Financial Incentives to Increase Pediatric HIV Testing
Phase: NA
Conditions: HIV
Sponsor: University of Washington

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
FINANCIAL INCENTIVES TO INCREASE PEDIATRIC HIV TESTING (FIT STUDY) 
Study Sponsors: UW Center for AIDS Research (CFAR) International AIDS Society, 
Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) Grant  
Draft or Version Number:  4.0 
February 18, 2018 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
i 
TABLE OF CONTENTS 
 
 
PAGE 
TABLE OF CONTENTS ............................................................................................................... I 
LIST OF ABBREVIATIONS ......................................................................................................... II 
EXECUTIVE SUMMARY ........................................................................................................... III 
1 
KEY ROLES AND CONTACT INFORMATION ...................................................................... 1 
2 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ......................................... 2 
2.1 
Background Information ............................................................................................. 2 
2.2 
Rationale ................................................................................................................... 2 
3 
OBJECTIVES ........................................................................................................................ 3 
3.1 
General Objective ...................................................................................................... 3 
4 
METHODS ............................................................................................................................ 4 
4.1 
Study Design ............................................................................................................. 4 
4.2 
Sites .......................................................................................................................... 5 
4.3 
Population ................................................................................................................. 5 
4.3.1 
Inclusion Criteria ......................................................................................... 5 
4.3.2 
Exclusion Criteria ........................................................................................ 5 
4.3.3 
Recruitment, Enrollment and Randomization............................................... 5 
4.3.4 
Laboratory procedures ................................................................................ 8 
4.4 
Sample Size and Framework ..................................................................................... 8 
4.5 
Data Collection .......................................................................................................... 9 
5 
ANALYSIS PLAN ................................................................................................................ 10 
6 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................... 13 
6.1 
Potential Risks and Benefits .................................................................................... 13 
6.1.1 
Potential Risks .......................................................................................... 13 
6.1.2 
Potential Benefits ...................................................................................... 15 
6.2 
Informed Consent Process ...................................................................................... 15 
6.3 
Participant Confidentiality ........................................................................................ 16 
7 
DATA HANDLING AND RECORD KEEPING ...................................................................... 17 
7.1 
Data Management ................................................................................................... 17 
7.1.1 
Data Safety and Monitoring Plan (DSMP) ................................................. 17 
7.2 
Types of Data .......................................................................................................... 17 
7.3 
Study Records Retention ......................................................................................... 17 
8 
PUBLICATION/DATA SHARING POLICY ........................................................................... 18 
9 
LITERATURE REFERENCES ............................................................................................. 19 
APPENDICES ........................................................................................................................... 21 
APPENDIX B: STUDY FLOW CHART ...................................................................................... 24 
APPENDIX C: LIST OF DATA COLLECTION INSTRUMENTS ................................................ 25 
APPENDIX D: ORAL CONSENT FOR RANDOMIZATIONERROR! BOOKMARK NOT DEFINED. 
APPENDIX E: PARENT/CAREGIVER WRITTEN CONSENT FOR ENROLLMENT AND CHILD 
HIV TESTING ......................................................... ERROR! BOOKMARK NOT DEFINED. 
APPENDIX F: ASSENT FORM: CHILD........................... ERROR! BOOKMARK NOT DEFINED. 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
ii 
LIST OF ABBREVIATIONS 
ANC 
Antenatal Care 
ART 
Combination Antiretroviral Therapy 
CATCH 
Counseling and Testing for Children with HIV 
CCC 
Comprehensive Care Clinic 
CFAR 
Center for AIDS Research 
ELISA 
Enzyme-Linked Immunosorbent Assay 
ERC 
Ethics and Research Committee 
FI 
Financial incentives 
FIT 
Financial Incentives to Increase Pediatric HIV Testing 
HIV 
Human Immunodeficiency Virus 
IRB 
Institutional Review Board 
KES 
Kenya Shilling 
KNH 
Kenyatta National Hospital 
KPS 
Kenya Paediatric Studies 
ODK 
Open Data Kit 
OVC 
Orphaned and Vulnerable Children 
PCR 
Polymerase Chain Reaction 
PMTCT 
Prevention of Mother-to-Child Transmission 
RCT 
Randomized Clinical Trial 
TBD 
To be determined 
UON 
University of Nairobi 
VCT 
Voluntary Counseling and Testing for HIV 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
iii 
EXECUTIVE SUMMARY 
Title: 
Financial Incentives to Increase Pediatric HIV testing (FIT) 
Objective: 
The study will have 2 phases: The pilot phase and the trial phase.  
 
PILOT  
The aim of the pilot phase is to evaluate the feasibility, acceptability 
and costs of a financial incentive intervention to motivate pediatric HIV 
testing in Western Kenya. The study will evaluate 3 cash incentive 
values and determine percent uptake of testing. A post-test 
questionnaire will explore parental satisfaction, mechanisms of 
incentive effectiveness and the impact of testing on emotional health 
and pediatric healthcare utilization.  
 
TRIAL  
This pilot will provide key data for the efficient launch of the trial phase. 
The trial will test 4 levels of financial incentives and compare to an un-
incentivized control group and determine uptake and cost-
effectiveness of pediatric HIV testing in Western Kenya.  
 
PILOT 
Aims: 
1. To pilot 3 levels of FI to motivate pediatric HIV testing, 
parents/caregivers with children of unknown HIV status attending 
an HIV treatment program will receive a financial incentive of 500, 
1000, or 1500KES. Incentives will be collected when 
parents/caregivers bring children for pediatric HIV testing, and the 
proportion completing HIV testing within will be compared between 
groups.  
2. To evaluate: a) satisfaction with incentives, b) motivational 
impact/mechanism, c) emotional impact of finding out child’s HIV 
status d) impact of finding out child’s HIV status on care-seeking 
behavior for the child. 
3. Secondary aims: To develop and pilot study protocols, 
questionnaires, data systems, and expertise for the conduct of the 
future RCT. To collect program cost data. 
TRIAL  
1. To determine whether offering small financial incentives increases 
uptake of pediatric HIV testing among HIV-infected parents.  
 
2.  To evaluate the cost-effectiveness of financially incentivizing 
pediatric HIV testing in Kenya 
 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
iv 
Methods 
PILOT 
Aim 1: parents/caregivers with children of unknown HIV status 
attending HIV treatment programs will receive a financial incentive of 
500, 1000, or 1500KES. Incentives will be collected when 
parents/caregivers bring children for pediatric HIV testing, and the 
proportion completing HIV testing will be compared between groups. 
Aim 2: Post-test questionnaire to assess acceptability. 
Secondary aims: Collect program cost data. 
TRIAL 
Aim 1: Parents/caregivers with children of unknown HIV status 
attending an HIV treatment program will be randomized to receive a 
financial incentive of 0 125, 250, 500, or 1000KES. Incentives will be 
collected when parents/caregivers bring children for pediatric HIV 
testing, and the proportion completing HIV testing will be compared 
between groups.  
 
