Re-engagement at Discharge 2: Improving Post-hospital Outcomes for Adults With HIV in Zambia
Phase: NA
Conditions: HIV/AIDS, Hospitalization, Transitions of Care, Opportunistic Infections
Sponsor: University of Maryland, Baltimore

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
PROTOCOL NAME:   
Re-engagement at Discharge 2:  
Improving post-hospital outcomes for adults with HIV in Zambia (ReCharge 2) 
 
PROTOCOL VERSION:   
2.5 
 
PROTOCOL VERSION DATE:   
16 April 2024 
 
NCT NUMBER:   
NCT05694546 
 
STUDY SPONSOR:     
National Institutes of Health, National Institute of Mental Health 
R34MH122265 
 
ORGANIZATION:    
 
MGIC Zambia, 31C Bishop’s Rd, Kabulonga, Lusaka, Zambia 
& Center for International Health, Education, and Biosecurity  
University of Maryland School of Medicine, Baltimore, USA 
 
PRINCIPAL INVESTIGATORS: 
 
Cassidy Claassen, MD, MPH 
Associate Professor, University of Maryland School of Medicine 
Honorary Lecturer, University of Zambia School of Medicine 
Technical Director, Center for International Health Education & Biosecurity 
MGIC-Zambia, 31C Bishops Rd, Kabulonga, Lusaka, Zambia 
CClaassen@ihv.umaryland.edu 
Zambia Cell: +260 971 075 439 
 
Michael Vinikoor, MD 
Associate Professor, University of Alabama at Birmingham 
Honorary Lecturer, University of Zambia School of Medicine 
Faculty Advisor, Centre for Infectious Disease Research in Zambia 
mjv3@uab.edu 
+260 972921285 
 
Co-Investigators:  
Wilbroad Mutale, MD, PhD 
Lloyd Mulenga, MBChB, PhD, MMed, MSc. 
Kirsten Stoebenau, PhD 
Chiti Bwalya, MPH 
Nyuma Mbewe, MBChB, MMed 
Brianna Lindsay, PhD 
Lottie Hachaambwa, MBChB 
Priscilla Mulenga, MBChB, MMed 
Suilianji Sivile, MBChB, MMed 
Linah Mwango, RNHNP 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
TABLE OF CONTENTS 
 
1. 
Protocol Synopsis ............................................................................................................. 4 
2. 
Background Information and Scientific Rationale ............................................................ 5 
2.1 
Background Information ............................................................................................ 5 
2.2 
Rationale .................................................................................................................... 5 
3. 
Literature Review ............................................................................................................. 6 
4. 
Study objectives ................................................................................................................ 7 
4.1 
Primary objective ....................................................................................................... 7 
4.2 
Secondary objectives ................................................................................................. 7 
4.3 
Exploratory objectives ............................................................................................... 7 
4.4 
Primary Endpoints – Program Feasibility ................................................................... 7 
4.5 
Secondary Endpoints – HIV cascade and clinical outcomes ....................................... 7 
5. 
Study design ..................................................................................................................... 8 
5.1 
ReCharge CHW intervention description ................................................................... 8 
5.2 
Intervention evaluation: pre/post implementation trial ........................................... 9 
5.3 
Qualitative study: feasibility, acceptability, and implementation factors ............... 11 
6. 
Study population ............................................................................................................ 14 
6.1 
Description of the study site .................................................................................... 14 
6.2 
Description of the study population ........................................................................ 14 
6.3 
Participant inclusion and exclusion criteria ............................................................. 14 
6.4 
Participant recruitment ............................................................................................ 15 
7. 
Data Collection & Management ..................................................................................... 16 
7.1 
Study Procedures ..................................................................................................... 16 
7.2 
Data Management and Storage ............................................................................... 16 
8. 
Statistical Considerations ............................................................................................... 17 
8.1 
Sampling frame and Sample Size Calculations ......................................................... 17 
8.2 
Data Analysis ............................................................................................................ 17 
9. 
Ethical Considerations .................................................................................................... 19 
9.1 
Permission to Conduct Research at UTH ................................................................. 19 
9.2 
Institutional Review Board (IRB) Review and Informed Consent ............................. 19 
9.3 
Potential risks and benefits ...................................................................................... 19 
9.4 
Voluntary participation ............................................................................................ 19 
9.5 
Informed consent ..................................................................................................... 20 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
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9.6 
Participant confidentiality ........................................................................................ 20 
9.7 
Participant withdrawal ............................................................................................. 20 
9.8 
Participant treatment .............................................................................................. 20 
10. 
Study Time Frame ........................................................................................................ 21 
11. 
Publication plan ........................................................................................................... 21 
12. 
Budget ......................................................................................................................... 22 
13. 
References ................................................................................................................... 23 
14. 
Appendix 1: Patient Interview Guide ........................................................................... 25 
15. 
Appendix 2: Patient Interview Guide (at 6 months) .................................................... 29 
16. 
Appendix 3: Caregiver Interview Guide ....................................................................... 32 
17. 
Appendix 4: CHW, CLO, Clinicians Interview Guide ..................................................... 37 
18. 
Appendix 5: Information and Consent Forms for ReCharge Patients .......................... 38 
19. 
Appendix 6: Information and Consent Forms for Hospital and Program Staff ............ 42 
20. 
Appendix 7: Information and Consent Forms for Discharged Patients ....................... 46 
21. 
Appendix 8: Information and Consent Forms for Caregivers ...................................... 50 
22. 
Appendix 9: Patient Health Questionnaire 9 (PHQ-9): Nyanja .................................... 54 
23. 
Appendix 10: Patient Health Questionnaire 9 (PHQ-9): Bemba .................................. 56 
24. 
Appendix 11: Patient Health Questionnaire 9 (PHQ-9): English .................................. 58 
25. 
Appendix 12: English - Modified Alcohol Use Disorders Identification Test-
Consumption .......................................................................................................................... 60 
26. 
Appendix 13: Nyanja - Modified Alcohol Use Disorders Identification Test-
Consumption .......................................................................................................................... 61 
27. 
Appendix 14: Bemba - Modified Alcohol Use Disorders Identification Test-
Consumption .......................................................................................................................... 62 
28. 
Appendix 15: Letter of Permission to Conduct Research at UTH ................................ 63 
 
 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
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1. Protocol Synopsis 
 
 
 
Full Title 
Re-engagement at Discharge 2:  
Improving post-hospital outcomes for adults with HIV in Zambia 
(ReCharge 2) 
Clinical Trial Phase 
N/A 
Principal Investigators 
Cassidy Claassen, MD, MPH 
Michael Vinikoor, MD 
Co- Investigators 
Wilbroad Mutale, MD, PhD 
Lloyd Mulenga, MBChB, PhD, MMed, MSc. 
Kirsten Stoebenau, PhD 
Chiti Bwalya, MPH 
Nyuma Mbewe, MBChB, MMed 
Brianna Lindsay, PhD 
Lottie Hachaambwa, MBChB 
Priscilla Mulenga, MBChB, MMed 
Suilianji Sivile, MBChB, MMed 
Linah Mwango, RNHNP 
Sample Size 
N = 100 
Study Population 
Eligible patients living with HIV hospitalized at University Teaching 
Hospital or Levy Mwanawasa Hospital, Lusaka, Zambia 
Accrual Period 
1/1/2023-6/1/2024 
Study Design 
Single Arm Pre/Post Pilot Study 
Study Duration 
2 years 
Study Agent/ 
Intervention Description 
Community health worker (CHW) follow-up after discharge from 
hospital 
Primary Objective 
1. To assess the feasibility and acceptability of CHW follow-up 
following hospitalization 
Secondary Objectives 
1. To estimate the potential impact of the pilot program on the 
proportion who are alive and virally suppressed at 6 months post-
discharge 
2. To understand implementation factors related to pilot program  
Exploratory Objectives 
1. To investigate barriers and facilitators to ART adherence for PLHIV 
following hospitalization 
2. To investigate barriers and facilitators to community-based 
support for PLHIV following hospitalization 
Primary Endpoints 
1. The proportion of discharged patients who are successfully visited 
after discharge. 
2. The proportion of discharge follow-up visits by a CHW that are 
comprehensive 
3. The proportion of initial post-discharge visits to the ART clinic that 
are attended by the participant’s CHW supporter.  
Secondary Endpoints 
1. HIV viral load at 6 months post-discharge.  
2. Mortality within 6 months of discharge. 
3. Retention in HIV care after discharge defined by no gap of >28 
days off ART from discharge date to 6 months post-discharge date. 
4. ART clinic visit within 1 month of discharge 
5. Transition back to ART care at original (pre-admission) clinic 

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2. Background Information and Scientific Rationale 
 
2.1 
Background Information 
Hospitalization presents a potential opportunity to alter the long-term outcomes of persons 
living with HIV (PLHIV) in sub-Saharan Africa (SSA).1 HIV-related hospital admissions remain 
common despite mature antiretroviral therapy (ART) programs,2 and while inpatient 
mortality rates are 10-30%, an additional 20-40% die within 1 year of discharge.3,4 Most 
hospitalized PLHIV are ART-experienced and had history of poor retention in care and viral 
suppression.3,5,6 For example, at a central hospital in Zambia, ~90% of hospitalized PLHIV had 
prior/current ART use (median of 30 months) and 50% of ART-experienced individuals were 
not virally suppressed, many of whom had disengaged from care. Current inpatient care 
focuses on stabilization and neglects to understand and intervene on the underlying reasons 
for suboptimal care engagement that contributed to the hospitalization. Discharge transition 
of care models for hospitalized PLHIV are virtually non-existent.7  
 
2.2 
Rationale 
Many PLHIV have poor outcomes following hospitalization, including high mortality, 
readmission, and gaps in HIV care engagement. This is likely multi-factorial and not all 
etiologies may be modifiable. While high mortality may be due to incurable cancer, the 
majority of deaths in PLHIV are thought to be caused by infectious diseases for which 
treatments exist. However, succumbing to these life-threatening infections after  discharge 
may be due to poor understanding of discharge instructions, lack of post hospital care, and 
poor understanding of required follow up. Psychosocial support also plays a role in the mental 
and physical health of these sick patients. 
In ReCharge 1, we gathered formative data and identified at least three major factors that 
undermine HIV clinical outcomes after hospital discharge. First, there are gaps in continuity 
of care between the discharging facility and outpatient. Second, support from family is often 
suboptimal due to lack of understanding on the cause of illness, lack of HIV status disclosure, 
and the cost of care. Third, HIV comorbidities may underpin or complicate the immediate 
reason for discharge or the post-discharge engagement in care. These data were 
disseminated to local experts in Zambia including from the Ministry of Health and used to 
create a new care model for post-discharge HIV care. The care model draws from other 
successful programs in Zambia. In ReCharge 2 we now propose to pilot the program and 
assess feasibility, acceptability, and potential for clinical impact. 
 
 
 
 
 

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3. Literature Review 
It is estimated that 1.2 million people are currently living with HIV in Zambia, representing 
between 11-12% of the adult population.8,9 Urban areas have had a consistently higher 
percentage of infected people than in rural areas. HIV infection is also higher among females 
than among males. Of the 1.2 million adults living with HIV, 700,000 (58.3%) were women.8 
The number of AIDS-related deaths since 2010 has reduced by 37%, from 26,000 deaths to 
17,000 deaths in 2018,8 a reduction due to the concerted efforts of the Zambian Government 
and its global partners in improving access to antiretroviral therapy. Over the past decade, 
there has been a rapid scale-up of antiretroviral therapy (ART) in Zambia as in other high HIV 
prevalence settings in Africa.8,10 As scale-up programs continue, accessibility to ART has 
increased tremendously. 
Despite the improved access, the number of patients failing therapy with increasing duration 
of exposure to ART remains high. Factors leading to treatment failure include poor adherence 
to treatment, prior exposure to antiretroviral treatment with the development of resistance 
from single dose nevirapine, primary viral resistance, inadequate drug absorption, suboptimal 
dosing, the complexity of the regimen, inadequate or inconsistent drug supply to mention but 
a few ; the mortality in such patients failing therapy is usually high.11-13 Inpatient settings in 
Zambia continue to have a high burden of HIV, with prevalence of >50% among admitted 
people.  
Hospitalization presents a potential opportunity to alter the long-term outcomes of persons 
living with HIV (PLHIV) in sub-Saharan Africa (SSA).1 HIV-related hospital admissions remain 
common despite mature antiretroviral therapy (ART) programs,2 and while inpatient 
mortality rates are 10-30%, most survive to be discharged home. Unfortunately, our team 
and others in East and Southern Africa have documented that an additional 20-40% of 
hospitalized people with HIV die within 1 year of discharge.3,4 Most hospitalized PLHIV are 
ART-experienced and had history of poor retention in care and viral suppression.3,5,6 For 
example, at University Teaching Hospital in Zambia, ~90% of hospitalized PLHIV had 
prior/current ART use (median of 30 months) and 50% of ART-experienced individuals were 
not virally suppressed, many of whom had disengaged from care. Current inpatient care 
focuses on stabilization and neglects to understand and intervene on the underlying reasons 
for suboptimal care engagement that contributed to the hospitalization. Discharge transition 
of care models for hospitalized PLHIV are virtually non-existent.7 Causes of death both during 
and after hospitalization are not well-understood because of the rarity of post-mortem 
examinations (especially in out of hospital death); however, most deaths are likely due to 
common HIV-related opportunistic infections. 
Re-engaging patients in HIV care and ART after a period of suboptimal retention has been 
termed ‘using the side door’.14,15 ‘Side door’ patients are underrepresented in HIV program 
evaluations as their data are censored at initial disengagement. These patients represent a 
unique population with distinct barriers to reconnect and to re-initiate on treatment,16,17 as 
compared to those using the ‘front door’ (i.e., proceeding with optimal retention from testing 
to ART initiation to long-term viral suppression). After hospitalization, long-standing barriers 
to ART may be exacerbated and new challenges (such as reduced functional status) may 
arise.18-20 These patients need differentiated care models to intensify and optimize their 
treatment. 

