Enhancing HIV-assisted Contact Tracing in Malawi Through Blended Learning: an Implementation Science Study
Phase: NA
Conditions: Human Immunodeficiency Virus
Sponsor: University of North Carolina, Chapel Hill

 
 
 
 
 
 
 
Enhancing HIV assisted contact tracing in Malawi through blended learning: 
an implementation science study 
 
 
NCT05343390 
 
UNCPM 22009 
 
NHSRC #20/06/2566 
 
IRB 20-1810 
R01 MH124526  
  
January 10, 2023 
 
Version 3.0 
 
 
 
 
 
 
 

Protocol v.3, page 2 of 34 
UNCPM 22009 
 
Study team  
 
Nora E. Rosenberg, PhD, MSPH 
Principal Investigator 
Department Health Behavior  
University of North Carolina Project Malawi 
Private Bag A-104 
Lilongwe, Malawi 
+265 099 109 06726 
Email: Nora_Rosenberg@unc.edu 
 
Tapiwa Tembo, MSc 
Site Principal Investigator 
Study Coordinator/Regional Research Fellow 
Baylor College of Medicine Children’s Foundation 
Malawi 
Private Bag B 
Lilongwe, Malawi 
Phone: +265 175 1047 
Email: ttembo@tingathe.org 
 
Maria Kim, MD, MSc 
Co-Principal Investigator 
Department of Pediatrics 
Baylor College of Medicine,  
Houston, TX 77030-3411, USA 
Phone: +1 832 822 1314 
Email: mariakim01@gmail.com 
 
Steven Masiano, PhD, MS 
Co-Investigator 
Postdoctoral Research Fellow 
Children’s Foundation Malawi 
Baylor College of Medicine 
Private Bag B-397, Lilongwe, Malawi 
Phone: +265 175 1047 
Email: tsmasiano@tingathe.org 
 
Katie Simon, MD 
Co-Investigator 
Assistant Professor 
Department of Pediatrics 
Baylor College of Medicine 
Houston, TX 77030-3411, USA 
Phone: 01750 877 
Email: ksimon@tingathe.org 
 
Victor Mwapasa, PhD, MPH 
Co-Investigator 
Professor 
University of Malawi College of Medicine 
1 Mahatma Ghandi Road 
Blantyre, Malawi 
Phone: +265 999 981 1496 
Email: vmwapasa69@gmail.com 
 
Vivian Go, PhD, MA, MPH 
Co-Investigator 
Associate Professor 
Department of Health Behavior 
Gillings School of Global Public Health 
Chapel Hill, NC 27599-7030, USA 
Phone: +1 919 966 3908 
Email: vgo@email.unc.edu 
 
Katie Mollan, MS 
Co-Investigator  
Senior Biostatistician 
Center for AIDS Research 
University of North Carolina School of Medicine 
Chapel Hill, NC 27599-7030, USA 
Phone: +1 919 966 8421 
Email: kmollan@unc.edu 
 
Sarah Rutstein, MD, PhD 
Co-Investigator  
Postdoctoral Research Associate 
Center for Infectious Diseases 
University of North Carolina  
Chapel Hill, NC 27599-7030, USA 
Phone: +1 919 966 4468 
Email: Sarah.Rutstein2@unchealth.unc.edu 
 
Mike Chitani, BA  
Baylor CoM Children’s Foundation Malawi 
Private Bag B 
Lilongwe, Malawi 
Email: mchitani@tingathe.org 
 
Technical Advisors 
• 
Rose Nyirenda, Head of HIV Unit 
• 
William C. Miller, MD, PhD, MPH 
• 
Michael Hudgens, PhD 
 
Students  
Marley Catlett, BA 
Allysha Choudhury, MPH 
Hanna Huffstetler, BA 
 
 
 
 

 
 
 
UNCPM 22009 
Protocol v 3.0, page 3 of 34 
 
Table of Contents 
Study team ..............................................................................................................................................................2 
PROTOCOL SUMMARY .......................................................................................................................................5 
Research question/Objective ..................................................................................................................................5 
Rationale .................................................................................................................................................................5 
Methods ..................................................................................................................................................................5 
Procedures and implementation interventions ........................................................................................................5 
Data collection, management, and analysis ............................................................................................................6 
Risks/benefits to subjects .......................................................................................................................................7 
Costs/compensation ................................................................................................................................................7 
Confidentiality assurances ......................................................................................................................................7 
Conflict of interest ..................................................................................................................................................7 
Collaborative agreements .......................................................................................................................................7 
Intended use of results ............................................................................................................................................7 
PROTOCOL .............................................................................................................................................................8 
Title ........................................................................................................................................................................8 
Abstract ..................................................................................................................................................................8 
Background and justification ..................................................................................................................................9 
Literature review ................................................................................................................................................. 10 
Overarching objective and specific aims/study objectives .................................................................................. 12 
Study design and outcomes ................................................................................................................................. 12 
Randomization ..................................................................................................................................................... 13 
Evidence based practice ...................................................................................................................................... 13 
Implementation strategies .................................................................................................................................... 14 
Study Setting ....................................................................................................................................................... 14 
Populations, Eligibility Criteria, and Sample Sizes ............................................................................................. 15 
Procedures ........................................................................................................................................................... 16 
Procedures in the context of COVID-19 ............................................................................................................. 17 
Data collection ..................................................................................................................................................... 17 
Evaluation framework ......................................................................................................................................... 20 
Aim 1 Analytic methods and power calculations (implementation outcomes) ................................................... 20 
Aim 2 Analytic methods and power calculations (HIV service uptake outcomes) ............................................. 21 
Aim 3 Analytic methods (Cost-effectiveness) ..................................................................................................... 24 
Additional exploratory analyses of interest ......................................................................................................... 25 
Ethical and human subjects considerations ......................................................................................................... 25 
Potential risks to subjects .................................................................................................................................... 25 

 
 
 
UNCPM 22009 
Protocol v 3.0, page 4 of 34 
 
Adequacy of protection against risks .................................................................................................................. 26 
Potential benefits to subjects ............................................................................................................................... 26 
Costs/compensation ............................................................................................................................................. 26 
Importance of the knowledge to be gained .......................................................................................................... 27 
Reportable events ................................................................................................................................................ 27 
Dissemination of results ...................................................................................................................................... 27 
Work plan and Timeline ...................................................................................................................................... 28 
Bibliography ........................................................................................................................................................ 29 
 
 
 
 
 
 

 
 
 
UNCPM 22009 
Protocol v 3.0, page 5 of 34 
 
PROTOCOL SUMMARY 
 
Research question/Objective   
This study seeks to understand whether a “blended learning” implementation approach is an implementable, 
effective, and cost-effective modality for building health worker capacity for voluntary assisted contact tracing. 
 
Rationale  
Voluntary assisted contact tracing (ACT) is an evidence-based approach that efficiently identifies persons in need 
of HIV treatment and prevention. Malawi, like many countries in sub-Saharan Africa, has adopted ACT policies 
to support its “95-95-95” targets for HIV testing, treatment, and viral suppression. However, Malawi’s ACT 
implementation has been poor due to deficits in health worker capacity and clinical coordination. Our team has 
developed a theory-based health worker training and continuous quality improvement process that addresses these 
barriers through a “blended learning” platform that combines digital and face-to-face modalities. This training 
package was field-tested in Malawi with promising preliminary results. In this proposal, the training package will 
be refined and rigorously evaluated. This is a two-arm pragmatic cluster randomized controlled trial (RCT) to 
compare the blended learning enhanced implementation package to the standard implementation package. This 
study aims to determine whether the enhanced blended learning package: enhances implementation outcomes 
(Aim 1), increases HIV service uptake (Aim 2), and is cost-effective (Aim 3). 
 
Methods 
Study design 
This is a 2-arm pragmatic cluster RCT comparing an enhanced blended learning implementation package to a 
standard implementation package. The study will be conducted at Tingathe-supported health facilities in 
Machinga and Balaka, Malawi. Thirty-three clusters will be randomized in a 2:1 ratio to the standard versus 
enhanced packages. All clusters will receive the standard of care. Additionally, enhanced clusters will receive an 
enhanced blended learning training and enhanced facility support. Three sets of primary outcomes will be 
compared between the standard and enhanced arm: implementation outcomes, service uptake outcomes, and cost-
effectiveness outcomes. The standard of care sites will receive the enhanced implementation package after the 
primary observation period ends. Long-term outcomes will be examined at all clusters. Prior to the trial, the 
enhanced implementation package and all study tools will be pilot tested for feasibility and acceptability. 
 
Population 
Study activities will take place in 33 clusters. At each cluster, two study populations will be enrolled and 
evaluated separately: health workers and patients. To be eligible for participation, health workers must be: (a) 
>=18 years old, (b) working full-time at one of the health facilities included in the study, and (c) involved in 
Malawi’s HIV program. Patients must be: (a) >=15 years old and (b) an index, contact or parent/guardian of an 
index or contact. Persons that do not meet these criteria will be excluded. We aim to enroll at least 2 health 
workers per cluster for a minimum of 66 health workers in the study. We will enroll up to 800 patients (600 
indexes and 200 contacts) over the study period.  
 
Procedures and implementation interventions  
 
Standard implementation  
All facilities participating in the study will receive standard ACT implementation strategies. In Malawi, the 
standard ACT implementation strategies consist of 1) a brief ACT training, and 2) routine facility support. The 
brief training is centralized and conducted in-person. It is primarily didactic and provides an overview of ACT 
procedures and counseling approaches. Tingathe (or other partners) provide routine supervision to all facilities for 
all supported activities. Routine supervision consists of examining facility performance data, and providing 
feedback on the overall program. None of these procedures will be altered by the study.  

 
 
 
UNCPM 22009 
Protocol v 3.0, page 6 of 34 
 
 
Enhanced implementation 
In addition to receiving the standard implementation strategies described above, the facilities randomized to the 
enhanced implementation arm will 1) receive the blended learning training and 2) participate in enhanced 
continuous quality improvement (CQI) processes. The blended learning training is designed for decentralized 
delivery. The content of the blended learning training builds on the themes described in the standard training, but 
includes more role modeling, practice and feedback. Furthermore, health workers involved in ACT will 
participate in ongoing CQI to examine their facility’s ACT performance, identify gaps, and implement actionable 
solutions.  
 