Population 
 
HIV-infected parents/caregivers and their children of unknown HIV 
status. 
Sites: 
Kisumu East County Hospital, Homabay County Referral  Hospital, 
Siaya County Referral Hospital, Additional sites in Western Kenya 
(TBD)   
Study Duration: 
24 months 
Outcomes 
PILOT  
Aim 1: Percent completing HIV testing overall and within each 
incentive stratum. 
 
Aim 2: Post-test questionnaire: 
a) Parent satisfaction with financial incentive  
b) Motivational mechanism  
c) Emotional impact of finding out child’s HIV status  
d) Impact of finding out child’s HIV status on care-seeking behavior for 
the child  
 
TRIAL 
Aim 1: Percent completing HIV testing and time to testing overall and 
within each incentive stratum. 
 
Aim 2: Incremental cost effectiveness ration (ICER) per child tested, 
positive child identified, positive child identified and linked to care, 
DALY averted comparing no incentive to 4 levels of incentives.  

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
v 
Figure 1. Schematic of Study Design: 
PILOT 
HIV+ parents of 
children with 
unknown HIV status 
(N=60)
500 KES Incentive (n=20)
1000 KES Incentive (n=20)
1500 KES Incentive (n=)
OUTCOMES
Aim 1:
% Completing testing
Aim 2:
Parental satisfaction
Motivational mechanisms
Emotional impact
Careseeking behavior
*500 KES = $5 USD
 
 
TRIAL  
OUTCOMES:
 
Uptake of testing
- % of parents completing 
testing for 1+ child(ren)
Cost-effectiveness of 
incentivizing testing
HIV-infected 
parents with 
children of 
unknown HIV 
status
(N = 800)
RANDOMIZATION
No incentive (N = 160)
125 KSH (N = 160)
250 KSH (N = 160)
500 KSH (N = 160)
1000 KSH (N = 160)
 
*500KES=$5 USD 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
1 
1 KEY ROLES AND CONTACT INFORMATION 
Project 
Directors 
Irene Njuguna, MBChB, MSc 
Study Physician 
University of Nairobi/University of Washington 
njugunairene06@yahoo.com 
 
Jennifer Slyker, PhD, MSc 
Assistant Professor, Global Health 
University of Washington 
jslyker@uw.edu  
 
Dalton Wamalwa MBChB, MMed, MPH 
Senior Lecturer, Paediatrics & Child Health 
University of Nairobi / Kenyatta National Hospital 
Email: dalton@africaonline.co.ke 
 
Co-
Investigators  
Grace John-Stewart, PhD, MPH, MD 
Professor, Medicine, Epidemiology, Pediatrics, Global Health 
University of Washington 
gjohn@uw.edu 
 
Joseph Babigumira, PhD, MS, MBChB 
Assistant Professor, Global Health, Pharmacy 
University of Washington 
babijo@uw.edu  
 
Elizabeth Maleche-Obimbo, MBChB, MMed, MPH 
Chair and Professor, Paediatrics & Child Health 
University of Nairobi / Kenyatta National Hospital 
eobimbo@hcc.or.ke  
 
Anjuli Wagner, MPH, PhDc 
Pre-doctoral Fellow, Epidemiology 
University of Washington 
anjuliw@uw.edu  
Institutions 
University of Washington 
4333 Brooklyn Avenue NE 
Box 359472 
Seattle WA 98195 USA 
 
University of Nairobi / Kenyatta National Hospital   
Off Ngong Road 
PO Box 19676 
Nairobi, Kenya 00202 
 
Funding 
agencies 
 
 
PILOT: University of Washington Center for AIDS Research (CFAR) International 
Pilot Award (Principal Investigator, J Slyker)  
 
TRIAL: International AIDS Society, Collaborative Initiative for Paediatric HIV 
Education and Research (CIPHER) Grant (Principal Investigator, I Njuguna) 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
2 
2 BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
2.1 
Background Information 
Despite encouraging parents to test older children for HIV, most of the world’s 3.2 million HIV-
infected children are diagnosed only when hospitalized or severely ill, after which they have 
extremely high mortality. Although early initiation of HIV treatment in children decreases 
mortality substantially[1], children lag adults in HIV treatment, ART-eligible children a third less 
likely to be on treatment compared to adults [2]. Although infants are systematically tested in 
prevention of mother-to-child HIV transmission (PMTCT) programs, there are no effective 
systems to systematically test older children until they are ill. We recently found that 
systematically asking HIV-infected parents to test their children increased testing 4-fold, 
however, 86% of parents still did not complete testing. New approaches are needed to 
motivate parents to test their HIV-exposed children. 
 
Financial incentives (FI) have been used to motivate desirable health behavior changes, 
including immunization[3], school attendance[4], medication adherence[5], smoking cessation in 
pregnancy[6], and tuberculosis screening[7, 8]. In the setting of HIV, FI have been used to 
motivate HIV testing [9-13], prevention [14] and ART adherence [5, 15]. The effectiveness of FI 
is hypothesized to depend upon our prioritization of immediate over long-term economic and 
health benefits [16]). Poverty alleviation also may overcome real financial and logistical barriers 
such as transport, time off work and food insecurity. In a randomized trial (RCT) of FI for 
schoolgirls and their families in Malawi, FI were associated with a >60% reduction in HIV and 
~80% reduction in HSV-2 prevalence at 18 months[14]; incentives were used to pay school 
fees, and thus eliminated the need for girls to engage in transactional sex with older men.  
 
We are aware of no studies to date that have examined FI for pediatric HIV testing. FI for 
pediatric HIV testing has many unique aspects. Unlike adults, children are unable to present 
themselves for care. There is urgency as undiagnosed HIV infection is often fatal; diagnosis is 
essential for monitoring of HIV infection and initiation of ART and prophylaxis for opportunistic 
infections. Once an undiagnosed child becomes sick, their HIV status will ultimately be revealed 
during hospitalization, a situation likely to present more stress for the parent than undergoing 
testing in a supportive outpatient setting when the child is well. Unlike FI for HIV prevention or 
adherence, where programs must be ongoing, pediatric HIV testing only need occur only once 
for children who are no longer HIV-exposed. Finally, parents may assume incorrectly that their 
child is infected; in Nairobi, ~90% of untested HIV-exposed children <12 tested negative 
(CATCH preliminary data). Learning a child’s negative status may provide enormous relief for 
the parent and improve family relationships. Parents who assume their child is positive may 
avoid accessing pediatric healthcare services for minor illnesses, for fear of an HIV test.  
2.2 
Rationale 
Testing HIV-exposed children in an outpatient setting prior to symptomatic illness potentially has 
widespread benefits for both infected and uninfected children, as well as their families. We 
hypothesize that offering a simple cash financial incentive (FI) will significantly increase pediatric 
HIV testing.  

