HIV Testing at Family Planning Clinics in Mombasa County, Kenya: A Cluster-Randomized Trial Comparing the Systems Analysis and Improvement Approach (SAIA) to Usual Procedures
Phase: NA
Conditions: HIV
Sponsor: University of Washington

 
HIV Testing at Family Planning Clinics in Mombasa County, Kenya: A Cluster-Randomized Trial comparing the 
Systems Analysis and Improvement Approach (SAIA) to Usual Procedures  
March 2021 Protocol 
NCT 02994355 
 
 
 
 
[DATE] 
UNIVERSITY OF WASHINGTON 
[Company address] 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 1 of 46 
 
 
 
ZIPLINE APPLICATION: IRB Protocol 
 
 
 
INSTRUCTIONS 
• 
If you are requesting a determination about whether your activity is human subjects research or qualifies for exempt status, 
you may skip all questions except those marked with a          . For example 1.1  must be answered. 
• 
Answer all questions. If a question is not applicable to your research or if you believe you have already answered a question 
elsewhere in the application, state “NA” (and if applicable, refer to the question where you provided the information). If you 
do not answer a question, the IRB does not know whether the question was overlooked or whether it is not applicable. This 
may result in unnecessary “back and forth” for clarification. Use non-technical language as much as possible.  
• 
To check a box, place an “X” in the box. To fill in a text box, make sure your cursor is within the gray text box bar before 
typing or pasting text. 
• 
The word “you” refers to the researcher and all members of the research team, unless otherwise specified.  
• 
For collaborative research, describe only the information that is relevant to you unless you are requesting that the UW IRB 
provide the review and oversight for your collaborators as well.  
• 
You may reference other documents (such as a grant application) if they provide the requested information in non-technical 
language. Be sure to provide the document name, page(s), and specific sections, and upload it to Zipline. Also, describe any 
changes that may have occurred since the document was written (for example, changes that you’ve made during or after the 
grant review process). In some cases, you may need to provide additional details in the answer space as well as referencing a 
document.  
 
INDEX 
1 Overview 
6 Children (Minors) and Parental Permission 
10 Risk / Benefit Assessment 
2 Participants 
7 Assent of Children (Minors) 
11 Economic Burden to Participants 
3 International Research Setting 
8 Consent of Adults 
12 Resources 
4 Recruiting and Screening Participants 
9 Privacy and Confidentiality 
13 Other Approvals, Permissions, and 
Regulatory Issues 
5 Procedures 
 
 
 
1 OVERVIEW 
Study Title: 
HIV Testing at Family Planning Clinics in Mombasa County, Kenya: A Cluster-
Randomized Trial comparing the Systems Analysis and Improvement Approach 
(SAIA) to Usual Procedures 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 2 of 46 
 
1.1 Home institution. Identify the home institution of the lead researcher as listed on the IRB application. Provide any 
helpful explanatory information.   
In general, the home institution is the institution (1) that provides the researcher’s paycheck and that considers him/her to be 
a paid employee, or (2) at which the researcher is a matriculated student. Scholars, faculty, fellows, and students who are 
visiting the UW and who are the lead researcher: identify your home institution and describe the purpose and duration of your 
UW visit, as well as the UW department/center with which you are affiliated while at the UW. 
 
Note that many UW clinical faculty members are paid employees of non-UW institutions. 
 
The UW IRB provides IRB review and oversight for only those researchers who meet the criteria described in the POLICY: Use of 
the UW IRB. 
 
University of Washington 
1.2 Consultation history. Have you consulted with anyone at HSD about this study? 
It is not necessary to obtain advance consultation. If you have: answering this question will help ensure that the IRB is aware 
of and considers the advice and guidance you were provided.   
 
X No 
 
 
 
Yes 
→ If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
      
1.3 Similar and/or related studies. Are there any related IRB applications that provide context for the proposed 
activities? 
Examples of studies for which there is likely to be a related IRB application: Using samples or data collected by another study; 
recruiting subjects from a registry established by a colleague’s research activity; conducting Phase 2 of a multi-part project, or 
conducting a continuation of another study; serving as the data coordinating center for a multi-site study that includes a UW 
site. 
 
Providing this information (if relevant) may significantly improve the efficiency and consistency of the IRB’s review. 
 
X 
No 
 
 
 
Yes 
→ If yes, briefly describe the other studies or applications and how they relate to the proposed 
activities. If the other applications were reviewed by the UW IRB, please also provide: the UW IRB 
number, the study title, and the lead researcher’s name. 
 
 
 
      

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 3 of 46 
 
1.4 Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or urgency that affect 
your proposed activity? 
HSD recognizes that everyone would like their IRB applications to be reviewed as quickly as possible. To ensure fairness, it is 
HSD policy to review applications in the order in which they are received. However, HSD will assign a higher priority to 
research with externally-imposed urgency that is beyond the control of the researcher. Researchers are encouraged to 
communicate as soon as possible with their HSD staff contact person when there is an urgent situation (in other words, before 
submitting the IRB application). Examples: a researcher plans to test an experimental vaccine that has just been developed for 
a newly emerging epidemic; a researcher has an unexpected opportunity to collect data from students when the end of the 
school year is only four weeks away.  
 
HSD may ask for documentation of the externally-imposed urgency. A higher priority should not be requested to compensate 
for a researcher’s failure to prepare an IRB application in a timely manner. Note that IRB review requires a certain minimum 
amount of time; without sufficient time, the IRB may not be able to review and approve an application by a deadline.  
 
X 
No 
 
 
 
Yes 
→ If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
      
1.5 Objectives Using lay language, describe the purpose, specific aims, or objectives that will be met by this specific 
project. If hypotheses are being tested, describe them. You will be asked to describe the specific procedures in a 
later section. 
 
If your application involves the use of a HUD “humanitarian” device: describe whether the use is for “on-label” 
clinical patient care, “off-label” clinical patient care, and/or research (collecting safety and/or effectiveness data). 
 
Our overarching objective is to assess the effectiveness, costs, and budget impact of implementing this systems 
analysis and improvement approach (SAIA) to increase HIV testing in FP clinics in Mombasa County. 
 
Our specific aims are as follows:  
AIM 1: To conduct a cluster-randomized trial comparing the effect of the SAIA approach versus 
usual procedures on rates of HIV testing in first-time attendees at 12 intervention versus 12 control 
FP clinics in Mombasa County, Kenya.  
HYP 1: After one year of study team support implementing SAIA vs. usual procedures, a higher 
proportion of first-time FP clinic attendees will be tested for HIV at intervention compared to control 
facilities  
AIM 2: To determine whether the SAIA training results in a lasting effect, we will compare HIV 
testing rates for first-time FP clinic attendees in SAIA intervention versus control facilities after an 
additional year, during which FP clinics in the intervention arm will be encouraged to continue to 
use the SAIA tools with minimal support from the study team. The Mombasa County Ministry of 
Health will take ownership of implementation during this phase.  
HYP 2: After an additional year with minimal support from the study team, there will continue to be 
significantly higher rates of HIV testing in first-time FP clinic attendees at intervention compared to 
control facilities.  
AIM 3: To estimate the incremental cost and budget impact of applying SAIA versus standard of care.  
Using an activity-based approach, we will perform a costing analysis, estimating cost per new HIV diagnosis, both 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 4 of 46 
 
during active support from the study team and after a period without active support. We will also estimate cost to 
scale up, and conduct a budget impact analysis from a Department of Health (DOH) perspective. 
1.6 Study design. Provide a one-sentence description of the general study design and/or type of methodology.   
Your answer will help HSD in assigning applications to reviewers and in managing workload. Examples: a longitudinal 
observational study; a double-blind, placebo-controlled randomized study; ethnographic interviews; web scraping from a 
convenience sample of blogs; medical record review; coordinating center for a multi-site study. 
 
This is a cluster-randomized controlled trial with FP clinics as the unit of randomization.  
1.7 Intent. Check all the descriptors that apply to your activity. You must place an “X” in at least one box. 
This question is essential for ensuring that your application is correctly reviewed. Please read each option carefully. 
 
Descriptor 
 
 
1. Class project or other activity whose purpose is to provide an educational experience for the researcher 
(for example, to learn about the process or methods of doing research). 
 
 
 
 
 
 
2. Part of an institution, organization, or program’s own internal operational monitoring. 
 
 
 
 
 
 
3. Improve the quality of service provided by a specific institution, organization, or program. 
 
X 
 
 
 
 
4. Designed to expand the knowledge base of a scientific discipline or other scholarly field of study, and 
produce results that: 
• 
Are expected to be applicable to a larger population beyond the site of data collection or the specific 
subjects studied, or 
• 
Are intended to be used to develop, test, or support theories, principles, and statements of 
relationships, or to inform policy beyond the study. 
 
X 
 
 
 
 
5. Develop information about a drug or device through its prospective use and assignment to subjects, which 
will then be submitted to the Food and Drug Administration (FDA) in support of a marketing or research 
application for an investigational drug or device, or for changes to the purpose, population, or dose for an 
already-approved drug or device. 
 
 
 
 
 
 
6. Focus directly on the specific individuals about whom the information or biospecimens are collected 
through oral history, journalism, biography, or historical scholarship activities, to provide an accurate and 
evidence-based portrayal of the individuals. 
 
 
 
 
 
 
7. A quality improvement or program improvement activity conducted to improve the implementation 
(delivery or quality) of an accepted practice, or to collect data about the implementation of the practice 
for clinical, practical, or administrative purposes. This does not include the evaluation of the efficacy of 
different accepted practices, or a comparison of their efficacy. 
 
X 
 
 
 
 
8. Public health surveillance activities conducted, requested, or authorized by a public health authority for 
the sole purpose of identifying or investigating potential public health signals or timely awareness and 
priority setting during a situation that threatens public health. 
 
 
 
 
 
 
9. Preliminary, exploratory, or research development activities (such as pilot and feasibility studies, or 
reliability/validation testing of a questionnaire) 
 
 
 
 
 
 
10. Expanded access use of a drug or device not yet approved for this purpose 
 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 5 of 46 
 
 
 
 
 
11. Use of a Humanitarian Use Device 
 
 
 
 
 
 
12. Other. Explain: 
 
 
 
 
 
 
 
      
1.8 Background, experience, and preliminary work. Answer this question only if your proposed activity has one or 
more of the following characteristics. The purpose of this question is to provide the IRB with information that is 
relevant to its risk/benefit analysis. 
• 
Involves more than minimal risk (physical or non-physical) 
• 
Is a clinical trial, or 
• 
Involves having the subjects use a drug, biological, botanical, nutritional supplement, or medical 
device. 
“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater 
than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or 
tests. 
 
a. Background. Provide the rationale and the scientific or scholarly background for your proposed activity, based 
on existing literature (or clinical knowledge). Describe the gaps in current knowledge that your project is 
intended to address. 
 
Do not provide scholarly citations. Limit your answer to less than one page, or refer to an attached document with 
background information that is no more than three pages long. 
 