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4. Study objectives 
 
4.1 
Primary objective 
1. To assess feasibility and acceptability of a post-discharge CHW follow-up program for 
adults with HIV 
 
4.2 
Secondary objectives 
1. To estimate the potential impact of the pilot program on the proportion who are alive 
and virally suppressed at 6 months post-discharge 
2. To understand implementation factors related to pilot program 
 
4.3 
Exploratory objectives 
1. To explore barriers and facilitators to the HIV care cascade for PLHIV following 
hospitalization 
2. Describe the prevalence of behavioral health comorbidities after hospital discharge 
among people with HIV 
3. To investigate the impact of HIV-associated coinfections and comorbidities on post-
hospital outcomes. 
4. To explore experiences of community health workers with the delivery of a post-
discharge community based CHW follow-up model for adults with HIV 
5. To characterize the prevalence of mental health co-morbidities such as depression 
among PLHIV during and following hospitalization 
 
4.4 
Primary Endpoints – Program Feasibility 
1. The proportion of discharged patients whose discharge summary is completed 
2. The proportion of discharged patients who undergo a home/community visit from a 
CHW within 1 week of discharge 
3. The proportion of discharged patients that attend their recommended hospital follow-
up appointment  
4. The proportion of discharged patients that carry their discharge summary to their 
recommended hospital follow-up appointment 
5. The proportion of discharged patients who have disclosed their HIV status at least one 
treatment supporter  
6. The proportion of discharged patients who are currently taking the recommended 
medications for HIV, coinfections, and comorbidities at 1-month post-discharge 
7. The proportion of discharged patients who seek relevant services (behavioral health, 
mental health) following screening and referral 
 
4.5 
Secondary Endpoints – HIV cascade and clinical outcomes  
1. HIV viral load at 6 months post-discharge.  
2. Readmission to hospital within 6 months of discharge 
3. Mortality within 6 months of discharge. 
4. Retention in HIV care after discharge defined by no gap of >28 days off ART from 
discharge date to 6 months post-discharge date. 
5. Engaged in ART care at a community (non-referral site) clinic at 6 months post-
discharge 
6. Mental health outcomes (i.e. depression level) post intervention  

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5. Study design 
This is a pilot implementation study with a mixed methods evaluation. The primary outcomes 
are feasibility and acceptability, which will be assessed among participants, CHWs, and other 
health workers involved in the pilot. Surveys and in-depth interviews (IDIs) will be used as 
means of collecting data. Secondary HIV care cascade and clinical outcomes, such as 
mortality, readmission, HIV VL, retention, etc. will also be assessed. Secondary outcomes will 
be compared, via a single-arm pre/post pilot study, with a comparator group recruited in the 
recent past (pre-intervention).  
 
5.1 
ReCharge CHW intervention description 
The ReCharge intervention is package of services designed to address major barriers to post 
discharge engagement identified through the ReCharge 1 formative research and based on 
reflective discussion and engagement with local expertise.  
The package will be overseen by a physician working at the discharging hospital and will be 
supported and managed by a Community Liaison Officer. This package will consist of 
enhanced discharge planning, made possibly by a discharge card that physicians will 
complete. The card will capture a summary of the discharge plan and follow-up appointment 
schedule for the discharged patient.  At the time of discharge, the CLO get will get involved 
to inform the patient about the program and if willing to be enrolled, the patient will be 
recruited into the programme.  
After discharge, the package for the enrolled patients will include home delivery of HIV 
support services to be provided a by community health worker (CHW) with support and 
coordination provided by the CLO based at the hospital. Additional technical support  will also 
be provided physician  based at the hospital. Once the patient has been recruited into the 
programme, the CHW will provide the first home visit within 7 days of hospital discharge. 
Several additional homes visits together with phone-based support will occur thereafter. The 
CHW visits will consist of the following elements: 
• Vital signs assessment: As is currently standard with UMB CHW home visits, the CHW 
measures the pulse and blood pressure using an electronic cuff and enters these into their 
tablet. If outside of safe ranges (per WHO ranges), the table prompts immediate escort to 
nearest health facility  
• Symptom screen: in addition to standard warning signs (such as the four TB screening 
questions), screening questions could be tailored based on discharge information (i.e. 
confusion following admission for crypto) 
• Medication check: The CHW will verify (visually) that patient has filled all medications, 
both ART, and non-ART (for ATT, hypertension, etc.) prescribed as per the discharge 
summary, and perform pill counts to verify proper adherence. Patient and caregivers will 
be counseling on why each medication was prescribed and what are expected side effects. 
If prescriptions have not been filled, then CHW can assist in facilitating medication 
dispensation from their outpatient clinic.  
• Outpatient follow-up verification: At the first visit (within one week), the CHW will discuss 
with patient and care giver the timing and location of follow-up. They will remind the 
client by phone 1 day before and if the patient misses that visit, the CHW will arrange to 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
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accompany the patient to the clinic at the soonest possible time. In Zambia, the standard 
post-hospital follow-up at outpatient occurs at 2 weeks. 
• Identify knowledge gaps among patient and family related to the reason for illness: The 
CHW will document the reason for illness and the family’s and patient’s understanding of 
the illness and list any questions they have. 
• Screening for behavioral health comorbidities: The CHW will screen for symptoms of 
depression and unhealthy alcohol use at ~1 month after discharge and make referrals as 
feasible. 
• Conduct a quick home observation to document the  patient home environment  to assess  
barriers existing as well as facilitators to engagement.  
 
To ensure that CHWs are fully supported, they will meet with CLO once per week to discuss 
their clients. CLOs reinforce adherence to the model. The CHW will also call their CLO 
supervisor urgently from the client household if certain parameters are outside of range, such 
as elevated pulse. The CLO can then engage the physician as needed. 
 
The ReCharge CHW intervention holds promise. First, it was designed based on a rigorous 
local formative project (ReCharge 1) and with inputs from clinical, community, and program 
experts and MOH. Also, CHW support is both highly feasible and acceptable, but can reduce 
death in PLWH. In the REMSTART trial, weekly home visits plus testing and treatment of 
cryptococcal disease among people with low CD4 reduced mortality significantly. Many of our 
clients will have CD4 >200; however, given their recent hospitalization, they are at high risk 
of mortality.  
 
5.2 
Intervention evaluation: pre/post implementation trial 
 
5.2.1 Study Design 
We plan to conduct a prospective pilot study among 100 PLHIV at study sites who will receive 
the ReCharge CHW intervention model. Although a range of outcomes will be assessed, and 
comparisons will be made to a historical control group, the main goal is to demonstrate 
feasibility and acceptability. If these are demonstrated, we will seek approval and resources 
for a fully-powered evaluation of the program. 
 
5.2.2 Historical control data:  
To make inferences around possible impact, which will inform the sample size of a fully-
powered future trial, before implementation of the intervention, we will collect historical 
control data on the outcomes of interest. We acknowledge that our comparison of trial 
outcomes to those from historical controls will be prone to time trends in patient outcomes 
and in clinical practices, which could make the intervention appear to have spurious effects. 
To minimize this bias, we will collect historical control data on discharged patients just prior 
to implementing the intervention. These will be participants with the same 
inclusion/exclusion criteria as intervention patients and recruited in the same way.  
 
5.2.3 HIV clinical care:  
Participants will receive routine HIV clinical care per national guidelines. For example, 
participants with high VLs at enrollment or at 6 months will be assumed to have poor 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
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retention/adherence and will be referred for a period of enhanced adherence counseling. If 
adherence improves but VL remains high, clinicians are recommended to switch the regimen. 
We expect our participants will be physically ill; therefore, they will likely be referred for a 
post-discharge appointment within 1-2 weeks of discharge and may have frequent 
appointments in the post-discharge period. ART dispensations will be per clinician 
recommendations. 
 
5.2.4 Quantitative outcomes:  
Our primary effectiveness outcome will be alive and virally suppressed at 6 months after 
hospital discharge. Patients who either pass away or have a viral load >60 copies/ml will be 
considered failures. Patients who are alive but have unknown VL will also be considered 
failures. Those who transfer care outside of Lusaka District (we expect this to be 2-3%, based 
on a prior study) will be censored. We will also evaluate numerous secondary outcomes, 
including retention on ART, defined as possession of ARVs within 30 days of the 6-month post-
discharge time point, consistent with PEPFAR TX_CURR definition.21 We will also assess ARV 
adherence (based on medication possession ratio), number of visits attended, and the rate of 
hospital re-admission.  
To ascertain these outcomes, our research assistant will contact the client each month post-
discharge to check vital status (alive versus dead) and whereabouts. At 6 months after 
discharge, we will confirm the location of last HIV care and arrange for patient to have HIV 
VL, either back at the hospital or at their local clinic. The team will extract electronic medical 
records from the clinic including visit, pharmacy, and laboratory data, including HIV viral load 
results. Transfers within Lusaka (where there are 30+ ART clinics) are common and this 
approach will allow us to have complete end-line data for most clients, including historical 
controls and pilot participants.  
We will also collect implementation outcome data during the trial, such as proportion of trial 
participants who do not receive any CHW services, the number and type (phone calls, home 
visits, meetings at the facility) of interactions between participants and CHWs. Semi-
structured interviews with a subset of patients will be done to check acceptability of the 
intervention. 
To begin to understand and anticipate meaningful patterns in our pilot data, we will also 
collect socio-demographics and socio-economic data on patients and their households, as 
well as capturing extent and severity of co-morbidities.  We will include the following 
measures, captured at the following time points:  
At enrollment/in hospital:  
• Education (highest completed grade attained) for patient and primary caregiver 
• Age, marital status, number of children 
• Relationship to household head 
• Religion and religiosity (affiliation, frequency of church attendance (weekly) 
• Distance to referral health clinic and to referring hospital (time takes to get to clinic / 
mode of transit) 
 
 

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At one month:  
• Mental health screening (PHQ) 
• Alcohol screening (AUDIT) 
• Household food insecurity (HFIES scale) 
• Household asset-based wealth index (DHS module) 
 
 
5.3 
Qualitative study: feasibility, acceptability, and implementation factors 
 
5.3.1 Study Design 
To characterize feasibility and acceptability, we prospectively enroll up to 100 hospitalized 
adults with HIV and provide them with the ReCharge CHW intervention. We will measure 
various indicators of feasibility. We will recruit and follow up longitudinally a cohort of 
participants (n=24) prospectively through the intervention, interviewing them at the start one 
or two weeks after being enrolled into the project and after the end of the intervention to 
understand the determinants of feasibility and acceptability. We will also include participants’ 
primary caregivers in interviews after towards the end of the intervention (n=20). 
Acceptability and feasibility will also be assessed through IDIs with the CLOs (n=2-4) and CHWs 
(n=4-8) involved in the pilot implementation as well as up to 6 other healthcare workers that 
will be based at the hospital and community clinic. 
The patient sub-sample will be followed longitudinally using a qualitative study variation of 
responsive and adaptive design approaches22 (see Table 2). IDIs will be conducted and 
transcribed by trained research assistants.  
IDIs are best suited to capturing individual experience and perceptions,23 our main objective 
with these study populations. The sample size for each study population category anticipates 
what is required to reach saturation on key themes, but may be supplemented if necessary, 
particularly likely for patients and caretakers. Data collection tools will be informed by 
Andersen’s Behavioral Model of Health Services Use24 which emphasizes the multi-level 
influences on health seeking behavior and related outcomes including enabling resources 
(e.g. family support, transportation), predisposing characteristics (e.g., self-stigma, 
knowledge), as well as broader healthcare system and external environmental influences.  
 