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
3 
3 OBJECTIVES 
3.1 
General Objective 
The study will evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of a 
financial incentive intervention to motivate pediatric HIV testing in parents receiving HIV 
treatment services in Western Kenya.  
Specific Aims: 
 
PILOT 
Aim 1: To pilot 3 levels of financial incentives to motivate pediatric HIV testing, 
parents/caregivers with children of unknown HIV status attending an HIV treatment 
program will receive a financial incentive of 500 KES (approximately $5), 1000 KES ($10), 
or 1500 KES ($15). Incentives will be collected when parents/caregivers come for pediatric 
HIV testing, and the proportion completing HIV testing will be compared between groups. 
Aim 2: Among parents completing pediatric HIV testing, to evaluate: a) satisfaction with 
incentives, b) motivational impact/mechanism, c) emotional impact of finding out child’s HIV 
status d) impact of finding out child’s HIV status on care-seeking behavior for the child. 
Secondary aims: To collect program cost data. 
TRIAL  
AIM 1: To determine whether offering small financial incentives increases uptake of 
pediatric HIV testing among HIV-infected parents. We will compare the proportion of 
children tested and time to testing between parents randomized to no incentive versus 4 
different levels of financial incentive.   
 
AIM 2: To evaluate the cost-effectiveness of financially incentivizing pediatric HIV 
testing in Kenya.  
 
Aim 2a: To determine the most cost-effective incentive value for the population 
under study. We will use cost-effectiveness analysis to determine the incremental cost 
effectiveness ratio (ICER) comparing standard targeted pediatric HIV testing to three 
levels of incentivized targeted pediatric HIV testing.   
 
AIM 2b: To model the cost-utility of small FI in diverse areas and populations with 
varying underlying infection prevalence. We will conduct a cost-utility analysis to 
compare the cost per disability adjusted life year (DALY) averted between standard 
targeted pediatric HIV testing and three levels of incentivized targeted pediatric HIV 
testing in areas with varying underlying infection prevalence, age, PMTCT coverage, 
uptake of testing, health care costs, transport costs, and patient wages.   

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
4 
4 METHODS 
4.1 
Study Design 
 
Conceptual framework: Our conceptual framework is shown in Figure 2. FI may motivate 
parents who are willing to test but face logistical or financial barriers, to take action to test. 
Unwilling parents, who face extreme fear or real dangers from revealing their HIV status may 
not be motivated by FI to take action to test. Social services (SS)—including enhanced 
counseling and peer support groups—may help parents move from unwilling to willing. We 
hypothesize that the proposed FI intervention will primarily move willing parents from “Willing to 
test” to “Taking action”.  
 
Figure 2: Conceptual framework 
 
 
 
 
Study design*:  
PILOT 
This pilot will be a 3-arm (1:1:1 allocation of 500, 1000, and 1500 KES incentives), un-blinded 
randomized interventional study involving 60 HIV-infected mothers receiving HIV care at the 
Kisumu East County Hospital. The primary outcome will be % completing child HIV testing. 
Because incentive programs may have opposite effects in women and men, we will limit this 
small pilot to mothers only, while the larger trial will include both women and men and powered 
to enable sex-stratified analyses. 
TRIAL  
The trial will be a randomized controlled trial (RCT) with 5 arms (1:1:1:1:1 allocation) no 
incentive, 125 KES, 250 KES, 500 KES and 1000 KES). We will randomize 800 parents with 
children of unknown status at HIV treatment clinics in Western Kenya (Figure 1). The primary 
outcome will be % of parents completing child HIV testing and time to testing. Because 
incentive effects may vary by sex, we will conduct secondary sex-stratified analyses.  
*The values of the FI for the pilot were estimated from the CATCH study to approximate:  direct 
costs (the median cost of transport for a parent and 2 children, plus food/beverage for a day 
spent at the clinic) (500KES), direct costs plus one day’s wages (1000 KES), and direct costs 
plus two days wages (1500 KES).  
The values of the FI for the trial were adjusted after preliminary pilot study results showed very 
high uptake of testing (>70%) and no differences in testing uptake in the 3 arms. Because of the 
small sample size in the pilot but very high testing uptake compared to CATCH, lower incentive 
level (125, 250 KES) was included and the 1500 arm dropped.   
Taking
action
(testing)
Unwilling to 
test
Willing to 
test
(no action)
FI
FI
SS
SS

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
5 
 
4.2 
Sites 
The pilot will be conducted at several sites (to be determined) in Western Kenya, which may 
include: Kisumu East County Hospital, Homabay County Referral Hospital, Siaya County 
Referral hospital and other satellite HIV clinics in Western Kenya.  
4.3 
Population 
Justification for involvement of children: Infants and children have a rapid HIV disease 
progression, and in the absence of diagnosis and treatment, are at a high risk for death. Earlier 
diagnosis and treatment improves not just survival, but decreases morbidity and improves 
growth and cognitive development.  In our recent CATCH study, we approached parents 
receiving HIV care at the KNH CCC and offered to test their children of unknown status either in 
the clinic or in the home. We found that approximately 8% of children <13 years old with 
unknown HIV status were infected with HIV. This high prevalence is reflective of the parents 
who opted for testing after counseling alone; for parents refusing to test their children the 
prevalence of HIV infection is unknown. 
4.3.1 
Inclusion Criteria 
• 
Parent/caregiver receiving HIV care  
• 
Parent/caregiver* has one or more children <13 years old  
• 
Child is HIV exposed (parent/caregiver report or clinic confirmation)  
• 
Caregiver reports child’s HIV status is unknown 
For the purposes of this study, both biologic parents and *caregivers of orphaned or 
abandoned children will be eligible for enrollment and pediatric testing. The reason 
for including non-biologic caregivers is that orphans and other vulnerable children 
(OVC) often have a high risk for HIV infection, given that their parents may have died 
from HIV infection. 
4.3.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in 
this study: 
• 
At enrollment, parents/caregivers will be asked about the safety of themselves 
and their family members using a standardized assessment tool; individuals 
experiencing or at risk of abuse will not be enrolled, but will instead be referred 
for counseling through the existing mechanisms available at their clinic using 
SOPs developed and tested during the CATCH study. 
4.3.3 
Recruitment, Enrollment and Randomization 
 
Pre-trial sensitization: We will conduct pre-trial sensitization activities to inform the Community 
Advisory Board and clinic staff about the study, and to gather insights into the appropriateness 
of our proposed incentive size and format. Additionally, we will utilize pre-trial discussions to 
determine appropriate measures for incentivizing families with >1 child, and how to logistically 
and sustainably operationalize cash disbursements. 
 
