Interrupting HIV and TB Stigma in the Household During TB Contact Investigation in Uganda
Phase: NA
Conditions: Hiv, Tuberculosis, Social Behavior, Stigma, Social, Stigmatization
Sponsor: Yale University

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HRP-503B – BIOMEDICAL RESEARCH PROTOCOL 
(2017-1)
Protocol Title: Interrupting HIV and TB stigma in the household during TB contact investigation in Uganda
Principal Investigator: J. Lucian Davis.
Version Date: June 23, 2021
(If applicable) Clinicaltrials.gov Registration #: Click or tap here to enter text.
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1.
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NCT05124665

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SECTION I: RESEARCH PLAN
1.
Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested. 
An estimated 39 million people worldwide are living with HIV, but nearly half do not know their 
status because they are unaware that they are at risk, unable to access counseling and testing, or 
unwilling to accept testing because of stigma and fear. Layered on to the stigma of HIV is the risk of 
tuberculosis (TB), the leading cause of death among persons living with HIV (PLWH); about 40% of 
those with TB worldwide are also unaware of their TB status, and for similar reasons. This layered 
stigma introduces interlinked social and psychological barriers to testing for HIV and TB among the 
close contacts of TB patients. There is a critical need for targeted interventions to address layered 
stigma, reduce fear of testing, and increase uptake of testing among individuals at high risk of HIV 
and/or TB, including those living with an index TB patient.
Home testing is a promising approach to increase testing and linkage to care for HIV because it can 
reach individuals outside the health system, eliminate the costs of traveling for testing, offer testing 
in a familiar environment, and increase engagement with care among those found to be living with 
HIV. Nevertheless, many individuals offered home HIV testing in sub-Saharan Africa decline to test. 
Our group has previously shown that social interactions at the time HIV testing is offered strongly 
influence perceived stigma and test uptake. When potential testers discern that others have 
declined, they say they fear that testing will be socially discrediting. In adjusted analyses, 
individuals were 4 times as likely to decline testing when the first member of their home declined 
testing as when that individual accepted. 
Nearly a century of research demonstrates that observations of peers’ choices profoundly influence 
perceptions, judgments, and subsequent behaviors. Moreover, status and social ties among group 
members modify their influences on one another. The scientific premise of this proposal is that we 
can apply established principles from social and behavioral science to facilitate interactions within 
the household that reduce perceived stigma and promote uptake of HIV testing. Specifically, we will 
design an intervention that 1) optimizes the order of test invitations to establish testing as the 
normative choice; 2) frames testing as a prosocial behavior that promotes household well-being; 
and 3) maximizes acceptability by offering oral testing. We hypothesize that offering and delivering 
HIV testing in ways that reduce perceived stigma will ultimately have strong effects on the 
proportion of patients completing HIV testing and linking to care.
Together with our partners in Uganda, we propose to develop and pilot a complex intervention to 
increase uptake of home HIV testing and linkage to HIV care among household members offered 
home-based HIV testing. We aim:
Aim 1: To develop a complex intervention to increase uptake of testing for HIV among 
household members by reducing perceptions of stigma associated with HIV and testing for 
HIV. Lay health workers (LHWs) will deliver a novel invitation strategy for HIV testing in 20 
purposively sampled households that includes 1) acceptance-optimized sequencing, 2) prosocial 
messaging, and 3) salivary HIV testing. We will administer HIV and TB stigma scales before and 
after the invitation. We will interview all household members following the visit and engage LHWs in 
focus group discussions to explore feasibility and acceptability of the invitation strategy. We will 
iteratively refine the intervention to optimize acceptability and reductions in perceived stigma, for 
evaluation in Aim 2.
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Aim 2: To evaluate the intervention on household HIV stigma and uptake of testing among 
household members undergoing TB contact investigation in a household-randomized pilot 
trial. We will recruit a prospective cohort of multiple-contact households undergoing routine contact 
investigation for TB. Households will be randomized to one of two study arms. Households in the 
control arm will receive routine household contact investigation services, including free, optional 
oral HIV testing. Households in the intervention arm will receive routine household contact 
investigation services and free, optional oral HIV testing with the social-behavioral framing 
intervention. LHWs in the intervention arm will use acceptance-optimized sequencing of invitations 
and a prosocial invitation script to offer salivary testing for HIV to household members. We will 
measure our co-primary outcomes of HIV and TB stigma using standardized instruments before 
invitation and after completion of post-test counseling. We will measure the proportion consenting to 
HIV testing, yield of HIV diagnoses, and the proportion of new PLWH linked to HIV care at 1 month 
and reassess household HIV and TB stigma at 3 months in a subset of participating households. 
Participants may also be contacted at a later point for interviews, focus-group discussions or 
surveys to better understand the implementation and impact of the intervention.
The expected impact of these studies is to generate preliminary data on a novel approach to 
offering home testing that reduces perceived stigma within households and its effects on testing 
and linkage to and retention in care, built on the scientific premise of longstanding research on 
group processes and social decision-making. These data will inform a future randomized study 
evaluating the clinical impact of these new stigma-reducing approaches to offering and delivering 
HIV counseling and testing. Our proposal aligns with NIH priorities for interventions that increase 
access to HIV care and reduce the effects of stigma on PLWH, PLWH with TB, and adolescents 
and children.
2.
Probable Duration of Project: State the expected duration of the project, including all follow-up and data 
analysis activities.  
The activities described here will take place from April 1, 2019 until approximately March 30, 2021.
3.
Background: Describe the background information that led to the plan for this project. Provide references to 
support the expectation of obtaining useful scientific data.
UNAIDS has called for 90% of persons living with HIV (PLWH) to know their HIV status by 20201,2; the 
World Health Organization (WHO) has called for elimination of active TB as a public health threat by 
2035. Nonetheless, major gaps exist: one-third of PLWH do not know their status; similarly, almost 40% 
of TB patients go undiagnosed each year. To reach these ambitious targets, HIV testing services must 
reach another 7.5 million people by 2020, and TB testing services another 4 million people.3 New data 
from the Population-based HIV Impact Project show that achieving high status awareness is a greater 
challenge than achieving high antiretroviral therapy uptake or viral load suppression in 7 Southern African 
countries, including Uganda.4
Home testing and counseling services for HIV can increase status awareness and linkage to care. Home-
based testing services are an important tool for reaching the UNAIDS/WHO targets by reaching and 
engaging populations who are unable or disinclined to visit facilities. Home testing programs can increase 
the proportion of individuals in the community who are aware of their HIV status5-8 and support linkage to 
HIV care.9,10 The improvements can be dramatic among key high-risk populations: a home-based HIV 
counseling and testing intervention in Zambia increased status awareness among 15-19-year-olds from 
28% to 89%.11 However, uptake of home-based testing is mixed in sub-Saharan Africa.12,13 Furthermore, 
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status awareness must be maintained through regular testing, but most home testing strategies involve 
a single test opportunity. Moreover, a systematic review found that the effectiveness of linkage strategies 
varies.14 
Household contact investigation for TB provides a platform for engaging high-risk households for home 
HIV testing.15,16 Household TB contact investigation is a longitudinal service offered over 2 years to the 
close contacts of TB patients. This offers an opportunity for LHWs to reach high-risk individuals with low 
rates of status awareness; prior studies show that offering HIV testing to adult and adolescent 
household contacts of TB patients is a feasible approach with substantial yield, in spite of suboptimal 
rates of consent to testing.17,18 In our preliminary studies, nearly 60% of individuals reached in multiple-
contact households were aged 15-25, and more than half were unaware of their HIV status.19,20 
Moreover, contact investigation represents an opportunity to deliver interventions to reduce stigma at 
the household level and engage household members over time, ensuring that status awareness is 
sustained and that those in need are linked to care. 
Stigma inhibits testing for HIV, care-seeking behaviors, and engagement in HIV care. Systematic reviews 
and meta-analyses demonstrate that stigma and perceived stigma are consistently associated with lower 
uptake of HIV testing21-23, doubled odds of late presentation for HIV/AIDS care24, lower likelihood of 
initiating ART after diagnosis21,25, lower levels of adherence21,26, and lower engagement in care.26 
However, the mechanisms that link HIV stigma and these outcomes are less well understood.26
Layered stigma is associated with worse outcomes than HIV stigma alone. Stigma is best understood as 
a dynamic social process rather than an individual attribute.27,28 When stigma is layered, social 
devaluation from two socially discrediting conditions can operate synergistically. Households undergoing 
TB contact investigation face or anticipate facing at least two stigmatized conditions, HIV and TB. TB-
HIV stigma has consequences for TB care-seeking, TB-HIV outcomes, and HIV management.29
Uganda provides a representative setting for expanding and improving home HIV testing by reducing 
household stigma for HIV & TB. Uganda is a high HIV-TB-burden country, with estimated HIV prevalence 
of 7.1% and TB prevalence of 253 per 100,000. More than 25% of PLWH are unaware of their HIV 
status.30 Uptake of door-to-door home HIV testing ranges from 69%–95%7,8,13, but uptake of HIV testing 
among household contacts of TB patients is only 53%.20 The PLWH Stigma Index found that >60% of 
Ugandan PLWH experienced malicious gossip in their family or community in the past year and nearly 
10% had been excluded from family activities.31 TB stigma may be even more common in Uganda; nearly 
50% of survey respondents hold stigmatizing attitudes toward TB, compared to 26% with stigmatizing 
attitudes toward HIV.32
There is a need to build awareness of and capacity for integrating stigma hypotheses and measures into 
research on HIV-TB in Uganda. We propose two specific capacity-building initiatives that will draw on 
experiences building capacity for mixed-methods and implementation research through our Fogarty D43 
Pulmonary Complications of AIDS Research Training program. First, we will sponsor a doctoral student 
from Makerere University to work on this project. Second, each year, we will sponsor a symposium 
