to hazards that could cause injuries or the spread of infection and illness. Use of PPE 
has been shown to be effective in reducing occupational exposures.33-35 Healers living with HIV 
may be perpetuating the epidemic, given their high HIV prevalence and their reluctance to attend 
clinical services (including HIV counseling, testing, and treatment). Healers may represent a 
reservoir of HIV-infected individuals with limited health facility contact. After acquiring HIV through 
their injection practices or elsewhere, healers are at risk of spreading the virus not only to their 
partners and children but also to other patients through further blood exposure, thus amplifying 
the effect of limited PPE/poor occupational hygiene. 
 
 

 
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2. Objectives 
The objective of this proposal is to adapt PPE training guidelines issued by the World Health 
Organization (WHO)36 and the U.S. Occupational Safety and Health Administration (OSHA)33 for 
use by healers and to fill the current evidence-to-practice gap by comparing effectiveness of two 
practical strategies for implementing evidence-based PPE guidelines.  
Our proposal compares two implementation strategies to increase PPE use and proper disposal 
during procedures and decrease the number of risky injections performed (de-implementation of 
traditional injections): (1) Health care worker (HCW)-led education on blood exposure risk and 
PPE use through a week-long training, followed by three educational outreach visits at the 
healer’s place of practice vs. (2)  “Early adopter” healer37-40 and HCW co-led training followed by 
three educational outreach visits. We hypothesize that “early adopter” healer messaging and 
delivery will have greater impact given their membership within the healer community. 
 
Aim 1. Gather information about how healers and health care workers are learning about PPE 
use to develop an acceptable and appropriate PPE training program.  
 
Aim 2: Compare fidelity to delivery of PPE training between the HCW-only and the healer plus 
HCW teams. 
We will compare training fidelity of the two teams via three constructs: (1) content, (2) coverage, 
and (3) duration41,42 to determine if there is a difference in fidelity between the two types of teams.  
Hypothesis 1: Training fidelity will be greater among healer + HCW teams, as they will have 
greater motivation to comprehensively deliver education and skill building sessions to healers. 
 
Aim 3: Compare the effects of the two implementation strategies on healer exposure to patient 
blood.  
We will enroll traditional healers into each PPE strategy using a stratified random sampling. 
Healers will use containers to collect all used sharps and used gloves over a six-month period 
and complete a low literacy data collection form to document glove use to identify gaps in PPE 
use.  
Hypothesis 1: Healers who are trained by the healer + HCW team will have a higher proportion 
of glove use during injections than those in the HCW-only trainer arm.  
 
4. Study Population 
Population  
Traditional healers and biomedical practitioners (including clinicians and nurses) providing 
patient care in the Bushbuckridge area.  
 
 
Inclusion Criteria 
 
1. Traditional healers > 18 years of age, who are registered as traditional healers with the 
government of South Africa, are currently practicing in the Bushbuckridge area, and conduct 
traditional vaccinations.  
 
2. Biomedical practitioners > 18 years of age, who are currently providing health care 
services to patients at government or private health facilities in Bushbuckridge.  

 
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3. Community members > 18 years of age, who currently live in Bushbuckridge and sought 
health care services from a traditional healer in the past year.  
 
Exclusion Criteria 
 
1. Traditional healers <18 years of age, who are not registered as traditional healers with 
the government of South Africa, are not currently practicing, or do not conduct traditional 
vaccinations on their patients.  
 
2. Biomedical practitioners < 18 years of age or who are not currently providing health 
services in the Bushbuckridge area.  
 
3. Community members < 18 years of age or who do not seek health care services from 
traditional healers.  
 
Calculation of Sample Size & Sampling Strategy  
Aim 1: We anticipate recruiting 20 traditional healers and 10 health care workers to achieve data 
saturation.  
 
Aim 2: With n=61 traditional healers per arm, we will have approximately 80% power to detect a 
difference between intervention arms for the fidelity scores of 0.5 standard deviations, and 
approximately 90% power to detect a difference of 0.6 standard deviations. These power 
calculations are based on a two-sample t-test and are likely conservative because the primary 
analyses will incorporate multiple (correlated) observations per healer. It should be noted that we 
do not have preliminary data for the fidelity scores; therefore, our power calculations are based 
on generic standard deviations. Finally, it should be noted that the sample size was primarily 
based on ensuring adequate power for Aim 3. 
 
Aim 3: From preliminary data collected from healers in Agincourt in 2019, the median proportion 
of glove use during vaccinations was 0.44, mean 0.39, and standard deviation (SD) 0.39. Our 
sample size is calculated based on a two-sample t-test and incorporates these preliminary data. 
Assuming the SD=0.39, then we anticipate needing 61 healers per arm (total of 122) to have 80% 
power to detect at the (alpha=0.05-level) a difference of  0.2 in the proportion glove use between 
the HCW-only and the healer + HCW teams (e.g., 0.4 vs. 0.2). Included below is the variability in 
power given different deltas (differences in the mean proportion of blood exposure between the 
two arms) (Table 1). Note, that these power calculations are approximate as primary analyses will 
be performed using negative binomial regression. Power calculations using negative binomial 
regression would require assuming a distribution of the offset (number of procedures performed 
per healer), which substantially complicate the calculations. Therefore, we present power 
calculations based on two-sample t-tests, which should be fairly similar.  
 
 
 
 
 
Table 1 Sample Size and Power 
 
N 
△ 
SD 
⍺ 
 P 
61 
0.17 
0.39 
0.05  66.57 
61 
0.18 
0.39 
0.05  71.52 
61 
0.19 
0.39 
0.05  76.08 
61 
0.20 
0.39 
0.05  80.22 
61 
0.21 
0.39 
0.05  83.89 

 
5 
61 
0.22 
0.39 
0.05  87.08 
61 
0.23 
0.39 
0.05  89.81 
61 
0.24 
0.39 
0.05  92.09 
61 
0.25 
0.39 
0.05  93.96 
N: number of healers per arm 
  
 
△: Difference to detect (delta) 
 
SD: Standard deviation  
 
⍺: Significance level (alpha) 
 
P: Power, % 
 
 
Randomization strategy 
To avoid concerns that, despite randomization, one intervention arm of healers will substantially 
differ from the other, we will conduct stratified randomization. Specifically, we will stratify based 
on healer sex and the number of patients seen in a given month (dichotomized into high/low based 
on the estimated median number of patients seen in the past month). This will result in 4 strata. 
At the time of randomization, each healer will be put in a strata and equal numbers of healers in 
each strata will be randomized to the two intervention arms.  
 