Randomization: Randomization will occur at recruitment in order to minimize bias associated 
with the drop-off between referred/enrolled participants. Individuals will be provided with a 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
6 
scratch-card, which when scratched will reveal their financial incentive (FI) value. Scratch-cards 
will be valid for a 2-month period, with individual exemptions to accommodate school holidays. 
We will not enroll at randomization, but will collect minimal data needed to link scratch cards 
from origin to testing. Data collected at randomization will include eligibility checklist, parent age 
and sex, number and ages and sexes of children and telephone contact number. The scratch-
card will contain a QR code, readable by smartphone [encoding scratch-card serial number and 
value, date activated & date of expiration]. Scratch-cards will ultimately be linked between 
randomization and test by ticket code and telephone number. Comparing the phone 
number given at the two visits will enable us to tell if the original randomization scratch-card has 
changed hands, without collecting patient names. Parents who do not consent to providing a 
phone contact will still be offered study and enrollment if they present later for pediatric HIV 
testing. 
 
Recruitment and randomization 
HIV-infected adults attending the CCC will be approached by a study peer counselor.  The peer 
counselor will take oral consent, assess eligibility and randomize those who are eligible. The 
peer counselor will assess interest in scheduling for the testing visit; and if interested, participant 
will give oral consent during which they will provide the study with their phone number.  A post-
recruitment script to inform the caregiver of the risks of depression and stress associated with 
disclosure and availability of disclosure services will be read to the participant.   
 
Enrollment and HIV testing visit 
Participants will be enrolled in the study when they present for pediatric HIV testing. At the 
enrollment and testing visit the study staff (nurse counselor) will assess the individual risk of 
interpersonal violence. Participants will be given further information on the study and will give 
consent for enrollment and HIV testing for the children. Data on socio-demographics, PMTCT 
history, child medical history and costs data will be collected.  
 
Parents with multiple children requiring testing: In families where testing is needed for 
more than one child, we will offer the opportunity to test all children of unknown status in the 
household. However in order to minimize the risk of testing unexposed children, we will only 
reimburse the scratch-card FI value for the first tested child. However, we will reimburse the 
cost of transport for additional children who require testing.  
 
Parents will retain their scratch-card and present it at the HIV testing visit. If the scratch-card is 
lost, we will use the telephone number to retrieve the FI value information.  
Child HIV testing will be completed by study staff. Following completion of child HIV testing, 
parents will receive the equivalent of the value indicated on the scratch-card. We anticipate 
using M-Pesa money transfers to reimburse clients; this is done via a cellphone. This process 
will provide a more secure audit trail and poses less risk to the study staff than cash 
reimbursement from the clinic. 
Following HIV testing, parents/caregivers will be asked to complete a post-test questionnaire to 
evaluate a) satisfaction with incentives, b) motivational impact/mechanism, c) emotional impact 
of finding out child’s HIV status d) impact of finding out child’s status on care-seeking behavior, 
e) costs associated with the HIV testing visit (transport, food, time off work, etc). 
Transport reimbursement 
All participants, including participants randomized to receive no FI will be provided with transport 
reimbursement following the completion of their child’s test. In order that this does not act as 
incentive, participants will not be told about this until after they have completed testing. 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
7 
Detailed list of enrollment and testing procedures 
Listed below are HIV testing procedures for this study.  
a) Written informed consent for enrollment and HIV testing 
b) Pre-HIV-1 test counseling 
c) Collect child assent for blood draw (optional parent choice) 
d) Conduct child HIV-1 testing 
e) Provide the child’s HIV-1 test results to the parent/caregiver and provide post-test 
counseling (with assisted disclosure to the child, where desired). For children under 
18 months who require DNA PCR test, a separate visit to provide results will be 
planned once results are available 
f) Reimburse parent/caregiver with the value of their FI scratch-card 
g) Referral of child to HIV-1 care clinic of the parent/caregiver’s choice, provide parent 
with written test results, if desired.* 
h) Complete study Post-Test Questionnaire 
 
*To optimize follow-up counseling for parents/caregivers, we will request permission to provide 
the child’s test result to the CCC where the adult is enrolled, so that it can be recorded in their 
medical record. This will enable clinic staff to appropriately tailor counseling at future visits and 
to coordinate care between parent and child. For example, if the child tests HIV negative and is 
no longer HIV-exposed, the parent will not be asked again to test their child; if exposure is 
ongoing the parent will be prompted to re-test, as appropriate. If the child tests positive, parents 
will receive further counseling and information, which may include reminders to follow-up with 
child enrollment in the Youth CCC program, and counseling regarding pediatric care, treatment, 
and disclosure. 
 
Assessment of linkage to care: 
All HIV positive children will be followed up to assess linkage to care. We will contact 
parents/caregivers at 1, 3, 6, 9 and 12 months post diagnosis. Study staff will make very attempt 
to ensure HIV positive children link to care. Caregivers who have not linked to care will be 
referred for additional psychosocial support as needed.  
 
End of study follow-up: 
 
HIV-negative children:  
At completion of HIV test visit 
HIV-positive children:  
At confirmation of linkage to care or at 12 month post-test call 
Reminders and tracing for missed testing visits: 
Once a child/caregiver pair is randomized in the study, the study staff will make a reasonable 
effort to test the child for HIV.  Participants who are randomized and do not present at clinic will 
be called using the telephone number obtained at randomization.  
 
Participant withdrawal  
Participants may voluntarily withdraw from the study for any reason at any time. The site 
investigator may also withdraw participants from the study in order to protect their safety.  
 