highlighting current research and future priorities in HIV and TB stigma at the Makerere Joint Annual 
Science and Health Conference at Makerere University, and include patients, families, researchers, and 
program officials.
Home HIV testing decisions in high-prevalence settings are commonly reached by households, not 
individuals. A meta-ethnographic review of 20 studies from East and Southern Africa found that decisions 
in response to offers of home-based HIV testing and counseling took place at the household or family 
level, not the individual level.33 Moreover, “courtesy stigma” (carryover stigma experienced by family 
members of the afflicted individual) can affect everyone in the household.34-36 Thus, individuals may 
decline testing not only because they fear the social consequences they will face individually, but because 
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they fear that their family will also face negative social outcomes. Interventions to reduce stigma and 
improve testing uptake must account for the social nature of participants’ decision-making processes: 
observing others’ HIV testing decisions may either normalize or marginalize testing for HIV. 
There is a need for novel interventions to reduce HIV stigma that are targeted to households. Although 
stigma is often measured at the individual level, the production of stigma is a social process that occurs 
in groups.37-39 Stigma processes within households may be particularly important for the outcomes of 
younger members: In a Kenyan study, 46% of children living with HIV were lost to follow-up due to 
enacted stigma40 or fear of stigmatization within the family or wider community.41 Yet a critical review 
found that among 100 studies assessing community-level factors such as stigma in low- and middle-
income countries (LMIC), only 5 evaluated interventions that aimed to act on group environments.21 There 
is a need for novel interventions that address stigma as a social process occurring within social groups 
rather than merely an individual experience.
A household stigma reduction intervention might not only improve the effectiveness of home testing 
services for promoting status awareness, but also have far-reaching effects on linkage to and 
engagement in care. Households are particularly powerful sites for intervention because they are primary 
social groups, composed of individuals with close, durable social ties to one another.42 Because ties 
among primary groups tend to persist even when stressed, these groups are critical, and often 
irreplaceable, sources of social support for PLWH, which is associated with a range of improved physical 
and mental outcomes.43-45 An intervention to reduce stigma at the household level may not only increase 
willingness to consent to test, but also ease subsequent steps in the continuum of HIV care and improve 
quality of life among PLWH.
Stigma reduction interventions are promising, but have thus far shown modest effectiveness. Strategies 
to reduce stigma and improve HIV test uptake typically focus on creating awareness (peer education, 
social marketing, school curricula), providing support (empathy instruction, counseling, support groups), 
influencing norms (community organizing, stigma discussions), or developing policies.39,46 A meta-
analysis of 42 studies to evaluate effectiveness of stigma reduction programs found small but significant 
effects on knowledge and attitudes towards PLWH; effectiveness was higher among programs that 
incorporated multiple sessions.47 However, most studies suffered methodological flaws, lacking 
appropriate randomization, allocation concealment, or follow-up assessment; there is a need for greater 
rigor and better-quality data.47 
Prosocial and behaviorally informed messaging can increase motivation to participate in health-related 
activities, including those that primarily benefit others. Experimental evidence shows that historical non-
vaccinators are motivated by prosocial messages more than by appeals to their own health.48,49 A 
randomized controlled trial found strong evidence that behaviorally informed messaging increased the 
return rate of HIV self-sampling kits.50 We hypothesize that prosocial framing of HIV testing as a 
communal (rather than merely individual) good will increase uptake of testing during household contact 
investigation for TB.
People are inclined to do as they observe. Experimental evidence has long shown that individuals’ 
observation of how group members ahead of them behave can profoundly shape their perceptions, 
judgements, and subsequent behaviors.51-53 Moreover, social influence theories from the sociology of 
networks suggest that that individuals’ social status and social network position determine the scope of 
their influence on other group members.54,55 Thus, individual testing decisions are likely to be influenced 
by observations of how others before them behave, especially if those others are of higher status or 
socially central to the household.
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We focus on interrupting stigma as a social process within a primary social group—the household—
rather than temporarily circumventing it. Many interventions to improve uptake of HIV counseling and 
testing attempt to circumvent stigma by increasing individual privacy, such as by providing oral self-
testing kits. However, these approaches do not reduce stigma; rather, they temporarily shield testers 
from the consequences of stigma, thereby leaving the possibility of stigma subsequently influencing 
linkage to and retention in care. Indeed, such interventions may increase the perception—including the 
misperception—that testing is socially discrediting. Those who test positive must be empowered to 
seek and engage in HIV care; those who test negative must be empowered to maintain status 
awareness by testing regularly. 
We aim to reduce stigma within the household, a group characterized by close, persistent social ties. 
While households are powerful social resources for accessing social support and overcoming barriers 
associated with community-level stigma, they have been largely ignored as a site of intervention for 
reducing stigma. In contrast, many interventions aim to operate on stigma more broadly at the 
community-level, such as through community discussions or social marketing. These approaches can 
reduce stigma, but are difficult to target to primary social groups. Even individuals who anticipate 
relatively little stigma in the wider community may fear stigma within an important primary group such 
as their household, especially if they perceive that influential primary group members hold negative 
assessments of PLWH or people who test regularly. Reducing perceived, anticipated, and enacted 
stigma within the household may have both larger and longer-lasting effects on status awareness, care-
seeking behaviors, and engagement in care. 
Finally, we adapt well-established principles from the social and behavioral sciences to reduce social 
uncertainty for potential testers, normalize testing, and reduce perceived stigma within households. We 
apply insights gained from experimental evidence on the role of conformity in group perception and 
behavior, prosocial motivation, and default choices to reduce HIV-TB stigma and increase uptake of 
HIV testing. We reason that reducing perceptions that other household members hold negative views of 
testing or PLWH will increase test uptake and strengthen social support available to PLWH within the 
household, beginning a virtuous circle of decreasing enacted stigma.54
4.
Research Plan: Summarize the study design and research procedures using non-technical language that can 
be readily understood by someone outside the discipline. Be sure to distinguish between standard of care vs. 
research procedures when applicable, and include any flowcharts of visits specifying their individual times and 
lengths. Describe the setting in which the research will take place.
Wide variation in uptake of home-based HIV testing and counseling suggests that small differences in 
how testing is offered may have large effects on test uptake by altering perceptions about stigma within 
the household. The objective of this project is to optimize a complex, behaviorally-grounded 
intervention to reduce perceived HIV stigma within households and thereby increase uptake of HIV 
testing and counseling among household members undergoing contact investigation for TB. 
We will explore several hypotheses, including: 1) acceptance-optimized sequencing of HIV test offers is 
acceptable to clients and health workers; 2) inviting the first tester to share with other household 
members their affirmative decision to test, without any obligation to share the results, is at least as 
acceptable to clients as concealing choice; 3) learning that the first household member chose to test 
will decrease perceived stigma; 4) provider-initiated invitation scripts employing prosocial 
messaging(55) can decrease stigma associated with testing; and 5) oral HIV testing will decrease HIV 
stigma by de-medicalizing HIV testing in the household setting. In this aim, we will carry out 
participatory research with household members who are offered home HIV testing while undergoing 
contact investigation for TB and LHWs delivering contact investigation. The expected outcome is a 
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novel approach to offering HIV testing centered around stigma reduction, as well as data on its 
acceptability to household members and health workers.
Population. We will include household contacts identified by index patients initiating treatment for TB at 
Kampala Capital City Authority health facilities. We will include households eligible for contact 
investigation under Uganda National TB Guidelines, including those with index patients who are 
microbiologically confirmed or clinically diagnosed including index patients who are children <5. We will 
exclude households for which the index patient reports <2 contacts over age 14, those who live outside 
of greater Kampala and those diagnosed with MDR-TB for both Aims of the study. 
Procedures for Aim 1
LHW focus group discussions. A social scientist and trained assistant will facilitate focus group 
discussions (FGDs) with LHWs responsible for carrying out household contact investigation for TB, 
including home-based HIV counseling and testing for household contacts 15 years and older.
Script development. We will develop the prototype script following the focus group discussions with 
non-participating LHWs, and initially refine the script through training and retraining of the study LHWs. 
Oral testing offer. LHWs will provide routine household contact investigation services, including TB 
education, screening, sputum collection, HIV testing, and clinic referral, according to routine public 
heath protocols. In purposively selected households and following the prototype invitation script, LHWs 
will offer oral HIV testing first to the household member statistically most likely to accept (e.g, oldest 
female), then to other eligible adults and adolescents using the FDA-approved OraQuick ADVANCE 
rapid HIV-1/2 antibody test.
Iterative, experience-based interviews. A social scientist will privately interview members of 20 
purposively sampled households, including households in which all eligible members accepted HCT 
during TB contact investigation, and households in which some or all did not accept HCT. We will 
prompt each household member to recount their decision process, describe their primary social ties 
and sources of social support, complete short stigma scales, and suggest changes to the prototype 
script and other aspects of how testing is offered. We will collate these data and adapt intervention 
components after every 5 households. 
TB Stigma: We will conduct a cross-sectional study nested within the Aim 1 procedures to describe the 
prevalence and characteristics of TB stigma in a population of households living with a TB patient. This 