Participant recruitment 
Within each participating cluster, we will recruit health workers involved in ACT activities, along with a subset of 
patients. Recruitment of health workers from included clusters will occur primarily at the beginning of the study, 
but will remain open over the study period. All health workers at a given cluster who are involved in ACT will be 
invited to participate, and a member of the study team will engage potential participants in a conversation about 
the purpose, nature, and duration of the study.  
 
Recruitment of patients (indexes and contacts) is expected to occur at each facility. The study team will approach 
potential indexes and contacts about participation. If interested, potential participants will be offered the 
opportunity to provide informed consent, and those who consent will be enrolled.  
 
Data collection, management, and analysis  
Data collection 
Health workers will be involved in: 1) a series of three health worker surveys 2), implementation adoption 
records, 3) simulated fidelity assessments for indexes and contacts, 4) authentic fidelity assessments for indexes 
and contacts, 5) in depth interviews and/or focus group discussions, and 6) time and motion assessments. All 
participating health workers will be assigned a unique study identification (ID) number.  
 
Enrolled patients (indexes and contacts) will take part in the following procedures: 1) recorded counseling 
session, 2) index and contact exit interviews, and 3) clinic record abstraction. All participants will be assigned a 
unique ID number, which will be used instead of personal identifiers to identify the patient in all data collected. 
 
We will also collect de-identified routine data from participating facilities. These records reflect routine 
programmatic data collected by the Malawi Ministry of Health or Tingathe. Data will be abstracted 
retrospectively. These records will include a) facility-level HIV testing registers, b) contact registers and c) index 
registers. Data from these sources will be used to inform our assessment of service uptake outcomes.  
 
Management  
Paper-based records will be stored in locked filing cabinets in locked rooms. Electronic data will either be 
collected using an encrypted electronic device or entered into a password-protected database by a trained data 
entry clerk. Electronic data will be stored on secure, password-protected servers. 
 
Analysis 
For Aim 1, we will compare health worker fidelity to ACT counseling procedures between the enhanced and 
standard implementation arms. We have >99% power to detect a difference in fidelity outcomes between arms.  
 
For Aim 2, we will compare HIV service uptake outcomes between the enhanced and standard implementation 
arms. Outcomes will include indexes who participate in ACT, contacts elicited, HIV self-test kits distributed, 
contacts tested, and contacts identified as HIV positive. We have >80-85% power to detect a difference in each of 
the outcomes of interest between randomization arms. 
 

 
 
 
UNCPM 22009 
Protocol v 3.0, page 7 of 34 
 
For Aim 3, we will compare the cost-related outcomes between the enhanced and standard implementation arms 
through cost-effectiveness analyses. 
 
Risks/benefits to subjects 
Risks: Risks are minimal for health workers and patients. For individuals participating in this study, there is a 
potential risk of breach of confidentiality as well as a risk of discomfort related to participation. Breach of 
confidentiality may occur if unique identifiers in datasets are linked back to personal identifiers. This is highly 
unlikely and measures will be taken to ensure that this does not occur. There is also a risk of discomfort with 
participation, but this is expected to be rare and minor.  
 
Benefits: Health workers may gain new knowledge and skills that make them better ACT providers or enhance 
their counseling skills. They may also enjoy the different study activities, such as discussing the ACT program in 
focus groups or interviews. Individual patients may enjoy exit interviews. This research is designed to create 
generalizable knowledge and enhance HIV programs in Malawi.  
 
Costs/compensation 
Health workers will receive the local equivalent of US$10 as compensation for study visits. Patients will receive 
the local equivalent of US$10 as compensation for their participation.  
 
Confidentiality assurances 
Measures will be taken to minimize the risks of breached confidentiality and participant discomfort. All study-
related activities will occur in private locations. To protect participants against risks associated with sensitive 
topics, they will be reminded that their answers to study questions will be kept confidential and that this 
information will not be shared with anyone. They will be allowed to refuse to answer certain questions. 
 
Clusters and participants will all be given unique ID numbers and all data will not contain any personal 
identifiers. Electronic data will either be collected using an encrypted device or entered into a password-protected 
database by a trained data entry clerk. Electronic data will be stored on secure, password-protected servers. All 
paper-based data, such as signed consent forms, will be stored in locked filing cabinets in locked rooms. Data will 
be stored following the termination of study completion and then destroyed.  
 
No subjects will be identified in any report or publication about this study.  In some cases, information in this 
research study could be reviewed by representatives of the University of North Carolina, research sponsors, or 
Malawi government agencies for purposes such as quality control or safety. We may present de-identified data for 
open access publications.  
 
Conflict of interest 
There are no conflicts of interest.  
 
Collaborative agreements  
We will also seek approval from University of North Carolina at Chapel Hill Institutional Review Board (IRB).  
 
Intended use of results 
The results of the study will be presented at international and local scientific meetings and published in scientific 
journals. The results will also be submitted to the NHSRC. The information collected in this study may lead to 
scale up of this implementation package in Malawi and beyond.

UNCPM 22009 
Protocol v.2, page 8 of 34 
 
 
PROTOCOL  
 
Title 
Enhancing HIV assisted contact tracing in Malawi through blended learning: an implementation science study 
 
Abstract            
Voluntary assisted contact tracing (ACT) is an evidence-based approach that efficiently identifies persons in need 
of HIV treatment and prevention. Malawi, like many countries in sub-Saharan Africa, has adopted ACT policies 
to support its “95-95-95” targets for HIV testing, treatment, and viral suppression. However, Malawi’s ACT 
implementation has been poor due to deficits in health worker capacity and clinical coordination. Through 
preliminary work, our team has developed a theory-based health worker training and continuous quality 
improvement process that addresses these barriers using a “blended learning” platform that combines digital and 
face-to-face modalities. This training package was field-tested in Malawi with promising preliminary results. In 
this proposal, the package will be rigorously evaluated in Malawi for implementation, service uptake, and cost-
effectiveness outcomes. This is a two-arm pragmatic cluster randomized implementation trial (n=33 clusters) to 
compare the enhanced implementation package to standard package. There are three objectives: determine 
whether the intervention enhances ACT implementation (Aim 1), determine whether the intervention increases 
HIV service uptake (Aim 2), and determine whether the intervention is cost-effective (Aim 3). The findings will 
offer important insights and innovations into how to bridge the gap between ACT research and practice, a critical 
step towards achieving the 95-95-95 targets. 
 
 
 

UNCPM 22009 
Protocol v.2, page 9 of 34 
 
Background and justification 
 
Despite progress towards the UNAIDS “95-95-95” targets (95% of HIV-positive persons tested, 95% of 
tested persons on treatment, and 95% of treated persons virally suppressed), a large gap remains in achieving the 
first 95% target.1 In sub-Saharan Africa, 81% of HIV-positive persons know their HIV status, leaving 4.9 million 
persons undiagnosed.1 Index-based interventions, in which HIV-positive “indexes” recruit their “contacts” (sexual 
partners and children) for HIV testing, efficiently identify HIV-positive persons in need of HIV treatment and 
HIV-negative persons in need of HIV prevention.2 In a randomized trial in Malawi, our team found that an 
assisted index-based approach, in which lay health workers traced contacts, led to 22% more contacts tested than 
a passive approach, which relied on patient recruitment.3 The assisted approach also led to more HIV-positive 
contacts linked to HIV treatment, more HIV-negative contacts using condoms, and improved index retention in 
HIV care.3, 4 In 2016, based on these and other compelling findings,5-8 the World Health Organization (WHO) 
issued guidelines strongly recommending voluntary Assisted Contact Tracing (ACT) and the President’s 
Emergency Plan for AIDS Relief (PEPFAR) has vigorously promoted ACT.9, 10 Many countries, including 
Malawi, have begun national ACT implementation.10, 11 However, ACT outcomes in routine programs have been 
worse than those in trials.11 In our initial ACT trial in Malawi, 74% of contacts received HIV testing compared to 
13% in Malawi’s national program.12 Rigorous implementation science is needed to optimize ACT in routine 
programs. 
 
Through formative work guided by the Consolidated Framework on Implementation Research,13 our team 
identified deficits in health worker counseling capacity and clinical coordination as the key determinants of poor 
ACT implementation in Malawi. At the health worker level, the need for ongoing ACT capacity-building was 
identified as critical. To address this, we developed an enhanced skill-building training guided by the theory of 
expertise14 and social cognitive theory15 which included: a) explanations of ACT skills; b) observations of 
modeled ACT skills, c) practice through ACT role-plays, and d) structured feedback. At the facility level, the 
need for greater coordination between health workers was identified as a key deficit. To address this deficit, we 
adapted a problem-solving process guided by continuous quality improvement principles.16 When this enhanced 
implementation package (training and problem-solving) was implemented with 500 health workers in 36 
facilities, the number of sexual contacts elicited, tested, and identified as HIV-positive all doubled.17  
 
In spite of these encouraging findings, we sought an alternative delivery modality to improve the 
scalability and sustainability of the enhanced implementation package. Digital packaging with a blended learning 
approach was a promising delivery modality. Blended learning is promoted by the WHO for health worker in-
service training in low- and middle-income countries (LMIC).18 These modalities blend the best features of 
electronic learning (e.g. quality, consistency, and convenience) with the best features of face-to-face learning (i.e. 
group engagement, interactivity, and feedback). Blended approaches are typically more effective than either face-
to-face or digital modalities alone for improving health worker knowledge and skills.19-21 In spite of these 
favorable characteristics, blended learning has never been rigorously evaluated for a full range of implementation, 
service uptake, and cost-effectiveness outcomes in a LMIC setting.18 Guided by principles of human-centered 
design thinking,22-24 we adapted our ACT implementation strategies into a tablet-guided blended learning package 
for facility-level use. When pilot-tested in six Malawian health facilities, we observed substantial increases in 
both health worker fidelity to ACT counseling procedures and the mean number of contacts tested. In “Enhancing 
HIV assisted contact tracing in Malawi through blended learning: an implementation science study,” we will 
assess this blended learning package using the RE-AIM framework.25 
 
 