Alternatives to participation 
Parents who wish to test their children but do not wish to participate in the study will be referred 
to the VCT. 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
8 
 
4.3.4 
Laboratory procedures 
All specimen transport, processing, testing and results reporting will be conducted in compliance 
with standards of good clinical and laboratory practice.  The study site will establish standard 
operating procedures, including specimen chain of custody and quality assurance and quality 
control procedures, for all protocol-specified laboratory tests prior to study initiation. As the 
transmission of HIV can occur through contact with contaminated needles, blood and blood 
products, appropriate precautions will be employed by all personnel in the drawing of blood, 
handling and shipping of blood samples during this study, as currently recommended by the 
United States Centers for Disease Control and Prevention. 
Study site staff will collect blood to test for HIV but samples will NOT be stored for future use. 
Rapid HIV-1 antibody test:  Children (aged >18 months and not breast-feeding) who are 
recruited to the study will be given a rapid HIV-1 test. This assay is a commercial ELISA kit to 
test for HIV-1 antibodies in blood that gives results within half an hour of specimen collection 
and can be administered in the home or in clinic. 
HIV-1 DNA PCR Assay:  For children who are <18 months or have breast fed in the last 6 
weeks, a few drops of blood will be collected on a filter paper for HIV-1 diagnosis, and subjected 
to a HIV-1 DNA PCR assay at the designated local laboratory.  If results from this assay are 
indeterminate, the child's blood sample will be sent to a local laboratory for HIV-1 RNA testing. 
4.4 
Sample Size and Framework 
PILOT: 
A total of 60 parent/caregivers will be offered 3 levels of financial incentives (1:1:1). This pilot 
study will be used to compare the proportion of parents testing their children for HIV in the 
setting of three financial incentives, but this study is not powered to determine efficacy.  
Outcome Measures 
Aim 1: Enrollment and testing uptake 
• 
% completing pediatric HIV testing, overall and within different incentive strata 
Aim 2: Post-test questionnaire 
• 
Parent satisfaction with financial incentive  
• 
Motivational mechanism  
• 
Emotional impact of finding out child’s HIV status  
• 
Impact of finding out child’s HIV status on care-seeking behavior for the child 
TRIAL:  
Sample size: Given 160 adults in each of 5 randomization arms, we will have >80% power to 
detect a minimum of 10-20% difference between each of the arms (Table 1), a substantial 
improvement in testing rates. Assumptions for the un-incentivized group are based on data from 
CATCH. We will have sufficient power to detect differences over a range of uptake scenarios 
(Table 1).  
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
9 
Table 1: Power calculations 
N=160 
No incentive
Power
125 KES
Power
250 KES
Power
500 KES
Power
1000 KES
0.13
>0.99
0.40
0.95
0.60
0.98
0.80
0.71
0.90
0.13
0.96
0.30
0.96
0.50
0.96
0.70
0.90
0.85
0.13
0.84
0.26
0.82
0.40
0.95
0.60
0.82
0.75
0.13
0.39
0.20
0.54
0.30
0.96
0.50
0.78
0.65
 
4.5 
Data Collection 
 
Enrollment and testing visit: A brief enrollment questionnaire will assess characteristics of 
participants, including: previous PMTCT history, time since parental diagnosis, parent on ART, 
caregiver relationship to child, previous child illnesses and costs information.  
Post-test interviews: The child’s HIV test result will be recorded following the test. Following the 
HIV test, parents will complete a short interview to assess a) satisfaction with FI, b) motivational 
impact/mechanism of FI, c) impact of finding out child’s HIV status on caregiver/family emotional 
health, and d) impact of finding out child’s HIV status on care-seeking behavior for the child. 
Costs: We will collect program cost and medical care resource utilization data to enable 
estimation of direct medical costs, direct non-medical costs and indirect costs. Direct medical 
costs include HIV test kits, medications, other lab tests, and personnel. Direct non-medical costs 
include incentive and transportation costs.  Indirect costs include wages lost due to time off of 
work. Data from local sources and literature will be used to estimate unit costs for resource-use 
estimates and complement data collected in the study. 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
10 
5 ANALYSIS PLAN 
PILOT Summary 
Aim 1: 
 
This pilot will compare the proportion of parents testing their children for HIV in the setting of 
three financial incentives. Table 3 describes the key variables that will be collected to enable 
comparisons between arms. Specifically, we will compare the proportion of enrolled parents 
completing testing in arms i (500 KES), ii (1000 KES), and iii (1500 KES): Xi/Ni vs Xii/Nii vs 
Xiii/Niii. With this small sample size, we will not have statistical power to compare arms; however, 
we expect to observe a dose-response curve of increasing uptake with increasing FI, known as 
a demand curve. We will use this demand curve to identify incentive levels after which there are 
diminishing returns—that is, uptake begins to plateau with increasing levels of FI. If a plateau is 
observed, we will evaluate program costs and the proportion tested to determine the optimal 
value for the FI for the RCT. If the proportion testing is similar among the three FIs, we will 
utilize the lowest value to minimize costs.  
 
 
Table 2. Key data collected during the pilot. 
S 
Total clients screened 
N 
Number of eligible clients given scratch-card 
E 
Number of clients enrolled into cohort study 
X 
Number completing pediatric testing  
Y 
Number not completing pediatric testing 
Notes. Arm i=500KES, arm ii=1000KES, arm iii=1500KES 
 
Aim 2: 
 
The post-test questionnaire will be used to reassess the level and format of financial incentives 
employed in the study as we design the RCT. If incentives are felt to be “too big to turn down,” 
we will reassess their suitability in the RCT. Answers regarding the format, motivational 
impact/mechanism of the FI, the emotional impact of testing and potential effect on health-
seeking behavior for the child will be used to refine protocols, improve counseling, and inform 
how best to include additional downstream outcomes (% children enrolled in HIV care 
programs, retention, % on ART) for the larger trial. 
 
TRIAL Summary:  
Aim 1: We will compare the proportion of parents testing and time to testing between groups 
randomized to no incentive versus incentive, and between the 5 arms (Figure 3), using a series 
of chi-squared tests. If randomization fails to balance potential confounders, we will compare the 
proportion of parents testing between arms using relative risk regression, adjusting for 
unbalanced confounders and time to testing using a stratified Cox proportional hazards 
regression model, adjusting for confounders. (Table 4). 
Aim 2:  We will plot a dose-response curve of testing proportion over increasing FI (demand 
curve, Figure 3). Demand curves will identify FI levels after which there are diminishing returns 
(uptake plateaus). We will conduct a cost-effectiveness analysis (Aim 2a) and a cost-utility 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
11 
analysis (Aim 2b) comparing un-incentivized to three levels of FI. This will enable estimation of 
an incremental cost-effectiveness ratio (ICER) per:  
Aim 2a: a) child tested, b) HIV-infected child identified, c) child linked to care 
Aim 2b: a) disability adjusted life years (DALYs) averted 
0 
0.1 
0.2 
0.3 
0.4 
0.5 
0.6 
0.7 
0.8 
0.9 
1 
No incentive 
Smallest 
incentive 
Low incentive 
Medium 
incentive 
High incentive 
 