will be achieved by distributing validated parallel Van Rie stigma scales (Van Rie TB-HIV-related stigma 
scales, attached.) to approximately 120 household contacts in approximately 40 consecutive 
households. The parallel Van Rie stigma scale is a scale that measures both TB and HIV/AIDS related 
stigma. The scale is structured to capture stigma related to these key domains: fear of transmission and 
disease, values and attitudes associated with shame, blame and judgments, and disclosure of disease 
status. These scales have been validated in a variety of settings and have excellent internal 
consistence, good construct validity, and moderate test-retest reliability. 
To further explore the relationship between perceptions of TB and attitudes toward TB evaluation, we 
will interview 5 low and 5 high TB-stigma scoring individuals from the parallel Van Rie stigma scales. 
During the study visits described above, the stigma scales will be scored immediately, eligible 
respondents identified, and eligible respondents invited to a 45-minute interview. If the invitation is 
accepted, the interview will be preferentially conducted during the same household visit, although if 
time or space concerns make this infeasible or unacceptabale, the interview may be rescheduled to a 
different time and location as specified or agreed to by the participant. In addition to stigma scale score, 
participants will be purposively selected to ensure variation by age and gender among interviewees. 
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These interviews will be conducted by a trained social scientist fluent in both English and Luganda in 
order to conduct interviews in the language of preference for the participants. 
The comparison between TB stigma scores and TB evaluation outcomes will be analyzed using a 
bivariate analysis. TB evaluation outcomes include whether the participant successfully completed 
sputum collection and/or if they completed a clinic follow-up if indicated by the health care worker. 
COVID Health Worker Cohort: We will also establish a prospective cohort of COVID-engaged health 
workers to longitudinally evaluate the psychosocial and physiological impact of COVID-19 response on 
health workers involved in TB units. Our aim is to learn more about health worker stress, burnout and 
the impact these things may have on HIV-TB services and the health system as a whole. 
We propose to reach out via telephone to survey and/or interview health care workers at any TB clinics 
around Uganda who are now also working on the frontline of the COVID-19 response to gather 
additional insights on the impact of the COVID-19 pandemic on TB and HIV services as well as gain 
insights on the impact of COVID-19 on health care worker stress and burnout over time. Clinics we plan 
to reach out to include those where we (U-TIRC) have previously worked on prior research projects or 
where partner organizations, such as Walimu, have strong connections with clinic staff to widen the 
scope of this study given the importance and urgency of gaining insights about the pandemic. We will 
interview health care workers repeatedly over the course of the pandemic including obtaining brief 
interviews approximately 3-6 months after the pandemic is deemed to be under control. These 
interviews will cover health workers’ experiences responding to COVID-19 and delivering routine 
services such as TB care, TB contact tracing, and HIV testing in the context of COVID-19. We will 
characterize the psychosocial dimensions of health worker response to COVID-19. We will invite them 
to voluntarily participate in a short, structured baseline telephone interview. We will then invite those 
who consent to participate in further short interviews at regular intervals as the COVID-19 outbreak 
matures. We might also have other interactions with these health workers in regard to TB and COVID-
19 experiences, all of which will take place via telephone, or if recommendations by the Ministry of 
Health change, in person while maintaining appropriate social distancing and/or personal protective 
equipment. Any qualitative data collected through these efforts will be audio recorded, transcribed and 
de-identified, and then destroyed. Only research study staff will have access to these files which are to 
be stored on secure cloud-based servers (Box.com) even after de-identification. At each qualitative data 
collection point, participants will be reminded that they may leave the study at any time, indicate a 
preference not to answer any question, and that the qualitative interview will be recorded.   
Measures. We will assess perceptions of stigma within the household using a pair of validated, 
comprehensive, parallel scales designed to assess perceived/attributed stigma for HIV and TB that we 
have adapted to the household level.(61) (Van Rie TB-HIV-related stigma scales, attached.) We will 
measure composite household stigma by pooling the measures of perceived and enacted stigma from 
all members of the household. We will collect individual age, gender, occupation (if applicable), income 
(if applicable), education in years, relationship to index patient, history of testing for HIV, month and 
year of last test, and self-reported symptoms of TB (including cough, subjective fever, or weight loss). 
We will collect measures of household stability, including household tenure in years. 
Sample size. We will deliver the script and interview contacts from 20 households (approximately 40-60 
individuals). In most studies, 10-15 subjects per group are required to reach saturation, the point at 
which interviews do not yield new themes.(62,63) We will carry out ≥2 FGDs with 15 experienced 
LHWs. For TB stigma related questions, we will distribute the stigma scale up to 40 households 
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(approximately 100-120 individuals). We will attempt to build a cohort of between 60 and 100 health 
care workers from around Uganda engaged in HIV and TB care during and after the COVID pandemic. 
Due to the changing nature of the pandemic and the changing staffing requirements for clinics, this 
number may change.   
Analysis. After professionally transcribing and importing interviews into a qualitative data analysis 
application, we will carry out a grounded-theory analysis. Two coders will independently read 
transcripts to identify themes, produce a codebook, and apply codes. We will assess the acceptability 
of acceptance-optimized sequencing of HIV test offers to clients and LHWs by inductive analysis of 
responses to the prototype sequence, and acceptability of inviting the first tester to share their choice to 
test (but not results) by inductive analysis of themes relevant to sharing of test decision. For both 
acceptability outcomes, we will calculate the proportions who affirmatively describe each element of the 
intervention as acceptable in principle and estimate the extent to which this is correlated within 
households. We will qualitatively assess change in perceived stigma associated with learning that the 
first household member chose to test as well as change in perceived stigma associated with provider-
initiated invitation scripts that apply prosocial messaging by analyzing the decision narratives. Because 
the aim of the interviews is to iteratively refine the intervention, the prototype will evolve over the course 
of data collection, and we will not conduct formal statistical tests.
Parallel follow-up survey and short-form interview, and validation studies: We will also conduct two sub-
studies nested within Aim 1 participants. These studies will help to adapt and validate a variation of the 
Van Rie HIV- and TB-related stigma scales to 1) improve their legibility to TB patients and their close 
contacts, 2) more effectively target these scales to distinguish between the presence of perceived 
stigma from the household versus perceived stigma from the community at large. We will make 
adjustments to the scales and then conduct short follow up surveys and/or interviews with Aim 1 
participants to compare HIV and TB stigma scale answers with those provided at baseline. We will re-
contact these participants via telephone, through a secondary household visit or through an invitiation 
to an acceptable site such as the health facility or the U-TIRC study offices.
Procedures for Aim 2: 
Routine data collection. We will collect routine household contact investigation and home HIV testing 
uptake data from the contact registers of the 4 participating TB units.
CHW Training We will carry out a participatory training with the study CHWs. First, CHWs will meet as 
a group to discuss study aims, the trial design, and the importance of study controls. Next, CHWs will 
be split into Clinic Based CHWs, Intervention CHWs and CHWs doing Routine Contact Investigation. 
Each group will separately review and role play their assigned procedures. Clinic Based CHWs will be 
trained to provide TB education and counselling, index patient enrolment, and randomization 
procedures. Intervention CHWs will be trained to deliver the social-behavioural intervention finalized in 
Aim 1. Standard of Care CHWs will be trained to deliver a standard offer of opt-in HIV testing. Both 
Standard of Care CHWs and Intervention CHWs will be trained in the use and delivery of oral HIV 
testing kits including the delivery of HIV education and counselling. 
Household-Randomized controlled trial. LHWs attached to 2 TB units in Kampala Uganda will identify, 
invite, consent, and enroll approximately 152consecutive, eligible index patients for household contact 
investigation for TB. We anticipate these households containing approximately 304 household contacts 
with approximately 1:1 randomization (half in each study arm). Upon index patient consent, we will 
collect demographic information from each index patient at enrollment, including age, gender, 
occupation (if applicable), income (if applicable), education in years, and household composition, 
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including number, age, gender, relationship to, and perceived influence of self-reported household 
contacts. After study enrolment and collection of index patient demographic data, a CHW will work with 
the index patient and, if available, treatment supporter to schedule the home visit. Households will be 
randomly assigned to one of the two CHW teams to receive the intervention or standard of care. The 
study CHW will note the self- reported number of household contacts aged 15 or older and requisition 
the appropriate number of HIV test kits based on the number of reported contacts, adding two extra kits 
for extra margin. 
LHWs will carry out home visits in pairs or with 3 LHWs dependent on the needs of that household. A 
LHW employed by the clinics will provide routine contact investigation services and a trained study 
LHW will collect research data and deliver the intervention for those randomized to the intervention arm 
of the study. While the LHW carries out standard contact investigation screening, the study LHW will 
administer a short HIV-TB stigma scale individually to all consenting adult members of the household in 
both arms. The research LHW will follow the assigned script based on randomization allocation to 
identify household members who are eligible and invite them to test for HIV, recording time-stamped 
offers, test decisions, and test results. The research LHW will collect household- and individual-level 
demographic, socioeconomic data, stigma scales, measures of household stability, including household 
tenure in years as well as relationship to and perceived influence of household members and clinical 
data using a structured survey. 
Procedures for all households: Upon arrival, the CHWs will enroll all eligible, consenting household 
contacts in the study. But before doing this, at the start, CHWs will introduce themselves and ask for 
introduction of contacts. At this time the master list of all the contacts will be created. 