UNCPM 22009 
Protocol v.2, page 10 of 34 
 
Literature review 
 
Although 81% of HIV-positive persons in sub-Saharan Africa (SSA) are now aware of their HIV status, 4.9 
million persons remain undiagnosed and half a million HIV-exposed infants do not receive timely early infant 
diagnosis each year.1, 26-28 Furthermore, a large share of HIV-negative adults remain unaware of being in HIV-
discordant relationships, and less likely to use effective HIV prevention strategies.29, 30 Index-based approaches, in 
which HIV-positive “indexes” recruit their “contacts” (sexual partners and children) for HIV testing, efficiently 
identify other HIV-positive persons in need of HIV treatment and HIV-negative persons in need of HIV 
prevention.2 Index-based approaches have higher diagnostic yields than any other testing approach2, 11 and hold 
promise for achieving the global target of 95% of HIV-positive persons tested for HIV.31  
 
Voluntary assisted contact tracing: “Assisted” index-based approaches, in which health workers support indexes 
with contact recruitment, are more effective at identifying contacts tested than “passive” approaches, which rely 
on patient recruitment.3 Assisted approaches also lead to more HIV-positive contacts linked to HIV treatment, 
more HIV-negative contacts using condoms, and improved index retention in HIV care.3, 4 In 2016, based on these 
and other compelling findings,5-8 the World Health Organization (WHO) issued guidelines recommending the 
implementation of voluntary Assisted Contact Tracing (ACT) and the President’s Emergency Plan for AIDS 
Relief (PEPFAR) has vigorously promoted ACT.9, 10 Many countries, including Malawi, have adopted ACT 
policies and intensified ACT implementation.10, 11, 32 However in most settings, routine ACT outcomes have been 
inferior to ACT trial outcomes. For example, in our Malawi-based ACT trial, 74% of sexual contacts received 
HIV testing and 72% were HIV-positive.3 Thus, it took two indexes to find one new HIV-positive contact. In 
contrast, in Malawi’s national ACT program, 13% of contacts received HIV testing12 and 17% were HIV-positive, 
thus requiring 45 indexes to find one new HIV-positive contact.  
 
Barriers and facilitators to ACT implementation in Malawi: To characterize the barriers and facilitators to 
implementation in the Malawian context, our research team used the Consolidated Framework on Implementation 
Research (CFIR).13, 33-35 The CFIR is a determinants framework comprised of five domains (intervention 
characteristics, individual characteristics, outer and inner organizational settings, and processes) and 39 constructs 
within these domains that interact with one another.13 With respect to intervention characteristics, complexity of 
ACT implementation was identified as a formidable barrier due to sensitivities around discussing sexual behavior 
with indexes, multiple potential contacts for each index, multiple tracing options for each contact, challenges with 
obtaining correct locator information for sexual contacts, and concerns around index safety. This level of 
complexity, along with the minimal pre-service training of lay health workers delivering ACT,36 exposed a set of 
individual characteristics: low competence and self-efficacy among both health workers and supervisors. For 
example, health workers expressed discomfort eliciting sexual partners and helping indexes decide which tracing 
method to select. Supervisors suggested that modeling these counseling behaviors would enhance skills, but were 
uncomfortable doing it themselves. In the outer setting, diverse patient needs of both indexes and contacts were 
not being met, as counseling was conducted generically in a non-client-centered manner. Networks and 
communication were identified as challenges in the inner setting: health workers in many parts of a single health 
facility (e.g., antenatal care, pediatrics, ART) interacted with potential indexes and contacts, but responsibilities 
were not clearly delineated and coordination between health workers was minimal. To address these challenges, 
several processes were proposed: training that consisted of engaging strategies (role modeling) and planning 
strategies (practice and feedback) to address perceived intervention complexity, low health worker competence 
and self-efficacy, and patient needs. To address network and communication challenges, group problem-solving 
approaches that incorporated reflection and evaluation were suggested.  
 
Lessons from other ACT programs in SSA: The facilitators we identified using the CFIR closely mirrored 
findings from successful ACT programs in SSA.37 In 2017-2018, contacts form Kenya and Mozambique 
accounted for 51% of the 1.7 million contacts tested across eighteen SSA PEPFAR countries, even though these 
countries only accounted for 14% of the population. Similarly, several Cameroonian districts scaled and sustained 
ACT before the WHO guidelines were published.38, 39 In an analysis of ACT implementation in these countries, 
the intensive ongoing nature of health worker capacity-building was essential.37 Although the implementation 
contexts differed, capacity-building processes were similar. Initial face-to-face trainings imparted ACT 

UNCPM 22009 
Protocol v.2, page 11 of 34 
 
counseling skills through skill-based learning and practice role-plays. Ongoing on-the-job mentorship and 
refresher trainings reinforced and enhanced these skills, consistent with regional capacity-building best 
practices.40-42 Routine monitoring and evaluation of implementation allowed for identification of challenges and 
improvements. 
 
Developing an enhanced ACT implementation strategy: From these findings, we arrived at two sets of 
implementation strategies: 1) enhanced health worker training to improve ACT competence and 2) group 
problem-solving grounded in continuous quality improvement principles to facilitate ACT coordination. This set 
of strategies aligns with a seminal review showing the combination of training and group problem-solving 
consistently and meaningfully improves health worker practices in low and middle income countries (LMIC).43 
Our specific training and problem-solving approaches were guided by theory and evidence:  
 
Training is the most common implementation strategy in LMICs, but is often conducted with suboptimal 
pedagogical practices and without any ongoing reinforcement.43 We developed a training guided by the theory of 
expertise,14 an educational theory which considers deliberate practice and a core set of activities (learning, 
observing, practicing, and receiving feedback) as essential for mastery.44-46 Applying this theory to ACT, we 
developed a set of training activities consisting of: a) explaining ACT counseling skills (learning), b) modeling 
ACT counseling skills through vignettes (observing), c) practicing counseling skills through role-plays (practice), 
and d) providing suggestions on improvement (feedback). This approach is supported by social cognitive theory, 
which posits that learning occurs in a social context with reciprocal interactions between the person, environment, 
and behavior.15 Observation of modeled ACT vignettes facilitates social learning; practice solidifies behavioral 
skills and enhances self-efficacy; and feedback refines and reinforces behavioral skills. These activities have 
enhanced counseling skills across a range of behavioral interventions, including those related to HIV treatment, 
prevention, and psychosocial support.20, 47-50 Group problem-solving draws on concepts from continuous quality 
improvement (CQI), a set of formal and systematic processes to identify and address health systems challenges.51, 
52 Similar processes have led to improvements in a range of outcomes in several SSA contexts, including with lay 
cadres. 53-58  
 
Using blended learning to promote scalability and sustainability: We evaluated the strategies outlined above in 
Mangochi, Malawi and demonstrated improved service uptake.17 While these strategies were effective, scaling and 
sustaining them posed a challenge. We hypothesized that delivering these effective strategies using a digital 
platform would make them more scalable and sustainable.59, 60 In recent years, digital learning has proliferated in 
the health sector, including in LMIC contexts, due to many enticing features: 1) learning is not time- or place-
dependent; 2) learning does not require an on-site instructor; 3) pace and degree of difficulty can be tailored to 
each learner; 4) progress and aptitude can be easily monitored; 5) high quality content can be delivered 
consistently; and 6) infrastructure needs are minimal.19, 21, 61-66 For in-service training in LMIC contexts, these 
features are appealing. Digital learning can be delivered at the health facility, eliminating travel and lodging 
expenses associated with centralized face-to-face trainings. Individual sessions can be delivered asynchronously 
so all staff are not absent from the clinic simultaneously, minimizing understaffing. New staff can acquire 
necessary skills right away, rather than waiting for a scheduled training. Health workers can further receive high 
quality instruction without relying on a highly skilled trainer.67, 68  The WHO has promoted the incorporation of 
digital modalities for training health workers in LMICs, but suggests complementing, rather than replacing, face-
to-face learning.18, 69 These “blended learning” approaches combine the best features of digital learning (i.e. 
quality, consistency, convenience) with the best features of face-to-face learning (i.e. interactivity, group 
engagement).64-66 They are typically more effective than either electronic or face-to-face learning alone for 
acquiring new knowledge and skills,19, 20 and are promising modalities for improving health worker counseling 
and communication.70-73  
 
Delivering ACT training through blended learning modalities: 
To facilitate meaningful and sustainable blended learning programs, technological, human, and cost features must 
be taken into consideration. We used human-centered design thinking to guide the adaptation of our effective 
ACT implementation strategies into a blended learning delivery platform.22, 23 Human-centered design thinking is 

UNCPM 22009 
Protocol v.2, page 12 of 34 
 
an approach that integrates the possibilities of technology, the preferences of people, and the requirements for 
business viability.24 Applied to rural Malawian health facilities, we identified important technological challenges, 
including limited internet connectivity, limited computer literacy, and non-universal personal mobile devices.74, 75 
These considerations led us to develop tablet-based content that did not require continuous internet connectivity 
for functionality. We provided the tablets. To address desirability for Malawian health workers, we developed 
content that was primarily audio- or video-based to ensure ease of use for this low literacy audience.21 All content 
was delivered with Malawian cultural and linguistic considerations in mind. Content was divided into modules 
and sub-modules to enable learning to occur in brief segments when workload permits. Finally, with respect to 
business aspects, we selected tablets, which are less costly than laptops. We opted for simple visuals and basic 
editing to limit the budget. For blended learning packages to be cost-effective, it is important to minimize up-front 
development costs, maximize the number of users, or, preferably, do both simultaneously.76-78 The final blended 
learning product was pilot-tested with promising preliminary results. The next step is to rigorously evaluate the 
blended learning ACT package at scale for a broader range of outcomes.    
 
Overarching objective and specific aims/study objectives 
The overarching objective is to determine whether an enhanced “blended learning” approach is an 
implementable, effective, and cost-effective modality for building health worker capacity for voluntary assisted 
contact tracing. This study has three specific aims: 
 
Aim/Objective 1: To compare the standard and enhanced arms for ACT implementation outcomes. Health 
worker fidelity to ACT counseling procedures will be assessed through audio-recorded encounters between health 
workers and indexes and between health workers and contacts.  
 
Aim/Objective 2: To assess the impact of the enhanced versus standard arms on ACT service uptake, including 
HIV-positive indexes identified, contacts elicited, self-test kits distributed, contacts tested, and HIV-positive 
contacts identified. 
 