5. Methods 
Measurement of Results 
 
Aim 1: We will use qualitative measures to understand the best strategies to delivery PPE training 
to traditional healers in Bushbuckridge.  
 
Aim 2: We will rate training fidelity via two constructs: (1) content and (2) coverage41,42 during the 
week-long training session and community-based outreach sessions (Appendix 2). 
Understanding the fidelity of training delivery is essential to interpreting the effect of the 
intervention on PPE behavior change. If HCW + healer teams can deliver training with greater or 
equal fidelity than HCWs alone, PPE training can be more quickly scaled up nationwide (given 
the large number of healers) and conducted at lower cost (healers charge considerably less per 
hour than HCWs). We believe that the healer + HCW teams may have more motivation to deliver 
the program with fidelity during community-based sessions than the team of HCWs alone because 
of healers’ desire to protect their peers living in their own community. Three HCWs who volunteer 
to work on this project will be randomly assigned to the intervention team (along with the healers), 
with six volunteer HCWs assigned to the control arm.  
 
Aim 3: Healers will complete an interviewer-assisted survey immediately post training (Appendix 
3) using the Consolidated Framework for Implementation Research framework43 (compatibility of 
PPE with current behavior, peer pressure to use PPE, perception of the inclusiveness of the 
training process, cost) and individual characteristics from the situated-IMB model (Figure 3)44,45. 
During the six months of the trial, healers in each arm will record data on our primary outcome: 
the proportion of injections conducted using PPE in two ways. 
(1) Collect used sharps and PPE. Healers will be given containers to place all used gloves and 
razors/sharps to both ensure healer safety and allow us to count materials used (healers use 
gloves and a single razor once per patient and subsequently throw them into latrines or trash 
piles). We will use the number of glove pairs as the numerator (number of times they used gloves 
during procedures) and the number of razor blades as the denominator (number of injections 
given). While some may be concerned with social desirability bias, healers have been told for 
years to use gloves and were very open with us about their non-use. Healers have no reason to 

 
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under- or over-inflate their PPE use as it will not benefit them- in fact, they would have to buy the 
razor blades or travel to a health facility to obtain additional latex gloves, something that seems 
unlikely in this population. (2) Self-report. Healers will record behavior (injection and glove use) 
every time they conduct an injection.  
 
 
Study Procedures 
Aim 1:  
Phase 1: Information Gathering: We will interview select traditional healers and health care 
workers who have received some training on the use and disposal of PPE. Among traditional 
healers we will probe into how we can improve the training they receive, their preferred method 
of receiving information, and perceived gaps in their knowledge. From health care workers, we 
will gather information about how they were trained in the donning and doffing of PPE, aspects of 
the training that they believe would be most useful to traditional healers, and strategies to deliver 
these messages in a way that would be accessible to those with low levels of literacy.  
 
Phase 2: Production of Draft Program: After we gather information from healers and health 
care workers, we will produce a draft of our training program. Our team will ensure we are 
maintaining fidelity to core elements and the underlying theoretical framework of the original 
evidence-based intervention. If there are substantive changes, we will draft additional measures 
to assess impact of these changes on the intervention outcomes.  We will also develop quality 
assurance metrics (e.g. to ensure healers are using and disposing of PPE safely) and process 
measures to track the program’s success.  
 
Phase 3: Topical Experts: With our advisory counselor, as well as local leaders (e.g. leader of 
the traditional healer association, head of HIV care and treatment in the Department of Health), 
we will elicit feedback on our draft protocol. These experts will be tasked to focus on “big picture” 
issues, specifically sustainability and integration into district, provincial, and national level 
systems.  
 
Data Collection:  
  
In-depth Interview Question Guide: All participants will provide feedback on the acceptability, 
feasibility, and appropriateness of PPE training via open-ended questions (e.g. What information 
was most useful?), as well as questions about perceived barriers and facilitators to PPE training 
(How difficult will it be to use the sharps containers?) (Appendix 1).  
 
Aims 2 & 3: Traditional healers randomized to both the control and intervention arms will receive 
PPE education and training, general HIV prevention education and skill building (including 
condom use, positive prevention, and pre-/post-exposure prophylaxis services), and three 
educational outreach and coaching visits at the healer’s place of practice to provide on-the-ground 
advice and support for PPE use. These training and educational outreach sessions are designed 
to allow healers to receive education about bloodborne disease transmission (information), 
accurately assess their risk of contracting bloodborne illness (motivation), and develop skills to 
effectively don, doff, and dispose of used PPE (behavior) (Appendices 2 and 3). Outreach visits 
will focus on delivering five key messages and troubleshoot any issues healers may have in 
following recommendations. We will assess the impact of our evidence-based PPE intervention 
on the knowledge, motivation, and behavioral skills developed by traditional healers using the 
Situated Information Motivation and Behavioral Skills (Situated-IMB) model.44 The use of in-class 

 
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and educational outreach strategies have yielded improvements in clinical care delivery,46-48 
including use of PPE,49 among physicians, nurses, and community health workers in low-resource 
settings. These strategies were selected in consultation with traditional healers in Agincourt who 
reported never having received training on how to protect themselves from exposures based on 
the strategies used around the world to train health care providers to avoid infection.33,36,49-51  PPE 
use is feasible and acceptable to most healers and their patients already,27 but they lack the 
knowledge and/or motivation to use gloves properly and regularly. 
 