They will introduce the reason for their visit and the services they will offer (TBCI, oral HIV 
testing) using the introductory script for either Intervention or Routine Contact Investigation 
households, depending on the household assignment. 

For the intervention arm, one CHW will take the index case to a private area to ask the influence 
questions using the paper form (master list) as a key. After completing this exercise, the CHW 
will then embark conducting household contact screening interviews followed by HIV testing and 
any other study related activities. All data will be collected via CommCare. 

Meanwhile, the other CHW will be conducting routine TB contact investigation activities and any 
other clinical procedures in household TB contact investigation. Details of these procedures are 
found below: 
a) Index case influence questions
After enrollment, CHWs will introduce themselves and ask for the introduction of contacts and it is at 
this time when a contacts master list will be created. Index patients will then be asked the influence 
questions. The questions will be asked in two steps, once to capture the number and once to capture 
the name. The other CHW will go head to conduct routine TB contact investigation activities. 
b) Household contact screening interview
After household contact enrolment, each contact will undergo a short interview. This interview will 
capture age, gender, occupation (if applicable), income (if applicable), education in years, relationship 
to index patient, history of testing for HIV, month and year of last HIV test, and self-reported symptoms 
of TB (including cough, subjective fever, or weight loss). 
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The short (13-item) version of the Van Rie TB- and HIV-related stigma scales will be administered 
immediately prior to TB screening, as well as at the conclusion of the visit. We will ask the index patient 
to share the number of rooms in the dwelling, the number of windows in the dwelling, and the number 
of individuals (including children) who dwell there. All screening interview components will be 
conducted by a CHW. Screening interview components are identical for all study groups. 
c) HIV testing procedures
Working in teams of two, CHWs will provide household contact investigation services, including offering 
oral HIV testing. One CHW will lead and accompany each HIV test while a colleague leads other 
household members through TB screening. 
To begin, the CHW responsible for offering HIV testing will individually invite the client to a place apart 
from the others. S/he will detail the process of HIV testing in Luganda and/or English, per client 
preference. A pictorial guide may be used to help walk the client through each step of the process using 
a Luganda- or English-language guide. The CHW will then provide pre-test counselling. 
Consenting household contacts who choose to test for HIV will swab their own gums. CHWs will be 
fully trained to provide HIV counselling and support throughout all testing procedures. 
Randomization: For aim 2 of the study, variable block randomization will be done at the level of the 
household and will be performed at the time of household enrollment. Block sizes will have a minimum 
of 2, a maximum of 6. We will utilize study randomizer, an online randomization tool with concealed 
randomization. When a CHW has deemed an index patient and their household to be eligible for the 
study, and after the index patient or their guardian has provided verbal informed consent, the CHW will 
place a phone call to the study coordinator. The study coordinator will then enroll the household using 
the study randomizer tool and let the CHW know the study allocation. The CHW will then fill in the 
appropriate allocation, along with the randomization ID, and contact the appropriate CHW team for the 
household visit. 
Households randomized to intervention group will be offered oral testing with the social-behavioral 
intervention. Households randomized to the standard of care group will be offered oral testing without 
any social-behavioral intervention. CHWs will operate in teams that are always assigned to the same 
arm of the study. There will be three teams of CHWs in total: one intervention group, one standard of 
care group, and one clinic-based group that will always be in charge of initial enrollment of index 
patients and recording any clinic follow up by individuals in either arm of the study. 
Integrated intervention. In Intervention Households only, the CHW will present the opportunity to test 
using the script and procedures described in the next section (“Specification of intervention 
components”). This script communicates that the individual is completely free to opt out of testing, but 
that testing is the norm. We will use “Opt-Out” testing language along with language letting them know 
that they can decline. 
If the household contact decides to opt out of HIV testing, the CHW will carry out a survey. These 
questions will take approximately the same amount of time as HIV testing and counselling procedures 
(~20 to 30 minutes) in order to blind other household members from the testing decision of that 
household contact. Contact decisions to test or not to test as well as test results will be recorded in 
CommCare. 
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Administering the oral test The CHW will open the OraQuick test packet in front of the consenting 
household contact and hand them the test swab. The CHW will remain with the client to directly 
supervise the test. Consenting clients will be directed to use the test swab to gently swipe once around 
their upper gums and once around their lower gums. Either side of the swab can be used. The swab 
will then be placed in the testing liquid for no more than 40 minutes. After 20 minutes has passed, the 
CHW will assist the participant in reading their HIV testing results. Procedures regarding HIV test 
results are outlined below. While awaiting test results, the CHW will provide basic education to the 
contact on HIV and/or TB and answer health related questions that the contact may have. 
HIV test results If the test is negative (one line next to the C and NO line in any form next to the T), the 
CHW will provide HIV counselling and support. If the HIV test is positive OR unconfirmed (one line next 
to BOTH the C and T regardless of how faint OR no line shown in window at all), the CHW will provide 
HIV counselling and support as well as a referral to the health centre for confirmatory capillary blood 
testing. 
Referral protocol Regardless of study arm, if the HIV test is positive or unconfirmed, the CHW will refer 
the client to the health center for evaluation and care using a referral slip. First, the CHW will explain 
the result in direct, simple language. For a positive result, they will explain: “The test shows you have 
HIV. You need to go to the ART clinic. I will support you.” The CHW will give the patient a referral slip 
and phone number to call upon reaching the clinic. Finally, the CHW will engage the client in planning 
to link to care by suggesting a specific day and time to present at the health facility and by guiding the 
client to plan for the facility visit, using prompts such as “How will you get to the clinic? Can someone 
go with you?” While the CHW may facilitate disclosure if requested, the CHW will never share individual 
results with others. 
Specification of intervention components In households assigned to the Intervention only, the following 
procedures will take place: 
a) Selection of first tester: Based on prior research, CHWs will be encouraged to offer HIV testing to the 
oldest female who is present at the time of HIV testing procedures. However, at the time of index 
patient enrolment, CHWs will ask the index patient whom they regard as the most influential person at 
home and that could also be the first tester. Ultimately, CHWs will decide which household contact is 
invited for testing first which will be documented in CommCare to help keep track of who was invited as 
the first tester. 
b) Prosocial script: CHWs will use a prosocial script encouraging HIV testing. The script features 
language that makes HIV testing a responsibility of the entire household and not just the individual. This 
prosocial script will be as follows: “Knowing your status sets a good example for your household.” 
c) Opt-out test framing: CHWs will follow an “opt-out” framing strategy for offering HIV testing, as 
opposed to “opt-in” framing. The opt-out script will be as follows: “This test kit is approved by the 
Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that 
okay?” 
d) Sharing the decision to test: If the initial household contact who is offered HIV testing agrees to test 
for HIV, the CHW will privately ask if he or she is willing to share his/her decision to test with other 
members of the household. We will NOT ask individuals to share HIV test results with members of their 
household. The CHW will only ask if they are willing to share their decision to test AFTER they have 
received the HIV test results. This invitation will be as follows: “Would you like to share your decision to 