Aim/Objective 3: To evaluate the cost-effectiveness of the enhanced versus standard arms. Using a hybrid 
decision tree/Markov model and prospectively collected cost data, we will estimate cost-effectiveness 
Study design and outcomes  
This is a 2-arm pragmatic cluster RCT comparing an enhanced blended 
learning implementation package to a standard implementation package. 
The study will be conducted at 34 Tingathe-supported health facilities in 
Machinga and Balaka, Malawi. Thirty-two of these facility will be 
considered unique clusters and 2 facilities will be combined to create a 33rd 
cluster. These 33 clusters will be randomized in a 2:1 ratio to the standard 
versus enhanced arms. All 33 clusters will receive the standard of care. 
Additionally, 11 of these clusters will receive an enhanced blended 
learning training (quarter 0) and enhanced facility support throughout 
quarters 1-4. Three sets of outcomes will be compared between the 
standard and enhanced arm over one year: implementation outcomes, 
service uptake outcomes, and cost-effectiveness outcomes.  
 
For Aim 1, the primary outcome is health worker fidelity to ACT 
counseling procedures.  
 
For Aim 2, the ACT cascade will be examined: indexes identified, contacts 
elicited, HIV self-test kits distributed, contacts tested, and contacts 
identified as HIV-positive.  
 
For Aim 3, we will compare the cost effectiveness between the enhanced 
and standard implementation arms through cost-effectiveness analyses.  
Figure 1.Study design and aims 

UNCPM 22009 
Protocol v.2, page 13 of 34 
 
 
The 22 standard of care sites will receive the enhanced implementation package after the initial cluster RCT 
period ends. All 33 sites will remain under observation for one additional year. Long-term outcomes will be 
examined at all 33 clusters through quarter 8 to examine delayed implementation and durability (Figure 2). The 
main study period will compare all outcomes in A versus B. Additionally, we will examine service uptake 
outcomes in (A+C+E) compared to (B+D). 
 
Figure 2. Study schedule 
Prior to implementation of the main trial, the blended learning package and all of the study tools will be pilot 
tested. The purpose of the pilot test is to examine feasibility and acceptability and refine the tools and 
implementation package for the trial.  
 
Randomization  
Machinga and Balaka Districts contain 34 facilities. Two small comparable facilities will be combined to create a 
total of 33 clusters (a number divisible by 3) to achieve 2:1 randomization. The clusters will be classified into 
strata of sizes 3, 6, or 9 based on key cluster-level characteristics, including district, facility type (hospital, health 
center, dispensary), and baseline performance (number of indexes identified) to help ensure balance of facility 
characteristics between the arms. Within each stratum, clusters will be randomly assigned in a 2:1 ratio to the 
standard or enhanced arms for the cluster RCT period (quarters 1-4). The facilities and their staff will not be 
blinded to study arm. However, on certain measures, such as audio-recorded fidelity assessments, coders will be 
blinded to randomization arm. The randomization schedule will be created by an independent statistician using a 
random number generator in SAS or comparable program. 
 
Evidence based practice  
In implementation science, an important first step is clear identification of the evidence-based practice, which in 
this case is ACT. In the Malawian context, ACT is a voluntary service which consists of offering support to HIV-
positive clients to recruit sexual partners and family members for HIV testing. ACT is simple in theory, but complex 
in practice. Indexes may be adults or children, newly diagnosed or already on treatment. Adult contacts may be 
PRE
0
1
2
3
4
5
6
7
8
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33/34
Enhanced training conducted in arm 1 and arm 2.
Periods of enhanced implementation 
Periods of standard implementation
Facility ID
Data harmonization/Standard of care
I.1
C
E
A
B
I.2a
I.2b
D

UNCPM 22009 
Protocol v.2, page 14 of 34 
 
spouses or casual partners, in heterosexual or same-sex partnerships. For each contact, indexes may select one of 
four contact recruitment options: 1) passive referral, in which the index invites partners or provides them with a 
self-test kit; 2) provider referral, in which a health worker recruits contacts; 3) contract referral in which a health 
worker recruits a contact if passive referral has been unsuccessful, and 4) dual referral in which a health worker 
supports disclosure to a contact, often in the context of couples HIV counseling and testing.9 Within a given facility, 
there are typically multiple possible entry-points for identifying indexes, including antenatal care, outpatient 
departments, labor and delivery wards, pediatrics, and HIV care clinics. The diversity of indexes and contacts (often 
with sensitive family and sexual dynamics) and the range of recruitment options give rise to a complex set of 
counseling tasks for health workers. Similarly, the multiple entry points for indexes and contacts pose coordination 
challenges throughout the facility.  
 
Implementation strategies 
Standard implementation  
All facilities participating in the study will receive standard ACT implementation strategies. In Malawi, the 
standard ACT implementation strategies consist of 1) an introductory, brief ACT training, and 2) routine monthly 
supervisory activities by an implementing partner like Tingathe. The training is centralized and conducted in-
person. It occurs one time, is primarily didactic, and provides an overview of ACT procedures and counseling 
approaches. Tingathe provides routine monthly supervision to all facilities for all of its supported activities, 
including HIV testing, ART provision, and viral load monitoring, in addition to ACT. In this standard 
implementation condition, the study will not alter anything.  
 
Enhanced implementation  
In addition to receiving the standard implementation strategies described above, the 11 clusters randomly assigned 
to the enhanced implementation arm will 1) receive the blended learning training and 2) participate in continuous 
quality improvement (CQI) processes. Unlike the standard training, the blended learning training is designed for 
decentralized delivery at the facility level. The content of the blended learning package builds on the themes 
described in the standard training. The training contains modules with individual asynchronous learning sessions 
and a synchronous interactive small-group session. The individual learning sessions contains descriptions of ACT 
skills, vignettes modeling these skills, and embedded comprehension questions. The small-group learning session 
contains practice role-plays, individual feedback, and facilitated group discussions. All training activities are 
documented in the tablet. To complement the training, all health workers involved in ACT will participate in 
ongoing problem solving examine their facility’s ACT performance, identify gaps, and work towards actionable 
solutions. These activities will be guided by and documented in the tablet.  
 
Study Setting  
The study will be conducted in Malawi, a country in Southeastern Africa with 19 million people. Malawi has a 
10.6% adult HIV prevalence and 1.1 million people living with HIV.79 Malawi has a mature HIV program that is 
approaching the 95-95-95 targets. In the first Malawi Population-based HIV Impact Assessment (MPHIA), an 
estimated 77% of HIV-positive adults were aware of their HIV status, 91% of these adults were on treatment, and 
91% of those on treatment were virally suppressed.79  
 
The study will be conducted in 34 health facilities that are supported by the Tingathe Program, the organization 
that will lead study implementation. The Tingathe Program is one of the three largest PEPFAR implementing 
partners in Malawi. Tingathe was initiated by Baylor College of Medicine Children’s Foundation-Malawi in 
partnership with the Malawi Ministry of Health (MOH). Tingathe takes a family-focused approach to the HIV 
epidemic by supporting the provision of high-quality, comprehensive HIV services. Tingathe has over 10 years of 
experience implementing HIV testing, care, and treatment programs in Malawi and currently provides support to 
Malawi’s HIV care and treatment program with more than 1,000 staff in 130 MOH facilities. 
 
Malawi has a dire human resource shortage with fewer than 2 physicians, 0.02 psychiatrists, and 0.01 psychologists 
per 100,000 people, some of the lowest global rates.80, 81 To address its formidable HIV burden with limited human 

UNCPM 22009 
Protocol v.2, page 15 of 34 
 
resources, Malawi has task-shifted many HIV-related activities, especially counseling tasks, to lay cadres. In 2015, 
to respond to gaps in HIV testing, Malawi introduced a cadre of HIV diagnostic assistants to improve coverage of 
early infant diagnosis, viral load testing, and rapid HIV antibody testing.36 HIV diagnostic assistants are lay persons 
with secondary education and four weeks of pre-service training. In its first year, nearly 1200 HIV diagnostic 
assistants were deployed to 450 facilities, resulting in improved diagnostic indicators.36 PEPFAR implementing 
partners, including Tingathe, have been integral in supervising this cadre. Tingathe also supervises community 
health workers who are responsible for a range of HIV-related tasks, including community tracing. HIV diagnostic 
assistants and community health workers conduct most ACT implementation.82 HIV diagnostic assistants typically 
diagnose HIV-positive indexes and support contact elicitation and selection of ACT options and community health 
workers typically conduct tracing.  
 
 
Populations, Eligibility Criteria, and Sample Sizes 
At each facility, two study populations will be enrolled: health workers and patients (indexes and contacts). 
Within each participating facility, we will recruit health workers, along with a subset of indexes and contacts 
(patients). Sample sizes were determined by conducting empirical power simulations using data from all 34 
Tingathe-supported facilities in Machinga and Balaka from 2019-2020. See power calculations in analytic 
sections.  
 
Health workers will be eligible for study participation if they are: (a) 18 years of age or older, (b) working full-
time at one of the health facilities included in the study, and (c) staff in Malawi’s Assisted Contact Tracing 
program. Persons who do not meet these criteria will be excluded. We will aim to enroll at least 2 health workers 
per cluster for a minimum of 66 health workers in the study, though we may enroll up to 400 health workers. In 
addition, in the pilot test, up to 20 health care workers will be enrolled. Persons will be excluded for conditions 
that in the opinion of the study investigator would compromise the ability of the participant to provide informed 
consent, undergo study procedures safely, or would prevent proper conduct of the study.  
 
Recruitment of health workers from included facilities will occur primarily at the beginning of the study, but will 
remain open to health workers who become eligible at any point in the two-year period. This may include health 
workers at the same facility who rotate into new roles or health workers from other facilities who transfer in. All 
health workers at a given facility who are involved in ACT will be invited to participate in the study, and a 
member of the study team will engage potential participants in a brief conversation about the purpose, nature, and 
duration of the study.  
 
Patients will be eligible for study participation if they are: (a) 15 years of age or older; (b) a potential index, 
contact, or the parent/guardian of a pediatric index or contact. Persons who do not meet these criteria will be 
excluded. We will enroll up to 600 indexes and 200 contacts over the study period. Persons will also be excluded 
for conditions that in the opinion of the study investigator would compromise the ability of the participant to 
provide informed consent (e.g. not understanding Chichewa), undergo study procedures safely, or would prevent 
proper conduct of the study.  In the pilot test, an additional 30 patients may be enrolled.  
 
Recruitment of patients (indexes and contacts) is expected to occur at each facility during the study period. The 
study team will be assigned to spend time at each facility and will approach potential indexes and contacts about 
participation in the study. Study team members will be trained in effective communication techniques and will 
engage the potential participants in brief conversations about the purpose, nature, and duration of the study. If 
interested, potential participants will be offered the opportunity to provide informed consent, and those who 
consent will be enrolled.  
 