Our intervention arm will receive the same training and educational outreach as the control arm, 
but with training and outreach conducted by a clinical team that includes healers who adopted 
and use PPE on their own (early adopters).37-40 Early adopters are people who identify a new 
behavior as innovative (i.e. use of latex gloves) and adopt this behavior before the majority of 
their colleagues. Used primarily in the Diffusion of Innovation Theory52 to explain adoption of new 
behaviors, we hypothesize that the strategy of engaging early adopting healers as trainers in 
collaboration with HCWs will increase peer pressure, perceived tension for change, participant 
self-efficacy, and acceptability of PPE use among healers who do not use any barrier to blood 
exposure. Early adopters can achieve this by highlighting relative advantages, compatibility with 
their role of a traditional healer and leader in the community, simplicity, and ease of trialability of 
using gloves with patients.52  
Participants will receive a baseline and end line (7 months post- training) HIV test (to detect any 
seroconversion events and to determine if those living with HIV are as motivated to use PPE as 
those who are HIV-negative). Participants will also complete baseline and end line surveys to 
assess their knowledge, motivation, and behavioral skills to determine the impact of training on 
the healer. Once a month, a study assistant will visit each healer to collect all used sharps and 
PPE; three times during the study the study assistant will also conduct observations of healers 
using PPE to determine if they are using it correctly post-training.  
Healers and healer care workers who are selected, consent and contribute to the training of 
healers will be reimbursed for their transportation to the training venue and provided with a small 
token of appreciation (a voucher to a local store for R150) at the conclusion of the workshops.  
 
6. Study Location 
6.1 Location  
The MRC/Wits Agincourt Research Unit oversees the maintenance and operation of the Agincourt 
Health and Demographic Surveillance Site (HDSS). Roughly 500km northeast of Johannesburg, 
the unit has been engaged in population-based health and demographic research since 1992. 
Strong ties with the local community ensure the continual functioning and sustainability of the 
research.     
Constituting a sub-district of the Bushbuckridge district, the Agincourt study site consists of 420 
km2 of semi-arid scrubland with low rainfall, poorly-suited for subsistence farming though used for 
game farming and low- density cattle rearing. The study area contains six government run clinics, 
a private community health centre, and one larger area public health centre with patients being 
referred to three district hospitals, each located at 25- 55 kilometers from the site and relying on 
namely public means for transport. 
 
6.2 Study Population 
The Agincourt HDSS population is comprised of roughly 120,000 individuals- mainly xiTsonga-
speaking- spread throughout 20,000 households in 31 research villages. Roughly one-third of the 

 
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permanent HDSS population is comprised of former Mozambican refugees, who immigrated to 
South Africa during the 1980s. Our population of focus will include traditional healers living in this 
region, their patients, and health care workers providing services at local health facilitates.  
 
7. Data Management and Analysis 
Data Management 
Qualitative Data: Data from interviews will be transcribed in the original language and 
subsequently translated into English (if necessary). We will randomly select 10% of the original 
interviews to be re-translated to check for accuracy. The English transcriptions will be imported 
into Atlas Ti © to be coded by Prof. Carolyn Audet. All data will be password protected to ensure 
confidentiality. Data will be stored in restricted access folders (protected by an additional 
password) that sits on the Agincourt and Vanderbilt servers. Both servers have daily backups 
scheduled; therefore, all data will be backed up on a day-to-day basis. 
 
The original recordings, which will not include participant names or other identifiable information, 
will be locked in a file cabinet at the Agincourt field site until they have been entered into the 
database and the data has been checked for errors. After this point they will be erased to ensure 
voices cannot be linked back to the transcripts. All paper copies of transcripts will be destroyed 
once they have been typed up, verified, and electronic versions sent to Vanderbilt. All electronic 
copies of transcripts will be kept in a password-protected folder on a secure server at Agincourt 
and Vanderbilt for a period of 7 years, after which time they will be destroyed by the study 
investigators. 
 
Quantitative data:  
Questionnaires, observations of training, as well as HIV testing data will be collected and 
uploaded to a REDCap database which is housed at Vanderbilt University. REDCap provides 
automated export procedures for seamless data downloads to Excel and common statistical 
packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad 
hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated 
fields. It also provides additional security options, including the ability to restrict a user’s ability to 
download data tagged as identifiers to further protect participant privacy.  
Study participants will be assigned a unique, coded identification number at the time of study 
enrolment.  In order to maintain participant confidentiality, all laboratory specimens, study case 
report forms, and reports will be identified using that coded number.  Only research staff will have 
access to the coded number. Key study personnel, including Drs. Audet and Wagner, will store 
research data, including medical and laboratory records, in locked cabinets and all e-files will be 
password protected. Data will be stored in password-protected files within secure buildings at the 
MRC/Wits Agincourt Research Unit’s rural field offices. We have additional measures to enhance 
security when data are housed at Vanderbilt. Access to all data will be ID and password-protected, 
including data warehouse software and computers managing and analyzing survey data. No data 
will be released with any information that may directly or indirectly identify participants, their 
clinical information, or laboratory results to outside agencies. 
Data Analysis 
Aim 1: Audio files will be transcribed by a research assistant. The PI will code and analyze the 
interviews using Atlas-Ti software. Framework analysis will be used to identify responses to our 
questions about the drivers, core facilitators, and barriers to intervention acceptability and 
success.53 Two code maps will be developed to categorize data: (1) To understand the social, 
structural, and informational drivers, facilitators, and barriers to acceptability of education and 
PPE skill building, and (2) To understand participant concepts of “best practice” for healer PPE 

 
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use (including best practice for communicating this use to patients). Data will be coded by two 
independent coders to ensure that Cohen’s Kappa is >85%. For quantitative surveys, results will 
be summed to generate three scores (acceptability, appropriateness, and feasibility). Descriptive 
analyses will be done with survey results from each permutation of the intervention to determine 
if changes made have resulted in improvements. We will triangulate qualitative and quantitative 
data to ensure understanding; inconsistencies in findings will be investigated to ensure 
understanding. 
 