Table 2: Sample & methods: qualitative study of CHW pilot 
 
Enrollment 
1-3 months Endline  
Total 
Patients IDIs 
24 
 
20-24 
16* 
Caregiver IDIs 
 
 
12 to 16 
16-20 
CLOs/CHWs IDIs 
 
6 
6 
6 
Hospital/ Facility- HCWs 
 
 
6-10 IDIs 
6-10 
*Reflects total number of patients followed longitudinally 
 
 
 

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5.3.2 Qualitative participants criteria and recruitment 
 
Patients and caregivers: We will begin with an oversample of 24 patients (every 3rd enrollee 
will be selected, adjusted to ensure a sex-stratified sample) to capture a total of 16 patients 
and their caregivers, stratified by retention in care, by endline (8 with high retention, 8 with 
low retention). IDIs at enrollment will establish a relationship, gather key insights toward 
understanding what led to the patient’s hospitalization, gather expectations of post-discharge 
health, care, and anticipated barriers and enablers to retention in HIV care. As we identified 
in the formative phase of this work, many of the challenges patients face after discharge stem 
from concerns that resulted in their hospitalization (e.g., internalized stigma, concerns with 
disclosure and acceptance of their status, co-morbidities that require complex management 
in the context of limited household resources).  The CHWs assigned to the patient will 
introduce the patient to a member of the qualitative research team either during 
hospitalization, or at the first home visit. The participant will then decide if they would be 
willing to talk with the interviewer either while being admitted or 1 week after discharge, If 
the patient is too sick or feels more comfortable to be interviewed after discharge, these 
interviews will take place within a week following the first CHW home-based visit at a time 
and place convenient for the discharged patient.  
 
At the six-month follow-up, we will re-interview up to 16 of these 24 for a second IDI reflecting 
on patient experience and capturing their perceptions of whether and how CHW follow-up 
addressed barriers or enhanced enablers to care to assess feasibility and acceptability. We 
will work with CLOs, CHWs, and clinic-level data to stratify the endline sample by patient 
outcome (retained versus not retained), and purposively select patients within strata to 
capture a range of demographic and facility-level characteristics. The same interviewer who 
interviewed the patient at time 1 will return to complete the interview at time 2. Again these 
interviews would take place at a time and place convenient for the patient. The interviewer 
will then ask the patient for permission to invite their primary caregiver to be interviewed as 
well.  If the patient and the caregiver consent, then the interviewer will also interview the 
care giver. Caregiver IDIs will address the experience of caring for the discharged patient 
throughout the intervention and their perceptions of CHW follow-up. When non-retained 
participant deaths are ascertained, we will try to perform an IDI with the caregiver (after 
reasonable time elapses for mourning) to understand the barriers to care, co-morbidities and 
other mortality causes (we estimate up to 4 such cases based on COLAH); we may therefore 
have more caregiver than patient endline interviews. 
 
In addition to the longitudinal sub-sample of 16 patients stratified by re-engagement in care 
outcomes; we will also purposively sample up to 8 patients (for a total of up to 24 endline 
interviews) who showed signs of mental illness or behavioral health concerns (i.e., scored 
above ≥10 points on the PHQ-9 screening tool for depression and related concerns; or scored 
above ≥3 on the AUDIT-C), and were referred by the team for mental health services. We will 
interview these patients to understand experiences of patients with mental health related 
challenges such as depression and alcohol abuse, and to assess how the referral process and 
related services were received by such patients. These interviews will be essential toward 
preparing for future work with patients experiencing similar challenges.   
 

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13 
 
CHWs: We will conduct two repeat IDIs with 2-4 CLOs and 4-8 CHWs (midline and endline), to 
understand their experience with program delivery both during and at the end of the 
intervention. The IDIs will focus on individual experiences with specific patients (positive and 
negative) and can be used to triangulate patient perceptions and programmatic challenges. 
 
Facility-based HCWs: To understand coordination and care continuity from hospital 
discharge, to community, to an outpatient facility, we will conduct IDIs with 6 HCWs (2 
hospital based, 4 clinic based) on their experience with CHWs and discharged patients. These 
will include inpatient staff, where we will address perceived advantages and disadvantages of 
CHW follow-up for quality of inpatient and outpatient care following discharge. 

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6. Study population 
 
6.1 
Description of the study site 
This study will be conducted at tertiary care hospitals in Lusaka. Lusaka has a high prevalence 
(~18%) of HIV infection among adults.9 Lusaka has 36 primary public-sector health centers (25 
of which are currently supported by CIRKUITS), six Level 1, and two Level 3 Hospitals, one of 
which is UTH. UTH outpatient departments, because of their unique capacities in Zambia, 
provide care for people from all provinces. However, >85% of admitted patients are from 
Lusaka.  
 
The UTH Department of Medicine is the largest of departments, with 280 inpatient beds and 
10,000-12,000 admissions per year (20-30 per day), 50-70% of whom are HIV-positive. Within 
DOM, a robust counselor-led (lay health worker) opt-out HIV rapid testing program is in 
place.25,26 This program reaches >90% of new admissions; the remaining 5-10% are not tested 
due to severity of illness. The median length of hospital stay is ~7 days. Patients stay in one 
of four open wards, each with 60-80 beds, and one clinician team (consisting of a Consultant, 
one senior, and 3-4 junior house officers) is in charge of each ward. Laboratory tests are 
provided by the UTH central laboratory. 
 
Levy Mwanwasa University Teaching Hospital (LMUTH) was recently upgraded to a level 3 
facility, overseen by Lusaka Provincial Health Department. Within just several years its ART 
department has grown >1,000 patients. The inpatient Department of Medicine includes >100 
beds and 40-60% are with HIV. Inpatient and discharge procedures are very similar to UTH 
and the LMUTH laboratory offers similar testing capacity.  
 
6.2 
Description of the study population 
This study will be conducted among all adult patients living with HIV who are admitted to ‘E 
Block’ medical wards at the University Teaching Hospital and Internal Medicine wards at 
LMUTH in Lusaka, Zambia between 1 January 2023 and 1 June 2024.  
 
6.3 
Participant inclusion and exclusion criteria 
• Hospitalized patients living with HIV soon to be discharged (n=100) 
o Inclusion criteria: (i) age 18+ years, (ii) HIV-positive, (iii) hospitalized for at least 1 
night at study site, (iv) clinically stable and expected to be discharged according to 
their clinician, and (v) objective evidence of suboptimal HIV outcome, defined as HIV 
VL above the lower limit of the assay or CD4 count <=200. 
o Exclusion criteria: (i) unable to provide informed consent, (ii) no phone, (iii) 
planning to reside outside of Lusaka urban district after discharge 
 
• Health systems leaders for one-on-one key informant interviews (around n=6): 
o Inclusion criteria: (i) age 18+ years old, (ii) experienced administrators and 
clinical heads in Zambia, and (iii) professional experience at UTH or another 
health facility in Lusaka 
o Exclusion criteria: (i)  declines to participate.  
 
• CHWs providing ReCharge intervention, for interviews (n=4-8): 

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o Inclusion criteria: (i) age 18+ years old, (ii) HIV peer educator or psychosocial 
counselor, and (iii) at least 2 years of experience supporting HIV care uptake 
at the community-level 
o Exclusion criteria: (i) declines to participate.  
 
• Caretakers of patients living with HIV who received the ReCharge intervention (up to 
20) 
o Inclusion Criteria: (i) age 18+ years old, (ii) serves as primary caretaker for 
participant-patient, (iii) resides with patient the majority of the time  
o Exclusion criteria: (i) patient does not permit inviting caretaker to participate, 
(ii) declines to participate 
 
 
6.4 
Participant recruitment 
1. Hospitalized patients living with HIV being discharged home 
Our team will integrate with the inpatient teams at the Internal medicine units at 
study sites. We will solicit from the teams patients who may be eligible to enroll. A 
research team member will assess criteria and if eligible the patient will need to 
provide written informed consent to enroll. We expect that 30-40% of adults admitted 
to Internal medicine have HIV, and among them, about 30% will meet criteria to 
participate. We expect it will take 3-4 months to enroll the needed sample size. 
 
2. Health systems leaders for Key Informant Interviews:  
Health system leaders will be recruited directly through email, phone and in-person 
introduction to the study from among individuals who are experienced administrators 
and clinical heads in Zambia, from both UTH and other health facilities in Lusaka. 
 
3. Community health workers (CHWs) for Interviews:  
We will identify a list of eligible CHWs through the CLO coordinator. These will be UMB 
CHWs recruited to deliver the recharge intervention   
 
4. Caregivers/Supporters of discharged HIV Patients:  
We will seek to conduct in-depth interviews with caregivers of the patients recruited 
into our qualitative study cohort of patients for the intervention . As explained above, 
we will first seek the consent of the patient to invite their caregiver to participate in 
the study and only interview the caregiver’s following their provision of their informed 
consent.  
 
 
 

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7. Data Collection & Management 
 
7.1 
Study Procedures 
The research team will consist of a small group of researchers with expertise in qualitative 
research and fluent in English, Nyanja, and Bemba, the primary languages spoken in Lusaka 
Province. The research team will be trained and supervised by UMB researchers with 
expertise in quantitative and qualitative research. The primary methods of research will 
enrollment in a study register. Qualitative procedures will include one-on-one interviews with 
participants identified through purposive and convenience sampling. All qualitative 
interviews will be conducted by trained research assistants. Following participant 
recruitment, IDIs will take place in a private room with the trained interviewer.  
 
 
7.2 
Data Management and Storage 
Quantitative data will be entered on a password-protected laptop and analyzed using Stata 15 (Stata, 
College Station, TX). Digital recordings from interviews with patients and the resulting 
transcriptions will be labeled only with a unique study ID and stored at Maryland Global 
Initiatives Corporation (MGIC) on the secure server. No personal identifiers will be captured 
to protect confidentiality. The database will be housed on a password-protected laptop 
computer owned by MGIC and will be backed up periodically to the MGIC server. Data analysis 
will occur both in Zambia and internationally and analysts will only work with de-identified 
data to protect confidentiality. 
 
MGIC has a robust ICT department that will provide primary data management services on 
this study. As a key partner to MoH in the HIV/AIDS response, MGIC collects and manages HIV 
program data for MoH at >100 HIV care facilities in Zambia. A 5x3 meter secured room at 
MGIC headquarters houses central servers and 2 senior data managers plus 2 senior ICT 
experts are on hand to support data capture, management, and storage. On this study, as 
mentioned above, our qualitative and quantitative data will be backed up on the server. 
However, only anonymized data will be backed up.  
 
 
 
 
 

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8. Statistical Considerations 
 
8.1 
Sampling frame and Sample Size Calculations 
 
8.1.1 Quantitative sample Size 
Our sample size calculation was based on the hypothesis that CHW follow-up will have 
substantial impact on the proportion who are alive and fully HIV virally suppressed at 6 
months. To detect a change in retention from 60% (based on prior studies) to 80% between 
historical controls and pilot study participants, with a two-sided alpha and 80% power, we 
would need a sample size of at least 82 pilot participants. We expect that, because of the 
clinical acuity of participants, some may pass away before discharge occurs, and these would 
be censored and not included in main analysis. Hence, we will inflate the sample to 100.  
 
8.1.2 Qualitative sample Size 
A total of 24 interviews at the start of the project will be conducted with patients recruited  
and another 16 at the end with some of the patients interviewed at the start. An additional 
16 interviews will also be conducted with care givers of the 16 patients who will be 
interviewed twice. Providers such as CHWs(n=4-10) and CLOs(n=2) and hospital staff(n=6-10) 
will also be part of the sample for the study. 
 
 
8.2 
Data Analysis 
8.2.1 Quantitative analysis 
We will describe and compare sociodemographic and clinical characteristics of historical 
controls and participants. For the primary outcome, we will compare proportions retained in 
care at 6 months between controls and CHW follow-up  recipients, after excluding 
participants who transferred out. Potential confounders between the intervention and 
outcome will be adjusted for in multivariable analysis. Sex-stratified models will be fit as 
secondary analyses, which are important in planning for the follow-on trial. We will compare 
the proportions who died in each group, as our central hypothesis is that re-engagement in 
HIV care after hospitalization can lower mortality. We recognize that with a sample size of 
100 we will be under-powered for multivariable and sex-stratified analyses (as well as the 
mortality comparison); however, the point estimates, when interpreted together with 
feasibility and acceptability data, will be informative and provide support for future use of 
this intervention. 
 
8.2.2 Qualitative analysis 
All qualitative interviews will be digitally recorded, transcribed, and simultaneously translated 
verbatim from Nyanja or bemba into English and then coded using Atlas.ti. Two research team 
members will conduct thematic analysis, reading and coding the data iteratively.27 We will 
first use a set of agreed upon deductive codes based on the domains addressed, followed by 
discussion and agreement on inductive codes that capture unanticipated and deeper analytic 
concepts.28 We will then identify and summarize key themes, with matrices for data reduction 
and analysis. We will organize findings as applicable, with attention to how our findings 
inform program development across key actors and institutions. Analyses will focus upon 

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18 
 
changes in patient and CHW perceptions of HIV care as a result of CHW follow-up , as well as 
triangulate perceptions of the feasibility and acceptability of intervention components across 
patients, caregivers, CHWs, and facility HCWs. Attention will be paid to potential 
determinants (patient-level, community-level, structural, facility-based) of pilot outcomes, 
with consideration for modifications toward scale-up. Weekly discussions and simultaneous 
coding of a subset of transcripts will ensure high interrater reliability throughout; themes and 
findings will also be vetted through meetings with the fieldwork team. Our Key Personnel 
feature two Co-Investigators with extensive qualitative experience (Bwalya, Stoebenau).   
 