UNCPM 22009 
Protocol v.2, page 16 of 34 
 
 
 
Procedures  
 
 
 
 
 
Facilities will participate in the following procedures: 
Pre-trial 
• 
All sites will have standard of care training  
Quarter 0 
• 
A facility survey will be conducted 
• 
Data harmonization will occur to ensure all facilities are collecting the same data in the same way. 
• 
All facilities will be randomized to one of the two study arms 
• 
11 sites randomized to the enhanced arm will receive enhanced blended learning training package 
Quarters 1-4 
• 
All ACT procedures will be conducted and service uptake data will be collected 
• 
All clusters will receive standard of care implementation  
• 
11 clusters will receive enhanced implementation  
Quarters 5-8 
• 
All ACT procedures will be conducted and service uptake data will be collected  
• 
11 clusters randomized to the standard arm will receive enhanced package (Q5)  
• 
11 clusters randomized to the standard arm will receive enhanced package (Q6)  
 
Health care workers (e.g. HDAs, CHWs, etc.) will participate in the following procedures: 
Pre-trial  
• 
At the time of recruitment, health workers will be offered the opportunity to provide informed consent. 
Those who provide informed consent will complete the remaining study procedures. 
• 
All participating health workers will be assigned a unique study ID number.  
• 
They will fill out HCW survey 1  
• 
Some will be purposively invited to participate in IDIs and/or FGDs 
Quarter 1 
• 
HCW Survey 2  
 
Pre 
Q0 
Q1 
Q2 
Q3 
Q4 
Q5 
Q6 
Q7 
Q8 
Facility survey (FS) 
 
X 
 
 
 
 
 
 
 
 
SOC training  
X 
 
 
 
 
 
 
 
 
 
Data harmonization  
 
X 
 
 
 
 
 
 
 
 
Randomization  
 
X 
 
 
 
 
 
 
 
 
Enhanced training 
Adoption/adherence (AD) 
 
11 
clusters 
 
 
 
 
11 
clusters 
11 
clusters 
 
 
SOC implementation  
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Enhanced implementation  
 
 
11 
Clusters 
11 
clusters 
11 
clusters 
11 
clusters 
22 
clusters 
33 
clusters 
33 
clusters 
33 
clusters 
Service uptake 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
HCW consent 
X 
 
 
 
 
 
 
 
 
 
HCW surveys 
X 
 
X 
 
 
X 
 
 
 
 
Simulated fidelity  
 
X  
X 
 
 
 
 
 
 
 
Authentic fidelity  
 
 
X 
X 
X 
X 
 
 
 
 
Exit interviews 
 
 
X 
X 
X 
X 
 
 
 
 
Time and motion 
 
 
X 
X 
X 
X 
 
 
 
 
Focus groups/in-depth 
interviews  
~8 
clusters 
 
~8 
clusters 
 
 
~8 
clusters  
 
 
 

UNCPM 22009 
Protocol v.2, page 17 of 34 
 
• 
Simulated fidelity assessments  
• 
Some will be purposively invited to participate in IDIs/FGDs  
• 
Health workers may be selected for authentic fidelity assessments throughout the study period. In these 
assessments, their interactions with indexes and contacts will be recorded.  
• 
Health workers will be observed for time-motion assessments for the costing component.  
 
Quarters 2-4 
• 
HCW Survey 3 
• 
Health workers may be selected for fidelity assessments throughout the study period. In these 
assessments, their interactions with indexes and contacts will be recorded.  
• 
Health workers will be observed for time-motion assessments for the costing component.  
• 
Some will be purposively invited to participate in IDIs/FGDs in ~quarter 4 
 
Patients (indexes and contacts) will participate in the following study activities (Quarters 1-4): 
• 
At the time of recruitment, patients will be offered the opportunity to provide informed consent. Those 
who provide informed consent will complete the remaining procedures. 
• 
All participating patients will be assigned a unique study ID number. This ID will be used, rather than 
personal identifiers. 
• 
Patients will have their ACT counseling session audio-recorded for the fidelity assessment. The purpose 
of the audio-recorded session is to evaluate the quality and thoroughness with which the counselor 
conducts the session.  
• 
Patients will then complete an exit interview. The goal of the exit interview is to learn about acceptability 
and the patient’s experience of their session. This exit interview will contain basic demographic questions 
and questions about the encounter. It will also contain questions to inform the costing components of the 
study.  
• 
Record abstraction will be conducted to learn about the impact of the study on their care-seeking.  
 
Procedures in the context of COVID-19 
Over the course of the study period, we will continue or suspend study procedures in accordance with guidance 
from the sponsor, NHSRC, UNC IRB, WHO, and the Government of Malawi in response to the evolving 
COVID-19 situation. We will be flexible with procedures to maximize the safety of study staff and participants 
and ensure scientific integrity.  
 
Where necessary and appropriate, we will conduct in-person procedures using precautions intended to safeguard 
the study staff and participants. These precautions may include: having study staff wear personal protective 
equipment (PPE) when interacting with attending participants; screening study staff and participants for COVID-
19 using temperature and a symptom questionnaire. Additionally, we will be flexible on the timing, location, and 
modality of study activities. We may go to the community to conduct procedures if this is deemed safer than 
clinic-based activities, use electronic platforms like video-conferencing or voice calls as needed, and conduct 
certain activities at earlier or later times if needed. Social distancing will be practiced. This applies to both 
programmatic activities (e.g. implementation) and research activities (e.g. assessments). 
 
Data collection  
All data will be collected by trained research assistants with certifications in human subject protections and good 
clinical practices. Electronic data will either be collected on an encrypted device or entered into a password-
protected database by a trained data entry clerk on an encrypted computer. Electronic data will be stored on 
secure, password-protected servers. Paper-based data will be stored in locked filing cabinets in locked rooms. 
 
Data sources 

UNCPM 22009 
Protocol v.2, page 18 of 34 
 
The following data sources will be used to collect study outcomes. All forms may undergo modification in 
content or timing of administration following pilot testing:  
• 
Facility survey: This tool will capture facility characteristics, including staffing, space, and ACT practices, 
as well as available modes of communication and transportation.   
• 
HCW surveys: This tool will capture key characteristics of health care workers enrolled in the study, 
including: demographics, technological literacy and attitudes, professional and training history, time spent 
on ACT, attitudes towards PLHIV; and knowledge, attitudes, and practices surrounding ACT.  
• 
Blended learning monitoring records: These data and meta-data, generated from blended learning 
modules, will monitor blended learning adoption. These data will only be available in the enhanced arm and 
will monitor blended learning adoption.  
• 
Authentic fidelity assessments/simulated fidelity assessments: These assessments will be completed by 
the study team to document fidelity to ACT counseling between health workers and indexes/contacts based 
on audio-recordings with clients (authentic) or actors (simulated). 
• 
Patient exit interviews: These will be collected by the study team to document index and contact 
acceptability, as well as intentions, anticipated stigma, and perceived health worker respect.  
• 
Focus group discussion and in-depth-interview transcripts: These will be collected by the study team to 
understand health worker acceptability and feasibility, as well as attitudes towards PLHIV.   
• 
HIV testing registers: These are facility-level documents with all persons tested, as well as age, gender, 
and HIV status. This data source will contribute to the total number of potential indexes. 
• 
Index registers: These are routine program documents that contain a list of all persons offered ACT 
services. They include index information. This will contribute to service uptake outcomes. 
• 
Contact registers: These are routine program documents that contain a list of all persons offered ACT 
services. They include a list of contacts, whether testing occurred, and HIV status. This will contribute to 
service uptake outcomes. 
• 
Time and motion survey: These will be collected by the study team to document the amount of time health 
workers spend on ACT activities. 
 
 

UNCPM 22009 
Protocol v.2, page 19 of 34 
 
Data elements 
Data element  
Description 
Population and Frequency 
Approximate  
Timing 
Source 
Implementation and cost outcomes 
Enhanced arm  
Adoption/adherence 
(AD) 
Completion of all modules and CQI 
activities. (Fidelity to the 
implementation intervention) 
 
All enrolled health care workers in enhanced arm (N=11 facilities x 
~2+ HCWs/facility=~22+  
*This will be examined in the SOC arms when enhanced 
implementation strategy is rolled out. 
1—  Q.0  
2a—Q.5*  
2b—Q.6* 
Module completion data 
(SurveyCTO) 
Facility survey (FS) 
 
Staffing, services, tracing modalities, 
volume, characteristics.  
 
All clusters (N=33 x 2-6 times) 
Q.0, 4 
facility survey  
(SurveyCTO) 
Simulated fidelity 
assessments  (SFA) 
-Observe HCW conducting simulated 
index and/or contact encounter 
 
Health care workers 
(N=33 clusters x ~2+ HCWs/facility=66+) 
Q.0-1 
 
Fidelity assessment tool 
(paper to SurveyCTO) 
Health care worker 
(provider) survey 
 
-Demographics, cadre, technology 
literacy, knowledge, attitudes, 
practices, aptitudes, past training, time 
spent on ACT activities 
All enrolled health care workers  
(N=33 clusters x ~2+ HCWs/cluster=66+) 
PRE 
Q.1 
Q.4 
 
Provider survey 
(SurveyCTO) 
Focus group discussions 
(FGDs)/In depth interviews 
(IDIs) 
 
-Learn about HCW feasibility and 
acceptability 
Compare SOC to ENH and PRE/Q1/Q4 
Health care workers  
(N=8 groups x 3 times~=24 FGDs) 
(N=3 IDIx x 8 facilities x  3 times~=72 IDIs)  
PRE 
Q.1 
Q.4 
 
Semi-structured guides 
(audio recording) 
(Survey CTO to document 
participants and timing) 
Fidelity Assessments (FA) 
-Observe HCW conducting true index 
and/or contact encounters 
 