test with the others? Sharing is completely optional. However, learning that someone else in their 
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household decided to test sometimes gives people the strength to test themselves. Sharing your 
decision might help another person find the strength to test.” Testers’ decisions to share or not share 
whether or not they tested will be recorded. 
TB and HIV stigma scales Study CHWs will individually administer the short-form HIV-TB stigma scales 
to all study participants regardless of group using the CommCare application alongside a visual aid. 
These scales have a total of 13 items and were validated in the Uganda setting as part of the Aim 1 
procedures. The scales will be administered first at the beginning of the home visit, then again at its 
conclusion. Each time, the CHW will briefly orient the participant to the response categories using a 
visual aid. 
Documentation and Data management All enrollment procedures, household contact interviews and 
HIV testing details will be collected using CommCare. All forms will be available within a customized 
CommCare application that prevents common errors (such as not filling out a question etc.). Quality 
control procedures will include review of all study data collection forms for completeness and accuracy, 
including quality assurance testing of all validation and skip logic within the application, prior to study 
initiation. The US study coordinator will initiate reports on missing data and provide feedback to all 
study team members on the quality of quantitative data. All changes will be recorded using a data 
management google doc tracking sheet that contains information on the change, who made the change 
and a link directly to the location of the change on CommCare. Any duplicate cases (i.e. two cases for 
one index patient or contact) will be archived and similarly recorded. 
Follow-up interview. At 3 months, the study LHW or a member of study team will contact a subset of 
households to schedule a follow-up visit or phone call if a second visit is unable to occur. The study 
LHW or a member of the study team will re-administer stigma scales to each participating member. 
Household members who are not present at the second household visit will be contacted by telephone 
to schedule a follow-up interview. 
Sample Size. 
During aim 2, we will distribute the stigma scales up to approximately 152 households containing 
approximately 304 household contacts with approximately 1:1 randomization (half in each study arm). 
We analyzed power for a 2-arm household-randomized, controlled trial using mixed models tests for 
two proportions in a two-level hierarchical design (household, contact). The assumptions and 
parameters within these calculations were based on data from Aim 1 and include: 
1.
The test statistic is the effect regression coefficient from a mixed-effects logistic regression 
model 
2.
Alpha = 0.05 
3.
Power = 90% 
4.
The proportion consenting to testing in the control group will be 0.85 
5.
The proportion consenting to testing in the intervention group will be 0.98 (a difference of +0.13 
vs the control group). 
6.
An average of two household contacts will be eligible for HIV testing per household. The intra-
class correlation (ICC) will be 0.59. 
The total number of households needed is sensitive to the mean cluster size. Under the preceding 
assumptions, the necessary number of households may range from 152 if the mean number of eligible 
contacts per households is 2 to 138 if the mean number of contacts per household is 3. The total 
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number of households needed is also sensitive to the ICC. Sample size estimates assuming a range of 
possible ICC values, ranging from the value observed during the preliminary research (0.59) to higher 
values (0.65, 0.70), are not presented here although considered by the study team. Finally, the total 
number of households needed is sensitive to the baseline (control group) proportion of tests accepted. 
Sample size estimates assuming three possible baseline testing rates (75%, 80%, and 85%) in control 
group households have been considered. We will plan an interim blinded power analysis by an external 
biostatistician to readjust sample size targets as necessary for actual mean cluster size and ICC after 
enrolling the first 100 households. 
Analysis. In the Aim 2 analysis, our primary outcome is change in perceived HIV-TB stigma after 
following the first household contact tracing visit; the secondary outcome is uptake of HIV testing; we 
will descriptively assess linkage to care from both baseline data and intervention households. We will 
calculate descriptive statistics for participant characteristics, and test associations between 
characteristics and perceived/attributed household stigma. To test the hypothesis that invitation scripts 
that apply acceptance-optimized sequencing of oral test offers and prosocial messaging can decrease 
HIV stigma within households, we will evaluate change in HIV-TB stigma using cluster-adjusted 
dependent t-tests and fitting multilevel models with clustered standard errors. To test the hypothesis 
that prosocial messaging and theory-informed sequencing of HIV test offers can increase test uptake, 
we will compare testing uptake among the intervention households and pre-implementation households 
using cluster-adjusted chi-squared tests of proportion and by fitting multilevel logistic regression 
models. All hypothesis tests will be carried out at alpha of 0.05, corrected for multiple tests as 
appropriate. We will report household ICC for stigma as well as test uptake. 
5.
Genetic Testing   
N/A ☒
6.
Subject Population: Provide a detailed description of the types of human subjects who will be recruited into 
this study.
We will include household contacts 15 years of age or older identified by index patients initiating 
treatment for TB at Kampala Capital City Authority health facilities. We will include households eligible 
for contact investigation under Uganda National TB Guidelines, including those with index patients who 
are microbiologically confirmed or clinically diagnosed and index patients who are children <5. We will 
exclude households for which the index patient reports <2 contacts over age 14, those who live outside 
of greater Kampala and those diagnosed with MDR-TB for both Aims of the study. Only household 
contacts are eligible for participation; close contacts are not eligible. For the purposes of this study, 
household contacts are defined as those individuals “sleeping under the same roof” as the index patient 
for one or more days or nights within the past three months. Close contacts, who will not be enrolled in 
this study, are those who do not live in the household but have spent 12 or more hours in an enclosed 
space with the index patient in the past three months. 
For the FGDs, we will include health workers engaged in contact investigation for TB and HIV.
7. Subject classification: Check off all classifications of subjects that will be specifically recruited for enrollment in 
the research project. Will subjects who may require additional safeguards or other considerations be enrolled 
in the study? If so, identify the population of subjects requiring special safeguards and provide a justification 
for their involvement.
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☐Children
☒ Healthy 
☐Fetal material, placenta, or dead fetus
☒Non-English Speaking
☐ Prisoners
☒Economically disadvantaged persons
☐Decisionally Impaired
☒ Employees
☒Pregnant women and/or fetuses
☐Yale Students 
☒ Females of childbearing potential
We will carry out focus group discussions and interviews with health workers affiliated with the Kampala 
Capital City Authority TB units. This is necessary because these health workers have substantial 
firsthand experience offering HIV testing during household contact investigation for TB and thus are 
uniquely positioned to offer insight into how to increase the appeal of HIV testing to clients. Recordings 
of interviews or focus group discussions with health workers will be kept in a password-protected drive 
and destroyed after transcription. All transcripts will be de-identified, and information will be kept in 
confidence. We will also request a waiver of written consent to minimize risk of disclosure.
Additionally, TB is a disease with a high incidence among the vulnerable populations listed, and thus it 
is important to include these patients in order to develop generalizable knowledge and ensure an 
intervention is designed with input from those who it is targeting.
NOTE: Is this research proposal designed to enroll children who are wards of the state as potential subjects?
Yes ☐  No ☒ 
8. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or exclusion?
Aim 1 Inclusion/Exclusion Criteria: 
Households: We will only include households who meet the Uganda National TB programme guidelines 
for household contact investigation as outlined below. Additionally, we will only include households with 
a sufficient number of adults to test study hypotheses about HIV testing. 
 