Aim 2: Analysis plan for content: A numeric scale will be used to assess the fidelity of the delivery 
of each topic in the training session. Topics include: (1) Delivered information about the definition 
of PPE, (2) Provided information about when to use PPE, (3) Provided information about what 
types of PPE to use in different circumstances, (4) Provided information about the appropriate fit 
of PPE, (5) Provided do’s and don’ts of glove use, (6) Provided information about don PPE, (7) 
Provided information about how and where to remove PPE, (8) Provided information about how 
to safely store used PPE, (9) Provided information about hand hygiene, (10) Provided instruction 
and feedback during PPE practice session. Each of the ten training items will be scored (each 
with a score of 0-10; 10 represents the greatest fidelity to the training guide, 0 not covering the 
material at all) for a total of 100 points.  The summation of all scores across topics will be used to 
measure fidelity to content for that training session. Each participant will participate in three 
training sessions. The mean difference between the two interventions in the total fidelity scores 
will be estimated using mixed effects linear regression models with 95% confidence intervals 
(CIs). These models will include random effects for the participant (to account for correlation 
across multiple sessions) and the trainer (to account for one trainer instructing multiple 
participants) and a 95% CI will be constructed. The outcome will be transformed as necessary to 
meet modeling assumptions. Covariates will include patient volume, sex, and baseline age. Any 
missing data will be imputed using chained equations with 20 imputation replications. Based on 
prior experience working with healers, we anticipate very low rates of loss to follow-up (LTFU). 
Healers who are LTFU will be censored at the time of their last recorded data collection, and 
inverse-probability of censoring weights based on healer characteristics randomization will be 
used, if necessary, to account for differences between healers who are LTFU and those who 
remain in the study. 
  
Analysis plan for coverage: We will calculate the percentage of sessions completed as the actual 
number of sessions completed for a participant divided by the total number of planned sessions. 
The percentage of sessions completed between the two intervention arms will be compared using 
mixed effects Poisson regression with the number of planned sessions (in most cases 3) as an 
offset. 95% confidence intervals will be constructed. The models will include random effects for 
the trainers. Covariates will include patient volume, sex, and baseline age. Missing data and LTFU 
will be handled as described above. 
 
Aim 3: The analysis will follow intent-to-treat protocol. Our primary outcome is the proportion of a 
healer’s procedures that were conducted using latex gloves (numerator = number of procedures 
with blood exposure, denominator = number of procedures). We will compare the blood exposure 
proportions between the two study arms using a negative binomial regression model. In the 
negative binomial regression, the outcome will be the number of times gloves were used and the 
number of procedures performed by the healer (number of razor blades) will be included as an 
offset. Such an analysis is appropriate because it properly accounts for heterogeneity between 
healers in the number of procedures performed, and the resulting estimates from the model can 
be interpreted as relative proportions (proportion of procedures with blood exposure in Arm 1 vs. 
proportion of procedures with blood exposure in Arm 2). In addition to our primary intervention 

 
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exposure variable, we will include healer sex and baseline age as covariates in our model. 
Sensitivity analyses will compare blood exposure proportions between the two intervention arms 
using a two-sample t-test; a Wilcoxon rank sum test will be fit as needed to avoid normality 
assumptions.  
 
Based on prior experience working with healers, we anticipate very low rates of loss to follow-up 
(LTFU). Healers who are LTFU will be censored at the time of their last recorded data collection, 
and inverse-probability of censoring weights based on healer characteristics randomization will 
be used, if necessary, to account for differences between healers who are LTFU and those who 
remain in the study. Missing data will be imputed using chained equations and 20 imputation 
replications. 
 
The secondary outcome, proportion of injection events, will be analyzed in a manner identical to 
that of our primary outcome except the outcome will be the total number of skin-cutting events 
performed by the healer, regardless of the use of PPE.  A negative binomial regression model will 
be fit using the number of overall procedures as an offset. While we will not specifically look at 
HIV seroconversion as a study outcome, we will assess healers’ baseline and end line HIV status 
for ethical reasons. Historical data show that the one-year incidence rate of HIV seroconversion 
is 1.7%. Since the incidence rate is low, we will likely not have adequate power to see a difference 
between intervention arms, but this information will allow us to appropriately power our 
subsequent R01 trial. 
 
A separate analysis will assess each strategies’ effect on PPE self-efficacy, PPE knowledge/ 
skills, and accurate risk assessment post-training. We will explore whether the intervention effects 
on these measures differ by a) trainer fidelity to the intervention and/or trainer identity (healer vs. 
clinician), respectively. These analyses will provide quantitative data to revise and refine, as 
needed, the intervention for evaluation in a large RCT effectiveness study as a means of 
improving prevention engagement while reducing stigma. 
 
8. Ethical Considerations 
Recruitment and Consent 
Aim 1: Traditional healers from the target community will be recruited via two strategies: (1) 
Healers in target catchment area are currently being mapped by two students (one from 
Vanderbilt and one from University of Witwatersrand). The healers are providing their 
address/location and contact information (phone numbers, contact for other family members) for 
use in future activities (including research endeavors). The healers will be contacted and given 
general information about the proposed study. All healers will be invited to community meetings 
where more information about the study procedures and aims will be provided. (2) The Kukula 
Traditional Healers association- the primary healer organization in the region- will hold 3 meetings 
to recruit healers interested in participating. Healers who express interest will be given the option 
for dates/locations where we will conduct recruitment fairs or the option to have a study assistant 
visit them at home. All recruitment will be conducted in a private room or at the home of the healer 
(as per the participants preference).  
 
Health care workers from the target community will be recruited if they provide primary care or 
HIV/TB services in the primary health care facility. A list of eligible providers will be elicited from 
the facility manager; three meetings to discuss the study will be held in the clinic. If the health 

 
11
care worker is interested in participating, they will be consented by a study assistant at the health 
facility or in a location of their preference.  
 
Aims 2 and 3: Traditional healers (participants) from the target community will be recruited via two 
strategies: (1) Healers in target catchment area are currently being mapped by two students. The 
healers are providing their address and contact information (phone numbers, contact for other 
family members) for use in future activities (including research endeavors). The healers will be 
contacted and given general information about the proposed study. All healers will be invited to 
community meetings where more information about the study procedures and aims will be 
provided. (2) The Kukula Traditional Healers association will hold 3 meetings to recruit healers 
interested in participating. Healers who express interest will be given the option for dates/locations 
where we will conduct recruitment fairs.  
 
Traditional healers (trainers) from the target community will be recruited based on results of a 
previous PPE use study among 200 healers. These healers have given us permission to contact 
them again for subsequent studies so we will visit their place of work to gauge their interest in 
acting as PPE trainers. We plan to recruit up to 10 healers who report using PPE effectively at 
every vaccination event.  
 