Health care workers, indexes, contacts  
((N= 33 cluster x minimum of 2 indexes/cluster=66-600) 
(N= 33 cluster x minimum of 2 contacts/cluster=66-200) 
Q.1-4 
Fidelity assessment tool 
(audio recording to paper to 
SurveyCTO) 
Index exit interviews  
Contact exit interviews 
(XIs) 
-Examine index acceptability  
-Examine contact acceptability 
Indexes and contacts: 
(N= 33 cluster x minimum of 2 indexes/cluster=66-600) 
(N= 33 cluster x minimum of 2 contacts/cluster=66-200) 
Q.1-4 
Index exit interview 
(SurveyCTO) 
Time and motion 
assessment (TM) 
-Assess the effort to which HCWs work 
on each activity 
Health care workers  
N=( ~2-3/cluster x 33 facilities=66-100 days of observation) 
Q.1-4 
Time and motion survey 
(paper to SurveyCTO) 
Effectiveness outcomes  (EF) 
Total potential indexes  
#ART patients who were supposed to 
be assessed per quarter plus the  #new 
HIV+ patients per quarter 
N=33 clusters x 8 quarters=264  
 
Q.1-8 
ART and HTS registers 
HTS registers  
(register to SurveyCTO) 
# indexes, #contacts 
elicited, # STKs distributed 
Number of indexes captured, contacts 
elicited and STKs distributed 
 
N=33 clusters x 8 quarters=264  
Q.1-8 
Index and contact registers 
 
# contacts tested 
# HIV+ contacts  
 
Number of contacts returned and the 
proportion HIV+ 
 
N=33 clusters x 8 quarters=264  
Q.1-8 
Index and contact registers 
 
 
 
 
 

UNCPM 22009 
Protocol v.2, page 20 of 34 
 
Evaluation framework  
Consistent with implementation science best practices,13, 37, 38 we have used an evaluation framework, RE-AIM, to 
guide analysis. 93, 94 The five RE-AIM constructs—Reach, Effectiveness, Adoption, Implementation, and 
Maintenance—align with our research questions. Reach, persons receiving the intervention, will be measured by 
the rate of potential indexes who are offered ACT. Effectiveness, the ability of an intervention to impact outcomes, 
will be measured by a range of service uptake outcomes. In addition, positive and negative aspects of index and 
contact experiences will be measured through exit interviews. Adoption will be measured by the proportion of the 
enhanced implementation package completed per site. Implementation will be assessed through fidelity 
assessments, measuring how well health workers adhere to counseling protocols. Maintenance, the degree to which 
a program becomes part of routine organizational practice, will be examined through the consistency in the other 
outcomes (effectiveness and implementation) over time. In addition, we expect to explore how the five RE-AIM 
domains relate to one another (Figure 8).83, 84 We hypothesize that adoption of blended learning activities will lead 
to better implementation and reach which, in turn, will lead to greater ACT effectiveness, and ultimately 
maintenance (sustainability) over time.   
 
 
 
Aim 1 Analytic methods and power calculations (implementation outcomes) 
In Aim 1, we will compare the implementation outcomes of the enhanced and standard arms. The primary 
hypothesis is that fidelity to counseling procedures will be better in the enhanced arm than the standard arm.  
 
Primary outcome of interest (fidelity): The primary implementation outcome of interest is health worker fidelity to 
ACT counseling procedures. This was selected as the primary implementation outcome because the enhanced 
training directly targets this outcome. Fidelity will be assessed using a 15-item scale assessing the quality, 
completeness, and adherence to ACT procedures with raw scores ranging from 0-30 (and recalculated as 0 to 100 
percentage points).  
 
At each of the 33 clusters, at least 2 ACT encounters between health workers and indexes at least 2 ACT encounters 
between health workers and contacts will be audio-recorded. A minimum of 132 observations total are needed for 
both indexes and contacts (4/per cluster), but up to 200 contact encounters and 600 index encounters may be 
conducted. For indexes, attempts will be made to achieve balance between recruitment from the ART and HTS 
settings. For contacts, attempts will be made to achieve balance between the clinic and community settings.  
 
Each audio-recording will be scored by two research officers blinded to the study arm and the two scores will be 
averaged. This tool has been field-tested. 
 
Analyses: Generalized estimating equations (GEE) to account for potential correlation at the cluster level will be 
implemented to compare health worker fidelity scores between the enhanced and standard arms. Models with 
identity links and normal distributions will be used to compare means between the two arms. A working correlation 
structure will account for the correlated nature of observations from the same cluster. Models will contain a term 
for randomization arm. To assess fidelity maintenance over time, we will implement models with an interaction 

UNCPM 22009 
Protocol v.2, page 21 of 34 
 
term between time and randomization arm. To assess differences by setting (indexes: ART vs. HTS; contacts: clinic 
vs. community), we will implement an interaction term between randomization arm and setting. Indexes and 
contacts will be analyzed separately. Data from the authentic and simulated fidelity assessments (below) may be 
combined. 
 
Statistical power and sample size: Sample size calculations are based on data collected during our pilot assessment 
of provider fidelity. The pilot fidelity score standard deviation, after rescaling to percentage points, was 20.5%. 
With 132 fidelity assessments from 33 clusters and assuming SD=20.5% and a working correlation estimate of 0.3 
or smaller, we will have >99% statistical power to detect a 30 percentage point difference between means (90 versus 
60) between the enhanced and standard arms. Even with smaller differences between arms of 15 percentage points 
(75 versus 60), we have >81% statistical power to detect a difference. Although only 132 authentic fidelity 
assessments are needed to achieve >80% power, up to 200 authentic fidelity assessments (contact clients) and 600 
(index clients) per cluster may be collected to examine trends within sub-groups. Power was calculated by inverting 
the closed-form sample size equation from section 4.1 of Liu & Liang (1997), where the average cluster size was 
used in place of n for a reasonable power approximation.  
 
Additional (tertiary/exploratory) implementation outcomes: Exploratory implementation outcomes of interest 
include simulated fidelity assessments, facility adoption of and adherence to the implementation strategies, health 
worker feasibility and acceptability, and patient acceptability.  
• 
Health care worker knowledge, attitudes, practices: These constructs will be assessed through the health 
worker survey.  
• 
Simulated fidelity assessments: These will be analyzed similarly to the authentic fidelity assessments 
described above. However, rather than conducting these with real patients and contacts, they will be conducted 
with actors simulating indexes and contacts. Each enrolled health care workers may participate in staged fidelity 
assessments with indexes and contacts.  
• 
Facility adoption/adherence: This will be assessed as the degree to which all blended learning activities 
took place in the enhanced arm, including modules viewed, practice sessions completed, feedback provided, and 
continuous quality improvement conducted. Each participating health worker will receive an adoption score. 
The facility score will be the mean of the health worker scores. We will analyze whether this adoption/adherence 
score is associated with fidelity and ACT service uptake outcomes among sites in the enhanced arm. This will 
allow for a detailed understanding of the relationship between the amount and nature of blended learning 
activities, as well as continuous quality improvement activities associated with outcomes of interest.  
• 
Health worker feasibility and acceptability: This captures the extent to which health workers find the 
implementation strategy and ACT intervention to be desirable and viable. This will be assessed through a series 
of three longitudinal focus group discussions (FGDs) and/or in-depth interviews with health workers in 
approximately 8 facilities ensuring balance between district and study arm. The purpose is to understand 
experiences with implementation barriers and facilitators. FGDs will be conducted immediately after 
randomization to learn about pre-study implementation, in quarter 1 to learn about early implementation, and in 
quarter 4 to learn about implementation maintenance. Each FGD will be conducted with a subset of 2-10 health 
workers from each facility. Data will be analyzed using thematic content analysis consisting of: 1) reading for 
content and writing memos, 2) coding, 3) data consolidation to identify key sub-themes, 4) data display, and 5) 
interpretation. 
• 
Patient acceptability: Index and contact acceptability using adapted validated scales of perceived health 
worker respect and anticipated stigma. This will be the same target population as the authentic fidelity 
assessments. We will explore the relationships between health worker fidelity and patient acceptability, as well 
as the relationship between patient acceptability and ACT service uptake outcomes.  
 
Aim 2 Analytic methods and power calculations (HIV service uptake outcomes) 
In Aim 2, we will compare the HIV service uptake outcomes between the enhanced and standard arms. The 
overarching hypothesis is that the enhanced package will lead to a range of improved HIV service uptake outcomes. 
 

UNCPM 22009 
Protocol v.2, page 22 of 34 
 
Outcomes of interest: Five ACT service uptake outcomes will be measured from index and contact registers on a 
quarterly basis. Each of these outcomes will be measured as a count per cluster per calendar quarter (three-month 
period). We will use facility-level data because the facility (i.e. cluster) is the primary unit of randomization. With 
33 clusters under observation for four quarters, the facility-level dataset for the primary analyses will contain 132 
observations (33 clusters * 4 quarters), 44 observations in the enhanced arm and 88 observations in the standard 
arm. The full two-year analyses will contain 264 observations (33 clusters * 8 quarters). The following measures 
will be calculated on a quarterly basis: 
  
• 
Total potential indexes: This is the total number of ART and HTS patients that should be screened for and 
potentially offered ACT. 
• 
1: Indexes who participate in ACT: The number of indexes in the index register.  
• 
2: Number of contacts elicited: The number of contacts listed by the participating indexes. Are they put 
into the index register here? 
• 
3a: Number of self-test kits distributed: The number of HIV self-test kits given to indexes for secondary 
distribution. Often, this is used as a method for testing contacts, rather than presenting to the clinic.  
• 
3b: Number of contacts tested: The number of contacts with a recorded HIV test result. These tests are 
typically performed by a health care worker.  
• 
4: Number of contacts diagnosed HIV-positive: The number of contacts in the contact register with an 
HIV-positive test result. 
 
Analyses: Data from quarters 1 through 4 (the cluster RCT design) will be analyzed using a negative binomial 
mixed-effects model accounting for quarterly repeated measures within each cluster. Models will use a log link, 
contain terms for randomization arm, and the natural-log transformed number of potential indexes will be 
incorporated as an offset term. Key baseline variables of interest, such as district, will be adjusted for. Rate ratios 
and 95% confidence intervals will be used to estimate the effect sizes and quantify the precision of effect estimates 
for the main analyses which will compare the enhanced versus standard arms for rates of each service uptake 
outcome per the total number of potential indexes (5 main endpoints denoted above). Secondary endpoints will take 
the same approach and use a negative binomial mixed effects model as well. Several secondary endpoints are 
proportion measures; for those endpoints effect size will be measured using a risk ratio and corresponding 95% 
confidence interval comparing the enhanced versus standard arms.To assess maintenance, interaction terms between 
quarters and randomization arm will be included to assess whether effects remain constant, intensify, or diminish 
over time during quarters 1 through 6. 
 