Inclusion:

Has an index patient ≥5 years of age with microbiologically confirmed TB

Has an index patient <5 years of age with confirmed TB
Exclusion: 

Fewer than 2 household contacts over age 14
Contacts: We will include all adult household contacts of TB patients. 
Inclusion: 

Household contact to a TB patient

≥15 years of age 
For the FGDs, we will include health workers employed in Kampala Capital City Authority clinics who 
are engaged in contact investigation for TB and HIV.
Aim 2 Inclusion/Exclusion Criteria: 
Households: We will only include households who meet the Uganda National TB programme guidelines 
for household contact investigation as outlined below. Additionally, we will only include households with 
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a sufficient number of adults (at least 2 individuals age 15 or above) to test study hypotheses about HIV 
testing. 
 
Inclusion:

Has an index patient with microbiologically confirmed TB

Has an index patient with confirmed TB via clinical diagnosis
Exclusion: 

Fewer than 2 household contacts over age 14

Lives outside of greater Kampala area
Contacts: We will include all adult household contacts of TB patients. 
Inclusion: 

Household contact to a TB patient

≥15 years of age 
9. How will eligibility be determined, and by whom? Write here
Eligibility of households and individual clients will be determined according to answers to routine 
screening questions used during household contact investigation by the lay health worker carrying our 
household contact investigation. If the individual is eligible, the lay health worker will invite them to the 
study.
For interviews with health care workers, individuals will be identified by the study team based on the 
employment records at the health centres of interest in Kampala, Uganda. 
10. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts, or 
inconveniences associated with subjects participating in the research. 
There are minimal risks to participants in this study. The primary risks to both index TB patients and to 
their household contacts are the psychological and social risks of disclosure of private information such 
as place of residence, or of disclosure of an individual’s TB diagnosis and/or HIV status. The primary 
research risks for health-care workers arising from the qualitative studies are the potentially punitive 
actions by the employer in response to the information they provide for research.
11. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized.
As is done in routine practice, lay health workers will make every effort to preserve the privacy and 
confidentiality of individual participants during household contact investigation. While individuals 
who have decided to test may be invited to voluntarily share their decision to test with their peers, 
individual testing and counseling will be carried out privately. Results will be delivered in private and 
contacts will not be asked to disclose their status following the test. Disclosure of participant HIV or 
TB status is expected to be rare, if it occurs. No other adverse effects are expected.
Recordings of interviews or focus group discussions with health workers or household contacts will 
be kept in a password-protected drive and destroyed after transcription. All transcripts will be de-
identified, and information will be kept in confidence. 
To minimize risk of loss of privacy or confidentiality, we will carry out a verbal informed consent 
process using the attached research study information sheets.
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12. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan (DSMP) based on 
the investigator’s risk assessment stated below. (Note: the HIC will make the final determination of the risk to 
subjects.)
a. 
What is the investigator’s assessment of the overall risk level for subjects participating in this 
study? Minimal
b.
If children are involved, what is the investigator’s assessment of the overall risk level for the 
children participating in this study? N/A
c.
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are  
available here http://your.yale.edu/policies-procedures/forms/420-fr-01-data-and-safety-
monitoring-plans-templates for
i.
Minimal risk
ii.
Greater than minimal
d. For multi-site studies for which the Yale PI serves as the lead investigator: N/A
The principal investigator is responsible for monitoring the data, assuring protocol compliance, and 
conducting the safety reviews at the specified frequency (quarterly).  During the review process the 
principal investigator will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to enrollment.
The principal investigator and the Institutional Review Board (IRB) have the authority to stop or 
suspend the study or require modifications.
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks to 
Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely event that 
such events occur, Reportable Events (which are events that are serious or life-threatening and 
unanticipated (or anticipated but occurring with a greater frequency than expected) and possibly, 
probably, or definitely related) or Unanticipated Problems Involving Risks to Subjects or Others that 
may require a temporary or permanent interruption of study activities will be reported immediately (if 
possible), followed by a written report within 5 calendar days of the Principal Investigator becoming 
aware of the event to the IRB (using the appropriate forms from the website) and any appropriate 
funding and regulatory agencies. 
The investigator will apprise fellow investigators and study personnel of all UPIRSOs and adverse 
events that occur during the conduct of this research project through 1) weekly study meetings carried 
out via teleconference during and immediately following the data collection period, or 2) via email as 
they are reviewed by the principal investigator. The protocol’s research monitor(s), Fogarty International 
Center of NIH (sponsor/funder) and the relevant IRB of Makerere University (local collaborator/host) 
will be informed of any UPIRSO, including adverse events, or Reportable Event within 5 days of the 
event becoming known to the principal investigator.
13. Statistical Considerations: Describe the statistical analyses that support the study design. 
Aim 1 is a formative qualitative study to refine an intervention; it is not designed for statistical tests. 
Based on the findings of the formative study described here, the study team will specify the final 
intervention and submit a modification to this protocol for a pilot study evaluating that intervention.
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In the Aim 2 analysis, we will calculate and compare uptake across each of the trial arms using an 
intention-to-treat analysis. We will also consider a per protocol analysis and model adjusted for 
imbalances in baseline confounders as secondary analyses. To test the hypothesis that a norming 
intervention can increase test uptake, we will compare testing uptake among the intervention 
households and control households using cluster-adjusted chi-squared tests of proportion and by fitting 
mixed effects logistic regression models with two levels (household, contact.) To test the hypothesis 
that invitation scripts that apply acceptance-optimized sequencing of oral test offers and prosocial 
messaging can decrease HIV stigma within households, we will evaluate change in HIV-TB stigma 
using cluster-adjusted dependent t-tests and fitting multilevel models with clustered standard errors. We 
will conduct a causal mediation analysis to determine to what degree the effects of the intervention on 
stigma explain the improvement in test uptake using observed-variable structural equation modeling. All 
hypothesis tests will be carried out at alpha of 0.05, corrected for multiple tests as appropriate. We will 
report household ICC for stigma as well as test uptake and will consider a household ICC of >0.2 a 
sufficient level of clustering necessitating adjustment. 
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SECTION II: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND DEVICES
If this section (or one of its parts, A or B) is not applicable, check off N/A and delete the rest of the section.
A.  RADIOTRACERS
☒N/A
B.  DRUGS/BIOLOGICS    ☒N/A
 B.  DEVICES
 ☒N/A
SECTION III: RECRUITMENT/CONSENT AND ASSENT PROCEDURES 
1. Targeted Enrollment: Give the number of subjects: 
a.
Targeted for enrollment at Yale for this protocol: 0
b.
If this is a multi-site study, give the total number of subjects targeted across all sites: 