Health care workers from the target community will be recruited if they provide primary care or 
HIV/TB services in the primary health care facility. A list of eligible providers will be elicited from 
the facility chief; one meeting to discuss the study will be held in the clinic. If the health care 
worker is interested in participating, they will be consented by a study assistant at the health 
facility or in a location of their preference. A letter of support for this study from the Provincial 
Department of Health is attached.   
 
Participant Confidentiality  
The study will be conducted according to national and international standards of research ethics, 
to ensure that the rights of all participants will be respected. Ethical approval from the Wits Human 
Research Ethics Committee (Medical), the Mpumalanga Provincial Research Committee, and of 
the Faculty of Medicine at Vanderbilt University will be obtained before any data collection activity 
commences.  
 
The involvement of individuals in the interviews will be strictly voluntary. After introducing 
him/herself, the interviewer will read the informed consent to the participant and answer any 
questions they may have. If he/she does not accept, the discussion with the interview will end. 
The participants will be assured of the utmost confidentiality on the part of the teams involved in 
the study. 
 
Information regarding consent will not be logged anywhere and signed forms will be stored in a 
locked cabinet separate from transcripts and other potentially identifying information from the 
study. Only the principal investigators will have access signed consent forms. Transcripts will also 
be maintained to ensure confidentiality and access is restricted to authorized investigators. The 
confidentiality of the information collected will be strictly guarded.  
 
Adverse Events 
The proposed research will establish the following data and safety monitoring procedures, in 
compliance with NIH requirements, to ensure participant safety and protect the validity and 
integrity of data. The study is low risk, with intervention content focusing on providing personal 
protective equipment to rural South African traditional healers. However, we acknowledge that 

 
12
the participant population is vulnerable and given that the focus of the research is on HIV, a 
stigmatized condition, the following safety plan will be implemented. 
Dr. Audet will be primarily responsible for monitoring the proposed study. Together Drs. Audet 
and Wagner (Wits), will meet regularly with the site study coordinator and research team to 
discuss and resolve any situations arising that relate to ethics or human subjects protection. 
Together with MRC/Wits Agincourt Research Unit senior field staff, they will devise and implement 
an appropriate remedial course of action that sufficiently addresses any critical incident or adverse 
event that arises.  Dr. Audet will promptly inform the VU IRB, while Dr. Wagner will inform the 
Wits HREC and Mpumalanga Province research ethics committee of any event that occurs.  
Any time an adverse event occurs and at least once a year the investigators will conduct a data 
and safety review. During this review process, the investigators will evaluate any adverse events 
and determine whether the event changes the risk/benefit ratio of the study and whether 
modifications to the protocol or consent process are required. When necessary, they will seek 
recommendations from Vanderbilt University, Wits University and/or Mpumalanga Province 
research ethics committee. 
The VU and South African (Wits and Mpumalanga Province) IRBs will also review the study 
proposal and annual reports will be submitted as part of the continuing review process. At this 
time, they will complete the following: (1) reassess the risks and benefits to participants, the 
informed consent process, and safeguards for human subjects; (2) review participant enrollment 
and retention; (3) consider any new scientific or therapeutic developments that might impact the 
safety of participants in the study; and (4) review any adverse events. Changes to the DSMP will 
be made as needed. 
The investigators will adhere to the VU and South African IRBs’ policies on unanticipated 
problems involving risks to participants or others. The following problems would require prompt 
reporting to the IRBs. This procedure outlines the process for reporting adverse events, serious 
adverse events, and unanticipated problems involving risk to participants or others. 
Investigator Responsibilities 
A. The Investigator submits any serious adverse event that requires reporting according 
to this policy and any other adverse event that may represent an unanticipated problem involving 
risk to participants or others as follows: 
1. A “Report of Unanticipated Problem Involving Risk to Participants or Others” is submitted 
to the IRB as soon as possible, but no later than 7 calendar days after the Investigator first 
learns of the event or problem. 
This form contains the Investigator’s assessment of causality (related or not related to the 
study) and a description of the actual event; 
2. The form also contains an evaluation of whether the event meets the following criteria: 
a.  An event that suggests that the research places subjects or others at a greater risk 
of physical or psychological harm than was previously known or recognized; 
b. Unanticipated (i.e., the event was not foreseeable); and 
c. Related (i.e., likely to have been caused by the research procedures)  

 
13
3. Finally, any associated materials such as medical record notations or reports with the 
name and medical record number of the individual redacted (removed) will be included with 
the report. 
4. When applicable, a “Request for Amendment” indicating changes associated with the 
event or problem is submitted. 
Serious Adverse Event (SAE) Reporting 
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS 
AE Grading Table), Version 1.0, December, 2004, will be used to determine clinical and laboratory 
grades of any/all grade 2 or higher events (including signs and symptoms, laboratory 
abnormalities, and diagnoses).  
In addition, any/all deaths, disabilities, malignancies, and/or any other conditions deemed serious 
and/or debilitating/incapacitating by the clinical team will be reported to all involved ethical review 
boards. The PI will submit SAE information as required by local regulatory or other local 
authorities, and the research team will adhere to these stringent requirements and submit full 
reports detailing any SAEs in a timely fashion (i.e. in accordance with existing standards). After 
the end of the protocol-defined SAE reporting period stated above, the site will report serious, 
unexpected, clinical suspected adverse drug reactions if the study site staff becomes aware of 
the event on a passive basis, i.e., from publicly  
 
Benefits  
Traditional healers in this study could potentially benefit from PPE education and skill building 
and increased engagement with the health system which will likely highlight the importance of 
protecting themselves from blood exposures. Health care workers in this study could potentially 
benefit from their additional PPE education and skill building, which could help protect themselves 
from blood exposure. 
 
9. Limitations 
This study will not be powered to assess seroconversion among traditional healers exposed to 
HIV but will give us proxy outcomes (blood exposure) and implementation outcomes 
(acceptability, fidelity to PPE use) to predict the success if we developed a larger trial.  
 
10. Dissemination Plan 
Results of this study will be collected into a report and shared with the national, provincial and 
local Departments of Health, traditional healers and biomedical practitioners in the Bushbuckridge 
are, and researchers at the University of Witwatersrand and Vanderbilt University and the 
Agincourt research community. Results of this study will also be presented in peer-reviewed 
journals and at conferences.  
 