 
 
 

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9. Ethical Considerations 
 
9.1 
Permission to Conduct Research at UTH 
Prior to seeking IRB approval, we will present this protocol to the UTH and Levy Head of 
Department and request permission to conduct this study at UTH. See appendices for letters 
of permission. 
 
9.2 
Institutional Review Board (IRB) Review and Informed Consent 
This protocol, and any subsequent modifications, will be reviewed and approved by the IRB 
at the University of Zambia Biomedical Research Ethics Committee (UNZABREC) of the 
University Teaching Hospital in Lusaka, Zambia before the commencement of the study, as 
well as the National Health Research Authority (NHRA). This protocol will also be reviewed by 
the IRB at the University of Maryland Baltimore. 
 
9.3 
Potential risks and benefits 
9.3.1 Potential risks 
There are no more than minimal risks to participation in this study for all participants. Patients 
and caretakers may be uncomfortable with some of the questions posed to them in one-on-
one interviews. The researcher will remind the participant that they do not have to answer 
any questions that make them feel uncomfortable. Loss of confidentiality is another potential 
risk; this is minimal and will be minimized by use of unique patient codes and de-identified 
data. 
 
9.3.2 Potential benefits 
There are no known direct benefits for participants in this assessment. We hope that the 
assessment will serve to inform and improve service provision and that participants will be 
pleased to know they have contributed to that effort. This information is useful on a societal 
level for advancing our understanding of the treatment of HIV in a resource-limited setting. 
 
9.3.3 Risk to benefit ratio and minimization of risks 
The knowledge gained from this study will be important as an addition to a very limited body 
of literature about post hospitalization outcomes among PLHIV in sub-Saharan Africa.  
 
9.4 
Voluntary participation 
During recruitment and implementation of IDIs, we will counsel participants that their 
participation is voluntary and regardless of the data they provide, their position with MoH, 
UTH, etc. will not be impacted in any way. Transcripts will be stripped of identifying 
information. We will approach patients who are eligible to participate in a discrete manner 
to maintain confidentiality. We are aware that private space is minimal in AMEU and the 
inpatient units and our staff will be coached on how to discuss sensitive issues in the most 
discrete ways possible to avoid inadvertent disclosure. If possible, a private space will be used 
for consenting and collection of data. When interviewees are conducted away from the 
hospital either at home or any other space, they will be conducted with consultation with the 
patient.  
Potential participants will be counseled that they can refuse to participate in the study and 
still receive HIV care at the treatment site. Participants will be free to not answer questions 

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20 
 
that they deem too personal during the study. Providers will be highly trained and will receive 
specific training in human subjects research. The study staff obtaining consent and collecting 
data will be highly trained in human subjects and responsible conduct of research and will 
have the appropriate certifications (e.g., NIH).  
 
9.5 
Informed consent 
Informed consent procedures will follow international standards. The consent form will be 
available in English, Nyanja, and Bemba; consent will occur in the language (among the three) 
chosen by the participant. If the participant is not literate in one of the three languages, an 
independent witness (either family member, friend, or clinic staff not working on the study) 
who is literate in the chosen language will be present and will participate in the consenting 
process. Study procedures will allow for potential participants to take time (potentially weeks 
to months if desired) to make a decision about whether or not to participate and a follow-up 
appointments in the days and weeks after the initial meeting can be scheduled, if desired. 
The participants will be encouraged to ask questions throughout the consent process and also 
throughout their entire participation in the study. 
 
9.6 
Participant confidentiality 
Throughout the study, we will maintain strict participant confidentiality in various ways. We 
will collect data using an ID number that is only linkable to the patient’s name, phone number, 
and address using a linkage file. Files will be maintained in a locked filing cabinet in a locked 
office and the linkage file will be locked separately. Only a member of the study team will 
keep the keys and be able to open the file cabinets containing participant records. Access to 
the files will be restricted to members of the study team. If necessary, the IRB, MoH, or other 
regulatory body will be granted access to study files. At the end of the study, linkage files and 
personal identifying information will be destroyed, leaving only de-identified data for ongoing 
analysis and dissemination.  
 
9.7 
Participant withdrawal 
Participants will be allowed to withdraw from the study at any time and for any reason and 
without stating a reason. Participants will be provided with the PI and other study team 
members’ phone numbers and if the participant informs the study team of her/his wish to 
leave the study, that wish will be honored. Participant data and records would be destroyed 
at that point and the ethics committee would be informed of the withdrawal. 
 
9.8 
Participant treatment 
Participants will receive clinical care and treatment according to the MoH guidelines on HIV 
management and per the standards of care. A study team member will be available to 
participants by phone at all times and patients who require hospitalization after discharge or 
additional medical attention will be referred to the appropriate public sector facility.  
 
 
 

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10. Study Time Frame 
Following IRB approval, we will organize a stakeholder meeting to explain the research and 
the purpose. We will then begin data collection using IDIs, followed by data analysis. 
Following completion of data analysis, the results will be disseminated through a variety of 
channels, including through educational programs at UTH, conference presentations, and 
publication in a peer-reviewed journal.   
 
Timeline for Major Activities 
2022 
2023 
2024 
Q3 Q4 Q1 Q1 Q3 Q4 Q1 Q2 Q3 Q4 
IRB Approvals 
 
X 
 
 
 
 
 
 
 
 
Stakeholder meetings  
X 
 
 
 
 
 
 
 
 
 
Pre-implementation data collection 
 
 
X 
X 
X 
 
 
 
 
 
CHW intervention implementation 
 
 
 
 
X 
 
 
 
 
 
Post implementation data collection 
 
 
 
 
X 
X 
 
 
 
 
Data collection: IDIs  
 
 
 
 
X 
X 
 
 
 
 
Data analysis 
 
 
 
 
 
X 
X 
X 
 
 
Local dissemination of findings 
 
 
 
 
 
 
X 
X 
 
 
Conference presentation 
 
 
 
 
 
 
 
X 
X 
 
Manuscript development & 
publication 
 
 
 
 
 
 
 
 
X 
X 
 
 
 
 
11. Publication plan 
It is expected that the results of the study will be presented at an infectious disease 
conference (e.g. CROI, IDSA/ICAAC, or IAS/IAC). It is anticipated that the study will generate 
an abstract. We anticipate that the study will also generate a manuscript that will be 
submitted to an infectious disease journal such as Journal of the International AIDS Society, 
or other journals of a similar caliber. It is anticipated that a manuscript would be submitted 
within 6 months of completion of the final analysis of the study data. 
 
 
 

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12. Budget 
 
Budget (in Kwacha) 
Year 1 
Personnel 
   Key personnel salaries 
   Other staff salaries 
 
300,000 
200,000 
Travel 
   Local travel (Lusaka) 
    
 
40,000 
 
Other 
   Participant costs (such as transport reimbursements) 
   Training costs (for study team and UTH staff) 
   Meeting costs (for sensitization and dissemination) 
   Miscellaneous costs (stationery, office rent, etc.) 
 
20,000 
40,000 
35,000 
20,000 
Indirect costs 
150,000 
Total 
800,000 
 
 
 
 
 
 

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13. References 
1. 
Hansoti B, Kelen GD, Quinn TC, et al. A systematic review of emergency department 
based HIV testing and linkage to care initiatives in low resource settings. PloS one. 
2017;12(11):e0187443. 
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Meintjes G, Kerkhoff AD, Burton R, et al. HIV-Related Medical Admissions to a South 
African District Hospital Remain Frequent Despite Effective Antiretroviral Therapy 
Scale-Up. Medicine. 2015;94(50):e2269. 
3. 
Peck RN, Wang RJ, Mtui G, et al. Linkage to primary care and survival after hospital 
discharge for HIV-infected adults in Tanzania: a prospective cohort study. Journal of 
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Wanyenze RK, Hahn JA, Liechty CA, et al. Linkage to HIV care and survival following 
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Ousley J, Niyibizi AA, Wanjala S, et al. High Proportions of Patients With Advanced 
HIV Are Antiretroviral Therapy Experienced: Hospitalization Outcomes From 2 Sub-
Saharan African Sites. Clinical Infectious Diseases. 2018;66(suppl_2):S126-S131. 
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LaCourse SM, Chester FM, Matoga M, et al. Implementation of routine counselor-
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Lilongwe, Malawi. Journal of acquired immune deficiency syndromes (1999). 
2015;69(1):e31. 
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Geng EH, Bangsberg DR, Musinguzi N, et al. Understanding reasons for and 
outcomes of patients lost to follow-up in antiretroviral therapy programs in Africa 
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syndromes (1999). 2010;53(3):405. 
8. 
UNAIDS. Zambia. https://www.unaids.org/en/regionscountries/countries/zambia. 
Accessed October 30, 2020. 
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Zambian Ministry of Health, Centers for Disease Control and Prevention, ICAP 
Columbia University, Central Statistics Office [Zambia]. Zambia Population-based HIV 
Impact Assessment (ZamPHIA): Final Report. Lusaka, Zambia2016. 
10. 
Stringer JS, Zulu I, Levy J, et al. Rapid scale-up of antiretroviral therapy at primary 
care sites in Zambia: feasibility and early outcomes. Jama. 2006;296(7):782-793. 
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Mehta S, Moore RD, Graham NMH. Potential factors affecting adherence with HIV 
therapy. AIDS. 1997;11(14):1665-1670. 
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Ajose O, Mookerjee S, Mills EJ, Boulle A, Ford N. Treatment outcomes of patients on 
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and meta-analysis. Aids. 2012;26(8):929-938. 
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Braitstein P, Brinkhof MW, Dabis F, et al. Mortality of HIV-1-infected patients in the 
first year of antiretroviral therapy: comparison between low-income and high-
income countries. Lancet. 2006;367(9513):817-824. 
14. 
Hallett TB, Eaton JW. A side door into care cascade for HIV-infected patients? JAIDS 
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Holmes CB, Bengtson AM, Sikazwe I, et al. Using the side door: non-linear patterns 
within the HIV treatment cascade in Zambia. Conference on Retroviruses and 
Opportunistic Infections; 2014; Boston, USA. 
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Mwamba C, Sharma A, Mukamba N, et al. ‘They care rudely!’: resourcing and 
relational health system factors that influence retention in care for people living with 
HIV in Zambia. BMJ global health. 2018;3(5):e001007. 

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17. 
Zanolini A, Sikombe K, Sikazwe I, et al. Understanding preferences for HIV care and 
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Cichowitz C, Pellegrino R, Motlhaoleng K, Martinson NA, Variava E, Hoffmann CJ. 
Hospitalization and post-discharge care in South Africa: A critical event in the 
continuum of care. PloS one. 2018;13(12):e0208429. 
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Connolly M, Grimshaw J, Dodd M, et al. Systems and people under pressure: the 
discharge process in an acute hospital. Journal of clinical nursing. 2009;18(4):549-
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Hesselink G, Schoonhoven L, Plas M, Wollersheim H, Vernooij-Dassen M. Quality and 
safety of hospital discharge: a study on experiences and perceptions of patients, 
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PEPFAR. Monitoring, Evaluation and Reporting Indicator Reference Sheet version 
2.3. In:2018. 
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Chun AY, Heeringa SG, Schouten B. Responsive and adaptive design for survey 
optimization. Journal of Official Statistics. 2018;34(3):581-597. 
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Kankasa C, Carter RJ, Briggs N, et al. Routine offering of HIV testing to hospitalized 
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Haachambwa L, Kandiwo N, Zulu PM, et al. Care Continuum and Postdischarge 
Outcomes Among HIV-Infected Adults Admitted to the Hospital in Zambia. Open 
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Saldana J. The Coding Manual for Qualitative Researchers. SAGE Publications; 2015. 
 
 
 

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14. Appendix 1: Patient Interview Guide 
 
IDI Interview Guide for patients, Interview 1 (~1-week post-discharge) 
                            
Background information:  
(Objectives: Rapport building, understanding of potential sources of support, assessment of living 
situation and economic status, understanding of other health-related behaviors as it relates to any 
leisure activities)  (Interests? Ways they earn a living?) 
 
1. Can you please tell me about yourself and the family members who live here with you? 
a. Tell me about everyone who lives here on a regular basis with you. How are they 
related to you? (Possible probes: married? Kids? Ages?)  
b. Can you talk about any other close family members who live nearby and who are 
important to you in your life? 
c. Tell me a bit about how people in this household get by, what are the different kinds 
of work they do? 
d. When you are feeling well, what are some of the things that you do when you have 
free time, or for recreation:  
i. Possible probes: Reading, watch TV, do you take alcohol, smoke, what about 
others in your family?  
 
 
2. (Objective: These questions are to understand the role of stigma and whether participant 
perceives stigma or themselves as burden or source of shame within household/community – 
in case these factors have played a role in how they are cared for/care for themselves;  
whether/how they feel their identity as a PLHIV has had any negative impacts on their life 
within their community)  
 
Thank you.  Now, if it’s okay, I’d like to understand a bit more about your health. To start, 
would you please tell me in detail how you learned about your status? (NOTE: try to get them 
to tell this to you as a story, they can set the stage/scene - Age, circumstance-  what year was 
it?)  
a. Can you talk about how you felt after learning about your status at that time? Have 
your feelings changed since that time and how?  
b. Have you told anyone about your status (or has anyone learned about your status 
without you telling them? How did they come to know about it?  
i. How was that experience (disclosure) for you?  
ii. Were there any changes in relationships with family over time? 
 