1. Many women in Africa remain unaware of their HIV status.  
In sub-Saharan Africa, 60% of the ~23 million people living with HIV are women (11). Over half of 
HIV-positive individuals remain unaware of their status, making it impossible to link them to 
services (10). Likewise, when women without HIV infection are not tested, opportunities to link them 
to HIV prevention services are missed. Addressing this HIV testing gap is among the most 
fundamental needs in global HIV treatment and prevention.  
2. Family planning services are common in many African countries.  
Demographic and health surveys from 
numerous African countries show that a 
high proportion of women access FP 
services, and that use of modern 
contraceptive methods continues to 
increase (6-9). In Kenya, 53% of currently 
married women and 61% of sexually active 
unmarried women reported using a modern 
method of contraception (9). Figure 1 
illustrates the striking increase in 
contraceptive use in married women in 
Kenya between 1989 and 2014. Adult HIV 
prevalence is superimposed on the same 
figure (18-23). This illustrates that a large proportion of Kenyan women, including many who are 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 6 of 46 
 
HIV-positive, could be reached through universal HIV testing in FP clinics.  
Integration sexual and reproductive health (SRH) services including FP with HIV services has been 
recognized as a key strategy for increasing access, uptake, quality, efficiency, and cost-effectiveness 
(14, 24). Integration and linkage of programs was emphasized in the US Government Global Health 
Initiative Strategy of 2010 (25).  
3. There are advantages to linking HIV testing and family planning services.  
From an HIV-prevention perspective, there are numerous reasons to link HIV testing to FP services. 
First, FP clinics have access to a large proportion of sexually active women. Second, integrating HIV 
testing into FP clinics opens the gateway for women to access prevention and treatment services (10). 
HIV-negative women may benefit from prevention strategies such as couples counseling and testing 
(26), condom use (27), pre-exposure prophylaxis (28), and treatment of positive partners (29). 
Likewise, HIV-positive women can decrease their risk of transmission to sex partners by taking ART 
(29-31). A third reason to integrate HIV testing and FP services is the potential to reduce mother-to-
child transmission of HIV by preventing unwanted pregnancies in HIV-positive women (32). On the 
other hand, many HIV-positive women will eventually desire additional children (33-42). Women 
with HIV, their partners, and their infants can benefit from knowing their status prior to conception 
(43).  
4. WHO supports integration of sexual and reproductive health with HIV services.  
In 2009, WHO reviewed evidence on linkages between SRH and HIV services (1), highlighting 
promoting and inhibiting factors that will be useful in planning future studies including this one 
(Figure 2). The SRH services (FP, maternal & child healthcare, gender based violence prevention and 
management, and STD prevention and management) were linked to HIV services including 
prevention, education, counseling, testing, prevention of mother-to-child transmission (PMTCT), 
clinical care, psychosocial, and other services. While differences in target audiences, provider time 
constraints, and structural barriers can be problematic for some linkages (44- 47), WHO and several 
reviews have concluded that integration is beneficial and feasible (1, 12-14). Many reviews also 
conclude that more data on integration of SRH and HIV services are needed (12-14).  
5. Provider-initiated testing and counseling is key to increasing HIV testing.  
A recent report from Central Province, Kenya showed that following training on provider-initiated 
testing and counseling (PITC), the proportion of visits at which HIV testing was offered in FP clinics 
was higher in PITC clinics (35%) compared to clinics that continued to use a referral system for HIV 
testing (20%), p<0.01 (48). A separate study in Kenya found that integration of services was 
motivating for staff and distributed clinics’ workload better (49). These findings are consistent with 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 7 of 46 
 
those of a systematic review of PITC in low- and middle-income countries, which support PITC as an 
important intervention to increase HIV testing (50).  
 
 
b. Experience and preliminary work. Briefly describe experience or preliminary work or data (if any) that you or 
your team have that supports the feasibility and/or safety of this study.   
 
It is not necessary to summarize all discussion that has led to the development of the study protocol. The IRB is interested 
only in short summaries about experiences or preliminary work that suggest the study is feasible and that risks are 
reasonable relative to the benefits. Examples: You have already conducted a Phase 1 study of an experimental drug which 
supports the Phase 2 study you are now proposing to do; you have already done a small pilot study showing that the 
reading skills intervention you plan to use is feasible in an after-school program with classroom aides; you have 
experience with the type of surgery that is required to implant the study device; you have a study coordinator who is 
experienced in working with subjects who have significant cognitive impairment. 
 
 
Dr. Sherr leads the SAIA Trial (R01 HD075057), which aims to improve 
PMTCT services in Kenya, Mozambique, and Cote d’ Ivoire by applying 
the SAIA approach proposed in the present application. The methods have 
been published following peer-review (51). Briefly, the SAIA intervention 
is used chronologically and iteratively to optimize PMTCT across the 
cascade (Figure 3). First, an Excel-based tool is 
used to analyze the facility’s PMTCT cascade (54), identifying steps where 
optimization would have the greatest impact on overall performance. 
Second, sequential process flow mapping is performed (Figure 4). The 
map guides step 3, in which healthcare workers identify, define, and 
implement workflow adaptations to eliminate bottlenecks. Step 4 involves 
monitoring the effect of the adaptations using routinely collected data. In 
step 5, additional iterations of the analysis and improvement cycle are 
implemented (Figure 5). To date, 17 of 18 intervention facilities have 
accepted the intervention, and report ownership of the process. Over a 6- 
month period, sites have implemented an average of six interventions; 81% 
of interventions show some improvement in relieving bottlenecks. We have 
identified five broad categories of interventions: service 
reorganization, expanding patient knowledge, improving communication, 
improving data, and introducing new interventions (norms, treatments, 
modalities, technologies. Several key lessons have been learned from the 
process to date: 
• GET LEADERS ON BOARD: Support from leadership is essential, and it 
may take time to get buy in 
• ENGAGE SUPPORT STAFF: Community health workers support and 
sustain implementation 
• GO FOR LOW HANGING FRUIT: Interventions that improve facility 
adherence to existing DOH norms 
• KEEP IT SIMPLE: Implement 1-2 interventions at a time 
• PUSH SYSTEMS THINKING: Effective continuous quality improvement 
must include user-friendly systems tools for use by frontline healthcare workers and managers 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 8 of 46 
 
1.9 Supplements. Check all boxes that apply, to identify Supplements you should complete and upload to the 
Supporting Documents SmartForm in Zipline. 
This section is here instead of at the end of the form to reduce the risk of duplicating information in this IRB Protocol form that 
you will need to provide in these Supplements. 
 
Check all 
That Apply 
Type of Research 
Supplement Name 
 
 
 
 
Department of Defense 
The research involves Department of Defense funding, facilities, data, or 
personnel. 
ZIPLINE SUPPLEMENT: 
Department of Defense 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Energy 
The research involves Department of Energy funding, facilities, data, or 
personnel. 
ZIPLINE SUPPLEMENT: 
Department of Energy 
 
 
 
 
 
 
 
 
 
 
 
 
Drug, biologic, botanical, supplement 
Procedures involve the use of any drug, biologic, botanical or 
supplement, even if the item is not the focus of your research 
ZIPLINE SUPPLEMENT: 
Drugs 
 
 
 
 
 
 
 
 
 
 
 
 
Emergency exception to informed consent  
Research that requires this special consent waiver for research involving 
more than minimal risk 
ZIPLINE SUPPLEMENT: 
Exception from Informed 
Consent for Emergency 
Research (EFIC) 
 
 
 
 
 
 
 
 
 
 
 
 
Genomic data sharing 
Genomic data are being collected and will be deposited in an external 
database (such as the NIH dbGaP database) for sharing with other 
researchers 
ZIPLINE SUPPLEMENT: 
Genomic Data Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
Medical device 
Procedures involve the use of any medical device, even if the device is 
not the focus of your research, except when the device is FDA-approved 
and is being used through a clinical facility in the manner for which it is 
approved 
ZIPLINE SUPPLEMENT: 
Devices 
 
 
 
 
 
 
 
 
 
 
 
 
Multi-site study 
(You are asking the UW IRB to review one or more sites in a multi-site 
study.) 
ZIPLINE SUPPLEMENT: 
Participating Site in Multi-
Site Research 
 
 
 
 
 
 
 
 
 
 
 
 
Participant results sharing 
Individual research results will be shared with subjects. 
ZIPLINE SUPPLEMENT: 
Participant Results 
Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
X 
 
 
 
 
 
 
 
2 PARTICIPANTS 
2.1 Participants. Describe the general characteristics of the subject populations or groups, including age range, 
gender, health status, and any other relevant characteristics. 
 
The unit of study and eventual randomization unit are the family planning clinics themselves. In 2014, 
there were 194 FP clinics in Mombasa County. Forty-three were public, while 151 were private, but 
worked with the DOH to dispense FP products provided at no cost by the government. Clinics ranged 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 9 of 46 
 
from dozens to hundreds of clients per month. In total, the county had 110,682 FP clients in 2014, of 
whom 38,418 were new (mean 21 new clients/clinic/month). About 10% of new visits were post-partum.  
In addition to FP clinics, there will be in-depth interviews conducted with FP clinic managers. These will 
likely be adults>18 years of age and both male and female.  
2.2 Inclusion and exclusion criteria. Describe the specific criteria you will use to decide who will be included in your 
study from among interested or potential subjects. Define any technical terms in lay language. 
 
Inclusion and Exclusion Criteria: 
 
Clinics will be enrolled in the study though clinic managers and clinic staff will consent to participate in 
in-depth interviews. A set of family planning clinics will be enrolled with the goal of having a wide 
range of clinic sizes, degree of urbanity and performance level of the clinic.  If clinics plan to be closed 
during the study period, they will be excluded. Additionally, if clinics are unwilling to be randomized or 
to participate in the SAIA intervention/approach then they will be excluded.  
 
2.3 Prisoners. IRB approval is required in order to include prisoners in research, even when prisoners are not an 
intended target population. 
a. Will you recruit or obtain data from individuals that you know to be prisoners? 
For records reviews: if the records do not indicate prisoner status and prisoners are not a target population, select “No”. See 
the WORKSHEET: Prisoners for the definition of “prisoner”.   
 
X 
No 
 
 
 
Yes 
→ If yes, answer the following questions (i – iv). 
 
i. Describe the type of prisoners, and which prisons/jails: 
 
      
 
ii. One concern about prisoner research is whether the effect of participation on prisoners’ 
general living conditions, medical care, quality of food, amenities, and opportunity for 
earnings in prison will be so great that it will make it difficult for prisoners to adequately 
consider the research risks. What will you do to reduce the chances of this? 
 
      
 
iii. Describe what you will do to make sure that (a) your recruitment and subject selection 
procedures will be fair to all eligible prisoners and (b) prison authorities or other prisoners will 
not be able to arbitrarily prevent or require particular prisoners from participating. 
 
      
 
iv. If your research will involve prisoners in federal facilities or in state/local facilities outside of 
Washington State: check the box below to provide your assurance that you will (a) not 
encourage or facilitate the use of a prisoner’s participation in the research to influence parole 
decisions, and (b) clearly inform each prisoner in advance (for example, in a consent form) 
that participation in the research will have no effect on his or her parole. 
 
 
Confirmed 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 10 of 46 
 
 
b. Is your research likely to have subjects who become prisoners while participating in your study?   
For example, a longitudinal study of youth with drug problems is likely to have subjects who will be prisoners at some 
point during the study. 
 
X No 
 
 
 
Yes 
→ If yes, if a subject becomes a prisoner while participating in your study, will you continue the 
study procedures and/or data collection while the subject is a prisoner? 
 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe the procedures and/or data collection you will continue with 
prisoner subjects 
 
 
 
      
2.4 Protected populations. IRB approval is required for the use of the subject populations listed here. Check the boxes 
for any of these populations that you will purposefully include in your research. (In other words, being a part of 
the population is an inclusion criterion for your study.) 
The WORKSHEETS describe the criteria for approval but do not need to be completed or submitted.   
 
Population 
Worksheet 
 
 
Children 
WORKSHEET: Children 
 
 
 
 
 
 
Children who are wards 
WORKSHEET: Children 
 
 
 
 
 
 
Fetuses in utero 
WORKSHEET: Pregnant Women 
 
 
 
 
 
 
Neonates of uncertain viability 
WORKSHEET: Neonates 
 
 
 
 
 
 
Non-viable neonates 
WORKSHEET: Neonates 
 
 
 
 
 
 
Pregnant women 
WORKSHEET: Pregnant Women 
 
 
 
 
“Children” are defined as individuals who have not attained the legal age for consent to treatments or procedures involved in 
the research and its specific setting. This will vary according to the location of the research (that is, for different states and 
countries). 
a. If you check any of the boxes above, use this space to provide any information you think may be relevant for 
the IRB to consider.  
 
N/A 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 11 of 46 
 
2.5 Native Americans or non U.S. indigenous populations. Will you actively recruit from Native American or non-U.S. 
indigenous populations through a tribe, tribe-focused organization, or similar community-based organization? 
Indigenous people are defined in international or national legislation as having a set of specific rights based on their historical 
ties to a particular territory and their cultural or historical distinctiveness from other populations that are often politically 
dominant.  
 
Examples:  a reservation school or health clinic; recruiting during a tribal community gathering 
 
X 
No 
 
 
 
Yes → If yes, name the tribe, tribal-focused organization, or similar community based organization. The 
UW IRB expects that you will obtain tribal/indigenous approval before beginning your research. 
 
 
 
 
      
2.6 Third party subjects. Will you collect private identifiable information about other individuals from your subjects? 
Common examples include: collecting medical history information or contact information about family members, 
friends, co-workers. 
“Identifiable” means any direct or indirect identifier that, alone or in combination, would allow you or another member of your 
research team to readily identify the person. For example, suppose that you are studying immigration history. If you ask your 
subjects several questions about their grandparents but you do not obtain names or other information that would allow you to 
readily identify the grandparents, then you are not collecting private identifiable information about the grandparents.  
 
X 
No 
 
 
 
Yes 
→ If yes, these individuals are considered human subjects in your study. Describe them and what 
data you will collect about them. 
 
 
 
 
      
2.7 Number of subjects. Can you predict or describe the maximum number of subjects (or subject units) you need to 
complete your study, for each subject group? 
Subject units mean units within a group. For most research studies, a group will consist of individuals. However, the unit of 
interest in some research is not the individual. Examples:   
• 
Dyads such as caregiver-and-Alzheimer’s patient, or parent and child 
• 
Families 
• 
Other units, such as student-parent-teacher 
Subject group means categories of subjects that are meaningful for your research. Some research has only one subject group – 
for example, all UW students taking Introductory Psychology. Some common ways in which subjects are grouped include: 
• 
By intervention – for example, an intervention group and a control group. 
• 
By subject population or setting – for example, urban versus rural families 
• 
By age – for example, children who are 6, 10, or 14 years old.  
 