 
Figure 3: Example demand curves: We will plot a dose-response curve (demand curve) of proportion of adults who 
test their children with each increasing level of financial incentive. Demand curves will identify FI levels after which 
there are diminishing returns (uptake plateaus). These tools will be accompanied by a cost-effectiveness analysis to 
quantitatively identify levels after which increased incentives do not result in sustained cost-effectiveness. 
We will model cost-effectiveness and cost-utility use decision trees (accompanied by Markov 
models for Aim 2b), and a lifetime horizon. We will perform these analyses from the perspective 
of the Kenyan government and from a societal perspective24.  We will conduct a series of one 
way and probabilistic sensitivity analyses. For aim 2b, sensitivity analyses will be used to 
estimate the differences in cost-utility by region in Kenya, informed by region-specific 
parameters for underlying infection prevalence, age, PMTCT coverage, uptake of testing, health 
care costs, transport costs, and patient wages (Table 4).  
Table 4: Data analysis: TRIAL 
 
 
Aim 1 
Aim 2a 
Aim 2b 
Data 
Proportion of parents 
completing testing in no, low, 
medium, and high incentives 
arms  
Direct medical costs: HIV test kits, medications, other lab tests, 
and personnel salaries 
Direct non-medical costs: incentive and transportation  
Indirect costs: wages lost due to time off of work.  
Data from local sources and literature will be used to estimate unit 
costs for resource-use estimates and complement data collected 
in the study.  
 
Outcomes: Numbers of children testing, testing positive, and 
linked to care will be measured directly during the study period. 
Disability adjusted life years averted (DALYs) will be estimated 
based on existing literature describing survival and disease 
progression in HIV-infected treated and untreated pediatric 
cohorts.  

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
12 
Analysis 
technique 
Chi-squared tests. If 
confounders not balanced by 
randomization, relative risk 
regression controlling for 
confounders 
Cost-effectiveness analysis in terms 
of cost per additional a) child tested, 
b) positive child identified, c) child 
linked to care; decision tree, 
univariate & probabilistic sensitivity 
analyses 
Cost-utility analysis in 
terms of cost per DALY 
averted; decision trees & 
Markov models, univariate 
and probabilistic sensitivity 
analyses 
Power 
Given 160 adults in each of 5 
randomization arms, we will 
have >80% power to detect a 
minimum of 10-20% difference 
between each of the arms 
(Table 1) 
N/A 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
13 
6 ETHICS/PROTECTION OF HUMAN SUBJECTS 
Institutional Review Board:  
This is a collaborative research proposal that will involve field and laboratory procedures in 
Nairobi, Kenya and data analyses in Nairobi and Seattle, Washington. The study will be 
reviewed by the Institutional Review Board (IRB) at the University of Washington and the 
Kenyatta National Hospital/University of Nairobi (KNH/UON) Ethics and Research Committee 
(ERC). The study will not recruit subjects prior to approval from both the University of 
Washington IRB and the KNH/UON ERC. 
6.1 
Potential Risks and Benefits 
 
Although PMTCT services are widely implemented and have wide coverage for infants, there 
are currently no routinely available systematic approaches to diagnosing older children with HIV 
infection prior to symptomatic illness. Early HIV diagnosis reduces morbidity and mortality and 
improves growth and development. This study has potential to inform novel strategies to 
increase HIV testing rates for HIV-exposed children. 
6.1.1 
Potential Risks 
 
Parent/caregiver: Parents may feel stress and discomfort at the prospect of testing their 
children for HIV infection, and in completing the test. Despite our attempt to make the 
financial incentive non-coercive in its value, some parents may find this value too big to turn 
down. Finding out the child’s HIV test result is positive may cause stress and depression. 
Although we will do our best to preserve the parent’s/caregiver’s privacy with regard to their 
own HIV status, and that of children testing positive, there is a risk for inadvertent 
disclosure of parental or child HIV status to the child being tested. 
 
Children: The HIV test itself involves a blood draw which children may find this frightening, 
stressful, and mildly painful. They may experience confusion at the conduct of the test if 
they are not told by the parent/caregiver why they are being tested.  
There is potential risk of stress and depression in children related to learning their 
caregiver’s HIV status if caregivers disclose either before or after child HIV testing. 
 
 
 
Confidentiality: There is a non-negligible risk of loss of confidentiality of HIV status or other 
medical information.  All key personnel have been trained in the Protection of Human 
Subjects and HIPAA. The Kisumu Clinical Trials field team has many years experience 
managing HIV-infected children in the setting of clinical trials, and will take every precaution 
to protect participants’ and their children’s confidentiality. Study staff will take strict 
measures to maintain confidentiality for participants.  All data will be kept in password-
protected databases, in a locked study office, accessible only to study personnel. Study 
identifiers will be linked to coded data; clinical staff will have access to patient identifiers, 
but the analysts will receive only coded data. Links between patient identifiers and study 
codes will be kept for a period of 5 years after the end of the study, at which time the link 
between patient IDs and codes will be destroyed. 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
14 
Alternatives to study participation:  Adults who wish to have their children tested for HIV or 
but do not wish to participate in the study will be referred to VCT for HIV counseling and 
testing.  
 
Potential SAEs and how these will be handled: 
 
Anticipated SAE from this study could include: parent/caregiver psychological trauma from a positive HIV 
test result, injury to the caregiver/parent/child from interpersonal violence from a partner, or injury to the 
child from the blood draw for the HIV test. 
 
Risk for these factors will be assessed at the enrollment/HIV testing visit, and additionally during follow-up 
communications to assess linkage-to-care. If SAEs are uncovered, these will be reported to the study 
personnel, who will report these to the IRB and ERC. 
 
After recruitment caregivers who are randomized will be informed of the risk of depression and 
stress in children related to HIV disclosure and will be informed that there are services available 
in the clinic to support this process. They will also be informed that disclosure of caregiver HIV 
status to the child is not necessary for enrollment. (Post-randomization recruitment script) 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
15 
 
6.1.2 
Potential Benefits 
 
Parents/caregivers of children testing negative: Based on data from our earlier study at this 
site, we anticipate approximately 90% of children will test HIV negative. For parents with 
children testing negative, receiving these test results will provide enormous psychological 
relief. Parents who had previously been reluctant to bring the child for other medical care 
(for fear of the child being tested for HIV) may be more willing to bring the child for 
treatment following the test. This may lead to better healthcare for the child. 
 