 
 
 
 
 
 
 
 
 
 

 
14
 
 
 
 
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17
 
 
 
 
Appendix 1: Interview Questions for Aim 1 
Trainers/Higher level creators of PPE training programs 
Demographics: 
Age (years) 
Gender (M/F/Trans/Non-binary) 
Race (Black, White, Indian, Coloured) 
Name of hospital/university/clinic where you work?  
Position 
Number of years practicing as a health care worker?  
Main Questions 
1. Tell me about how you train future health care workers on infection prevention and control. (Probes: 
How do you tailor this to the type of student you are teaching? how much time (days and hours) do you 
allocate? What topics do you focus on? How do you introduce the topic? Is the training formal (i.e. they 
all attend at the same time or does it occur informally in the clinic, ward or operating theatre?) 
2. Thinking about the training material, how much time is spent on theory (i.e. germ theory and droplet 
versus aerosolized contagions) versus practice (donning, doffing and disposal)? In your view, is the 
balance between theory and practice adequate? Is there anything missing in the training that you feel is 
missing in the training that you provide?  
3. How do you train them in the donning, doffing and disposal of personal protective equipment? What 
type of PPE do you train on (e.g. gloves, masks, surgical gowns, hair nets, foot coverings, visors)? 
(Probes: How do you tailor this to the type of student you are teaching? what kinds of difficulty do 
trainee’s experience? How to you help them overcome those challenges?)  
4. How has the training changed since COVID-19? Have you noticed a change in the use of PPE during 
COVID (probes: do you think health care workers are using PPE more appropriately during COVID)? 
5. Once students have their basic training how frequently do you think they need refresher training? 
What are common mistakes health care workers make once they get accustomed to using PPE. How do 
they let their guards down?  

 
18
6. What role does peer pressure from other providers (or more senior staff [e.g. consultant or head 
matron]) have in the proper use or misuse of PPE? How do you create a positive culture? How do you 
overcome one that is problematic?  
7. We are planning to train traditional healers to properly use PPE in an effort to protect them from 
infectious disease.  If you were to train a lay person, thinking specifically about traditional healers, how 
would you approach it? What topics would you focus on?  What challenges do you imagine 
encountering?  
8. What types of reinforcement or retraining would you imagine they would need? 
 
Front Line Health Care Providers 
Demographics: 
Age (years) 
Gender (M/F/Trans/Non-binary) 
Race (Black, White, Indian, Coloured) 
Name of hospital/university/clinic where you work?  
Position 
Number of years practicing as a health care worker?  
Main Questions 
1. Tell me about the PPE training you have received during your training? (Probe: what did they teach 
you?) Who provided the training?  (Probe: where did you receive it [hospital, offsite, part of 
orientation?]; who gave the training [scrub nurse, ID physician, microbiologist?]). What strategies did 
they suggest employing to use it correctly? Did you have any difficulties using and disposing of PPE?  
2. Think back to your first clinical rotation after graduation. How well were other health care providers 
using PPE? What were people doing correctly? How were they using PPE incorrectly?  
3. Did your PPE use change after you began working?  What role does peer pressure from other 
providers (or your seniors) have on your use of PPE?  
4. Can you describe any issues accessing or disposing of PPE at your health facility? Probe: is this 
infrequent? What steps are being taken to fix the issue?) 
5. Did you have any refresher training on the use or disposal of PPE before COVID hit South Africa? 
(What did the training include? If you had a previous training, did it change your use of PPE?) 

 
19
5. During COVID-19, has your health facility provided additional PPE training and resources? What did 
the training include? How effective was it at changing PPE behavior in your facility? Changing your 
behavior?  
6. Have you ever tried to train a lay person to use PPE? Can you tell me about that experience? What 
were the challenges?  
7. We are planning to train traditional healers to properly use PPE in an effort to protect them from 
infectious disease.  If you were to train a lay person, thinking specifically about traditional healers, how 
would you approach it? What topics would you focus on?  What challenges do you imagine 
encountering?  
8. What types of reinforcement or retraining would you imagine they would need?  
9. Is there anything else about PPE use that you think we should know about before we start this study? 
10. With regards to PPE, what have you found to be the most effective way at conveying both the theory 
and practical aspects of PPE during training? If you have been involved in multiple PPE trainings or 
refresher trainings, which one did you feel was the most effective and why? (Probe: Did the person 
giving the training affect the effectiveness of the training?  If so, what type of person gave the training 
[e.g. ID physician, scrub nurse, etc.) Was the training organized better? If so, describe.) 
 
 

 
20
Traditional Healers 
Demographics: 
1. Sex of respondent. 0= Male 1= Female 
These are some general questions about you and your life. 
2. How old are you today (age in years)? 
__________________________________ 
3 What is the highest grade of education that you have completed? 
__________________________________ 
4. What languages do you speak fluently? (check those English that apply)  
Shangaan 
Afrikaans 
Portuguese 
Zulu 
Xhosa 
Other 
5. What community do you live in? 
__________________________________ 
6. What is your marital status?  
1= Single 
2= Married 
3= Living with partner 
4= Widowed 
5= Divorced 
6= Separated 
7. What religion are you? (list options) 
8. Are you in a polygamous relationship (do you/ does  
your partner have multiple wives)? Yes No 
9. How many years have you been practicing as a 
traditional healer? __________________________________ 
10. What type of traditional healer do you MOST identify as?  
1= traditional healer 
2= Religious healer (Muslim) 
3= Religious healer (Christian) 
4= Herbalist 
5= Prophet 
8= Other 
8a. If other, please specify: 
11. Have you ever received an HIV test? Yes No 
12. If you are willing to share the results, what were they?  
0= Refused to share 
1= Negative 
2= Positive 

 
21
3= Don't know/ didn't return for results 
4= Indeterminate 
13. HIV Rapid Test Results (baseline and end line, only used if negative or no results 
from prior test, we don’t re-test positives) 
1= Negative 
2= Positive 
4= Indeterminate 
5= Refused Test 
 
 
Demographics for health care providers  
1. Sex of respondent. 0= Male 1= Female 
2. How old are you today (age in years)? 
__________________________________ 
3 What is the highest grade of education that you have completed? 
__________________________________ 
4. What languages do you speak fluently? (check those English that apply)  
Shangaan 
Afrikaans 
Portuguese 
Zulu 
Xhosa 
Other 
5. What community do you live in? 
__________________________________ 
6. What is your marital status?  
1= Single 
2= Married 
3= Living with partner 
4= Widowed 
5= Divorced 
6= Separated 
7. What is your current clinical position? 
8. Health care facility where you are employed?  
 