-40 to 60 individuals drawn from 20 households (Aim 1) 
-Approximately 8 to 15 lay health workers with experience carrying out TB contact investigation
-Approximately 60-100 health workers participating in HIV and TB care services during the 
COVID-19 pandemic
- Approximately 152 index patients and their approximately 304 household contacts (Aim 2)
2.
Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used.
☐Flyers
☐ Internet/web postings
☐ Radio
☐ Posters
☐ Mass email solicitation
☐ Telephone
☐ Letter
☐ Departmental/Center website
☐ Television
☐ Medical record review* 
☐ Departmental/Center research boards
☐ Newspaper
☐ Departmental/Center newsletters
☐ Web-based clinical trial registries
☐ Clinicaltrails.gov 
☐ YCCI Recruitment database
☐ Social Media (Twitter/Facebook): 
☒ Other: Lay health worker invitation
* Requests for medical records should be made through JDAT as described at 
http://medicine.yale.edu/ycci/oncore/availableservices/datarequests/datarequests.aspx
3.  Recruitment Procedures: 
a. Describe how potential subjects will be identified. Lay health workers will invite eligible index patients to invite 
them and their households to the study.. For the FGDs, study staff will invite current lay health worker 
employees to participate by telephone at their workplace, during normal business hours. For health workers 
involved in the cohort during the COVID-19 pandemic, study staff will invite health care workers involved in 
HIV and TB care services whom study staff have identified through consortium health care sites, existing study 
sites, or through partner relationships to participate via telephone. 
b. Describe how potential subjects are contacted. 
-Eligible index patients will be verbally invited to participate when they are offered routine household contact 
investigation
-Eligible household contacts of consenting index patients will be verbally invited to participate during 
household contact investigation for TB
- For the FGDs, lay health workers will receive a telephone invitation to voluntarily participate in a single focus 
group discussion.
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- For the health worker COVID cohort, health workers will receive a telephone invitation to voluntarily 
participate in several short interviews or surveys about the effect of the pandemic on their own experiences 
and the delivery of services for HIV and TB
c.
Who is recruiting potential subjects?
 -Lay health workers will recruit eligible household contacts they encounter during household contact 
investigation for TB.
-For the health worker, a researcher from Makerere University’s Uganda TB Implementation Research 
Consortium will recruit potential participants.
4. Assessment of Current Health Provider Relationship for HIPAA Consideration:
Does the Investigator or any member of the research team have a direct existing clinical relationship with any 
potential subject? 
☐Yes, all subjects
☐Yes, some of the subjects
☒No
If yes, describe the nature of this relationship. Write here
5. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization for either the 
entire study, or for recruitment purposes only.  Note: if you are collecting PHI as part of a phone or email 
screen, you must request a HIPAA waiver for recruitment purposes.) This is an international study, not subject 
to HIPAA. 
The investigator assures that the protected health information for which a Waiver of Authorization has been 
requested will not be reused or disclosed to any person or entity other than those listed in this application, except 
as required by law, for authorized oversight of this research study, or as specifically approved for use in another 
study by an IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale HIPAA-Covered 
entity must be accounted for in the “accounting for disclosures log”, by subject name, purpose, date, recipients, 
and a description of information provided.  Logs are to be forwarded to the Deputy HIPAA Privacy Officer.
6.
Process of Consent/Assent: Describe the setting and conditions under which consent/assent will be obtained, 
including parental permission or surrogate permission and the steps taken to ensure subjects’ independent 
decision-making. 
All patients and their household contacts will receive a verbal invitation to participate in accordance 
with National TB guidelines. Additionally, all willing and eligible index patients and their household 
contacts will be asked to review the research study information sheet /verbal informed consent 
document outlining all study related activities, then provide verbal consent to participate in the 
study. Lay health workers trained in administering informed consent procedures, Human Subjects’ 
Protection and Good Clinical Practice will carry out and document all verbal informed consent 
encounters. For participants under age 18 who do not meet the definition of an emancipated minor, 
permission to participate will be obtained from a parent or legal guardian. Among index patients, 
children aged 14-17 must provide assent to participate after their parent provides permission. 
Among contacts, only household members 15 years of age or older will be eligible for HIV testing; 
those aged 15-17 must provide assent to participate after their parent provides permission.
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After a participant agrees to participate and/or a parent provides permission, the lay health worker 
will carry out the routine contact investigation procedures, recording clinical and demographic 
information about the patient on an electronic tablet. This information will include names and ages 
of all household members, contact telephone numbers for the index patient and a treatment 
supporter.
7.
Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the personnel obtaining 
consent will assess the potential subject’s ability and capacity to consent to the research being proposed. 
8.
Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for research involving 
non-English speaking subjects. If enrollment of these subjects is anticipated, translated copies of all consent 
materials must be submitted for approval prior to use. 
Subjects who do not speak English or Luganda will be excluded from this formative study. All LHWs 
administering study protocol will be fluent in both English and Luganda. All consent forms will be available in 
both English and Luganda and will be administered in the language of preference. 
As a limited alternative to the above requirement, will you use the short form* for consenting process if you 
unexpectedly encounter a non-English speaking individual interested in study participation and the translation of 
the long form is not possible prior to intended enrollment?  YES ☐  NO ☒
Note* If more than 2 study participants are enrolled using a short form translated into the same language, then 
the full consent form should be translated into that language for use the next time a subject speaking that 
language is to be enrolled.
Several translated short form templates are available on the HRPP website (yale.edu/hrpp) and translated HIPAA 
Research Authorization Forms are available on the HIPAA website (hipaa.yale.edu). If the translation of the short 
form is not available on our website, then the translated short form needs to be submitted to the IRB office for 
approval via modification prior to enrolling the subject.   Please review the guidance and presentation on use of 
the short form available on the HRPP website.
If using a short form without a translated HIPAA Research Authorization Form, please request a HIPAA waiver in 
the section above. 
9.
Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or a full waiver 
of consent, depending on the study. If you will request either a waiver of consent, or a waiver of signed consent 
for this study, complete the appropriate section below.  
☐Not Requesting any consent waivers 
☒Requesting a waiver of signed consent:
☐ Recruitment/Screening only (if for recruitment, the questions in the box below will apply to 
recruitment activities only)
☒ Entire Study – We will obtain verbal consent from household contacts participating in 
interviews and intervention optimization and piloting using the attached informed consent 
information sheets. We will obtain verbal consent from health workers also. 
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 For a waiver of signed consent, address the following:
Would the signed consent form be the only record linking the subject and the research?  YES ☒  NO ☐ 
Does a breach of confidentiality constitute the principal risk to subjects? YES ☒  NO ☐
 