 
3. Objective: To understand how the participant has approached treating their HIV, different 
treatment regiments they may have tried prior to ART, different influences on different ways 
of getting treatment etc. AND to establish the context around their starting on ART, and how 
they got it and how they felt about it from the beginning. Also want to see if the mechanisms 
by which they accessed it have changed at all as this may be part of the problem.  
 
Thank you so much for sharing that with me. Now I’d like to understand more about your 
experience with caring for your health. NOTE: Ask these items only if the person reported 
knowing their status before being hospitalized. 

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a. Let’s start with right after you learned your status. Can you talk about how you cared 
for your health during that time? (Try to figure out when this was – before/after test 
and treat?)  
b. Now let’s talk about any changes more recently in how you have looked after yourself. 
c. Let’s talk in a bit more detail about ART if you don’t mind.    
i. Have you ever been on ART? Can you describe how you started to take ART? 
(If not already addressed above) 
ii. Who encouraged you to start, when did you start, how did you start taking 
ART?  
iii. What was your experience with taking ART? (Emotional response to taking it, 
physical response to taking it in the body).  
iv. Can you talk about where and how you have accessed ART over time and 
whether or how this changed? 
 
d. Ask all participants: Apart from going to the clinic as a way of taking care of your 
health, have you tried different methods or ways of taking care of your health over 
time? Can you talk about these?  
i. Can you talk about who encouraged you to take these different approaches 
(ART? other healing practices? Church/religious influence?)  
ii. If influenced by church – ask them to talk more about this – Can you talk 
more about the guidance you received from your church?  
iii. Can you also tell me a bit more about the church? (What type)  
e. Can you talk about any other health challenges you have been facing?  
 
 
4. Objective: These questions will help us to understand their perceived barriers to staying on 
treatment. Hope here is that some of these might be amenable to intervention with CHWs…. 
So we want to try to identify any of these. 
Many of us have a difficult time accessing and staying in HIV care or on treatment( That is 
accessing the drugs, staying on ART without stopping).  For many, the challenges they face 
with staying on ART lead them to be non-adherent (not taking treatment everyday) or even 
stop taking it. Can you describe any experiences you have had with this?  
For these question, make that you probe on challenges by asking the participants on 
challenges related to accessing ART, Taking ART, Staying on ART etc.  
a. Can you talk about any challenges you faced with taking ART?  
i. Challenges at home/In household? Community?  
ii. Concerns with taking it because of advice received  (from family, friends, 
church) 
iii. Challenges with clinic / accessing drugs? (Stigma, time, cost, distance, rude 
staff) 
iv. Challenges/barriers within yourself (acceptance of status, motivation, beliefs, 
fears, side-effects, what others might think etc.)   
b. Now, among all of the reasons you have just mentioned, which of these reasons would 
you say mattered the most. What makes you say that? (rank exercise) 
c. Were you able to overcome any of these challenges? (If yes, can you talk about how 
you overcame the challenges? If no, what could help you to overcome these 
challenges?) 
 
 

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5. (Objective: Understand their support system since diagnosis, changes to that system, and 
whether they have one or feel they have one and who primarily it consists of – Does their family 
support them, who in the family – did someone supporting them early on move away, leave, 
pass away? Etc.)  
Now I would like to understand more about the people in your life who have supported you 
since you learned about your status.  
a. Who would you say has helped or supported you the most? In what ways? 
b. Have the people who have cared for you/supported your health changed over time?  
i. Can you talk about this and why was there this change, how did this affect 
you and your treatment/health? (PROBE to identify role of family members 
in the household) 
 
Thank you for sharing this with me. Now I’d like to ask you more about your most recent health 
challenges that took you to the hospital, if you don’t mind.   
 
6. Can you talk about your most recent hospitalization, tell me about what happened?  
a. What led to your going to the hospital?  
b. How did you get there? Who helped you realize you needed to go? Who helped you 
to get there?  
c. Can you just let me know, quickly, about how many other times you have been 
admitted to the hospital in the past since you learned about your status?  
i. Can you talk about the events that led to your hospitalization in 
the past? 
 
 
(Objective: Want to know about the additional concerns they may have been facing with their health 
that led to their hospitalization; additional questions here on social support/family support) 
 
7. Thinking now about the most recent time you were in the hospital - Can you talk about your 
experience in the hospital? 
a. What did you learn about the cause of your illness that led to your being 
hospitalized while you were there?  
i. What other information was shared with you by the doctors/nurses 
about your medical condition?  
ii. How did that make you feel?  
b. Can you talk about how being in the hospital made you feel? 
i. PROBE on whether those feelings have motivated them to act or lose 
hope…without saying this directly!    
 
 
8. Now, can you please tell me about what was the discharge process like for you?  
a. Can you talk about how you learned you were going to be discharged? (PROBE: 
sudden, knew a few days in advance?) 
b. How did you feel about being discharged when you were? (Early? Late? From their 
perception) 
c. Can you describe for me in detail everything you were advised to do following 
discharge?  
i. What exactly do you remember being told to do once you left the 
hospital? 

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ii. Did the hospital provide you with any referral to help you get 
connected to care?  
iii. How did you feel about the advice/instructions you were given?  (Easy 
to understand, not feasible, helpful, unhelpful, etc.) 
 
 
9. Now, let’s talk about how it was after you left the hospital. How has it been since you were 
discharged? Can you talk about that?  
a. How have you been feeling? 
b. What has been worrying you?  
c. What is going well or getting better? 
d. Who has been helping you with your health since discharge? Can you talk about how 
they have been helping? 
 
 
10. Now I’d like to ask you more about what you need in order to completely recover.  
a. What do you think are the things that you need in order to get better? 
b. What does your family need in order to be able to support you to get better? 
c. In addition to medical advice and treatment, what additional form of support do you 
need to stay/get healthy? ( e.g., Nutrition , information, psychological, financial, 
religious ) 
d. What are all the challenges you are facing now to stay/get healthy? 
i. With treatment, clinic, or access to healthcare 
ii. With family or support 
iii. With finances following hospital stay 
iv. Within community or its expectations 
v. Others?  (Probe on those related to ART and ART use, especially cost of 
healthcare -transportation, labs, tests, medicines) 
vi. What is it that you think should be done to help you overcome these 
challenges?  
e. What kinds of support are you receiving? And from where? Whom?  
 
 
11. Thank you very much for you time. Do you have any question or comments before we close 
this interview? 
a.  Is there anything else that you would like us to talk about that you think is important 
for me to understand about your problems with your health?  
b. Do you have any additional recommendations you would like to share on whether or 
how CHWs, or other healthcare workers, could better serve patients after discharge 
to ensure they recover as best as possible? 
 
 
 
 

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15. Appendix 2: Patient Interview Guide (at 6 months) 
 
 
IDI Interview Guide for patients, Interview 2 (at six months) 
 
Thank you for agreeing to speak with me today. I’d like to talk with you today about your experiences 
since we spoke together last time.   
 
1. To begin, can you talk about how it was after you left the hospital. If possible, try to remember 
back to the first few weeks following your return from the hospital in ____ (name month).  
Tell me how you were feeling just after you returned home.   
a. Can you talk about your energy levels when you first got home? 
b. How about your levels of pain?  
c. Can you talk about the medications you were prescribed? Can you describe what you 
were prescribed and what you took?  
i. (if prescribed new drugs) Can you talk about how the medications made you 
feel?    
d. Can you talk about who in your home or community (family, friends/neighbors) 
helped you with your recovery process after discharge?  
i. How did they help you?   
 
2. Now I’d like to ask you about any healthcare you have received since discharge, if any.  
a. Can you describe in detail any follow-up visits to hospital/clinic you have had since 
discharge?  (IF they have followed-up, then ask: ) 
i. What? Where? When since discharge? How many? For what purpose? 
(INTERVIEWER – note how /what compares to the advice they received) 
ii. How have these appointment(s) gone?  
iii. Have you received any support for these follow-ups? (Family, CHWs) 
iv. What has been good about these appointment(s)? 
v. What has been difficult about these follow-ups? 
vi. Are you facing any challenges with continuing to follow-up visits  for your 
care? Can you talk about these? (Probe on logistics, healthcare setting, 
finances since discharge, family, community) 
vii. Some people are told to take different medications after discharge. Have you 
had any experience with that and if yes how is that going? 
viii. After being discharged, can you describe where have you been collecting your 
drugs?  
1. If referred back to your clinic, how has your experience been with 
that?   
 
b. (IF they have not had any interaction with healthcare system since discharge) Can 
you talk about the reasons that you have not seen anyone/gone to a clinic since you 
left the hospital?  
i. (IF mentions any challenges – probe A LOT) Can you talk about any barriers or 
challenges you experienced with follow-ups after discharge?  
1. ? (Probe on logistics, healthcare setting, finances since discharge, 
family, community) 
ii. (IF mentions that it is not necessary – probe – this is a misunderstanding)  

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iii. (If mentions that they have an appointment booked, then ask):  Do you think 
there will be any challenges for you with getting to this appointment? Can 
you talk about those challenges?  
iv. (If they missed the appointment) – Can you talk about the reasons you were 
unable to make the appointment? (PROBE on what’s next) 
 
3. Now I’d like to ask you more about your relationship with the CHW who supported you 
following discharge.  
a. Can you talk about the different ways the CHW supported your recovery, if at all? Let’s 
list these. Phone calls? Visits? What else?  
b. Can you talk about which of these ways helped you the most?  
i. Are there any things that you were able to do (care you were able to receive, 
medications you were able to access) that you may not have been able to 
do/get without support from the CHW?  
ii. How did the CHW support your follow-up visit with the hospital, if at all? 
iii. How did the CHW support your follow-ups with your clinic, if at all?   
c. Which of these things helped you the least, or you would have preferred they had 
not?  
i. Can you talk about anything the CHW did that you did not appreciate or find 
useful or helpful?  
d. What else would you have appreciated from the CHW? How else would you have liked 
them to help you?  
i. If you could go back in time to when you were in the hospital, is there anything 
you would have liked to have gone differently that you think would have 
helped you to recover faster or to get better?  
 
4. (for those who screened for mental health/alcohol). I believe we referred you for additional 
care with (Strong Minds / ___ alcohol care).  
a. Can you talk about what happened after you received the referral? 
b. Can you talk about any visits you had to (Strong minds / ___ ).  
c. Can you talk about your experience there? What did you learn? How did it make you 
feel? 
d. Can you talk about what has happened, if anything, since your first visit? 
 
5. What would you say is the biggest change or the most significant and positive thing that has 
happened for you as a result of this program (support from CHWs)?  
a. What makes you say that?  
 
6. Can you talk about any changes that have taken place for you in the last six months?  
a. Disclosure? – any changes in who knows your status?  
b. Behavioral health – any changes in behaviors that might be risky? (e.g., alcohol)  
c. Relationships – any changes in your personal relationships with family members? 
d. Self-esteem – Any changes in how you feel about yourself?  
 
7. We are going to try to build up this program to support more patients like you who are leaving 
the hospital to help support them to recover.  
a. Can you think of any recommendations you have for us that could help to make this 
support program stronger?   
b. What do you think are the things that you need in order to get better? 
c. What does your family need in order to be able to support you to get better? 

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d. In addition to medical advice and treatment, what additional form of support do you 
need to stay/get healthy? ( e.g., Nutrition , information, psychological, financial, 
religious ) 
e. What are all the challenges you are facing now to stay/get healthy? 
i. With treatment, clinic, or access to healthcare 
ii. With family or support 
iii. With finances following hospital stay 
iv. Within community or its expectations 
v. Others?  (Probe on those related to ART and ART use, especially cost of 
healthcare -transportation, labs, tests, medicines) 
vi. What is it that you think should be done to help you overcome these 
challenges?  
f. What kinds of support are you receiving? And from where? Whom?  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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32 
 
16. Appendix 3: Caregiver Interview Guide   
 
Interview with Care Giver 
 
IDI Interview Guide for Caretakers of Patients – End line 
 
When appropriate, please make sure you collect this information from the participant.  
o Community name:    
o Age:  
o Gender: 
o Education level 
o Religion 
 
NOTE: We will need to develop coding scheme to link caretaker to patient for transcription purposes.  
 
1. (Rapport building) First, tell me about yourself and your family in your household.(Children? 
Dependents?) 
a. Tell me a little bit about how you are related to _____________? 
b. Tell me about the role you play in this household?  
c. What kind of work do you do?  (If lives in different household from patient, then ask: 
Tell me a bit about how people in this household get by, what are the different kinds 
of work they do?) 
 
 
(Transition to new topic)  
 
 
We recently talked to ____________ and we would like to talk to you about your role since their 
hospitalization.  
 