The IRB reviews the number of subjects you plan to study in the context of risks and benefits. You may submit a Modification 
to increase this number at any time after you receive IRB approval. If the IRB determines that your research involves no more 
than minimal risk: you may exceed the approved number and it will not be considered non-compliance. If your research 
involves more than minimal risk: exceeding the approved number will be considered non-compliance.  
 
 
No 
→ If no, provide your rationale in the box below. Also, provide any information you can about the 
scope/size of the research. You do not need to complete the table. 
 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 12 of 46 
 
 
 
Example: you may not be able to predict the number of subjects who will complete an online survey 
advertised through Craigslist, but you can state that you will post your survey for two weeks and the number 
who respond is the number who will be in your study. 
 
 
      
 
X 
Yes 
→ If yes, for each subject group, use the table below to provide your estimate of the maximum 
desired number of individuals (or other subject unit, such as families) who will complete the 
research. 
 
 
 
Group name/description 
Maximum desired number of individuals (or other 
subject unit, such as families) who will complete 
the research 
*For clinical trials: provide numbers for your site and for 
the study-wide total number 
 
Preliminary review of FP clinics 
 
 
Randomization of FP clinics 
 
 
In-depth interviews 
 
 
      
      
 
      
      
 
      
       
 
 
3 INTERNATIONAL RESEARCH SETTING 
Answer the questions in this section ONLY if your research will occur at sites outside of the United 
States 
3.1 Reason for sites. Describe the reason(s) why you selected the sites where you will conduct the research. 
 
Many women in Africa remain unaware of their HIV status. However, many women access family planning 
services. By conducting this research in Kenya, we hope to make an impact on the number of women who are 
tested for HIV. The National AIDS & STI Control Programme (NASCOP) has stated that women who access FP 
services should be tested for HIV though estimates suggest that this is not actually happening.  
3.2 Local context. Culturally-appropriate procedures and an understanding of local context are an important part of 
protecting subjects. Describe any site-specific cultural issues, customs, beliefs, or values that may affect your 
research or how it is conducted. 
Examples: It would be culturally inappropriate in some international settings for a woman to be directly contacted by a male 
researcher; instead, the researcher may need to ask a male family member for permission before the woman can be 
approached. It may be appropriate to obtain permission from community leaders prior to obtaining consent from individual 
members of a group. 
 
This federal site maintains an international list of human research standards and requirements: 
 http://www.hhs.gov/ohrp/international/index.html  
 
There should not be any cultural barriers to conducting this research. FP clinics that are approached will be 
introduced to the study through stakeholders meeting and a letter of introduction from the Mombasa County 
Ministry of Health.  

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 13 of 46 
 
3.3 Site-specific laws. Describe any local laws that may affect your research (especially the research design 
and consent procedures). The most common examples are laws about: 
• 
Specimens – for example, some countries will not allow biospecimens to be taken out of the country. 
• 
Age of consent – laws about when an individual is considered old enough to be able to provide consent vary 
across states, and across countries.   
• 
Legally authorized representative – laws about who can serve as a legally authorized representative (and who 
has priority when more than one person is available) vary across states and countries. 
• 
Use of healthcare records – many states (including Washington State) have laws that are similar to the 
federal HIPAA law but that have additional requirements. 
 
If clinic staff are under 18 years of age, they will be allowed to participate only if they qualify as emancipated 
minors who are legally considered adults under Kenyan law (14 years or older and married or pregnant).  
3.4 Site-specific administrative or ethical requirements. Describe local administrative or ethical requirements that 
affect your research.  
Example: A school district may require you to obtain permission from the head district office as well as school principals before 
approaching teachers or students; a factory in China may allow you to interview factory workers but not allow you to pay 
them.  
 
We have received ethical approval from the Kenyatta National Hospital-University of Nairobi Ethics and Research 
Committee (ERC) prior to starting this research.  
 
 
4 RECRUITING and SCREENING PARTICIPANTS 
4.1 Recruiting and Screening. Describe how you will identify, recruit, and screen subjects. Include information about: 
how, when, where, and in what setting. Identify who (by position or role, not name) will approach and recruit 
subjects, and who will screen them for eligibility.   
 
Individual FP clinics will be approached after the sub-county Ministries of Health are aware of the study. A letter 
of introduction from the Mombasa County Ministry of Health will accompany study staff. Clinic managers will 
assent to the preliminary clinic review and then if selected to be randomized into the study.  
 
Clinic managers and clinic staff will be approached by study staff to discuss participating in in-depth interviews. 
Individual health workers will be recruited confidentially at a convenient time in their work day. They will be 
reassured that they are free to decline to participate.  
4.2 Recruitment materials.  
 
a. What materials (if any) will you use to recruit and screen subjects? 
Examples: talking points for phone or in-person conversations; video or audio presentations; websites; social media 
messages; written materials such as letters, flyers for posting, brochures, or printed advertisements; questionnaires filled 
out by potential subjects. 
 
A letter will be presented to FP clinic managers upon arrival to their facility. This letter details that investigators 
from the Mombasa County Department of Health, the University of Nairobi, Kenyatta National Hospital and the 
University of Washington are conducting research to learn about HIV testing at Family Planning (FP) clinics. 
This research has been approved by the Kenyatta National Hospital, University of Nairobi Ethics and Research 
Committee and by the Department of Health, Mombasa County. The research will include an initial review of 60 
Family Planning clinics. Following this review, there will be a randomized clinical trial of an implementation 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 14 of 46 
 
science tool compared to usual procedures in 24 randomly selected FP clinics.  This letter is signed by the Chief 
Officer, County Department of Health.  
b. Upload descriptions of each type of material (or the materials themselves) to the Consent Forms and 
Recruitment Materials SmartForm of Zipline. If you will send letters to the subjects, the letter should include a 
statement about how you obtained the subject’s name, contact information, and any other subject-specific 
information (such as a health condition) that is mentioned in the letter.  
HSD encourages researchers to consider uploading descriptions of most recruitment and screening materials instead of the 
materials themselves. The goal is to provide the researchers with the flexibility to change some information on the materials 
without submitting a Modification for IRB approval of the changes. Examples: 
• 
You could provide a list of talking points that will be used for phone or in-person conversations instead of a script.   
• 
For the description of a flyer, you might include the information that it will provide the study phone number and the 
name of a study contact person (without providing the actual phone number or name). In doing so, you would not 
need to submit a Modification if/when the study phone number or contact person changes. Also, instead of listing the 
inclusion/exclusion criteria, you might state that the flyer will list one or a few of the major inclusion/exclusion 
criteria. 
• 
For the description of a video or a website, you might include a description of the possible visual elements and a list of 
the content (e.g., study phone number; study contact person; top three inclusion/exclusion criteria; payment of $50; 
study name; UW researcher).  
4.3 Relationship with participant population. Do any members of the study team have an existing relationship with 
the study population(s)?  
Examples: a study team member may have a dual role with the study population (for example, being their clinical care 
provider, teacher, laboratory directory or tribal leader in addition to recruiting them for his/her research). 
 
X 
No 
 
 
 
Yes 
→ If yes, describe the nature of the relationship. 
 
 
 
      
4.4 Payment to participants. Describe any payment you will provide, including: 
• 
The total amount/value 
• 
Whether payment will be “pro-rated” so that participants who are unable to complete the research may still 
receive some part of the payment 
The IRB expects the consent process or study information provided to the subjects to include information about the number 
and amount of payments, and especially the time when subjects can expect to receive payment. One of the most frequent 
complaints received by HSD is from subjects who expected to receive cash or a check on the day that they completed a study 
and who were angry or disappointed when payment took 6-8 weeks to reach them.  
 
Do not include a description of any expenses that will be reimbursed.  
N/A 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 15 of 46 
 
4.5 Non-monetary compensation. Describe any non-monetary compensation you will provide. Example: extra credit 
for students; a toy for a child. If you will be offering class credit to students, you must provide (and describe) an 
alternate way for the students to earn the extra credit without participating in your research.  
N/A 
4.6 Consent for recruiting and screening. Will you obtain consent for any of the recruiting and screening procedures? 
(Section 8: Consent of Adults asks about consent for the main study procedures). 
“Consent” includes: consent from individuals for their own participation; parental permission; assent from children; consent 
from a legally authorized representative for adult individuals who are unable to provide consent. 
 
Examples:   
• 
For a study in which names and contact information will be obtained from a registry: the registry should have consent 
from the registry participants to release their names and contact information to researchers. 
• 
For a study in which possible subjects are identified by screening records: there will be no consent process.  
• 
For a study in which individuals respond to an announcement and call into a study phone line: the study team person 
talking to the individual may obtain non-written consent to ask eligibility questions over the phone.  
 
X 
No 
→ If no, you must still answer question 4.7 below. 
 
 
Yes 
→ If yes, describe the consent process. 
 
 
 
      
 
a. Documentation of consent. Will you obtain a written or verifiable electronic signature from the 
subject on a consent form to document consent for all of the recruiting and screening 
procedures? 
 
 
No 
→ If no, describe the information you will provide during the consent process and 
for which procedures. 
 
 
 
 
      
 
 
Yes 
→ If yes, upload the consent form to the Consent Forms and Recruitment Materials 
page of Zipline. 
 
 
 
4.7 Data and specimens for recruiting and screening. For studies where you will obtain consent, describe any data 
and/or specimens (including any PHI) you will obtain for recruiting and screening (prior to obtaining consent) and 
whether you will retain it as part of the study data.  
Obtain means to possess or record in any fashion (writing, electronic document, video, email, voice recording, etc.) for 
research purposes and to retain for any length of time. 
 
Examples: names and contact information; the information gathered from records that were screened; results of screening 
questionnaires or screening blood tests; Protected Health Information (PHI) from screening medical records to identify possible 
subjects. 
 
N/A 
 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 16 of 46 
 
5 PROCEDURES 
5.1 Study procedures. Using lay language, provide a complete description of the study procedures, including the 
sequence, intervention or manipulation (if any), time required, and setting/location. If it is available and you think 
it would be helpful to the IRB: Upload a study flow sheet or table to the Supporting Documents SmartForm in 
Zipline.  
For studies comparing standards of care: It is important to accurately identify the research procedures. See UW IRB POLICY: 
Risks of Harm from Standard Care and the draft guidance from the federal Office of Human Research Protections, “Guidance 
on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care”; October 20, 2014. 
 
Preliminary Performance Review 
 
The initial step will include a performance review of 50 FP clinics, purposively sampled to include a 
range of large and small, public and private, urban, peri-urban, and rural facilities. We will use routinely 
reported data in the FP Registers to measure the proportion of new clients counselled and tested for HIV. 
These data will be used to assign a performance score to each clinic, as shown in Figure 6. This will also 
help to confirm that different clinics are using the same registers. If multiple registers are identified, then 
we will keep records of the different versions that exist and compare between registers when able.  
Figure 6: Definitions & Calculation of Performance Score Using Data from FP Register    
While HIV testing in new clients is our primary outcome, we feel that a performance score incorporating 
both counseling and testing may provide a better baseline measure of performance. Nonetheless, we will 
also consider the individual HIV Counseling and HIV Testing scores if they do not tend to track together, 
and will adapt our randomization accordingly. If too few clinics perform any HIV counseling or testing, 
we will choose alternative measures of performance in the FP Register, such as recording of client 
number, client type (new/revisit), age, telephone number, and village/landmark. The rationale for 
conducting this initial step in 50 clinics, rather than just the 24 needed for completion of the RCT, is to 
provide a larger sample to enter the restricted randomization process. Preliminary examination of these 
data will allow us to fine-tune our choice of variables on which to balance the study arms and to optimize 
the planned length of outcome evaluation periods to capture sufficient endpoints. If any clinics seem 
inappropriate for participation (e.g. planned closure or unmatchable outliers), they may be removed prior 
to the randomization.  
Aim 1:  
In the 12 intervention facilities, the study team will first work with FP clinic staff and managers to 
identify one or more sets of best practices, which will help to guide the subsequent iterative process 
improvement steps. A combination of quantitative, qualitative, observation, and flow-mapping data will 
be used for this purpose  
Quantitative data: We will collect data on health system factors that could influence facility 
performance. We will develop a standardized reporting form, refining assessment items according to 
current implementation experience, but expect to cover domains including commodities, facility 
characteristics, human resources, information systems, management, and structure of linkage to HIV 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 17 of 46 
 