Statistical power assumption, models, and estimates: Sample size calculations were guided by data from the 33 
proposed clusters in the two districts from 2019-2020. In these two districts (Machinga and Balaka), Tingathe 
supports 34 MOH facilities with implementation of the national HIV program and supervises approximately 150 
community health workers and 100 HIV diagnostic assistants. Two nearby facilities in Balaka will be combined for 
analysis such that the 34 facilities are handled as 33 clusters. 
 
Across these 33 clusters, 4600 persons are diagnosed with HIV each year and another 49,000 are already taking 
ART. From this, we estimated 35 new HIV-positive diagnoses per cluster per quarter and 372 ART patients per 
cluster per quarter or approximately 407 total potential indexes per facility per quarter. On average, of these 407 
total potential indexes, there were approximately 86 indexes identified (0.21), 97 contacts elicited (0.24), 12 self-
test kits distributed (0.03), 25 contacts tested (0.06), and 3 contacts diagnosed as HIV-positive (0.007). These values 
informed our assumptions for the standard arm.  
 
Power for primary analyses: 
Standard power formulas were not equipped for this cluster RCT design due to contingencies in the count outcomes 
with differing cluster sizes, repeated measures and within-facility correlated data. Thus, for power calculations in 
Aim 2, we applied these parameters to a simulation study of these facilities in SAS v9.4.87, 88 The number of total 
potential indexes per facility per quarter was accounted for as a statistical offset term.89 The number of total potential 

UNCPM 22009 
Protocol v.2, page 23 of 34 
 
indexes per facility per quarter was generated from a Poisson distribution with a cluster-specific mean. Count values 
per cluster per quarter for each of 5 outcomes were generated from a negative binomial distribution with the random 
intercept variance, over-dispersion parameter, and arm-specific rates specified using a generalized linear mixed 
effects model with a log link. The Poisson facility-specific means, random intercept variances negative binomial 
over-dispersion parameters, and mean values for the standard arm were estimated from background data. To 
compute power, the simulated study data were analyzed using a negative binomial mixed-effects model accounting 
for repeated measures within a cluster. Statistical power was computed using simulation studies of 10,000 cluster 
RCT datasets. Based on these assumptions, and a significance level α=0.05, we have 80-85% statistical power to 
detect a difference between the arms for each of the outcomes of interest.  
 
 
  
Additional service uptake analyses from the trial (tertiary outcomes) 
In addition to the primary analyses described above, rather than using total potential indexes as the statistical offset 
value, an indicator from the previous step of the cascade will be used. Power calculations were conducted for these 
secondary endpoints as well. The empirical power approach for rate ratios was described for the primary analysis. 
For proportion endpoints, a logistic mixed-effects model was used to simulate proportion values between [0, 1], and 
empirical power to detect a given risk ratio was calculated from a log-binomial mixed-effects model analysis. 
 
 
TPI denominators
Effect 
size
Key measures:
Enhanced
Standard 
RR
Enhanced
Standard
RIV
Scale
0. Total potential indexes
n/a
n/a
1
407
407
n/a
1. Total indexes
0.3100
0.2113
1.47
126
86
0.0981
0.0854
85%
2. Contacts Elicited
0.3700
0.2383
1.55
151
97
0.1268
0.1880
81%
3a. Self-test kits distributed
0.0650
0.0295
2.20
26
12
0.0001
1.9077
82%
3b. Contacts Tested
0.1247
0.0614
2.03
51
25
0.3340
0.2847
85%
4. HIV+ Contacts Diagnosed
0.0155
0.0074
2.10
6
3
0.3334
0.3039
82%
RR=rate ratio
RIV = random intercept variance; estimated variance of the random intercept for cluster j
Scale parameter for the negative binomial mixed-effects model summarizes over-dispersion
Standard arm counts calculated by averaging background data from Oct 2019-April 2020 and Sep–Nov 2020
Nominal type I error rate of α=0.05 is used throughout, with no adjustment for multiple endpoints
Statistical 
Power
Assumed values for empirical power calculations:
Endpoint Rates
Expected counts
Nuisance 
parameters
Cascade Denominators
Type
Effect size
Key measures:
RR
Enhanced Standard
RIV
Scale
0. Total potential indexes (TPI)
1
407
407
n/a
1. Total indexes (TI)
R
0.3100  per TPI 0.2113  per TPI
1.47
126
86
0.0981
0.0854
85%
2. Contacts Elicited (CE)
R
1.4200  per TI
1.1279  per TI
1.26
179
97
0.0274
0.0658
83%
3a. Self-test kits distributed
P
0.2250  per CE
0.1237  per CE
1.82
40
12
0.4260
n/a
83%
3b. Contacts Tested 
P
0.4400  per CE
0.2577  per CE
1.71
79
25
0.5770
n/a
82%
4. HIV+ Contacts Diagnosed
P
0.0770  per TI
0.0349  per TI
2.21
14
3
0.5681
n/a
81%
R = Rate; P = Proportion; RR = rate ratio for rates or risk ratio for proportions; 
RIV = random intercept variance (i.e., estimated variance of the random intercept for each cluster)
Scale nuisance parameter for the negative binomial mixed-effects model summarizes over-dispersion for rate endpoints
Standard arm counts are per cluster per quarter and calculated by averaging background data from Oct 2019-April 2020 and Sep-Nov 2020
Nominal type I error rate of α=0.05 is used throughout, with no adjustment for multiple endpoints
Statistical 
Power
Assumed values for empirical power calculations:
Nuisance 
parameters
Endpoint Rates
Expected counts
Enhanced
Standard 
n/a
n/a

UNCPM 22009 
Protocol v.2, page 24 of 34 
 
Temporal trend analyses 
In addition to analyzing the primary cluster RCT data described above, we will explore temporal trends. Based on 
Figure 2, we will examine all of the indicators described above, comparing the periods preceding enhanced 
implementation (B+D) to the periods following enhanced implementation (A+C+E).  Period A will also be 
compared to period C. In these analyses, the analytic procedures described for the primary and secondary analyses 
will be followed. These models will have terms for the primary exposure of interest and time.  
  
 
Aim 3 Analytic methods (Cost-effectiveness)  
In Aim 3, we will explore the budget impact and cost-effectiveness of the enhanced and standard approaches. Our 
modeling will allow us to examine the inherent tradeoffs of the high upfront and ongoing expenditures of the 
enhanced package with the anticipated future health benefits, such as earlier linkage to care and averted illness that 
are known to be realized with more effective contact tracing and testing. All analytic decisions will be guided by 
best practices in implementation economics, a rapidly evolving field.  
 
Cost measurement: We will embed an empirical costing study in our trial. Costs will be collected in two ways: 
micro-costing and time-motion logs (self-reported and directly observed). Micro-costing will be used to quantify 
resources associated with the development and implementation of the entire enhanced package. This includes costs 
of blended learning development, tablets, HIV tests and supplies, travel and telecommunications for tracing, and 
training expenses. Cost data will be available through contractual information with developers, receipts, and MOH 
supply chain partners. We will also extract data from project expenditure and management records, including 
purchase logs and human resources records (e.g. health worker rota), where appropriate. Time-motion assessments 
in both arms will record staff time and effort on ACT tasks, allowing us to reliably apportion effort expended on 
ACT activities. This includes health worker and facilitator time spent with the blended learning package and time 
spent counseling indexes, tracing contacts, and supporting contacts with HIV prevention or treatment services. Data 
for time-motion logs will be collected by observing staff in each cluster approximately two times. Our research 
team has conducted these assessments previously. They will be conducted in line with the STAMP checklist 
(Suggested Time and Motion Procedures).90-92 Additionally, on the provider survey, health care workers will report 
estimated time spent on these activities.  
 
We will record this information in structured spreadsheets that document each resource, category, quantity, and unit 
cost. This comprehensive costing will follow international conventions for costing (i.e. including items for staff, 
equipment, consumables, and any overhead that are not common to both arms); discounting future costs; and 
reporting based on accepted practices93 and guidelines from the Panel on Cost-Effectiveness in Health and 
Medicine.94 We will not include any costs related to study-specific activities (e.g. data collection).  
 
We will first conduct a budget impact analysis, comparing total costs associated with the development and 
implementation of the enhanced implementation strategy to the standard strategy to provide affordability 
information.95-97 This will be conducted from the perspective of the health-system, evaluating programmatic costs 
at a per facility basis. We will initially examine only facilities under observation, but ultimately extrapolate the 
model to 750 sites that make up Malawi’s national HIV program.98 Due to up-front costs of developing the capacity-
building blended learning tool, as the scale and duration of implementation increases and expands, we expect that 
the cost per facility will decrease.  
 
Cost effectiveness modeling: We will conduct cost-effectiveness analysis, modeling incremental cost effectiveness 
ratios (ICERs) per contact tested and  per HIV-positive patient diagnosed. We may also examine incremental cost 
per HIV infection averted and per disability adjusted life year (DALY) averted comparing the enhanced to the 
standard approach. We will construct a hybrid decision-tree/Markov model to reflect the relevant programmatic 
components and clinical outcomes based on ACT implementation as described above and a literature review of key 
parameters. This model will first be limited to the trial population, estimating approximately 50,000 total potential 
index patients in these 33 clusters over one year, and then expanded to the national program—estimating 
approximately 800,000 potential annual indexes over one, three, and five years. Imbedded Markov models will 

UNCPM 22009 
Protocol v.2, page 25 of 34 
 
account for the health-state trajectories of HIV-positive and HIV-negative contacts, as well as pediatric and adult 
contacts. All transition probabilities will be informed by mean observed ACT indicators in the trial (base case) with 
distribution of upper and lower extremes informed by the highest and lowest performing sites. One-way sensitivity 
will be conducted with all model parameters individually. Probabilistic uncertainty will be conducted using Latin 
Hypercube Sampling, varying all parameters simultaneously. Analyses will be performed using Excel and the 
Excel-based add-on, DecisionTree or comparable software.  
 
 
Additional exploratory analyses of interest  
In addition to the three aims described above, a range of exploratory questions and tertiary analyses may be 
explored relating different indicators to one another. Some examples include: 
• 
Which health worker, patient, and facility characteristics are associated with selection of each type of 
contact tracing method? 
• 
Which health worker and facility characteristics are associated with improved fidelity?  
• 
Which facility characteristics are associated with adoption and adherence to the implementation 
intervention? 
• 
Is adoption of and adherence to the implementation intervention associated with improved service 
uptake?  
• 
Is health worker fidelity associated with patient acceptability? 
Ethical and human subjects considerations 
Institutional Review Board oversight and informed consent 
Approval for the study will be sought from UNC’s IRB and Malawi’s National Health Sciences Research 
Committee. These two bodies will provide oversight for the study. This protocol and the informed consent 
documents and any subsequent modifications will be reviewed and approved by both bodies. All procedures 
conform to US and Malawian ethical standards regarding research involving human subjects.  
 