 
2. First could you please talk about the events that led to _____’s hospitalization in _____ 
[month]? 
a. What, in your mind, were the reasons that ____ got sick and needed to be 
hospitalized? 
b. Has he/she ever been hospitalized before this? How many times in the past has this 
happened?  
i. 
If yes, what are the reasons  ____ has been hospitalized in the past?  
 
 
3. What role did you play in looking after ___ when ____ was in the hospital? (IF bedside, or 
there often, then ask following):  
a. What was the discharge process like? Can you talk about how you learned when ____ 
was going to be discharged? (PROBE: sudden, knew a few days in advance?) 
b. How did you feel about ____being discharged when they were? (Early? Late? From 
their perception) 
c. Can you talk about the advice the doctors/nurses gave ____  about what he was 
supposed to do following discharge?  
i. What exactly do you remember about this? 

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ii. Was ________ given any referral to a local clinic?  
iii. How did you feel about the advice/instructions you were given?  (easy to 
understand, not feasible, helpful, unhelpful, etc.) 
iv. Was _____ given any medicine from the hospital? Was there any that you 
were asked to buy because the hospital did not have?  
 
 
4. Let’s talk about what it’s been like since ____ returned home after the last hospitalization. 
How has that been for you?   
a. What is going well for you and for _____ so far?  
b. Can you talk about any follow-up for clinic care, appointments ____ has attended 
since coming home?  
c. (if got care) Can you describe the role you played in getting ____ to the hospital/clinic 
for their follow-up care appointments? 
i. Can you describe whether  ____ received any new medication or treatment 
recommendations since discharge? If so – how has it been to support ____’s 
medication/treatment adherence?  
d. (If has not followed-up) Can you talk more about the reasons that ___ has not had 
a follow-up visit yet?  
i. What challenges have you faced with supporting ____ to follow-up with care 
since leaving the hospital?  
1. Hospitalization can be expensive. Can you talk about any of the 
impacts of those costs for you and your family?  
 
 
5. What other challenges have you had in caring for _____ ? (Time, resources, types of 
treatment).  
a. Challenges  
i. 
Individual level – lack of emotional support, over burden, lack of 
information/knowledge, uncooperative patient  
ii. 
Household level – Relationship dynamics, financial challenges 
iii. 
Community level – stigma, people in the community asking questions  
b. How do these challenges you face affect/influence how ___takes his/her treatment? 
 
 
6. How would you like ____ to be getting care? What do you think ___ needs to get better?  
a. What kind of advice do you give( name  of the patient) to help him/her stay healthy? 
b.  What kind of support do you wish you had to better support( name  of the patient) 
c. What would you like to see happen differently that can help ……. To stay healthy?  
d.  What else could help you to be able to address those challenges, or what would 
need to happen to help remove those challenges?  
 
 
7. Now I’d like to ask you more about your relationship with the CHW who supported ___ 
following discharge.  
a. Can you talk about the different ways the CHW supported ___ recovery, if at all? Let’s 
list these. Phone calls? Visits? What else?  
b. Can you talk about which of these ways helped ___ and you the most?  

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i. Are there any things that you were able to do (care you were able to receive, 
medications you were able to access) that you may not have been able to 
do/get without support from the CHW?  
ii. How did the CHW support ___ follow-up visit with the hospital, if at all? 
iii. How did the CHW support ___ follow-ups with your clinic, if at all?   
c. Which of these things helped ___ the least, or you would have preferred they had 
not?  
iv. Can you talk about anything the CHW did that you did not appreciate or find 
useful or helpful?  
d. What else would you have appreciated from the CHW? How else would you have liked 
them to help ____?  
v. If you could go back in time to when ____ was in the hospital, is there anything 
you would have liked to have gone differently that you think would have 
helped ____ to recover faster or to get better?  
 
 
8. What would you say is the biggest change or the most significant and positive thing that has 
happened for ____ as a result of this program (support from CHWs)?  
a. What makes you say that?  
 
 
9. Can you talk about any changes that have taken place for ____in the last six months?  
a. Disclosure? – any changes in who knows ___status?  
b. Behavioral health – any changes in behaviors that might be risky? (e.g., alcohol)  
c. Relationships – any changes in ____personal relationships with family members? 
d. Self-esteem – Any changes in how ___feels about themselves?  
 
 
10. We are going to try to build up this program to support more patients like ____who are leaving 
the hospital to help support them to recover.  
a. Can you think of any recommendations you have for us that could help to make this 
support program stronger?   
b. What do you think are the things that you need in order to get better? 
c. What does your family need in order to be able to support you to get better? 
d. In addition to medical advice and treatment, what additional form of support do you 
need to stay/get healthy? ( e.g., Nutrition , information, psychological, financial, 
religious ) 
e. What are all the challenges you are facing now to stay/get healthy? 
vi. With treatment, clinic, or access to healthcare 
vii. With family or support 
viii. With finances following hospital stay 
ix. Within community or its expectations 
x. Others?  (Probe on those related to ART and ART use, especially cost of 
healthcare -transportation, labs, tests, medicines) 
xi. What is it that you think should be done to help you overcome these 
challenges?  
f. What kinds of support are you receiving? And from where? Whom? 
 
 
 

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35 
 
 
ONLY ASK IF STATUS OF PATIENT IS KNOWN 
 
If it’s okay, I would like to ask you some questions about _____’s status and your struggles and 
efforts to support _____ with this.  
 
1. First, can you tell me when/how you learned about ____’s HIV status? How was that 
experience for you? (Stigma, fear, friends/family response, reaction)  
a. How has ____’s HIV status affected your life in this family? 
i. PROBE: has this had any effect on your relationship within your family?   
b. Can you talk about whether _____’s status has had any impact on your role in 
the community? What about ____ ‘s role in the community?  
 
2.  What form of treatment has _____ been getting since diagnosis, to your knowledge?    
a. What is it that has worked well for ______ with the treatment  he/she  is  taking?  
b. What has not been working well?( type or combination of drugs, changing from 
first line  to second line treatment, taking tuberculosis treatment too, etc.)  
 
3. Now I would like to talk to you about access to care for (name of the patient).  
a. Where did  ____ access his/her care from?  Can you talk about any changes in 
how ____ accessed care over time?  
b. Apart from getting care from the clinic, are there other places and forms of 
treatment where _____ got care?  
i.  Probe about traditional medicine, faith healing.  
ii. How has this affected his/her journey  on treatment?  
c. What, if anything, seemed to work well for ____ ‘s HIV care?  
d. What did you encourage ___ to do? What did others encourage ___ to do?  
 
4. (If the patient learned their HIV status before hospitalization): Many people have a 
difficult time accessing and staying in HIV care or on treatment.  For many, the challenges 
they face with staying on ART lead them to be unable to take treatment every day or even 
stop taking it. Can you describe any experiences _____  has had with this?  
c. Can you talk about any challenges _____ faced with taking ART?  
i. Challenges at home/In household? Community?  
ii. Concerns with taking it because of advice received  (from family, friends, 
church) 
iii. Challenges with clinic / accessing drugs? (Stigma, time, cost, distance, 
rude staff) 
iv. Challenges/barriers within yourself (acceptance of status, motivation, 
beliefs, fears, side-effects, what others might think etc.)   
d. Now, among all of the reasons you have just mentioned, which of these reasons 
would you say mattered the most. What makes you say that? (rank exercise) 
e. Was ____ about to overcome any of these challenges? If Yes:  how? If no, what 
could help you to overcome these challenges?) 
f. Were you able to help ____  overcome any of these challenges? (If yes, can you 
talk about how you were able to support _____ to overcome the challenges?  
g. Are there other resources you would need to help ____ overcome some of these 
challenges?  Can you talk about that?  
 
 

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36 
 
 
11. Thank you very much for you time. Do you have any question or comments before we close 
this interview? Is there anything that you would like us to talk about that which we have not 
talked about which you think is important for( name  of the patient)  that can help him get 
better or do well on his treatment journey?  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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17. Appendix 4: CHW, CLO, Clinicians Interview Guide   
 
Interview with CHW, CLO, Clinicians 
 
Endline, ReCharge Interview with CHW, CLO, Clinicians (hospital, clinic) 
 
Interviews with providers involved in ReCharge.  
1. To help understand more about your involvement in Recharge broadly, tell me your 
responsibilities in this intervention. What role did you play with caring for patients LHIV who 
had been hospitalized and then discharged following their discharge? 
 
2. To understand how this program worked and its weaknesses, let’s talk more specifically about 
examples of two patients you worked with. Think of one that worked out well. Think of one 
that did not. (each question to be asked for both types of patient). 
a. Talk about your first encounter with this patient. How did it go? Where was it? What 
did you learn? What did you do to help them? 
b. Talk about your first visit with them after discharge? How did it go? Where? What 
happened?  
c. Talk about other calls, supports you provided? What happened? What did you do, 
how did they respond?  
d. Talk about what you learned about what the patient needed, how did you support 
that? 
e. Talk about the patient’s involvement in care after discharge? What services did they 
get? Where? How?  
f. Talk about your role with anyone else in the patient’s life – caregiver? Children? 
Others? 
g. Talk about how you supported the patient’s recovery? 
h. Tell me what you think was the most important contribution you made to this 
patient's recovery?  
i. 
Tell me what you think enabled / prevented them from recovering? 
j. 
What else could the program have done to better support this patient? 
k. (for patient that did not go well) What explains, in your mind, why this patient did not 
do well/recover?  
i. What would the program change to help patients like this one to do better in 
the future? 
 
3. What are your recommendations for how CHWs should work with hospital to help discharged 
HIV patients? 
 
4. What are your recommendations for how CHWs should work with clinics to help discharged 
HIV patients? 
 
5. What are your recommendations for how CHWs should facilitate relationship between 
hospitals and clinics to help discharged HIV patients?  
 
 
 
 
 
 

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18. Appendix 5: Information and Consent Forms for ReCharge Patients  
 
 
 
THE UNIVERSITY OF ZAMBIA 
 
 
BIOMEDICAL RESEARCH ETHICS COMMITTEE 
 
Telephone: 256067 
 
 
 
 
 
                               Ridgeway Campus 
Telegrams: UNZA, LUSAKA 
 
 
 
 
 
                      P.O. Box 50110 
Telex: UNZALU ZA 44370 
 
 
 
 
 
                      Lusaka, Zambia 
Fax: + 260-1-250753 
E-mail:  unzarec@unza.zm 
Assurance No. FWA00000338 
IRB00001131 of IOR G0000774 
 
 
 
Information Sheet and Consent Form for Discharged Patients for Re-Engagement at Discharge 2 
 
 
Improving post-hospital outcomes for adults with HIV in Zambia (ReCharge 2) 
 
Investigators: 
Names 
Institutions 
Contacts of the Investigators 
Dr. Cassidy 
Claassen 
University of Maryland at Baltimore (USA) and 
University of Zambia School of Medicine 
cclaassen@ihv.umaryland.edu 
 
Dr. Michael 
Vinikoor 
University of Alabama at Birmingham (USA) and 
University of Zambia School of Medicine 
mjv3@uab.edu 
 
 
Background and rationale for the study: 
Hello. I am    ( name)    and I work with the University of Maryland team in Zambia. I would like to talk 
to you about an upcoming study that you may be able to help with. This form explains why we are 
doing this study and what you will be asked to do if you choose to be in this study. We will read this 
form with you. Please ask any questions you have about this study at any time to fully understand this 
information so that you can make an informed choice about being in this study.  
 
Many hospitalized patients at referral hospitals in Zambia are living with HIV. After being stabilized at 
the hospital and discharged to go home, people living with HIV experience a challenging recovery 
process, and during this time, the risk of readmission to the hospital and/or death is high. Outcomes 
are especially poor when the person living with HIV also had a low CD4 count and/or has a high HIV 
viral load (VL). After discharge, challenges may come from the need to receive follow-up care at 
multiple health facilities, inconsistent or poor support from family, and behavioral health issues like 
mental illness and alcohol use.  

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Purpose: 
The purpose of this study is to evaluate a new program that may help people living with HIV after they 
are discharged from the hospital. If we learn through this study that the program is beneficial  to 
patients, their families, and health workers, we recommend that more patients receive it. You are 
being asked to participate in the study because you are 18 years or older, were hospitalised and 
discharged, and we spoke with you at the point of discharge about taking part in the new Recharge 
programme that is being conducted  in your community.   
 
Procedures: 
If you say yes, we would like to  come and visit you, and have two separate 30–45-minute  interviews  
at different times. If you will allow us and give permission, we would like to audio-record and type out 
the transcript for analysis. We hope the first interview would take place 3 months into the programme 
and the second would take place towards the end of the programme (around 6 months).  
 
We will include you in the program from today until 6 months after you are discharged. Before 
discharge we will ask you questions about where you live, including your contact details, and about 
your family or community supporters. We will also obtain some information from your medical 
records about your medical history. If you have not had the needed labs done, we will collect up to 10 
ml (2 teaspoons) of blood for these tests and will bring you the results. At discharge, we will give you 
a card to bring with you to any follow-up appointments. The card has information about your medical 
history, medications, and appointments.  
 