care. 
Qualitative data: We will carry out half-day direct continuous monitoring observations of FP service 
delivery at each intervention clinic to identify patient flow bottlenecks, assess wait times, and observe 
quality of staff interaction with patients. Research teams will conduct open-ended semi-structured 
individual in-depth interviews (IDIs) with clinic managers and staff from each clinic to identify key 
health system factors perceived by respondents to influence clinic performance. In-depth interviews will 
focus on organizational values and goals, senior management roles and engagement, staff presence and 
expertise, communication, coordination, problem solving, and training (58). Detailed observation and 
interview notes will be collected and compiled. We anticipate that we would notify staff of the 
observation. If a staff member did not want to be observed, we would allow them to opt out. This could 
mean either avoiding observation in their work area, or not observing within that clinic, depending on 
what was required to respect the staff member’s request. Interviews will also be recorded to check 
accuracy, clarify, and refine the final interview notes. The IDI and observation notes will be analyzed 
using Atlas.ti software to identify key themes (59).  
Sequential process flow mapping: Process mapping is an essential component of quality improvement in 
healthcare (51), allowing workers to identify key areas for intervention. To develop sequential process 
flow maps, trained research assistants will work with staff at each intervention clinic to generate an 
initial draft of the map on paper. The map will then be transferred to an electronic format using Microsoft 
Visio. The document produced in this process will be reviewed again with FP clinic staff to insure that it 
is an accurate representation of the processes and to fine tune the flow map as needed.  
Analysis of Data from Detailed Performance Review of Intervention Clinics  
We will evaluate the association between facilities’ characteristics and performance scores, both overall 
and for the individual HIV Counseling and HIV Testing components (52). Results will be interpretable as 
showing that facility factor ‘x’ is associated with ‘y’ percent more women getting through counseling, 
testing, or both. With this small dataset, we are not focused on statistical significance. Instead, we will be 
interested in the magnitude of associations and triangulation with our qualitative data and observations. 
Qualitative data will be analyzed from the interview notes and recordings, using a rapid assessment 
approach to identify recurring themes. The quantitative data, qualitative data, and flow maps will be 
summarized in a report that highlights performance facilitators and barriers. We will then review the data 
with FP managers and staff to identify unique innovations and draft an intervention guide including best 
practices to guide the subsequent steps. Given variations between facility types, there may be more than 
one set of best practices.  

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 18 of 46 
 
Step 1: Understanding the cascade from FP clinic enrollment to HIV testing. The purpose of this 
step is to help clinic staff and managers to 
answer the questions, “What are we trying to 
accomplish?”, and, “How will we know that a 
change is an improvement?” (53). Using 
readily available data from the FP Register, 
we will determine the number of new FP 
clients enrolled, counselled about HIV testing, 
and tested for HIV. To facilitate 
systems thinking, we will utilize a Microsoft 
Excel-based tool like the one that is currently 
being used in the SAIA Trial. While the present 
tool is not easily converted to a figure, an 
earlier and less detailed version used 
for studies in Mozambique highlights many of the key features of the cascade analysis tool (Figure 7) 
(55). Specifically, the tool demonstrates patient flow through the system, highlighting bottlenecks where 
patients are lost and calculating the potential increase in efficiency if loss were reduced or eliminated at 
each step, assuming that all other steps are held constant (55).  
Step 2: Use process mapping to identify modifiable bottlenecks. This step compels FP clinic staff and 
managers to address the question, “What change can we make that will result in improvement (53)?” 
Aided by the process map clinics will identify one or more processes to target for improvement.  
Step 3: Define and implement workflow adaptations to eliminate modifiable bottlenecks. This step will 
involve development of a written implementation plan addressing the questions, “Who will be 
responsible for implementing the intervention?”, “What activities will be initiated?” and “What 
materials/inputs are needed for the intervention?” (56). Small costs for materials/inputs can be covered 
from the grant budget and tracked for the costing and budget impact analysis. Interventions will be 
conceived by clinic staff and management with support from study staff using a combination of best 
practices from the intervention guide and context specific adaptations based on strengths and challenges 
at individual facilities.  
Step 4: Monitor change in performance. The goal of this step is for staff and managers to effectively 
use routinely collected data to understand the impact of workflow adaptations on the movement of 
patients through the system. Data from one to two months will be evaluated using the Excel-based tool 
introduced in Step 1. A graphic time-series display of key outcome data will be created to visually depict 
improvements.  
Step 5: Repeat the analysis and improvement cycle (steps 1-4). This step reflects the concept that 
workflow quality improvement is a continuous and iterative process, with each new cycle of innovation, 
testing, and learning building on prior cycles (53). Multiple cycles will be completed over a period of 12 
months.  
At control clinics, we will collect the same information from the FP register as the intervention arm 
(contraceptive method, age, client type, HIV counselling, HIV tested and HIV status), periodically, but 
not more often than every three months. We do not want to collect these too frequently, as this 
observation alone might have some intervention impact on the control clinics (Hawthorne Effect).  
 
Figure 7. Example of Microsoft Excel-based 
analysis tool for identifying facility-level 
bottlenecks in the care cascade

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 19 of 46 
 
Randomization:  
Randomization will be performed by a statistician from our CFAR biometrics core, who does not have 
any other role in this study. We will use a restricted randomization that considers all possible 
combinations where the clusters are balanced on new client volume and performance score, then 
randomly selects one of these combinations as the randomization. This allows analysis of the data as if 
they were unmatched.  
After randomization, clinics allocated to the control arm will receive no 
further training or support from the study team. The only study team 
involvement at control facilities following randomization will be 
outcome ascertainment. At intervention facilities, the study team will 
train FP clinic staff on the SAIA intervention and support them during 
the active intervention phase shown in blue in Figure 8. After a second 
year of observation with minimal support in the intervention arm and no 
support in the control arm, the study team will again ascertain outcomes. 
Ownership of the SAIA intervention will transition to the MOH team 
during year two of the trial. 
To understand acceptability, feasibility, complexity, and appropriateness 
of SAIA as an implementation strategy, we will conduct exit interviews 
following the Aim 1 trial.  
Aim 2  
Minimal Intervention Period during the Second Year of the Trial 
and Transition of the SAIA intervention to MOH ownership 
We would like to know if SAIA training can produce a lasting effect without long-term support from the 
study team. This seems plausible, and cost-effective, given the success of expanded HIV testing in the 
ANC setting (11). The study team will train FP clinic staff on SAIA intervention during the first year of 
the study and then provide minimal support during the second year of the 
study to assess for sustainability of this approach (Aim 2).  During year 
two, ownership of the SAIA intervention will transition to the Mombasa County Ministry of Health.  
Aim 3 
Figure 8. Study 
P
fil

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 20 of 46 
 
We will perform a costing analysis, estimating incremental cost per outcome (e.g. new HIV diagnosis). 
We will also estimate cost to scale up, and perform a budget impact analysis (BIA) from the Kenyan 
DOH perspective. Our analysis will be conducted from the programmatic/payer (DOH) perspective. We 
will estimate economic costs in this analysis, including actual financial outlays and costs of donated and 
volunteer time (Table 1).  
Activity Based Micro-Costing Methods  
We will estimate the incremental costs of implementing SAIA compared to standard procedures. 
Intervention costs will include costs associated with SAIA (start-up, personnel, transport, 
communication, consumables and overhead costs). Cost data will be collected from the study budget, 
clinic expense reports, published information on labor costs, and staff interviews. These data will be used 
to complete intervention cost worksheets at SAIA intervention and control facilities. Intervention clinic 
data will be collected during start-up, to capture the initial costs of program implementation, and again 
when the intervention is running at steady state. Costs will be categorized as fixed or variable. Variable 
costs indicate which costs could change (e.g. using free communication instead of standard telephone 
rates) and influence study estimates.  
Time-and-Motion Studies  
Time-and-motion studies will be conducted over a two-week period at each site while the intervention is 
running at full capacity. A mentee trained in this process will collect data on the time required to 
complete each step of the SAIA process. Observing multiple visits will allow estimation of the average 
time taken for each step, and any time taken for research purposes (e.g. consent or assent of clinic staff 
members) will be subtracted from the estimated time needed for the intervention. Multiple providers and 
clients will be observed to capture the range of time required for a successful SAIA intervention. We 
anticipate that we would notify staff of the observation. If a staff member did not want to be observed, 
we would allow them to opt out. This could mean either avoiding observation in their work area, or not 
observing within that clinic, depending on what was required to respect the staff member’s request. 
Through staff interviews and accounting for time available for the SAIA intervention, the number of 
patients supported by a clinic will be estimated. Together, the micro-costing data and the time-and-
motion studies will be used to estimate the average cost of new HIV-positive and HIV-negative 
diagnoses.  
Budget Impact Analysis  
For BIA, we will consider direct program costs. Direct medical costs will be measured using established 
micro- costing methods, described above, to ensure that measurements of DOH costs reflect the 
opportunity cost of the resources used in delivering services. Further, the “top-down” approach of 
expense report collection will be compared with the “bottom-up” micro-costing approach to triangulate 
Table 1. Costing characteristics 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 21 of 46 
 
and refine our cost estimates.  
Data Analysis for Costing and Budget Impact Analysis  
To the extent possible, we will use guidelines to facilitate standardization of cost data collection and 
reporting and to increase the transparency and generalizability of our results. For all key inputs and 
outputs, we will follow standard practices (57), including the guidelines by the Panel of Cost-
Effectiveness in Health and Medicine (58). We will report on all costs using a recommended discount 
rate of 3% per year, as well as an alternative 5% discount rate and undiscounted inputs. We will conduct 
sensitivity analyses around key cost inputs to account for the uncertainty in our results.  
Disclaimer: Due to restrictions on human subject research as a result of the COVID-19 pandemic, most 
activities for Aim 2, which began in February 2020, were on hold between March and August 2020. 
Activities resumed in September 2020, but were interrupted again by a strike, in response to unpaid 
wages and lack of PPE in the context of the COVID-19 pandemic. This has led to a number of our FP 
clinics being unable to participate in the trial for portions of the original 12-month period described in the 
Aims and Study Procedures. As a result, Aim 2 data collection will be extended an additional 6 months, 
for a total of 18 months of data collection for Aim 2.  
5.2 Data variables. Describe the specific data you will obtain (including a description of the most sensitive items). If 
you would prefer, you may upload a list of the data variables to the Supporting Documents SmartForm instead of 
describing the variables below. 
 
The primary outcome will be the proportion of eligible (not known HIV+) new FP clients who are tested 
for HIV during the evaluation periods at the end of 12 months of SAIA training and following an 
additional year in which intervention clinics are encouraged to continue to implement the SAIA 
intervention with minimal support from the study team. The secondary outcome will be the proportion of 
new FP clients who are counseled about HIV testing. When data are not filled, we will assume the 
counseling or testing has not been done. While we recognize that there are few variables available in 
implementation research datasets (e.g. clinic size, public/private, rural/urban), these variables will be 
collected for comparison of the randomization arms to assess balance across intervention groups.  
Our primary analysis will follow the intent-to-treat principle. The proportion of eligible new FP clients 
tested for HIV and the proportion of new FP clients counselled about HIV testing will be compared in 
intervention versus control facilities using generalized estimating equations with a binary link, clustered 
by clinic. Because there will be more than a year between the first and second assessments, we anticipate 
that these will take place as separate analyses, as they are completed.  
5.3 Data sources. For all types of data that you will access or collect for this research: Identify whether you are 
obtaining the data from the subjects (or subjects’ specimens) or whether you are obtaining the data from some 
other source (and identify the source). 
If you have already provided this information in Question 5.1, you do not need to repeat the information here. 
 
We are obtaining are data from: 1. FP registers and 2. In-depth interviews from FP clinic managers. 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 22 of 46 
 
5.4 Retrospective/prospective. For all types of data and specimens that you will access or collect for this research: 
Describe which data are: 
• 
Retrospective (i.e., exist at the time when you submit this application) 
• 
Prospective (i.e., do not yet exist at the time when you submit this application) 
• 
Both retrospective and prospective (for example, past and future school records) 
 
This is both a prospective and retrospective study as we are obtaining data from clinics records in addition to 
subject interviews.  
5.5 Identifiability of data and specimens. Answer these questions carefully and completely. This will allow HSD to 
accurately determine the type of review that is required and to assist you in identifying relevant compliance 
requirements. Review the following definitions before answering the questions: 
Access means to view or perceive data, but not to possess or record it. See, in contrast, the definition of “obtain”. 
Identifiable means that the identify of an individual is or may be readily (1) ascertained by the researcher or any other 
member of the study team from specific data variables or from a combination of data variables, or (2) associated with the 
information.  
Direct identifiers are direct links between a subject and data/specimens. Examples include (but are not limited to): name, date 
of birth, medical record number, email or IP address, pathology or surgery accession number, student number, or a collection 
of your data that is (when taken together) identifiable.  
Indirect identifiers are information that links between direct identifiers and data/specimens. Examples: a subject code or 
pseudonym.   
Key refers to a single place where direct identifiers and indirect identifiers are linked together so that, for example, coded data 
can be identified as relating to a specific person. Example: a master list that contains the data code and the identifiers linked 
to the codes. 
Obtain means to possess or record in any fashion (writing, electronic document, video, email, voice recording, etc.) for 
research purposes and to retain for any length of time. This is different from accessing, which means to view or perceive data.  
a. Will you or any members of your team have access to any direct or indirect identifiers? 
 