Parents of children testing positive: Receipt of a positive test result may be a relief to some 
parents, compared with the stress of “not knowing”. Upon receiving a positive result, 
parents will be linked to treatment services for their children. These services are free, and 
include treatment monitoring, prophylaxis for opportunistic infections, antiretroviral therapy, 
and psychosocial services will help HIV-infected children to live longer healthier lives. 
Parents who had previously been reluctant to bring the child for other medical care (for fear 
of the child being tested for HIV) may be more willing to bring the child for treatment 
following the test. This may lead to improved healthcare for the child. 
 
Child: Identifying the child’s HIV status will enable parent/caregivers to make better-
informed decisions regarding their treatment and care. Children with undiagnosed HIV 
infection are at a very high risk of death, and starting antiretroviral therapy (ART) as soon 
as possible is lifesaving. Starting ART also reduces the risk of other associated infections, 
growth and developmental impairment. Knowing the child’s status also enable parents and 
healthcare providers to appropriately tailor psychosocial and behavioral messages to 
children as they enter adolescence. 
 
Societal: The results of this this study may benefit society broadly by providing a new tool 
to encourage pediatric HIV testing. If acceptable, feasible, and cost-effective this 
approach could be implemented at other sites to increase HIV testing rates children. 
 
The societal costs of having a large population of children with unidentified HIV infection 
include impaired cognitive development, poor school performance, reduced earning 
potential in adulthood, and high medical costs for those surviving childhood. Early HIV 
diagnosis thus improves long-term survival and reduces long-term economic costs. 
 
Additionally, adolescents becoming sexually active have the potential to pass on HIV 
infection if undiagnosed. Treatment initiation greatly reduces the risk of onward HIV 
transmission, so increasing the number of children on treatment has the potential to 
further reduce downstream infection in their future sexual partners. 
 
6.2 
Informed Consent Process 
 
Adults:  
A short oral consent will be obtained from caregivers prior to randomization. Oral consent will be 
collected to obtain phone numbers.  Written, informed consent will then be obtained from all 
study participants for enrollment and child testing. Prior to enrollment, participants will have the 
proposed study explained to them, will have their questions answered, and will be asked to 
provide written consent for their participation. Interviews will be conducted in private by trained 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
16 
personnel, and data collected will be kept confidential and access restricted to study staff. 
Consent forms will be available in the subject’s preferred language of English or Kiswahili or 
Dholuo. 
 
Children: Children aged 7 years old and above will be asked to provide written assent for blood 
draw, for parents who agree to the assent procedures. Children will not be told the purpose of 
the test unless the parent desires this and communicates this to study staff at the enrollment 
counseling visit.  
 
Mature Minors: Adolescents less than 18 years who have their own children will be eligible to 
give consent and will not be excluded from the study.  
 
6.3 
Participant Confidentiality 
Study staff will take strict measures to maintain confidentiality for participants. All study staff 
have been trained in data protection and privacy. All data will be kept in password-protected 
databases, in a locked study office, accessible only to study personnel. Study identifiers will be 
linked to coded data; clinical staff will have access to patient identifiers, but the analysts will 
receive only coded data. Links between patient identifiers and study codes will be kept for a 
period of 5 years after the end of the study, at which time the link between patient IDs and 
codes will be destroyed. 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
17 
7 DATA HANDLING AND RECORD KEEPING 
7.1 
Data Management  
 
Data collection: Data collection instruments will be developed by the protocol team. Our team 
plans to use mobile phones and tablets in lieu of paper forms to collect data for this study. 
Electronic data collection will improve data accuracy by eliminating the extra step of entering 
data from paper data collection forms into an electronic database. The program used to collect 
and store the data is entitled Open Data Kit (ODK).  
In comparison to paper data collection, electronic data collection is potentially more secure. All 
data are password protected from the moment of data collection. Data are stored on the 
password-protected phone/tablet until they are uploaded to the study’s secure electronic 
database, at which point they are automatically deleted from the phones and no longer 
accessible. Data are transmitted and stored using a high level of encryption – an “HTTPS” 
website utilizing SSL/TLS (secure socket layer/ transport layer security) – which is comparable 
to the security used by groups such as Google for data protection. This level of security is 
present for all mediums of data transmittal (e.g. 3G or wireless internet connection). There still 
exists a small possibility that the electronic database could be compromised, but this risk is 
comparable to more traditional data management systems that include paper forms entered into 
an electronic database.  
Data management: A dedicated data manager will be responsible for the management and 
monitoring of study data. The data team will communicate frequently with the Seattle-based 
team for reporting, data cleaning, study monitoring, and interim analyses. Weekly enrollment 
and testing reports will be generated to track study progress and ensure quality data collection. 
7.1.1 
Data Safety and Monitoring Plan (DSMP) 
 
Given the very low risk of adverse effects for participants posed by this study, we will use a Data 
Safety Monitoring Plan (DSMP) to ensure that any unforeseen negative impact of study 
participation on linkage to care are identified and addressed. At the midpoint of the intervention 
phase, the PI will determine if there is any evidence of a negative impact associated with the 
intervention by looking at rates of early linkage to care. If we find any evidence of harm during 
the intervention phase, the investigators will assess the evidence and consider halting the study 
and providing supplemental counseling to encourage engagement in care. 
7.2 
Types of Data 
Questionnaires 
HIV test results 
Program cost data 
7.3 
Study Records Retention 
The link between study identifiers and patient IDs will be kept under lock and key. The link 
between patient identifiers and study ID codes will be retained for 5 years following completion 
of the study, in order to maintain integrity of the data. After this time, links to identifiable data will 
be destroyed. 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
18 
8 PUBLICATION/DATA SHARING POLICY 
 