For up to 3 months after you are discharged, a counsellor working with our team will be assigned to 
help you recover. The counselor will periodically phone you and/or, if it’s ok with you, visit you at 
home or in the community to provide you with additional support to help meet your mental, 
emotional, social, and spiritual needs as well as those of your family. We will also provide you with 
health education to you and your family, help you follow the discharge plan from your doctors, and 
remind you about follow-up appointments. The first home visit will happen within 1 week of discharge. 
Thereafter, the counsellor will phone you and/or meet you several more times. S/he may also 
accompany you to your follow-up appointments. The counsellor will check to see if you are having any 
negative thoughts or feelings that suggest depression or if you have challenges with heavy alcohol use 
and will refer you to the clinic if necessary.  
 
At 6 months after you are discharged, you will have a final study visit at the hospital. At the visit, we 
will obtain information from your medical records, and collect up to 10 ml (2 teaspoons) of blood to 
check your viral load and bring you the results.  
 
Who will participate in the study? 
Up to 100 people meeting the study criteria will participate. 
 
Risks/Discomforts: 
One possible risk is that people will find out about your medical information. We will safeguard your 
confidentiality. We will only discuss your medical information with people you designate. When 
visiting you at home or in the community, our team will never reveal the reasons for the visit to others. 
In addition, we will call you and ask if it is okay to visit you. If you don’t want us to visit you at home, 
you can tell us an alternative location where we can meet you.  During surveys and interviews, you 
may feel embarrassed, worried, and/or uncomfortable talking about your medical information and/or 
experiences. You do not have to answer any questions you don’t want to and you can stop 
participating at any time. The blood draw may cause a small amount of pain or discomfort, and could 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
40 
 
carry a risk of infection. We will follow all standard sterile procedures to minimize discomfort as well 
as infection. 
 
Benefits: 
Research is designed to benefit society by gaining new knowledge. You may not receive any direct 
benefit from being in this research study, but we believe it will help us to provide better treatment to 
people with HIV who are hospitalized.  
 
Alternatives: 
You may choose not to take part in this study. Also, you can choose to participate now and decide to 
stop later at any time.  
 
Confidentiality: 
Every effort will be made to keep your personal information confidential. Only the research team and 
your physicians will have access to your medical records and/or study file. Your study file will not 
include your name but a study ID number to keep the records anonymous. No names will be used in 
audio-recorded interviews and after typing out the content, audio recordings will be destroyed. 
Summary results from this study will be reported on clinicaltrials.gov. However, information from the 
study that is published for scientific and/or programming purposes will not contain any of your 
personal identifying information like names, address, etc. Your records may be reviewed by 
representatives of the University of Zambia Biomedical Research Ethics Committee, the University of 
Maryland Institutional Review Board, the study sponsor (NIH), the U.S. Office for Human Research 
Protections (OHRP), the Zambian Ministry of Health, or the Office for Human Research Protections. 
However, these reviews will only be used to ensure that the study is being conducted properly and 
that your records are being stored appropriately.  
 
Cost: It will not cost you anything to be in this study.   
 
Reimbursement: We will reimburse you for your time and transportation costs during the study. You 
will receive K100 today, at discharge from the hospital, and at each home or clinic/hospital visit where 
our team meets you.  
 
Questions: If you have any questions, concerns, or complaints about this study, you may contact the 
Principal Investigator, Dr. Cassidy Claassen, at University of Maryland at Baltimore, 31C Bishops Road, 
Kabulonga Area, Lusaka, Zambia; Phone: +260 971075439; Email: cclaassen@ihv.umaryland.edu 
 
Questions about participants rights: 
If you have questions about your rights as a research participant, you may contact the people listed 
above. You can also contact the UNZABREC Chairperson for the Institutional Review Board (IRB) 
and/or the UMB Institutional Review Board: 
UNZA Biomedical Research Ethics Committee 
Ridgeway Campus, Nationalist Road, Lusaka 
University of Maryland Baltimore IRB 
620 W. Lexington St., 2nd Floor 
Landline Phone: 0211 256 067 
Other Phones: 0955 155 633, 0955 155 634 
Baltimore, Maryland, USA 21201 
Phone: +1 410 706 5037 
Email: unzarec@zamtel.zm 
Email: hrpo@umaryland.edu 
 
 
Statement of voluntariness: 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
41 
 
You are free to withdraw from the study at any time. You are also free to refuse to answer any 
questions that make you feel uncomfortable or that you deem private or otherwise. Just let the 
interviewer know that you prefer not to answer that question. Whether or not you take part in this 
study is your choice. There will be no penalty if you decide not to be in the study. You will not lose any 
benefits you are otherwise owed. Your choice to leave the study will not affect your access to 
healthcare now or in the future.  You will be given any new information gained during the course of 
the study that might affect your willingness to continue to take part.  
 
The University of Maryland, Baltimore (UMB) is committed to providing participants in its research 
studies all rights due to them under State and federal law.  You give up none of your legal rights by 
signing this consent form or by participating in this study.  This study has been reviewed and approved 
by an Institutional Review Board (IRB).  The IRB is a group of scientists, physicians, experts, and 
community representatives.  The IRB’s membership includes persons who are not affiliated with UMB 
and persons who do not conduct research studies.   
 
If you have questions, concerns, complaints, or believe you have been harmed through participation 
in this study as a result of researcher negligence, you can contact members of the IRB or the Human 
Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain 
information, or offer input about your rights as a research participant.  The contact information for 
the IRB and the HRPO is: 
University of Maryland, Baltimore 
Institutional Review Board Human Research Protections Office 
620 W. Lexington Street, Baltimore, MD 21201 
410-706-5037 
 
STATEMENT OF CONSENT  
 
........................................................................... has described to me what is going to be done, the 
risks, the benefits involved and my rights regarding this study. I understand that my decision to 
participate in this study will not alter my usual medical care. In the use of this information, my identity 
will be concealed. I am aware that I may withdraw at any time. I understand that by signing this form, 
I do not waive any of my legal rights but merely indicate that I have been informed about the research 
study in which I am voluntarily agreeing to participate. A copy of this form will be provided to me. 
 
Name of participant: 
 
 
……………………………………………………….……….….….. 
Signature of participant:  
 
……………………………………….……………………….….….. 
Date (DD/MM/YY): 
 
 
…………………………………………….………………….….….. 
 
Name of witness*: 
 
 
………………………………………………….…………….….….. 
Signature of witness*:   
 
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
Name of study staff member: 
 
…………………………………………………….………….….….. 
Signature of study staff member:  
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
*Note: Witness name, signature and date are required on this consent form only when the consenting volunteer 
is not able to read and/or is illiterate 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
42 
 
19. Appendix 6: Information and Consent Forms for Hospital and Program Staff  
 
 
 
THE UNIVERSITY OF ZAMBIA 
 
BIOMEDICAL RESEARCH ETHICS COMMITTEE 
 
Telephone: 256067 
 
 
 
 
 
                               Ridgeway Campus 
Telegrams: UNZA, LUSAKA 
 
 
 
 
 
                      P.O. Box 50110 
Telex: UNZALU ZA 44370 
 
 
 
 
 
                      Lusaka, Zambia 
Fax: + 260-1-250753 
E-mail:  unzarec@unza.zm 
Assurance No. FWA00000338 
IRB00001131 of IOR G0000774 
 
 INFORMATION SHEET AND CONSENT FORM FOR HOSPITAL AND PROGRAMME STAFF 
Title of the proposed study: Re-engagement at Discharge 2: Improving post-hospital outcomes for 
adults with HIV in Zambia (ReCharge 2) 
 
Investigators: 
Names 
Institutions 
Contacts of the Investigators 
Dr. Cassidy 
Claassen 
University of Maryland at Baltimore (USA) and 
University of Zambia School of Medicine 
cclaassen@ihv.umaryland.edu 
 
Dr. Michael 
Vinikoor 
University of Alabama at Birmingham (USA) and 
University of Zambia School of Medicine 
mjv3@uab.edu 
 
 
Background and rationale for the study: 
Hello. I am___________________ and I work at University of Maryland in partnership with the 
University of Maryland and Levy Mwanawasa University Teaching Hospital (LMUTH) and University 
Teaching Hospital (UTH). I would like to talk to you about an upcoming study that you may be able to 
help with. This form explains why we are doing this study and what you will be asked to do if you 
choose to be in this study. We will read this form with you. Please ask any questions you have about 
this study at any time to fully understand this information so that you can make an informed choice 
about being in this study.  
 
Many hospitalized patients at referral hospitals in Zambia are living with HIV. After being stabilized at 
the hospital and discharged to go home, people with HIV experience a challenging recovery process, 
and during this time, the risk of readmission to the hospital and/or death is high. Outcomes are 
especially poor when the person with HIV also had a low CD4 count and/or has a high HIV viral load 
(VL). After discharge challenges may come from the need to receive follow-up care at multiple health 
facilities, inconsistent or poor support from family, and behavioral health issues like mental illness and 
alcohol use.  
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
43 
 
Purpose: 
The purpose of this study is to evaluate a new program that may help people living with HIV after they 
are discharged from the hospital. If we learn through this study that the program is  beneficial/helpful 
to patients, their families, and health workers, we recommend that more patients receive it.  
 
You are being asked to be in the study  because you are a healthcare worker, a community health 
worker (CHW), or a community liaison officer (CLO) taking care of or providing support to recently 
discharged patients from this hospital. You may also be a program administrator who oversees the 
management of discharged patients.   
 
Procedures: 
If you agree to take part, we will invite you to attend a one-on-one interview session at a space/room 
where there is privacy. If you agree to participate in this interview, the interviewer will ask  about your 
thoughts and perspectives of the  programme, and ask your opinion about  ways to support patients 
better after hospital discharge. The interview will be audio-recorded and typed out for analysis. 
However, the information will not be linked to individual names to provide confidentiality. The 
interview will take around 1 to 1½ hours to complete.  
 
Who will participate in the study? 
Around 100 people will take part in an interview. 
 
Risks/Discomforts: 
You may feel embarrassed, worried, and/or uncomfortable talking about your opinions and 
experiences. You do not have to take part in every discussion or answer every question. You do not 
have to answer any questions you don’t want to and you can stop participating at any time. 
 
Benefits: 
Research is designed to benefit society by gaining new knowledge. You may not receive any direct 
benefit from being in this research study, but we believe it will help us to provide better treatment to 
people with HIV around the time of hospitalization.  
 
Alternatives: 
You may choose not to take part in this study. Also, you can choose to participate now and decide to 
stop later at any time.  
 
Confidentiality: 
Every effort will be made to keep your personal information confidential and only the research team 
will have access to the audio recording from the interview. Your name will not be revealed to further 
minimize any breach of confidentiality. Forms or recordings will be given a code. Summary results 
from this study will be reported on clinicaltrials.gov. However, results published for scientific and 
programming purposes will not contain any identifying information. Your records may be reviewed by 
representatives of the University of Zambia Biomedical Research Ethics Committee, the University of 
Maryland Institutional Review Board, the study sponsor (NIH), the U.S. Office for Human Research 
Protections (OHRP), the Zambian Ministry of Health, or the Office for Human Research Protections. 
However, this information will be kept confidential and will only be used to ensure that the study is 
being conducted properly and that your records are being stored appropriately.  
 
Cost: It will not cost you anything to be in this study.   
 
Reimbursement: We will reimburse your travel costs at K100.00 for an interview.  

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
44 
 
Questions: If you have any questions, concerns, or complaints about this study, you may contact the 
Principal Investigator, Dr. Cassidy Claassen, at University of Maryland at Baltimore, 31C Bishops Road, 
Kabulonga Area, Lusaka, Zambia; Phone: +260 971075439; Email: cclaassen@ihv.umaryland.edu 
 
Questions about participants rights: 
If you have questions about your rights as a research participant, you may contact the people listed 
above. You can also contact the UNZABREC Chairperson for the Institutional Review Board (IRB) 
and/or the UMB Institutional Review Board: 
 
UNZA Biomedical Research Ethics Committee 
Ridgeway Campus, Nationalist Road, Lusaka 
University of Maryland Baltimore IRB 
620 W. Lexington St., 2nd Floor 
Landline Phone: 0211 256 067 
Other Phones: 0955 155 633, 0955 155 634 
Baltimore, Maryland, USA 21201 
Phone: +1 410 706 5037 
Email: unzarec@zamtel.zm 
Email: hrpo@umaryland.edu 
 
Statement of voluntariness: 
You are free to withdraw from the study at any time. You are also free to refuse to answer any 
questions that make you feel uncomfortable or that you deem private or otherwise. Just let the 
interviewer know that you prefer not to answer that question. Whether or not you take part in this 
study is your choice. There will be no penalty if you decide not to be in the study. You will not lose any 
benefits you are otherwise owed. Your choice to leave the study will not affect your access to 
healthcare now or in the future.  You will be given any new information gained during the course of 
the study that might affect your willingness to continue to take part.  
 