Main Questions: 
1. Can you tell me about any training you have received to use gloves and/or a mask or face shield when 
you are treating a patient? Who provided this training? What are the skills you have learned?  

 
22
2. Can you tell me if you use gloves during each procedure where you could be exposed to blood? If you 
don’t use gloves, do you use something else, like a plastic bag?  
3. If you do not always use gloves, can you tell us why? Probe: cost, access, don’t believe in germ theory 
of disease, God will save me) Are there specific patients where you ensure that you always where 
gloves? (e.g., someone you suspect has HIV?) 
4. Now that COVID is widespread, do you use a mask when you have patients in your hospital or home? 
If you don’t use a mask, can you tell me why not? Are there specific patients where you always use a 
mask? (e.g., someone you suspect has COVID-19 or TB?). If you use a mask, what type of mask do you 
use (e.g. cloth, surgical [the blue looking ones], N95)? Where did you get the mask? If you had to pay for 
the mask, how much did you pay?  
5. How has COVID affected your physical interaction with patients? Do you see patients in person (more 
or less than before)? Do you talk to patients over the phone (more or less than before)? If you see 
patients in in-person have you changed the way that you do anything (length of consultant, change in 
traditional vaccinations or other procedures? 
6. What effect has COVID had on you as a traditional healer? 
5. Have you ever had a patient ask you about your gloves/mask use?  If so, did this happen during the 
current COVID situation? What did the patient ask and what was your response? 
5. We want to provide training to you and your colleagues to ensure traditional healers are protected 
from infectious diseases. Would you prefer to learn these lessons from another traditional healer or 
from a health care provider? Why? What do you think are the most important lessons for you to learn?  
6. Lets talk about disposal of gloves for a moment. When you decide that you need to protect your 
hands, do you put gloves/bags on both hands or only one? Do you reuse them or dispose of them? If 
you reuse them, how do you clean them? If you dispose of them, where do you put them?  
7. Lets talk about disposal of masks for a moment. What kind of masks are you using, one that can be 
washed or one that needs to be disposed of? If you use one that can be washed, how often do you wash 
it? If you use a disposable one, where are you getting them? How long do you use it before putting it in 
the trash?  
8. We will be providing sharps containers and containers for used gloves/bags and razor blades for those 
healers who enroll in the study. We will come by every week to collect these materials. Do you think 
anyone would have difficulty using it?  
9. Our aim in providing this training and material is to ensure traditional healers are protected from 
infectious disease. Besides the training, masks, gloves and sharps containers. As a traditional healer, is 
there anything else that you think we should be discussing or considering? If so, what?    
9. Is there anything else about glove or mask use that you think we should know about?  

 
23
Appendix 2: PPE Training Content Fidelity Evaluation 
Directions: Score each measure with a value between 0-10 (0 is assigned if the topic is not discussed, 10 
for discussed fully); total score is out of 100 
 
1. Delivered information about the definition of PPE. 
Score ________ 
2. Provided information about when to use PPE. 
Score ________ 
3. Provided information about what types of PPE to use in different circumstances. 
Score ________  
4. Provide information about the appropriate fit of PPE. 
Score ________ 
5. Provide do’s and don’ts of glove use.  
Score ________ 
6. Provided information about don PPE. 
Score ________ 
7. Provided information about how and where to remove PPE. 
Score ________ 
8. Provided information about how to safely store used PPE. 
Score ________ 
9. Provided information about hand hygiene.  
Score ________ 
10. Provided instruction and feedback during PPE practice session. 
Score ________ 
 
TOTAL SCORE FOR TRAINING SESSION _______ / 10 

 
24
Appendix 3: Combined CFIR and IMB Model Predicting PPE use 
Part A. Example CFIR questions  
Intervention Characteristics 
1. Did you find the PPE training strategy acceptable? 
2. How feasible do you think it will be to implement PPE use?  
3. How do you think cost will impact your ability to implement PPE? 
Inner Setting 
1. How important to do think it is for healers to start using PPE during every injection?  
2. Does the use of PPE clash with your current practices?  
Outer Setting 
1. How has your perception of the use of PPE been influenced by other healers in the from the 
Kukula Organization  
2. How have your patients influenced your use of PPE during treatments?  
Process 
1. Tell us about your experience being recruited and engaged in the PPE training?  
2. How has your perception of the use of PPE been influenced by the leaders in the Kukula 
Organization.  
3.  
Part B. Questions from the Situated-Information Motivation Behavior Questions  
Information (from the HIV Knowledge Scale, Ciampa et al. 2012) True/False/Do Not Know 
1. A person can get HIV by getting an injection with a needle that was already used on someone 
else.  
2. A person can get HIV by sharing blades. 
3. A person can get HIV from mosquito bites. 
4. A person can get HIV by sharing forks, spoons or cups with a person who has HIV.  
5. A person can get HIV from a curse 
6. Using gloves during injections will prevent HIV transmission. 
Motivation (5-point Likert scale, strongly disagree to strong agree) 
1. I believe I can use PPE every time I conduct an injection 
2. I believe I am at high risk of HIV infection.  
3. I believe PPE will prevent me from contracting HIV from my patients during treatments.  
 