This study will comply with the NIH Public Access Policy, which ensures that the public has 
access to the published results of NIH funded research. It requires scientists to submit final 
peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed 
Central upon acceptance for publication.   
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
19 
9 LITERATURE REFERENCES 
1. 
Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, et al. Early antiretroviral 
therapy and mortality among HIV-infected infants. N Engl J Med 2008,359:2233-2244. 
2. 
UNAIDS. The Gap Report. In; 2014. 
3. 
Weaver T, Metrebian N, Hellier J, Pilling S, Charles V, Little N, et al. Use of contingency 
management incentives to improve completion of hepatitis B vaccination in people 
undergoing treatment for heroin dependence: a cluster randomised trial. Lancet 
2014,384:153-163. 
4. 
Rivera JA, Sotres-Alvarez D, Habicht JP, Shamah T, Villalpando S. Impact of the 
Mexican program for education, health, and nutrition (Progresa) on rates of growth and 
anemia in infants and young children: a randomized effectiveness study. JAMA 
2004,291:2563-2570. 
5. 
Javanbakht M, Prosser P, Grimes T, Weinstein M, Farthing C. Efficacy of an 
individualized adherence support program with contingent reinforcement among 
nonadherent HIV-positive patients: results from a randomized trial. Journal of the 
International Association of Physicians in AIDS Care 2006,5:143-150. 
6. 
Donatelle RJ, Prows SL, Champeau D, Hudson D. Randomised controlled trial using 
social support and financial incentives for high risk pregnant smokers: significant other 
supporter (SOS) program. Tobacco control 2000,9 Suppl 3:III67-69. 
7. 
Malotte CK, Hollingshead JR, Rhodes F. Monetary versus nonmonetary incentives for 
TB skin test reading among drug users. American journal of preventive medicine 
1999,16:182-188. 
8. 
Malotte CK, Rhodes F, Mais KE. Tuberculosis screening and compliance with return for 
skin test reading among active drug users. American journal of public health 
1998,88:792-796. 
9. 
McCoy SI, Shiu K, Martz TE, Smith CD, Mattox L, Gluth DR, et al. Improving the 
efficiency of HIV testing with peer recruitment, financial incentives, and the involvement 
of persons living with HIV infection. Journal of acquired immune deficiency syndromes 
2013,63:e56-63. 
10. 
Thornton RL. The Demand for, and Impact of, Learning HIV Status. The American 
economic review 2008,98:1829-1863. 
11. 
Haukoos JS, Witt MD, Coil CJ, Lewis RJ. The effect of financial incentives on adherence 
with outpatient human immunodeficiency virus testing referrals from the emergency 
department. Academic emergency medicine : official journal of the Society for Academic 
Emergency Medicine 2005,12:617-621. 
12. 
Lee R, Cui RR, Muessig KE, Thirumurthy H, Tucker JD. Incentivizing HIV/STI testing: a 
systematic review of the literature. AIDS Behav 2014,18:905-912. 
13. 
Nglazi MD, van Schaik N, Kranzer K, Lawn SD, Wood R, Bekker LG. An incentivized 
HIV counseling and testing program targeting hard-to-reach unemployed men in Cape 
Town, South Africa. J Acquir Immune Defic Syndr 2012,59:e28-34. 
14. 
Baird SJ, Garfein RS, McIntosh CT, Ozler B. Effect of a cash transfer programme for 
schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster 
randomised trial. Lancet 2012,379:1320-1329. 
15. 
Rigsby MO, Rosen MI, Beauvais JE, Cramer JA, Rainey PM, O'Malley SS, et al. Cue-
dose training with monetary reinforcement: pilot study of an antiretroviral adherence 
intervention. Journal of general internal medicine 2000,15:841-847. 
16. 
Operario D, Kuo C, Sosa-Rubi SG, Galarraga O. Conditional economic incentives for 
reducing HIV risk behaviors: integration of psychology and behavioral economics. Health 
psychology : official journal of the Division of Health Psychology, American 
Psychological Association 2013,32:932-940. 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
20 
17. 
Kohler H-P, Thornton RL. Conditional Cash Transfers and HIV/AIDS Prevention: 
Unconditionally Promising? World Bank Economic Review 2011. 
 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
21 
APPENDICES 
The following documents are included as appendices: 
• 
Appendix A: Study Timeline 
• 
Appendix B: Study Flow Chart 
• 
Appendix C: List of Data Collection Instruments 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
22 
APPENDIX A: Study Timeline 
Pre-Award Activities: 
• 
Protocol development 
• 
Regulatory approvals (human subjects, foreign clearance) 
• 
Questionnaire development 
• 
First CAB meeting to introduce the study 
 
Award Activities: 
YEAR 1 
1st Quarter (Site prep): 
• 
Finalize SOPs, staff training, site preparation 
• 
Development of data systems & database  
 
2nd Quarter (Data collection) PILOT 
• 
Recruitment (estimated 2-3 weeks)  
• 
Follow-up and HIV testing visits (estimated 2-3 months) 
• 
Cost data collection 
 
3rd Quarter (Analysis): 
• 
Pilot data analysis 
• 
Begin Recruitment/Enrollment for TRIAL 
 
4th Quarter (Presentation and Stakeholder feedback): 
• 
TRIAL Enrollment 
• 
Manuscript submission for PILOT 
• 
Stakeholder feedback (CAB and staff CCC meetings) 
 
YEAR 2  
Quarter 1 and 2 
Enrollment and follow-up  
Follow-up and testing visits 
 
Quarter 3 
Complete testing visits  
 
Quarter 4 (Presentation and Stakeholder feedback): 
• 
Data analysis for larger trial  
• 
Manuscript submission 
• 
Stakeholder feedback (CAB and staff CCC meetings 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
23 
Post-Award Activities: 
• 
CFAR progress and closeout report 
• 
CIPHER closeout report  

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
24 
APPENDIX B: Study Flow Chart 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
25 
APPENDIX C: List of Data Collection Instruments 
Form Name 
Purpose 
Responsi
ble Party 
Format 
and 
Security 
Status 
Recruitment 
Log 
Collection of basic 
parent/caregiver 
information and eligibility, 
record randomization 
allocation 
Study 
Peer 
Counselor 
ODK 
Draft  
Enrollment & 
Testing 
Questionnaire 
Collection of detailed 
parent/caregiver 
information, record of 
testing visit & result, 
documentation of FI 
reimbursement, 
documentation of referral 
for HIV+ children 
Study 
Nurse 
Counselor 
ODK 
Draft  
Post-test 
Questionnaire 
Assess acceptability of FI, 
collect cost data 
Study 
Nurse 
Counselor 
ODK 
Draft  
PCR test 
results 
Record and provide parent 
with HIV PCR result for 
children <18 months 
Study 
Nurse 
Counselor 
ODK 
Draft  
Locator form  
Detailed tracing information 
including alternative phone 
number and physical 
address 
 
(Needed for the linkage 
information later on for HIV 
positive children because 
people change phone 
numbers)  
Study 
Nurse 
Counselor 
Paper 
based 
record 
Draft  
 
 
 
 
 
 
 

FIT PROTOCOL Version 4.0 
Feb 18, 2018 
 ________________________________________________________________________________________________________  
 
 ____________________________________________________________________________________________ 
 
 
26