X 
Yes 
→ If yes, describe which identifiers and for which data/specimens.  
 
 
 
We will be abstracting data from FP registers that will have FP client names and contact 
information. We will be covering this prior to image capture.  
 
 
No 
→ If no, select the reason(s) why you (and all members of your team) will not have access to 
direct or indirect identifiers. 
 
 
 
 
 
There will be no identifiers.  
 
 
 
 
 
 
Identifiers or the key have been (or will have been) destroyed before you have 
access.  
 
 
 
 
 
 
You have (or will have) entered into an agreement with the holder of the identifiers (or 
key) that prohibits the release of the identifiers (or key) to you under any 
circumstances.   
 
 
 
 
 
 
You should be able to produce this agreement for IRB upon request. Examples: a Data Use 
Agreement, Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying 
link). This includes situations involving an Honest Broker. 
 
 
 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 23 of 46 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or key to 
you. Describe them below.   
 
 
 
 
 
 
      
b. Will you obtain any direct or indirect identifiers? 
 
X 
Yes 
→ If yes, describe which identifiers and for which data/specimens. 
 
 
 
 
We will obtain names and signatures of clinic staff for in-depth interviews. These consent 
documents will be kept in a locked cabinet. In-depths interviews will be audio 
recorded. Audio recordings will be transcribed in Kiswahili, and then translated 
verbatim into English.  Transcripts from these interviews will be de-identified.  
 
 
No 
→ If no, select the reason(s) why you (and all members of your team) will not obtain direct or 
indirect identifiers. 
 
 
 
 
 
There will be no identifiers.  
 
 
 
 
 
 
Identifiers or the key have been (or will have been) destroyed before you have 
access.  
 
 
 
 
 
 
You have (or will have) entered into an agreement with the holder of the identifiers (or 
key) that prohibits the release of the identifiers (or key) to you under any 
circumstances.   
 
 
 
 
 
 
You should be able to produce this agreement for IRB upon request. Examples: a Data Use 
Agreement, Repository Gatekeeping form, or documented email. 
 
 
There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying 
link). This includes situations involving an Honest Broker. 
 
 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or key to 
you. Describe them below.   
 
 
 
 
 
 
      
c. If you obtain any identifiers, indicate how the identifiers will be stored (and for which data). 
 
 
You will store the identifiers with the data. Describe the data to which this 
applies: 
 
 
 
 
 
 
      
 
 
You will store identifiers and study data separately but you will maintain a link 
between the identifiers and the study data (for example, through the use of a 
code). Describe the data to which this applies: 
 
 
 
 
 
 
      
 
 
 
You will store identifiers separately from the study data, with no link between 
the identifiers and the study data. Describe the data to which this applies: 
 
X 
 
 
 
 
Transcripts will be de-identified and kept separately from signed consent documents. 
Digital audio devices will be retained in possession of the interviewer until the digital 
audio content is transferred to an encrypted and password protected computer. In the 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 24 of 46 
 
event that a device needs to be stored prior to transfer of the digital audio, the device 
would be stored in a locked cabinet, within a locked room, and separately from the 
stored informed consent form that includes the clients name. 
d. Research collaboration. Will individuals who provide you with coded information or specimens for 
your research also collaborate on other activities for this research? If yes, identify the activities 
and provide the name of the collaborator’s institution/organization. 
Examples include but are not limited to: (1) study, interpretation, or analysis of the data that results from the coded 
information or specimens; and (2) authorship on presentations or manuscripts related to this work. 
N/A 
5.6 Newborn dried blood spots. Will you use newborn dried bloodspots collected in the United States on or after 
March 18, 2015? 
 
X 
No 
 
 
 
Yes → If yes, is this research supported by any federal funding (including any fellowship or career 
development award that provides salary support)? 
 
 
 
 
 
No 
 
 
 
Yes 
→ If yes, describe how you will ensure that the bloodspots were collected with 
parental permission (in compliance with a 2015 law that applies to federal-funded 
research). 
 
 
 
      
5.7 Protected Health Information (PHI). Will you access, obtain, use, or disclose a participant’s identifiable PHI for any 
reason (for example, to identify or screen potential subjects, to obtain study data or specimens, for study follow-
up) that does not involve the creation or obtaining of a Limited Data Set? 
PHI is individually-identifiable healthcare record information or clinical specimens from an organization considered a “covered 
entity” by federal HIPAA regulations, in any form or media, whether electronic, paper, or oral. 
 
X 
No 
→ If no, skip the rest of this question; go to question 5.8 
 
 
Yes 
→ If yes, answer all of the questions below. 
 
 
a. Describe the PHI you will access or obtain, and the reason for obtaining it. Be specific. 
 
      
b. Is any of the PHI located in Washington State? 
 
 
No 
 
 
 
Yes 
 
c. Describe how you will access or obtain the PHI. Be specific. 
 
      
d. For which PHI will you obtain HIPAA authorization from the subjects by having them sign a HIPAA 
Authorization form, before obtaining and using the PHI?  
 
      
 
Confirm by checking the box that you will use the UW Medicine HIPAA Authorization form 
maintained on the HSD website if you will access, obtain, use, or disclose UW Medicine PHI. 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 25 of 46 
 
 
 
Confirmed 
 
 
e. For which PHI will you NOT obtain HIPAA authorization from the subjects? 
      
 
Provide the following assurances by checking the boxes. 
 
 
The PHI will not be reused or disclosed to any other person or entity, except as required by 
law, for authorized oversight of the research study, or for other research for which the use or 
disclosure of PHI would be permitted. 
 
 
 
 
 
 
You will fulfill the HIPAA “accounting for disclosures” requirement. See UW Medicine Privacy 
Policy #25. THIS IS ONLY FOR UW RECORDS. 
 
 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
 
 
 
 
 
5.8 Genomic data sharing. Will you obtain or generate genomic data (as defined at 
https://gds.nih.gov/13faqs_gds.html)? 
 
X 
No 
 
 
 
Yes 
→ If yes, answer the question below. 
 
a. Is this research funded by NIH through a grant or contract application submitted to NIH 
on or after January 25, 2015? 
 
 
No 
 
 
 
Yes 
→ If yes, you must comply with the NIH Genomic Data Sharing policy. Complete 
the ZIPLINE SUPPLEMENT Genomic Data Sharing and upload it to the 
Supporting Documents SmartForm of Zipline. 
 
 
5.9 Data and specimen sharing/banking. Do you plan to share some or all of the data, specimens, or subject contact 
information with other researchers or a repository/database, or to bank them for your own future unspecified 
research uses? You are strongly encouraged to consider the broadest possible future plans you might have, and 
whether you will obtain consent now from the subjects for future sharing or unspecified uses. Answer NO if 
your only sharing will be through the NIH Genomic Data Sharing described in question 5.8. 
Many federal grants and contracts now require data or specimen sharing as a condition of funding, and many journals require 
data sharing as a condition of publication. “Sharing” may include: informal arrangements to share your banked 
data/specimens with other investigators; establishing a repository from which you formally share with others through written 
agreements; or sending your data/specimens to a third party repository/archive/entity such as the NIH dbGaP database, the 
Social Science Open Access Repository (SSOAR), or the UCLA Ethnomusicology Archive.   
 
X 
No 
 
 
 
Yes → If yes, answer all of the questions below. 
 
a. Describe what will be stored, including whether any direct or indirect (e.g., subject codes) 
identifiers will be stored.  
 
      

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 26 of 46 
 
 
b. Describe what will be shared, including whether direct identifiers will be shared and (for 
specimens) what data will be released with the specimens.  
 
      
 
c. Who will oversee and/or manage the sharing?.  
 
      
 
d. Describe the possible future uses, including limitations or restrictions (if any) on future uses or 
users. As stated above, consider the broadest possible uses. 
 
Examples: data will be used only for cardiovascular research; data will not be used for research on 
population origins. 
 
      
 
e. Consent. Will you obtain consent now from subjects for the banking and/or future sharing?  
 
 
No 
 
 
 
Yes 
→ If yes, be sure to include the information about this consent process in the 
consent form (if there is one) and in your answers to the consent questions in 
Section 6. 
 
 
 
f. Withdrawal. Will subjects be able to withdraw their data/specimens from banking or sharing?  
 
 
No 
 
 
 
Yes 
→ If yes, describe how, and whether there are any limitations on withdrawal. 
 
Example: data can be withdrawn from the repository but cannot be retrieved after they 
are released. 
 
      
 
g. Agreements for sharing or release. Confirm by checking the box that you will comply with UW 
(and, if applicable, UW Medicine) policies that require a formal agreement between you and 
the recipient for release of data or specimens to individuals or entities other than federal 
databases.   
 
Data Use Agreements or Gatekeeping forms are used for data; Material Transfer Agreements are used 
for specimens (or specimens plus data. Do not attach your template agreement forms; the IRB neither 
reviews nor approves them 
 
 
Confirmed 
 
5.10 Communication with subjects during the study. Describe the types of communication (if any) you will have with 
already-enrolled subjects during the study. Provide a description instead of the actual materials themselves.   
Examples: email, texts, phone, or letter reminders about appointments or about returning study materials such as a 
questionnaire; requests to confirm contact information.  
 
We anticipate conducting the exit interviews with FP clinic staff that we have been working with 
throughout the randomized clinical trial (and whom we interviewed previously for HIV counseling and 
testing practices). Study staff will text or call FP clinic staff and see if they are available to spend 
approximately 1 hour with our staff to answer some questions about SAIA. Written informed consent 
will be obtained.  
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 27 of 46 
 
In the event that social distancing prevents participants from signing the written informed consent 
document, the consent process will be over the phone with study staff reading the consent document.  
5.11 Future contact with subjects. Do you plan to retain any contact information you obtain for your subjects so that 
they can be contacted in the future? 
 
X 
No 
 
 
 
Yes 
→ If yes, describe the purpose of the future contact, and whether use of the contact information will 
be limited to your team; if not, describe who else could be provided with the contact information. 
Describe your criteria for approving requests for the information. 
 
 
 
Examples: inform subjects about other studies; ask subjects for additional information or medical record 
access that is not currently part of the study proposed in this application; obtain another sample. 
 
      
5.12 Alternatives to participation. Are there any alternative procedures or treatments that might be advantageous to 
the subjects? 
If there are no alternative procedures or treatments, select “No”. Examples of advantageous alternatives: earning extra class 
credit in some time-equivalent way other than research participation; obtaining supportive care or a standard clinical 
treatment from a health care provider instead of participating in research with an experimental drug.  
 
X 
No 
 
 
 
Yes 
→ If yes, describe the alternatives. 
 
 
 
      
5.13 Upload to the Supporting Documents SmartForm of Zipline all data collection forms (if any) that will be directly 
used by or with the subjects, and any scripts/talking points you will use to collect the data. Do not include data 
collection forms that will be used to abstract data from other sources (such as medical or academic records, or 
video recordings. 
• 
Examples: survey, questionnaires, subject logs or diaries, focus group questions. 
• 
NOTE: Sometimes the IRB can approve the general content of surveys and other data collection instruments rather than 
the specific form itself. This prevents the need to submit a modification request for future minor changes that do not add 
new topics or increase the sensitivity of the questions. To request this general approval, use the text box below to identify 
the questionnaires/surveys/ etc. for which you are seeking this more general approval. Then briefly describe the scope of 
the topics you will cover and the most personal and sensitive questions. The HSD staff person who screens this application 
will let you know whether this is sufficient or whether you will need to provide more information. 
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. You may also 
provide URLs (website addresses) or written descriptions below. Examples of materials that usually cannot be uploaded: 
mobile apps; computer-administered test; licensed and restricted standardized tests. 
• 
For data that will be gathered in an evolving way: This refers to data collection/questions that are not pre-determined 
but rather are shaped during interactions with participants in response to observations and responses made during those 
interactions. If this applies to your research, provide a description of the process by which you will establish the data 
collection/questions as you interact with subjects, how you will document your data collection/questions, the topics you 
plan to address, the most sensitive type of information you will plan to gather, and the limitations (if any) on topics you 
will raise or pursue. 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 28 of 46 
 
Use this text box (if desired) to provide: 
• 
Short written descriptions of materials that cannot be uploaded, such as URLs 
• 
A description of the process you will use for data that will be gathered in an evolving way. 
• 
The general content of questionnaires, surveys and similar instruments for which you are seeking general 
approval. (See the NOTE bullet point in the instructions above.) 
 