 

 
25
Appendix 4: Behavior Assessment of PPE Skills at the completion of the training sessions 
Hand Hygiene Checklist 
Score each method of hand hygiene based on the tasks indicated: done - 1; not done or done incorrectly - 0; not 
applicable or not assessed - N/A.  
Method 
Task 
Status 
Notes 
Alcohol-
Based 
Hand Rub 
ABHR is appropriate choice of hand hygiene for the 
situation 
  
  
Remove inappropriate jewelry 
  
  
Use enough alcohol rub to thoroughly wet both hands 
  
  
Spread product over all surfaces of hands (palms, 
between fingers, fingertips, back of hands and wrists) 
  
  
Rub hands for at least 15s or until product is dry 
  
  
 Alcohol-Based Hand Rub Subtotal  
  
Soap and 
Water 
Remove inappropriate jewelry 
  
  
Wet hands and apply soap 
  
  
Lather all surfaces of hands for 15s (palms, between 
fingers, fingertips, back of hands and wrists) 
  
  
Rinse all sides of hands under running water 
  
  
Dry hands with paper towels 
  
  
Turn off taps with paper towels 
  
  
Soap and Water Subtotal  
  
TOTAL SCORE 
  
Donning Checklist 
Indicate the personal protective equipment (PPE) required for the scenario then number them in the table as the user 
dons each item. Score the use of each item based on the tasks indicated: done - 1; not done or done incorrectly - 0; 
not applicable or not assessed - N/A.  
PPE 
Required:  
  
  
  
User's PPE 
sequence↓ 
Task 
Status 
Notes 
Hand 
Hygiene 
#____ 
Hand Hygiene was performed 
  
  
The choice of Hand Hygiene was appropriate 
  
  
Gown 
#____ 
Choose correct type of gown (if available) 
  
  
Put gown on with the opening at the back 
  
  
Tie neck and waist ties 
  
  
Mask 
#____ 
Chosen mask is appropriate face protection for the 
situation 
  
  
Place mask over the nose and mouth 
  
  
Mold metal strip to nose 
  
  
Secure elastics or ties 
  
  
Eye 
Protection 
#____ 
Put on  
  
  
Adjust to fit (e.g. face shield should fit over brow) 
  
  

 
26
Gloves 
#____ 
Remove inappropriate jewellery 
  
  
Choose correct type of gloves (if available) 
  
  
Choose well-fitting gloves 
  
  
Put on gloves (if gown is worn, place gloves over 
gown cuffs) 
  
  
Subtotal  
  
PPE Selection Score 
(Add 5 points for each required item that was selected and subtract 5 
points for each necessary item that was not selected.) 
  
PPE Donning Sequence Score 
(No points if any sequence errors. Award 5 points for each required 
item/step in a perfect sequence - as listed in table.) 
  
TOTAL SCORE 
  
Doffing Checklist 
Score the use of each item based on the tasks indicated: done - 1; not done or done incorrectly - 0; not applicable or 
not assessed - N/A.  
Number of items to be doffed: _________ 
Number of hand hygiene steps required: ___________ 
User's PPE 
sequence↓ 
Task 
Status 
Notes 
Gloves 
#____ 
Remove the first glove using glove-to-glove technique  
  
  
Remove the second glove using skin-to-skin 
technique, turning gloves inside out 
  
  
Drop into garbage without touching bin 
  
  
Gown 
#____ 
Unfasten the ties or Velcro and peel gown away from 
the neck 
  
  
Remove the gown slowly, pulling away from the body, 
without touching the outside or contaminating clothing 
  
  
Roll the gown into a bundle inside-out or fold dirty-to-
dirty 
  
  
Discard the gown in appropriate receptacle 
  
  
Hand 
Hygiene 
#____ 
Hand Hygiene was performed 
  
  
The choice of Hand Hygiene was appropriate 
  
  
Eye 
Protection 
#____ 
Remove goggles/visor using the earpiece/band 
  
  
Lift away from the face without touching the 
face/eyes/nose 
  
  
Discard in the garbage/If reusable, clean and disinfect 
  
  
Mask 
#____ 
Undo the ties or elastics without touching the front of 
the mask 
  
  
Holding the ties or elastics, lift mask away from the 
face 
  
  
Discard mask in the garbage 
  
  
Hand 
Hygiene 
#____ 
Hand Hygiene was performed 
  
  
The choice of Hand Hygiene was appropriate 
  
  
Subtotal  
  

 
27
 Doffing Sequence Score 
(No points if any sequence errors. Award 5 points for each required 
item/step in a perfect sequence - as listed in table.) 
  
TOTAL SCORE 
  
 
PPE Handling 
(Correct and careful use of PPE) 
N/A 
1 
2 
3 
4 
5 
  
Incorrect donning/doffing of 
PPE with critical errors 
  
Mostly correct 
donning/doffing of PPE with 
few non-critical errors and/or 
correction of critical errors 
  
Perfectly correct 
donning/doffing of PPE with 
no errors 
Flow of Operation 
(Forward planning and continuity of procedure) 
N/A 
1 
2 
3 
4 
5 
  
Demonstrated no forward 
planning and appeared 
unsure of next steps with 
irregular progression of 
actions 
  
Demonstrated some forward 
planning and anticipation of 
the situation with steady 
progression of actions 
  
Demonstrated obvious 
forward planning and 
anticipation of the situation 
with effortless progression of 
actions 
Self-Contamination 
(Avoidable/unnecessary contamination of PPE user during or after care activities) 
N/A 
1 
2 
3 
4 
5 
  
 Indiscriminately 
contaminated self during 
and/or after client/patient 
care activities 
  
Made appropriate corrections 
for self-contamination during 
and/or after client/patient 
care activities 
  
Perfect technique employed 
to prevent self-contamination 
both during and after 
client/patient care activities 
Contamination of Environment 
(Contamination of environmental surfaces during or after care activities) 
N/A 
1 
2 
3 
4 
5 
  
Touched environmental 
surfaces inappropriately 
putting others at risk of 
transmission of 
microorganisms through 
contaminated surfaces 
  
Touched environmental 
surfaces inappropriately but 
corrected errors to prevent 
transmission of 
microorganisms through 
contaminated surfaces 
  
Did not touch environmental 
surfaces inappropriately, 
preventing risk of 
transmission of 
microorganisms through 
contaminated surfaces 
Cross-Contamination 
(Contamination of client/patient due to contaminated PPE used between care activities and procedures) 
N/A 
1 
2 
3 
4 
5 
  
Indiscriminately caused 
cross-contamination of PPE 
and/or client/patient between 
care activities 
  
Made appropriate corrections 
for cross-contamination of 
PPE and/or client/patient 
between care activities 
  
Appropriate technique used 
throughout the procedure to 
prevent cross-contamination 
of PPE and/or client/patient 
between care activities 
TOTAL SCORE|