OR
Does the research pose greater than minimal risk? YES ☐    NO☒ 
Does the research include any activities that would require signed consent in a non-research context? YES ☐   
NO ☒
SECTION IV: PROTECTION OF RESEARCH SUBJECTS
    Confidentiality & Security of Data:
1.
What protected health information (medical information along with the HIPAA identifiers) about subjects will 
be collected and used for the research?   We will collect individual age, gender, occupation (if applicable), 
relationship to index patient, history of testing for HIV, month and year of last test, and self-reported symptoms 
of TB (including cough, subjective fever, or weight loss). 
2.
How will the research data be collected, recorded and stored? Focus group data along with any interview data 
will be digitally recorded and transcribed. Audio recordings will be destroyed when transcription is complete. 
All qualitative data will be de-identified at a point in time when deemed appropriate by the PI. Households 
interview data will be collected using password protected tablets with a secure data capture application and 
stored on a secured server.
3.
How will the digital data be stored? ☐CD  ☐DVD  ☐Flash Drive  ☐Portable Hard  Drive   ☒Secured Server  
☐Laptop Computer  ☒Desktop Computer  ☐Other
4.
What methods and procedures will be used to safeguard the confidentiality and security of the identifiable 
study data and the storage media indicated above during and after the subject’s participation in the study? 
The lay health workers will be carefully trained in how to protect the privacy of study participants and 
will complete training in Human Subjects’ Protection and Good Clinical Practice. Care will be taken 
to protect the confidentiality of subjects’ HIV and TB status, along with any other potentially 
stigmatizing information, during enrollment and collection of data. All patient-identifiable data will be 
stored in locked or password-protected areas accessible only to study personnel. No patient-
identifiable data will be collected beyond what is routinely collected by health centers during the 
course of routine contact investigation. 
HIV results will be stored using a custom-built, secure clinical data capture application called Commcare 
(Dimagi, Cambridge, MA). Community health workers have previously used this application for secure data 
collection during household contact investigation and home HIV testing offers.
The audio files from qualitative data collection will be stored on a secure, encrypted, password-
protected drive in the research offices in Uganda. All names inadvertently used during the discussions 
will be replaced by number-based aliases (e.g., Participant #1) in the final transcripts. Transcripts will 
be entered into a password-protected software program and only members of the research team will 
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have access to this program. Hard copies of transcripts will be kept in a locked file cabinet. Audio 
files will be destroyed once transcripts are complete.
A positive HIV test is not reportable to the Ugandan government by law. The 2016 Uganda National HIV Testing 
Guidelines state throughout (e.g., page 10, Privacy and Confidentiality) that HIV results may only be reported 
or recorded with individual patient consent. Test results will only be shared with the clinic or added to their 
patient record if patients give verbal consent to do so.
All portable devices must contain encryption software, per University Policy 5100.  If there is a technical reason a 
device cannot be encrypted please submit an exception request to the Information Security, Policy and Compliance 
Office by clicking on url http://its.yale.edu/egrc or email it.compliance@yale.edu
5.
What will be done with the data when the research is completed? Are there plans to destroy the identifiable 
data? If yes, describe how, by whom and when identifiers will be destroyed. If no, describe how the data and/or 
identifiers will be secured. 
Identifiers will be destroyed upon completion of transcription and qualitative analysis.  
6.
If appropriate, has a Certificate of Confidentiality been obtained? N/A
SECTION V: POTENTIAL BENEFITS
Potential Benefits: Identify any benefits that may be reasonably expected to result from the research, either to 
the subject(s) or to society at large. (Payment of subjects is not considered a benefit in this context of the risk 
benefit assessment.) 
Study subjects will benefit from participation in this study through the potential identification, diagnosis 
and treatment of other patients with active TB disease or living with HIV. Diagnosing and treating co-
occurring infectious TB cases where they are present will reduce household members’ and index 
patients’ risk of reinfection with TB at a later time, and lead to improved health and well-being of the 
index patient’s family. In addition, participation in this study could lead to reduced stigma of HIV and TB 
in the patient’s household. Potential benefits to society include identification of strategies to reduce HIV- 
and TB-related stigma. If successful, the intervention could potentially be scaled up to reduce HIV-TB 
stigma and improve uptake of HIV testing during household contact investigation in similar settings.
         SECTION VI: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1.
Alternatives: What other alternatives are available to the study subjects outside of the research? 
Any individual may choose not to participate at any time. Participation or non-participation will not affect their 
access to routine contact investigation services.
2.
Payments for Participation (Economic Considerations): Describe any payments that will be made to subjects, 
the amount and schedule of payments, and the conditions for receiving this compensation.
No payments will be made to participants.
Health care workers will receive 20,000 UGX (approximately $5.50 USD) for participation in interviews
3.
Costs for Participation (Economic Considerations): Clearly describe the subject’s costs associated with 
participation in the research, and the interventions or procedures of the study that will be provided at no cost 
to subjects. 
There are no costs to participants.
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4.
In Case of Injury: This section is required for any research involving more than minimal risk, and for minimal 
risk research that presents the potential for physical harm (e.g., research involving blood draws).
a.
Will medical treatment be available if research-related injury occurs? N/A
b.
Where and from whom may treatment be obtained? N/A
c.
Are there any limits to the treatment being provided? N/A
d.
Who will pay for this treatment? N/A
e.
How will the medical treatment be accessed by subjects? N/A
IMPORTANT REMINDERS
Will this study have a billable service?  Yes ☐ 
 No☒
A billable service is defined as any service rendered to a study subject that, if he/she was not on a study, would 
normally generate a bill from either Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s 
insurer. The service may or may not be performed by the research staff on your study, but may be provided by 
professionals within either Yale-New Haven Hospital or Yale Medical Group (examples include x-rays, MRIs, CT 
scans, specimens sent to central labs, or specimens sent to pathology). Notes: 1. There is no distinction made 
whether the service is paid for by the subject or their insurance (Standard of Care) or by the study’s funding 
mechanism (Research Sponsored). 2. This generally includes new services or orders placed in EPIC for research 
subjects. 
If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research management system, for 
Epic to appropriately route research related charges. Please contact oncore.support@yale.edu
Are there any procedures involved in this protocol that will be performed at YNHH or one of its affiliated entities?  
Yes ☐  No ☒ 
IMPORTANT REMINDER ABOUT RESEARCH AT YNHH 
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at the HRU, the 
Principal Investigator and any co-investigators who are physicians or mid-level practitioners (includes PAs, APRNs, 
psychologists and speech pathologists) who may have direct patient contact with patients on YNHH premises 
must have medical staff appointment and appropriate clinical privileges at YNHH. If you are uncertain whether 
the study personnel meet the criteria, please telephone the Physician Services Department at 203-688-2615. By 
submitting this protocol as a PI, you attest that you and any co-investigator who may have patient contact has a 
medical staff appointment and appropriate clinical privileges at YNHH.
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