Minor changes may be made to the Key Informant Interview Guide for Family Planning Clinic Staff 
without submitting the materials for IRB review as long as the changes are within the scope and range of 
the current topics.  
 
 
 
The exit interview guide includes questions about acceptability, appropriateness, feasibility, and 
complexity of SAIA. The draft of the interview guide has been uploaded to Zipline.  
5.14 Send HSD a Confidentiality Agreement if you will obtain or use any private identifiable UW records without 
subject’s written consent (for example, screening medical records or class grades to identify possible subjects). 
The Confidentiality Agreement form must be completed, printed, signed, and mailed to the Human Subjects Division at Box 
359470. Your IRB application cannot be approved until we receive the Confidentiality Agreement. 
 
 
6 CHILDREN (MINORS) and PARENTAL PERMISSION 
6.1 Involvement of minors. Does your research include minors (children)?     
Minor or child means someone who has not yet attained the legal age for consent for the research procedures, as 
described in the applicable laws of the jurisdiction in which the research will be conducted. This may or may not 
be the same as the definition used by funding agencies such as the National Institutes of Health. 
• 
In Washington State the generic age of consent is 18, meaning that anyone under the age of 18 is 
considered a child.  
• 
There are some procedures for which the age of consent is much lower in Washington State. See the 
WORKSHEET: Children for details.   
• 
The generic age of consent may be different in other states, and in other countries.  
 
X 
No 
→ If no, go to Section 8. 
 
 
Yes 
→ If yes, provide the age range of the minor subjects for this study and the legal age for consent in 
your population(s). If there is more than one answer, explain.   
 
 
 
 
      
 
 
Don’t know 
→This means is it not possible to know the age of your subjects. For example, this may be 
true for some research involving social media, the Internet, or a dataset that you obtain 
from another researcher or from a government agency. Go to Section 8. 
 
 
6.2 Parental permission. Parental permission means actively obtaining the permission of the parents. This is not the 
same as “passive” or “opt out” permission where it is assumed that parents are allowing their children to 
participate because they have been provided with information about the research and have not objected or 
returned a form indicating they don’t want their children to participate. 
a. Will you obtain parental permission for: 
 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 29 of 46 
 
 
 
All of your research procedures 
→ Go to question 6.2b. 
 
 
 
 
None of your research procedures 
→ Use the table below to provide your justification, and skip 
question 6.2b. 
 
 
 
 
 
 
Some of your research procedures 
→ Use the table below to identify the procedures for which you will 
not obtain written parental permission. 
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 
Children 
Group1 
Describe the procedures or 
data/specimen collection (if any) for 
which there will be NO parental 
permission 
Reason why you will not 
obtain parental 
permission 
Will you inform 
them about the 
research?2 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
2. Will you inform them about the research beforehand even though you are not obtaining active permission? 
b. Indicate by checking the appropriate box(es) your plan for obtaining parental permission 
 
 
Both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available; or when 
only one parent has legal responsibility for the care and custody of the child 
 
 
 
 
 
 
One parent, even if the other parent is alive, known, competent, reasonably available, and shares legal 
responsibility for the care and custody of the child.  
 
 
 
 
 
 
This is all that is required for minimal risk research. 
 
If you checked both boxes, explain: 
 
      
6.3 Children who are wards. Will any of the children be wards of the State or any other agency, institution, or entity? 
 
 
No 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 30 of 46 
 
 
 
Yes 
→ If yes, an advocate may need to be appointed for each child who is a ward. The advocate must be in 
addition to any other individual acting on behalf of the child as guardian or in loco parentis. The 
same individual can serve as advocate for all children who are wards. 
 
 
 
Describe who will be the advocate(s). Your answer must address the following points: 
• 
Background and experience 
• 
Willingness to act in the best interests of the child for the duration of the research 
• 
Independence of the research, research team, and any guardian organization 
 
      
 
 
7 ASSENT OF CHILDREN (MINORS) 
Go to Section 8 if your research does not involve children (minors). 
7.1 Assent of children (minors). Though children do not have the legal capacity to “consent” to participate in 
research, they should be involved in the process if they are able to “assent” by having a study explained to them 
and/or by reading a simple form about the study, and then giving their verbal choice about whether they want to 
participate. They may also provide a written assent if they are older. See WORKSHEET: Children for circumstances 
in which a child’s assent may be unnecessary or inappropriate.   
a. Will you obtain assent for: 
 
 
All of your research procedures and child groups 
→ Go to question 7.2. 
 
 
 
 
 
 
None of your research procedures and child groups 
→ Use the table below to provide your 
justification, then skip to question 7.5. 
 
 
 
 
 
 
Some of your research procedures and child groups 
→ Use the table below to identify the 
procedures for which you will not obtain 
assent.  
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 
Children 
Group1 
Describe the procedures or 
data/specimen collection (if any) for 
which assent will NOT be obtained 
Reason why you will not obtain assent 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 31 of 46 
 
7.2 Assent process. Describe how you will obtain assent, for each child group. If your research involves children of 
different ages, answer separately for each group. If the children are non-English speakers, include a description of 
how you will ensure that they comprehend the information you provide. 
 
      
7.3 Dissent or resistance. Describe how you will identify a child’s objection or resistance to participation (including 
non-verbal indications) during the research, and what you will do in response.  
 
      
7.4 Documentation of assent.  Which of the following statements describes whether you will obtain documentation of 
assent? 
 
 
None of your research procedures and child groups 
→ Use the table below to provide your 
justification, then go to question 7.4.a. 
 
 
 
 
 
 
All of your research procedures and child groups 
→ Go to question 7.4.a, do not complete the 
table 
 
 
 
 
 
 
Some of your research procedures and/or child groups 
→ Complete the table below and then to go 
question 7.4.a 
 
 
 
 
Children 
Group1 
Describe the procedures or data/specimen 
collection (if any) for which assent will 
NOT be documented 
Reason why you will not document assent 
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If your answer is the same for all children groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
 
a. Describe how you will document assent. If the children are functionally illiterate or are not fluent in English, 
include a description of what you will do. 
 
 
      
 
b. Upload all assent materials (talking points, videos, forms, etc.) to the Consent Form and Recruitment 
Materials SmartForm of Zipline. Assent materials are not required to provide all of the standard elements of 
adult consent; the information should be appropriate to the age, population, and research procedures. The 
documents should be in Word, if possible. 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 32 of 46 
 
7.5 Children who reach the legal age of consent during participation in longitudinal research.  
Children who were enrolled at a young age and continue for many years: It is best practice to re-obtain assent (or 
to obtain it for the first time, if you did not at the beginning of their participation).  
Children who reach the legal age of consent: You must obtain informed consent from the now-adult subject for (1) 
any ongoing interactions or interventions with the subjects, or (2) the continued analysis of specimens or data for 
which the subject’s identify is readily identifiable to the researcher, unless the IRB waives this requirement.  
 
a. Describe your plans (if any) to re-obtain assent from children.  
 
      
 
b. Describe your plans (if any) to obtain consent for children who reach the legal age of consent.  
• 
If you plan to obtain consent, describe what you will do about now-adult subjects whom you are unable 
to contact.   
• 
If you do not plan to obtain consent or think that you will be unable to do so, explain why.  
 
      
7.6 Other regulatory requirements. (This is for your information only; no answer or response is required.) 
Researchers are responsible for determining whether their research conducted in schools, with student records, 
or over the Internet comply with permission, consent, and inspection requirements of the following federal 
regulations: 
• 
PPRA – Protection of Pupil Rights Amendment 
• 
FERPA – Family Education Rights and Privacy Act 
• 
COPPA – Children’s Online Privacy Protection Act 
 
 
8 CONSENT OF ADULTS 
Review the following definitions before answering the questions in this section. 
CONSENT 
is the process of informing potential subjects about the research and asking them 
whether they want to participate. It usually (but not always) includes an 
opportunity for subjects to ask questions. It does not necessarily include the 
signing of a consent form. This question is about the consent process. 
CONSENT DOCUMENTATION 
refers to how a subject’s decision to participate in the research is documented. 
This is typically obtained by having the subject sign a consent form. 
CONSENT FORM 
is a document signed by subjects, by which they agree to participate in the 
research as described in the consent form and in the consent process. 
ELEMENTS OF CONSENT 
are specific information that is required to be provided to subjects. 
PARENTAL PERMISSION 
is the parent’s active permission for the child to participate in the research.  
Parental permission is subject to the same requirements as consent, including 
written documentation of permission and required elements. 
SHORT FORM CONSENT 
is an alternative way of obtaining written documentation of consent that is most 
commonly used with individuals who are illiterate or whose language is one for 
which translated consent forms are not available. 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 33 of 46 
 
WAIVER OF CONSENT 
means there is IRB approval for not obtaining consent or for not including some of 
the elements of consent in the consent process. 
WAIVER OF DOCUMENTATION 
OF CONSENT 
means that there is IRB approval for not obtaining written documentation of 
consent. 
8.1 Groups Identify the groups to which your answers in this section apply. 
 
X Adult subjects 
 
 
Parents who are providing permission for their children to participate in research 
 
→ If you selected PARENTS, the word “consent” below should also be interpreted as applying to parental 
permission and “subjects” should also be interpreted as applying to the parents. 
8.2 The consent process. This series of questions is about whether you will obtain consent for all procedures except 
recruiting and screening and, if yes, how. 
The issue of consent for recruiting and screening activities is addressed in question 4.6. You do not need to repeat your answer 
to question 4.6. 
 
a. Are there any procedures for which you will not obtain consent? 
 
 
No 
 
 
X 
Yes 
→ If yes, use the table below to identify the procedures for which you will not obtain consent. 
“All” is an acceptable answer for some studies. 
 
 
Be sure to consider all research procedures and plans, including future contact, and sharing/banking of data and specimens 
for future work. 
Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which there will be NO 
consent process 
Reason why you will not obtain 
consent 
Will you 
provide 
subjects with 
info about the 
research after 
they finish? 
 
 
 
YES 
NO 
FP clinic 
Preliminary Clinic Review 
Clinic manager assent 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
FP clients 
FP data register 
We will not have direct access to the 
FP clients and will be obscuring 
names of clients in image capture. 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
FP clinic 
Randomized trial 
Clinic manager assent for 
participation 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all groups you can collapse your answer across the groups and/or procedures. 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 34 of 46 
 
b. Describe the consent process, if you will obtain consent for any or all procedures, for any or all groups. Address 
groups and procedures separately if the consent processes are different. 
Be sure to include: 
• 
The location/setting where consent will be obtained 
• 
Who will obtain consent (refer to positions, roles, or titles, not names).  
• 
Whether/how you will provide an opportunity for questions 
• 
How you will provide an adequate opportunity for the subjects to consider all options 
 
Assent of participation of FP clinics:  Letters of introduction from Mombasa County will be sent to 
individual clinics. Following this, clinic managers will be approached and asked for voluntary 
participation in the initial performance evaluation of the clinic. They will also be advised that they 
may be asked to continue to participate in the randomized controlled trial, and that trial participation 
could include assignment to either the intervention or control arm. The study will be explained in 
detail. After answering any questions, we will ask the manager to provide verbal assent for 
participation of the clinic and staff.  
Individual FP clinic staff: Study staff will obtain informed consent for participation in in-depth 
interviews. They will be reassured that they are free to decline to participate without penalty. The 
consent process will follow the Standard Operating Procedure that is in place for all of our research 
activities in Mombasa (see Appendix). This consent process includes the following procedures: 
Ensure that the consent process is taking place in a private area.  
Use the informed consent checklist as a guide throughout the consent process and 
enter the time at the beginning of the sheet.  
Give the consent form for the client (FP clinic staff member) to read in their 
language of choice (English or Kiswahili) and allow enough time for the staff member 
to read the consent form.   
After the potential participant reads the consent/has it read to her, review the key 
points. 
Ask the potential participant if they have any questions and discuss any questions or 
concerns.   
Clarify any misunderstanding and determine eligibility.   
Once eligibility is determined the counselor can proceed with the consent process.   
Sign the informed consent checklist and retain if the staff member enrolls   
 
The potential participant should sign and date first and must write her/his own 
name. The person obtaining consent signs last.   
Potential participants must demonstrate their understanding of key concepts about the informed 
consent before signing. Specific questions used to assess understanding may include items such as:  

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 35 of 46 
 
 
1.  Please describe what your role will be in this research study? 
 
2.  Is participation in these interviews voluntary? 
 
3.  If you do not participate, will this reflect negatively in your work evaluations or job status?  
The consent form will include the possibility of negative consequences regarding employment if staff 
members are identified as providing negative information about the workplace. We will also explain 
how we plan to keep these data confidential.  
FP clinic clients: We are requesting a waiver of consent for the FP clinic clients, as we will only be 
abstracting information that will be de-identified. 
c. Comprehension. Describe how you will ensure or test the subjects’ understanding of the information during the 
consent process. 
 