Written informed consent will be obtained on paper or electronically. All study participants will sign an informed 
consent prior to enrollment in an appropriate language (English or Chichewa). The consent form will describe the 
purpose of the study, the procedures to be followed, the contact information of the local study contact 
investigator, and the risks and benefits of participation in accordance with all applicable regulations.  
 
Literate participants will document their provision of informed consent by signing their informed consent form. 
Non-literate participants will be asked to document their informed consent by marking their informed consent 
form (e.g., with an X, thumbprint, or other mark) in the presence of a literate third-party, impartial witness. Any 
other local IRB/ethics committee requirements for obtaining informed consent from non-literate persons also will 
be followed.  
 
Participants will be provided with copies of their informed consent forms if they are willing to receive them and 
believe they will not lead to difficulties if found by partners or other persons. It will be stressed with each 
potential participant that participation in this study is completely voluntary. Potential participants will be told that 
if they choose not to participate, there will be no penalty; they can continue to participate in other research studies 
or programs at the site and there will be no changes in the services they may receive at the clinic where they were 
contacted about this study. The consent will also inform participants that they have the right to refuse or withdraw 
from participation at any time.  
 
The investigators have experience obtaining informed consent for trials in Malawi and thus the informed consent 
process has been designed to maximize understanding of potential risks.  
 
Potential risks to subjects  
There are two types of potential risks that may occur during this study: breach of confidentiality as well as a risk 
of discomfort related to participation.  

UNCPM 22009 
Protocol v.2, page 26 of 34 
 
 
Breach of confidentiality may occur if unique identifiers in datasets are linked back to personal identifiers. This is 
highly unlikely and measures will be taken to ensure that this does not occur. Discomfort with participation is also 
expected to be rare and minor. Health workers may feel uncomfortable about participating and may not enjoy 
having their performance and counseling skills assessed, or discussing experiences in a group of colleagues and 
peers. Indexes and contacts may feel uncomfortable having sensitive discussions with health workers recorded, as 
they may be of a sensitive nature. Similarly, they may feel uncomfortable answering questions on a survey about 
personal information, especially about sexual or care-seeking behaviors. Should a social harm or adverse event 
occur as a result of study participation, this will be documented, and appropriate referrals for medical, legal, or 
psychosocial support will be made.   
 
Adequacy of protection against risks 
Health workers and patients will be recruited at the facility. Eligible persons will be recruited by trained research 
staff fluent in their native language to initiate the consent process. Research staff will go over the entire informed 
consent with the eligible persons and describe: the purpose of the study, the detailed procedures to be followed, 
the risks and benefits of participation, the duration of participation, and the steps taken to protect the participant. 
The eligible person will be given the opportunity to ask questions. No coercion will be placed on persons to enroll 
in the study. It will be explained that declining consent will not have any impact on the care they receive. Trained 
research staff will be trained to discuss the pros and cons of participation with all prospective participants. The 
consent will also inform persons that they can withdraw at any time should they change their mind. Written 
informed consent will be obtained from each participant and participants will be provided with a copy of their 
informed consent forms. Study staff will document the informed consent process. The entire consent process will 
be conducted in accordance with the relevant US-based institutional review board, as well as the National Health 
Sciences Research Committee, the local regulatory body.  
 
To minimize the risk of breach in confidentiality, all study-related activities will occur in private locations. All 
health worker and patient-level datasets will contain a unique ID number and will not contain any personal 
identifiers. All logs connecting participants to their unique ID will be maintained separately from all data and 
securely stored in double-locked filing cabinets in a central office, rather than at the facility level. Individual-level 
data will be collected and transmitted using encrypted technologies and saved on secure password-protected 
servers. All audio-recorded data will be processed, coded, and verified in a timely manner. As audio-recorded data 
is processed, the original audio-files will be destroyed. 
 
To protect participants against risks associated with sensitive topics, they will be reminded that the answers to 
their questions will be kept confidential and that this information will not be shared with anyone. If patients or 
health workers anticipate discomfort, they can decline consent, as participation is voluntary. If any patients or 
health workers experience discomfort with any aspect of participation, they can terminate their participation early 
and withdraw from the study. Alternatively, they can continue participation, but decline a particular activity.   
 
Potential benefits to subjects 
Health workers may gain new knowledge and skills that make them better ACT providers or enhance their 
counseling skills more generally. Those in the enhanced arm may enjoy participating in blended learning 
activities. Those in the standard arm will have access to blended learning after the end of the main trial and 
knowing this may be appealing. Those in both arms may enjoy discussing the ACT program with their colleagues 
in focus group discussions. For individual patients, they may enjoy exit interviews and reflecting on their 
experience in ACT. Finally, this research is designed to create generalizable knowledge and enhance ACT 
programs in Malawi and beyond. Some patients and health workers may experience benefits from believing that 
their participation may contribute to improved service delivery. 
 
Costs/compensation 
Health workers will receive the local equivalent of US$10 as compensation for study visits. Patients will receive 
the local equivalent of US$10 as compensation for their participation. 

UNCPM 22009 
Protocol v.2, page 27 of 34 
 
 
Importance of the knowledge to be gained 
There is considerable potential for the proposed research to generate findings of importance. Specifically, the 
activities proposed are designed to enable the delivery of high-quality ACT training to scale across Malawi. This 
has implications not only for Malawi but also for other countries with high HIV prevalence. Results will be 
disseminated nationally, regionally, and internationally.  
 
Reportable events 
All serious adverse events associated with the procedures will be appropriately reported to the UNC IRB and the 
Malawi NHSRC according to their reporting procedures. Field staff in Malawi will be trained to complete 
descriptions of adverse events that will then be sent electronically to both the PI and the co-PI. Thus, adverse 
events will be monitored at three levels; by the Principal Investigators, by the UNC IRB and by the NHSRC.  Of 
course, efforts will be taken to minimize the potential for adverse events. Intervention and research staff training 
will stress ensuring confidentiality and avoidance of negative events, and quality assurance/quality control 
(QA/QC) will be performed regularly to ensure adherence to proper counseling techniques. Two types of reports 
will be made involving the conduct of the study.  Adverse Events Reports will be made using standard forms 
available from the relevant IRBs for adverse events associated with the study procedures or subject 
participation.  Serious medical adverse events are unlikely. Incident Reports will also be made of any incidents 
involving the conduct of the trial (e.g., enrolling a participant who did not meet eligibility criteria, etc.) These 
reports will be made in the form of a letter or memo to the Chairs of the relevant IRBs signed by either the PI or a 
co-PI. All reporting form study staff to the PI, site PI, or co-PI should be made in real-time whenever possible (i.e. 
when the participant is still present). However, if this is not possible, a written report must be made within 24 
hours.  
 
Copies of adverse event reports will be stored at UNC and in the study offices at Tingathe.  Adverse events or 
incident reporting in this trial has been considered in the context of several important characteristics of the study. 
First, this is a minimal-risk study as defined in federal regulations: “the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in 
daily life or during the performance of routine physical or psychological examinations or tests.”  
 
In addition, we will provide contact information for participants, information on how to contact the local research 
staff to report such events as breaches of confidentiality, HIV-related disruption of families, acts of 
discrimination, and physical harm. We will ask participants to return to the research site or otherwise contact 
research staff in order to make such reports as well as receive referrals to mitigate potential harm. This will not 
include identifying information about the study or references to HIV or HIV testing, so that the cards will not 
have the potential to jeopardize the confidentiality of participants.  
 
Dissemination of results 
The results of the study will be presented at international and local scientific meetings and published in scientific 
journals. The results will also be submitted to the NHSRC. The information collected in this study may lead to 
larger cluster randomized trials that will allow further evaluation of the impact of blended learning modalities for 
training health workers in voluntary assisted contact tracing.
 
 

Page 28 of 34 
 
Work plan and Timeline  
The timeline below depicts planning, implementation, data collection, data analysis, manuscript preparation, and 
stakeholder engagement during the full research period. 
 
The study is divided into three phases (preparation, implementation, and analysis/dissemination) that occur over a 
three-year period (Table 1). The first six months of the study reflect a planning phase. Trial implementation and 
analysis will occur over the next 2-year period. The final six months of the study will be dedicated to analysis and 
dissemination and providing technical assistance to support scale-up.  
 
Timeline  
 
 
 
Activity 
Year 1 
Year 2 
Year 3 
Calendar Quarter 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Finalize intervention for 
enhanced arm 
x 
x 
 
 
 
 
 
 
 
 
 
 
Site selection  
x 
 
 
 
 
 
 
 
 
 
 
 
Site/community sensitization 
x 
x 
 
 
 
 
 
 
 
 
 
 
Data training harmonization  
 
x 
 
 
 
 
 
 
 
 
 
 
Randomization  
 
x 
 
 
 
 
 
 
 
 
 
 
Standard training (both arms) 
 
x 
 
 
 
 
 
 
 
 
 
 
Enhanced implementation 
activities (enhanced arm, n=11 
sites) 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
Standard implementation 
activities  
(standard arm, n=22 sites) 
 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
Delayed implementation of 
enhanced activities (standard 
arm, n=22 sites) 
 
 
 
 
 
 
x 
x 
 
 
 
 
Technical assistance to support 
scale up 
 
 
 
 
 
 
 
 
 
 
 
x 
Data collection 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Adoption  
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Fidelity assessments  
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
ACT data abstraction from 
registers 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Feasibility/acceptability 
 
 
x 
 
x 
 
 
 
x 
 
 
 
Time and motion  
 
 
x 
 
x 
 
 
 
x 
 
 
 
Annual facility surveys 
 
 
x 
 
 
 
x 
 
 
 
 
 
Analysis  
 
 
 
 
 
 
x 
x 
 
 
x 
x 
Manuscript development  
 
 
x 
 
 
 
 
x 
x 
 
 
x 
Local/international 
presentations  
 
 
x 
 
 
x 
 
 
 
 
 
x 

Page 29 of 34 
 
  
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