Consents will be written in both English and Kiswahili with study staff performing the consent 
process being fluent in both English and Kiswahili. In order to assess comprehension of potential 
participants for the in-depth interview, we will ask similar questions as follows:  
1.  Please describe what your role will be in this research study? 
 
2.  Is participation in these interviews voluntary? 
 
3.  If you do or do not participate, will this reflect negatively in your work evaluations or job 
status?  
d. Influence. Does your research involve any subject groups that might find it difficult to say “no” to your research 
because of the setting or their relationship with you, even if you don’t pressure them to participate?   
Examples: Student participants being recruited into their teacher’s research; patients being recruited into their healthcare 
provider’s research, study team members who are participants; outpatients recruited from an outpatient surgery waiting 
room just prior to their surgery. 
 
X 
No 
 
 
 
Yes 
→ If yes, describe what you will do, for each of these subject groups, to reduce any effect of the 
setting or relationship on their decision. 
 
 
 
 
Examples: a study coordinator will obtain consent instead of the subjects’ physician; the researcher will 
not know which subjects agreed to participate; subjects will have two days to decide after hearing about 
the study. 
 
      
e. Ongoing process. For research that involves multiple or continued interaction with subjects over time, describe 
the opportunities (if any) you will give subjects to ask questions or to change their minds about participating. 
 
FP clinics will have the opportunity to withdraw the study at any time.  

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 36 of 46 
 
8.3 Written documentation of consent. Which of the statements below describe whether you will obtain 
documentation of consent? NOTE: This question does not apply to screening and recruiting procedures which 
have already been addressed in question 4.6. 
Documentation of consent that is obtained electronically is not considered written consent unless it is obtained by a method 
that allows verification of the individual’s signature. In other words, saying “yes” by email is rarely considered to be written 
documentation of consent 
a. Are you obtaining written documentation of consent for: 
 
 
None of your research procedures  
→ Use the table below to provide your justification then go to 
question 8.4. 
 
 
 
 
 
 
All of your research procedures  
→ Do not complete the table; go to question 8.3.b. 
 
 
 
 
 
 
Some of your research procedures 
→ Use the table below to identify the procedures for which you will 
not obtain written documentation of consent from your adult 
subjects.  
 
X 
 
 
Adult subject 
group1 
Describe the procedures or data/specimen collection (if any) for 
which there will be NO documentation of consent 
Will you 
provide them 
with a written 
statement 
describing the 
research 
(optional)? 
 
 
YES 
NO 
FP clinic 
Preliminary  clinic review assent by clinic manager 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FP clients 
Data abstraction from FP register with client names removed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FP clinic 
Randomized trial with assent by clinic manager 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FP clinic staff 
Exit in-depth interviews during COVID19 social distancing guidelines 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If your answer is the same for all adult groups or all procedures, you can collapse your answer across the groups and/or 
procedures. 
8.4 Non-English-speaking or -reading adult subjects. Will you enroll adult subjects who do not speak English or who 
lack fluency or literacy in English? 
 
 
No 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 37 of 46 
 
 
X 
Yes → If yes, describe the process you will use to ensure that the oral and written information provided to 
them during the consent process and throughout the study will be in a language readily 
understandable to them and (for written materials such as consent forms or questionnaires) at an 
appropriate reading/comprehension level. 
 
 
 
Consent documents will be translated from English into Kiswahili and then back-translated 
to English to confirm consistency in language and appropriate cultural context.  
 
a. Interpretation. Describe how you will provide interpretation and when. Also, describe the 
qualifications of the interpreter(s) – for example, background, experience, language proficiency 
in English and in the other language, certification, other credentials, familiarity with the 
research-related vocabulary in English and the target language.  
 
Study staff performing the semi-structured interviews and in-depth interviews will be 
fluent in both English and Kiswahili and consent documents will be in both languages.  
All study staff are fluent in English and Kiswahili, so there is no interpretation required 
between staff and participants. In the course of a study that involves trained health 
professionals, we do not expect to identify individuals in coastal Kenya who do not 
speak one or both of these languages fluently.   
 
b. Translations. Describe how you will obtain translations of all study materials (not just consent 
forms) and how you will ensure that the translations meet the UW IRB’s requirement that 
translated documents will be linguistically accurate, at an appropriate reading level for the 
participant population, and culturally sensitive for the locale in which they will be used.  
 
Consent documents will be translated from English into Kiswahili and then back-translated to 
English to confirm consistency in language and appropriate cultural context. 
8.5 Barriers to written documentation of consent. There are many possible barriers to obtaining written 
documentation of consent. Consider, for example, individuals who are functionally illiterate; do not read English 
well; or have sensory or motor impairments that may impede the ability to read and sign a consent form. 
a. Describe your plans (if any) for obtaining written documentation of consent from potential subjects who may 
have difficulty with the standard documentation process (that is, reading and signing a consent form). Skip this 
question if you are not obtaining written documentation of consent for any part of your research.  
Examples of solutions: Translated consent forms; use of the Short Form consent process; reading the form to the person; 
excluding individuals who cannot read and understand the consent form.   
 
Consent documents will be translated from English into Kiswahili and then back-translated to English to 
confirm consistency in language and appropriate cultural context. 
8.6 Deception. Will you deliberately withhold information or provide false information to any of the subjects? 
 
X No 
 
 
 
Yes 
→ If yes, describe what information and why. 
 
 
Example: you may wish to deceive subjects about the purpose of the study. 
 
      

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 38 of 46 
 
 
a. Will you debrief the subjects later? (Note: this is not required.) 
 
 
No 
 
 
 
Yes 
→ If yes, describe how you will debrief the subjects. Upload any debriefing 
materials, including talking points or a script, to the Consent Form and 
Recruitment Materials SmartForm of Zipline. 
 
 
 
      
8.7 Cognitively impaired adults, and other adults unable to consent. 
 
a. Cognitively impaired adults and other adults unable to consent. Do you plan to include such individuals in 
your research? 
 
Examples: individuals with Traumatic Brain Injury (TBI) or dementia; individuals who are unconscious, or who are 
significantly intoxicated. 
 
X 
No 
→ If no, go to question 8.8. 
 
 
Yes 
→ If yes, answer the following questions. 
 
a.1. Rationale. Provide your rationale for including this population in your research.  
 
      
 
a.2. Capacity for consent / decision making capacity. Describe the process you will use to 
determine whether a cognitively impaired individual is capable of consent decision 
making with respect to your research protocol and setting.  If you will have repeated 
interactions with the impaired subjects over a time period when cognitive capacity could 
increase or diminish, also describe how (if at all) you will re-assess decision-making 
capacity and consent during that time. 
 
 
      
 
a.3. Permission (surrogate consent). If you will include adults who cannot consent for 
themselves, describe your process for obtaining permission (“surrogate consent”) from a 
legally authorized representative (LAR).   
 
For research conducted in Washington State, see the SOP: Legally Authorized Representative to 
learn which individuals meet the state definition of “legally authorized representative”. 
 
 
      
 
a.4. Assent. Describe whether assent will be required of all, some, or none of the subjects. If 
some, indicate which subjects will be required to assent and which will not (and why 
not). Describe any process you will use to obtain and document assent from the subjects.  
 
 
      

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 39 of 46 
 
 
a.5. Dissent or resistance. Describe how you will identify the subject’s objection or resistance 
to participation (including non-verbal) during the research, and what you will do in 
response. 
 
 
      
8.8 Consent-related materials. Upload to the Consent Forms and Recruitment Materials SmartForm of Zipline all 
consent scripts/talking points, consent forms, debriefing statements, Information Statements, Short Form consent 
forms, parental permission forms, and any other consent-related materials you will use. 
• 
Translations must be included. However, you are strongly encouraged to wait to provide them until you know that the IRB 
will approve the English versions. 
• 
Combination forms: It may be appropriate to combine parental permission with consent, if parents are subjects as well as 
providing permission for the participation of their children. Similarly, a consent form may be appropriately considered an 
assent form for older children.  
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. You may also 
provide URLs (website addresses) or written descriptions below. Examples of materials that usually cannot be uploaded: 
mobile apps; computer-administered test; licensed and restricted standardized tests. 
 
 
9 PRIVACY AND CONFIDENTIALITY 
9.1 Privacy protections. Describe the steps you will take, if any, to address possible privacy concerns of subjects and 
potential subjects. 
Privacy refers to the sense of being in control of access that others have to ourselves. This can be an issue with respect to 
recruiting, consenting, sensitivity of the data being collected, and the method of data collection. 
Examples:  
• 
Many subjects will feel a violation of privacy if they receive a letter asking them to participate in a study because they 
have ____ medical condition, when their name, contact information, and medical condition were drawn from medical 
records without their consent. Example: the IRB expects that “cold call” recruitment letters will inform the subject 
about how their information was obtained. 
• 
Recruiting subjects immediately prior to a sensitive or invasive procedures (e.g., in an outpatient surgery waiting 
room) will feel like an invasion of privacy to some individuals. 
• 
Asking subjects about sensitive topics (e.g. details about sexual behavior) may feel like an invasion of privacy to some 
individuals. 
 
All procedures will be explained to subjects prior to enrollment in the study and all conversations and will be 
conducted individually in a private setting. All hard copies of research data will be kept in a secure locked area 
accessible only to study staff requiring access to this information for research purposes.  Computerized databases 
will be maintained on password protected computers using encryption software accessible only to authorized 
research personnel. 
9.2 Identification of individuals in publications and presentations. Do you plan to use potentially identifiable 
information about subjects in publications and presentations, or is it possible that individual identities could be 
inferred from what you plan to publish or present?  
 
X 
No 
 
 
 
Yes → If yes, will you obtain subject consent for this use? 
 
 
Yes 
 
 
 
No 
→ If no, describe the steps you will take to protect subjects (or small groups of 
subjects) from being identifiable. 
 
 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 40 of 46 
 
 
      
9.3 State mandatory reporting. Each state has reporting laws that require some types of individuals to report some 
kinds of abuse, and medical conditions that are under public health surveillance. These include: 
• 
Child abuse 
• 
Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult 
• 
Sexual assault 
• 
Serious physical assault 
• 
Medical conditions subject to mandatory reporting (notification) for public health surveillance 
 
Are you or a member of your research team likely to learn of any of the above events or circumstances while 
conducting your research AND feel obligated to report it to state authorities? 
 
X No 
 
 
 
Yes 
→ If yes, the UW IRB expects you to inform subjects of this possibility in the consent form or during the 
consent process, unless you provide a rationale for not doing so: 
 
 
 
 
 
      
9.4 Retention of identifiers and data. Check the box below to indicate your assurance that you will not 
destroy any identifiers (or links between identifiers and data/specimens) and data that are part of your 
research records until after the end of the applicable records retention requirements (e.g. Washington 
State; funding agency or sponsor; Food and Drug Administration) for your research. If you think it is 
important for your specific study to say something about destruction of identifiers (or links to identifiers) 
in your consent form, state something like “the link between your identifier and the research data will be 
destroyed after the records retention period required by state and/or federal law.” 
This question can be left black for conversion applications (existing paper applications that are being “converted” into a 
Zipline application.) 
 
See the “Research Data” sections of the following website for UW Records management for the Washington State research 
rectords retention schedules that apply in general to the UW (not involving UW Medicine data): 
http://f2.washington.edu/fm/recmgt/retentionschedules/gs/general/uwgsResearch#R  
 
See the “Research Data and Records” information in Section 8 of this document for the retention schedules for UW Medicine 
Records: http://www.uwmedicine.org/about/Documents/UWMRRS-1.5.pdf 
 
 
Confirm 
9.5 Certificates of Confidentiality. Do you have or, are you planning to obtain, a federal Certificate of Confidentiality 
for your research data? 
 
X No 
 
 
 
Yes 
 
9.6 Data and specimen security protections. Identify your data classifications and the security protections you will 
provide, referring to the ZIPLINE GUIDANCE: Data and Security Protections for the minimum requirements for 
each data classification level. You cannot answer this question without reading this document. Data security 
protections should not conflict with records retention requirements. 
 
a. Which level of protections will you apply to your data and specimens? If you will use more than one level, 
describe which level will apply to which data and which specimens. 
 
 
      

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 41 of 46 
 
 
b. Use this space to provide additional information, details, or to describe protections that do not fit into one of 
the levels. 
 
 
Observation data from FP clinics will use clinic roles, instead of staff names. All observation notes 
and flow mapping will be stored on a password-protected computer and encrypted using Bitlocker or 
similar encryption software. Data that have not been decrypted appear as blank files.  
Health worker interviews will be recorded, and detailed field notes will be collected by the 
interviewer. Interview data will be stored on a password-protected computer and encrypted. 
Interview recordings will be destroyed five years after completion of the research. Digital audio 
devices will be retained in possession of the interviewer until the digital audio content is transferred 
to an encrypted and password protected computer. In the event that a device needs to be stored prior 
to transfer of the digital audio, the device would be stored in a locked cabinet, within a locked room, 
and separately from the stored informed consent form that includes the clients’ name.  
Data collected on clinic clients will be abstracted from routine health service records, and will not 
include any individual patient identifying information. These data will also be stored on a password 
protected computer and encrypted. We will physically cover name and contact information using an 
opaque material (e.g. cardboard strips) prior to scanning, so that digital records will not have any 
identifiable information. 
 
 
10 RISK / BENEFIT ASSESSMENT 
10.1 Anticipated risks. Describe the reasonably foreseeable risks of harm, discomforts, and hazards to the subjects 
and others of the research procedures. For each harm, discomfort, or hazard: 
• 
Describe the magnitude, probability, duration, and/or reversibility of the harm, discomfort, or hazard, AND 
• 
Describe how you will manage or reduce the risks. Do not describe data security protections here, these are 
already described in Question 9.6. 
• 
Consider physical, psychological, social, legal, and economic risks, including risks to financial standing, employability, 
insurability, educational advancement or reputation. 
• 
Examples of “others”: embryo, fetus, or nursing child; family members; a specific group.  
• 
Do not include the risks of non-research procedures that are already being performed.  
• 
If the study design specifies that subjects will be assigned to a specific condition or intervention, then the condition or 
intervention is a research procedure - even if it is a standard of care.  
• 
Examples of mitigation strategies: inclusion/exclusion criteria; applying appropriate data security measures to prevent 
unauthorized access to individually identifiable data; coding data; taking blood samples to monitor something that 
indicates drug toxicity. 
• 
As with all questions on this application, you may refer to uploaded documents. 
 
FP clinics: Entire FP clinics that participate in the observation period and/or in the randomized 
controlled trial are not expected to be at risk for injury or side effects. However, we acknowledge the 
potential for stress or discomfort during the observation period if this identifies individuals as 
performing poorly or highlighting negative aspects of the workplace. Steps will be taken to mitigate this 
risk as detailed in response to question 2.  
Individual staff members: No adverse effects would be expected to result directly from the semi-
structured interviews or observation of clinic procedures. However, there is potential for negative 
consequences regarding employment for staff if they are identified as performing poorly or providing 
negative information about the workplace. This could take the form of harassment, transfer, lack of 
promotion, dismissal, etc. Staff in smaller facilities might be particularly at risk for inadvertent 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 42 of 46 
 
disclosure if the content of their interviews identified them as being in a particular position. Several steps 
will be taken to mitigate this risk in response to question 2.   
FP clinic clients: For patients accessing care through FP clinics, the risks associated with seeking family 
planning services will not be different from the risks associated with seeking these services in the 
absence of the research. However, there is the potential for a loss of privacy by data abstraction from 
health records/register. Steps to mitigate this risk are detailed in response to question 2.  
 
10.2 Reproductive risks. Are there any risks of the study procedures to men and women (who are subjects, or partner 
of subjects) related to pregnancy, fertility, lactation or effects on a fetus or neonate?   
Examples: direct teratogenic effects; possible germline effects; effects on fertility; effects on a woman’s ability to continue a 
pregnancy; effects on future pregnancies. 
 
X No 
→ If no go to question 10.3 
 
 
Yes 
→ If yes, answer the following questions: 
 
a. Risks. Describe the magnitude, probability, duration and/or reversibility of the risks. 
 
 
 
      
 
b. Steps to minimize risk. Describe the specific steps you will take to minimize the magnitude, 
probability, or duration of these risks. 
Examples: inform the subjects about the risks and how to minimize them; require a pregnancy test before 
and during the study; require subjects to use contraception; advise subjects about banking of sperm and 
ova. 
 
If you will require the use of contraception: describe the allowable methods and the time period when 
contraception must be used. 
 
 
 
      
 
c. Pregnancy. Describe what you will do if a subject (or a subject’s partner) becomes pregnant 
For example; will you require the subject to immediately notify you, so that you can discontinue or modify 
the study procedures, discuss the risks, and/or provide referrals or counseling? 
 
 
 
      
10.3 Unforeseeable risks. Are there any research procedures that may have risks that are currently unforeseeable?   
Example: using a drug that hasn’t been used before in this subject population. 
 
X No 
 
 
 
Yes 
→ If yes, identify the procedures. 
 
 
 
      
10.4 Subjects who will be under regional or general anesthesiology. Will any research procedures occur while 
subjects-patients are under general or regional anesthesia, or during the 3 hours preceding general or regional 
anesthesia (supplied for non-research reasons)? 
 
X No 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 43 of 46 
 
 
 
Yes 
→ If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
Inserting an intra-venous (central or peripheral) or intra-arterial line for research 
purposes 
 
 
 
 
 
 
Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research purposes 
 
 
 
 
 
 
Obtaining a research sample from tissue or organs that would not otherwise be 
removed during surgery 
 
 
 
 
 
 
Administration of a radio-isotope for research purposes** 
 
 
 
 
 
 
Implantation of an experimental device 
 
 
 
 
 
 
Other manipulations or procedures performed solely for research purposes (e.g., 
experimental liver dialysis, experimental brain stimulation) 
 
 
 
 
 
 
If you checked any of the boxes: 
You must provide the name and institutional affiliation of a physician anesthesiologist who is a 
member of your research team or who will serve as a safety consultant about the interactions 
between your research procedures and the general or regional anesthesia of the subject-
patients. If your procedures will be performed at a UW Medicine facility or affiliate, the 
anesthesiologist must be a UW faculty member.  
 
 
      
 
 
** If you checked the box about radio-isotopes: you are responsible for informing in advance all 
appropriate clinical personnel (e.g., nurses, technicians, anesthesiologists, surgeons) about the 
administration and use of the radio-isotope, to ensure that any personal safety issues (e.g., 
pregnancy) can be appropriately addressed. This is a condition of IRB approval. 
10.5 Data and Safety Monitoring. A Data and Safety Monitoring Plan (DSMP) is required for clinical trials (as defined 
by NIH). If required for your research, upload your DSMP to the Supporting Documents SmartForm in Zipline. If 
it is embedded in another document you are uploading (for example, a Study Protocol, use the text box below to 
name the document that has the DSMP. 
 
N/A 
10.6 Un-blinding. If this is a double-blinded or single-blinded study in which the participant and/or you do not know 
the group to which the participant is assigned: describe the circumstances under which un-blinding would be 
necessary, and to whom the un-blinded information would be provided. 
 
N/A 
10.7 Withdrawal of participants. If applicable, describe the anticipated circumstances under which participants will be 
withdrawn from the research without their consent. Also, describe any procedures for orderly withdrawal of a 
participant, regardless of the reason, including whether it will involve partial withdrawal from procedures and 
any intervention but continued data collection or long-term follow-up. 
 
N/A 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 44 of 46 
 
10.8 Anticipated direct benefits to participants. If there are any direct research-related benefits that some 
or all individual participants are likely to experience from taking part in the research, describe them 
below: 
Do not include benefits to society or others, and do not include subject payment (if any). Examples: medical benefits such as 
laboratory tests (if subjects receive the results); psychological resources made available to participants; training or education 
that is provided.  
 
FP clinics:  All clinics that could be randomized will have a performance evaluation of HIV testing procedures completed. 
This evaluation alone is useful quality assurance information for the clinic. Individual clinics and managers could then act 
independently of the intervention study to make changes to procedures to increase HIV testing.  
 
Individual Staff Members:  Participation in semi-structured interviews will provide a forum for staff members to provide 
confidential feedback on how the clinic runs and any problems or issues that are commonly encountered in their work. This 
information, in an aggregated form, can then be reported back to other clinic staff and managers. In this way, participating in 
the interviews may increase clinic organization and flow, improving work satisfaction for individual staff members. 
 
Clinics in the intervention arm of the trial will have the benefit of in-depth review of procedures and application of the SAIA 
intervention to improve rates of HIV testing. This process could also improve job satisfaction for individual staff members 
and could benefit clinic attendees. 
 
FP clinic clients: Performance evaluation of clinics could lead to improved clinic function and increase in HIV testing in 
clinic clients.  
10.9 Individual subjects findings.   
 
a. Is it likely that your research will unintentionally discover a previously unknown condition such as a 
disease, suicidal intentions, or genetic predisposition? 
 
X No 
 
 
 
Yes 
→ If yes, explain whether and how you would share the information with the subject. 
 
 
 
      
 
b. Do you plan to routinely share the individual results of your study procedures with the subjects – such as 
genetic test results, laboratory tests, etc.? 
 
X No 
 
 
 
Yes 
→ If yes, complete and upload the SUPPLEMENT: Participant Results Sharing to the Supporting 
Documents SmartForm of Zipline 
 
 
10.10 Commercial products or patents. If a commercial product or patent could result from this study, describe 
whether subjects might receive any remuneration/compensation and, if yes, how the amount will be 
determined: 
 
N/A 
 
 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 45 of 46 
 
11 ECONOMIC BURDEN TO PARTICIPANTS 
11.1 Financial responsibility for research-related injuries. Answer this question only if the lead researcher is not a 
UW student, staff member, or faculty member whose primary paid appointment is at the UW.  
 
Describe who will be financially responsible for research-related injuries experienced by subjects, and any 
limitations. Describe the process (if any) by which participants may obtain treatment/compensation.   
 
      
11.2 Costs to subjects. Describe any research-related costs for which subjects may be responsible (e.g., CT scan 
required for research eligibility screening; co-pays; cost of a device; travel and parking expenses that will not be 
reimbursed). 
 
      
11.3 Reimbursement for costs. Describe any costs to subjects that will be reimbursed (such as travel expenses).   
 
      
 
 
12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, fellows, or post-docs.) Provide the following information 
about your faculty advisor.  
• 
Advisor’s name 
• 
Your relationship with your advisor (for example: graduate advisor; course instructor) 
• 
Your plans for communication/consultation with your advisor about progress, problems, and changes.  
 
N/A 
12.2 Study team communication. Describe how you will ensure that each study team member is adequately trained 
and informed about the research procedures and requirements (including any changes) as well as their research-
related duties and functions. 
 
 
There is no study team. 
 
 
 
 
The study team in its entirety will be trained for each step of the process using both lecture-based training, 
practice with CRFs, training on study specific procedures. This training will be repeated annually or if 
sooner if there are any changes.  
 
 
13 OTHER APPROVALS, PERMISSIONS, and REGULATORY ISSUES 
13.1 Other regulatory approvals. Identify any other regulatory approvals that are required for this research, by 
checking applicable boxes 
Do not attach the approvals unless requested by the IRB.   
 
Approval 
Research for which this is required 
 
 
Radiation Safety 

01/06/2017 
ZIPLINE APPLICATION: IRB Protocol 
#2003 
Version 1.3 
 
 
Page 46 of 46 
 
 
 
Procedures involving the use of radioactive materials or an ionizing 
radiation producing machine radiation, if they are conducted for research 
rather than clinical purposes. Approvals need to be attached to the 
Supporting Documents page in Zipline. 
 
 
 
 
Institutional Biosafety 
Procedures involving the transfer/administration of recombinant DNA, 
DNA/RNA derived from recombinant DNA, or synthetic DNA. 
 
 
 
 
 
 
RDRC 
Procedures involving a radioactive drug or biological product that is not 
approved by the FDA for the research purpose and that is being used 
without an IND, for basic science research (not to determine safety and 
effectiveness, or for immediate therapeutic or diagnostic purposes). 
 
 
 
 
 
 
ESCRO 
Procedures involving the use of some types of human embryonic stem 
cells. 
 
 
 
 
13.2 Approvals and permissions. Identify any other approvals or permissions that will be obtained.  For example:  
from a school, external site/organization, funding agency, employee union, UW Medicine clinical unit.   
Do not attach the approvals and permissions unless requested by the IRB. 
 
      
13.3 Financial Conflict of Interest. Does any member of the team have a Financial Conflict of Interest (FCOI) in this 
research, as defined by UW policy GIM 10?    
 
X No 
 
 
 
Yes 
→ If yes, upload the Conflict Management Plan for every team member who has a FCOI with respect 
to this research, to the Supporting Documents page of Zipline. If it is not yet available, use the text 
box to describe whether the Significant Financial Interest has been disclosed already to the UW 
Office of Research.