The University of Maryland, Baltimore (UMB) is committed to providing participants in its research 
studies all rights due to them under State and federal law.  You give up none of your legal rights by 
signing this consent form or by participating in this study.  This study has been reviewed and 
approved by an Institutional Review Board (IRB).  The IRB is a group of scientists, physicians, experts, 
and community representatives.  The IRB’s membership includes persons who are not affiliated with 
UMB and persons who do not conduct research studies.   
 
If you have questions, concerns, complaints, or believe you have been harmed through participation 
in this study as a result of researcher negligence, you can contact members of the IRB or the Human 
Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain 
information, or offer input about your rights as a research participant.  The contact information for 
the IRB and the HRPO is: 
 
University of Maryland, Baltimore 
Institutional Review Board Human Research Protections Office 
620 W. Lexington Street, Baltimore, MD 21201 
410-706-5037 
 
 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
45 
 
STATEMENT OF CONSENT  
 
........................................................................... has described to me what is going to be done, the 
risks, the benefits involved and my rights regarding this study. I understand that my decision to 
participate in this study will not alter my usual medical care. In the use of this information, my identity 
will be concealed. I am aware that I may withdraw at any time. I understand that by signing this form, 
I do not waive any of my legal rights but merely indicate that I have been informed about the research 
study in which I am voluntarily agreeing to participate. A copy of this form will be provided to me. 
 
 
Name of participant: 
 
 
……………………………………………………….……….….….. 
Signature of participant:  
 
……………………………………….……………………….….….. 
Date (DD/MM/YY): 
 
 
…………………………………………….………………….….….. 
 
Name of witness*: 
 
 
………………………………………………….…………….….….. 
Signature of witness*:   
 
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
Name of study staff member: 
 
…………………………………………………….………….….….. 
Signature of study staff member:  
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
*Note: Witness name, signature and date are required on this consent form only when the consenting volunteer 
is not able to read and/or is illiterate 
 
 
 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
46 
 
20. Appendix 7: Information and Consent Forms for Discharged Patients to Enroll into the 
Qualitative Study  
 
THE UNIVERSITY OF ZAMBIA 
 
BIOMEDICAL RESEARCH ETHICS COMMITTEE 
 
Telephone: 256067 
 
 
 
 
 
                               Ridgeway Campus 
Telegrams: UNZA, LUSAKA 
 
 
 
 
 
                      P.O. Box 50110 
Telex: UNZALU ZA 44370 
 
 
 
 
 
                      Lusaka, Zambia 
Fax: + 260-1-250753 
E-mail:  unzarec@unza.zm 
Assurance No. FWA00000338 
IRB00001131 of IOR G0000774 
 
 
 
INFORMATION SHEET AND CONSENT  FORM FOR DISCHARGED PATIENTS ENROLLED INTO  THE 
QUALITATIVE STUDY  
 
Title of the proposed study: Re-engagement at Discharge 2: Improving post-hospital outcomes for 
adults with HIV in Zambia (ReCharge 2) 
Investigators: 
Names 
Institutions 
Contacts of the Investigators 
Dr. Cassidy 
Claassen 
University of Maryland at Baltimore (USA) and 
University of Zambia School of Medicine 
cclaassen@ihv.umaryland.edu 
 
Dr. Michael 
Vinikoor 
University of Alabama at Birmingham (USA) and 
University of Zambia School of Medicine 
mjv3@uab.edu 
 
 
Background and rationale for the study: 
Hello. I am    ( name)    and I work with the University of Maryland team in Zambia. I would like to talk 
to you about an upcoming study that you may be able to help with. This form explains why we are 
doing this study and what you will be asked to do if you choose to be in this study. We will read this 
form with you. Please ask any questions you have about this study at any time to fully understand this 
information so that you can make an informed choice about being in this study.  
 
Many hospitalized patients at referral hospitals in Zambia are living with HIV. After being stabilized at 
the hospital and discharged to go home, people with HIV experience a challenging recovery process, 
and during this time, the risk of readmission to the hospital and/or death is high. Outcomes are 
especially poor when the person with HIV also had a low CD4 count and/or has a high HIV viral load 
(VL). After discharge challenges may come from the need to receive follow-up care at multiple health 
facilities, inconsistent or poor support from family, and behavioral health issues like mental illness and 
alcohol use.  
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
47 
 
Purpose: 
The purpose of this study is to evaluate a new program that may help people living with HIV after 
being discharged from the hospital. If we learn through this study that the program is beneficial to 
patients, their families, and health workers, we  will recommend that more patients receive it. You are 
being asked to be in the study because you are 18 years or older, you were hospitalized and after 
discharge, and you were enrolled into the ReCharge programme. 
 
Procedures: 
If you agree to take part in this study, we'll come to your house for two 30- to 45-minute interviews, 
which we'd like to record and type up for analysis, with your permission. We hope that these two 
interviews will happen three months into the program and near the end of the programme (around 6 
months). If it is okay with you, we would like to have the first interview with you today. If today is not 
convenient for you, we can reschedule the interview for another day as soon as you are discharged 
and ready. You will advise us when it is ok for us to conduct this interview with you .During these 
interviews, we will ask you about your experiences with the ReCharge program and what worked and 
what didn't. These interviews will take place where you feel most comfortable, which could be at 
home or anywhere else in the neighborhood. 
 
Once we finish talking to you, we would like to also talk to another family member that has been 
supporting you after you were discharged from hospital.  
 
Who will participate in the study?  
About 40 people  with relatives who were admitted and discharged from  LMUTH/UTH.  
 
Risks/Discomforts: 
You may feel embarrassed, worried, and/or uncomfortable talking about your opinions and 
experiences. You do not have to take part in every discussion or answer every question. You do not 
have to answer any questions you don’t want to and you may stop participating at any time. Some of 
the questions in the interviews could be potentially stressful to answer. 
 
Benefits: 
Research is designed to benefit society by gaining new knowledge. You may not receive any direct 
benefit from being in this research study, but we believe it will help us to provide better treatment to 
people with HIV around the time of hospitalization. 
 
Alternatives: 
You may choose not to take part in this study. Also, you can choose to participate now and decide to 
stop later at any time. The alternative to joining in this study is for you to receive regular care for HIV 
and any other medical problem that led to your admission to LMTTH/UTH. 
 
Confidentiality: 
Every effort will be made to keep your personal information confidential and only the research team 
will have access to the audio recording from the interview. Your name will not be revealed to further 
minimize any breach of confidentiality. Forms or recordings will be given a code. Summary results 
from this study will be reported on clinicaltrials.gov. However, results published for scientific and 
programming purposes will not contain any identifying information. Your records may be reviewed by 
representatives of the University of Zambia Biomedical Research Ethics Committee, the University of 
Maryland Institutional Review Board, the study sponsor (NIH), the U.S. Office for Human Research 
Protections (OHRP), the Zambian Ministry of Health, or the Office for Human Research Protections. 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
48 
 
However, this information will be kept confidential and will only be used to ensure that the study is 
being conducted properly and that your records are being stored appropriately.  
 
Cost: It will not cost you anything to be in this study but your time.   
 
Reimbursement: 
We will reimburse you at K100.00 today, and at the final visit at 6 months. 
Questions: If you have any questions, concerns, or complaints about this study, you may contact the 
Principal Investigator, Dr. Cassidy Claassen, at University of Maryland at Baltimore, 31C Bishops Road, 
Kabulonga Area, Lusaka, Zambia; Phone: +260 971075439; Email: cclaassen@ihv.umaryland.edu 
 
Questions about participants rights: 
If you have questions about your rights as a research participant, you may contact the people listed 
above. You can also contact the UNZABREC Chairperson for the Institutional Review Board (IRB) 
and/or the UMB Institutional Review Board: 
UNZA Biomedical Research Ethics Committee 
Ridgeway Campus, Nationalist Road, Lusaka 
University of Maryland Baltimore IRB 
620 W. Lexington St., 2nd Floor 
Landline Phone: 0211 256 067 
Other Phones: 0955 155 633, 0955 155 634 
Baltimore, Maryland, USA 21201 
Phone: +1 410 706 5037 
Email: unzarec@zamtel.zm 
Email: hrpo@umaryland.edu 
 
Statement of voluntariness: 
You are free to withdraw from the study at any time. You are also free to refuse to answer any 
questions that make you feel uncomfortable or that you deem private or otherwise. Just let the 
interviewer know that you prefer not to answer that question. Whether or not you take part in this 
study is your choice. There will be no penalty if you decide not to be in the study. You will not lose any 
benefits you are otherwise owed. Your choice to leave the study will not affect your access to 
healthcare now or in the future.  You will be given any new information gained during the course of 
the study that might affect your willingness to continue to take part.  
 
The University of Maryland, Baltimore (UMB) is committed to providing participants in its research 
studies all rights due to them under State and federal law.  You give up none of your legal rights by 
signing this consent form or by participating in this study.  This study has been reviewed and 
approved by an Institutional Review Board (IRB).  The IRB is a group of scientists, physicians, experts, 
and community representatives.  The IRB’s membership includes persons who are not affiliated with 
UMB and persons who do not conduct research studies.   
 
If you have questions, concerns, complaints, or believe you have been harmed through participation 
in this study as a result of researcher negligence, you can contact members of the IRB or the Human 
Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain 
information, or offer input about your rights as a research participant.  The contact information for 
the IRB and the HRPO is: 
 
University of Maryland, Baltimore 
Institutional Review Board Human Research Protections Office 
620 W. Lexington Street, Baltimore, MD 21201 
410-706-5037 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
49 
 
STATEMENT OF CONSENT  
 
........................................................................... has described to me what is going to be done, the 
risks, the benefits involved and my rights regarding this study. I understand that my decision to 
participate in this study will not alter my usual medical care. In the use of this information, my identity 
will be concealed. I am aware that I may withdraw at any time. I understand that by signing this form, 
I do not waive any of my legal rights but merely indicate that I have been informed about the research 
study in which I am voluntarily agreeing to participate. A copy of this form will be provided to me. 
 
Name of participant: 
 
 
……………………………………………………….……….….….. 
Signature of participant:  
 
……………………………………….……………………….….….. 
Date (DD/MM/YY): 
 
 
…………………………………………….………………….….….. 
 
Name of witness*: 
 
 
………………………………………………….…………….….….. 
Signature of witness*:   
 
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
Name of study staff member: 
 
…………………………………………………….………….….….. 
Signature of study staff member:  
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
*Note: Witness name, signature and date are required on this consent form only when the consenting volunteer 
is not able to read and/or is illiterate 
 
 
 
 
 
 
 
 
 
 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
50 
 
21. Appendix 8: Information and Consent Forms for Caregivers 
 
 
 
THE UNIVERSITY OF ZAMBIA 
 
 
BIOMEDICAL RESEARCH ETHICS COMMITTEE 
 
Telephone: 256067 
 
 
 
 
 
                                Ridgeway Campus 
Telegrams: UNZA, LUSAKA 
 
 
 
 
 
                       P.O. Box 50110 
Telex: UNZALU ZA 44370 
 
 
 
 
 
                       Lusaka, Zambia 
Fax: + 260-1-250753 
E-mail:  unzarec@unza.zm 
Assurance No. FWA00000338 
IRB00001131 of IOR G0000774 
 
 
IMFORMATION SHEET AND CONSENT FORM FOR  CARE GIVERS OF DISCHARGED PATIENTS 
ENROLLED INTO  THE QUALITATIVE STUDY  
 
Title of the proposed study: Re-engagement at Discharge 2: Improving post-hospital outcomes for 
adult patients in Zambia (ReCharge 2) 
 
Investigators: 
Names 
Institutions 
Contacts of the Investigators 
Dr. Cassidy 
Claassen 
University of Maryland at Baltimore (USA) and 
University of Zambia School of Medicine 
cclaassen@ihv.umaryland.edu 
 
Dr. Michael 
Vinikoor 
University of Alabama at Birmingham (USA) and 
University of Zambia School of Medicine 
mjv3@uab.edu 
 
 
Background and rationale for the study: 
Hello. I am ____________________________________ and I work with the University of Maryland 
team in Zambia. I would like to talk to you about an upcoming study that you may be able to help with. 
This form explains why we are doing this study and what you will be asked to do if you choose to be 
in this study. We will read this form with you. Please ask any questions you have about this study at 
any time to fully understand this information so that you can make an informed choice about being in 
this study.  
 
Many patients hospitalized at referral hospitals in Zambia are hospitalized due to different illness. 
After being stabilized at the hospital and discharged to go home, some people experience a 
challenging recovery process, and during this time, the risk of readmission to the hospital and/or death 
is high. After discharge challenges may come from the need to receive follow-up care at multiple 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
51 
 
health facilities, inconsistent or poor support from family, and behavioral health issues like mental 
illness and alcohol use.  
 
Purpose: 
The purpose of this study is to evaluate a new program that may help people after discharge from the 
hospital. If we learn through this study that the program is beneficial to patients, their families, and 
health workers, we  will recommend that more patients receive it.  
 
You are being asked to be in the study because you are 18 years or older, and you have a relative who 
was hospitalized and after discharge, they were enrolled into the recharge programme. This relative  
has identified you as the person who has been supporting them for the past number of months.  
 
Procedures: 
If you agree to take part in this study, we'll come to your house for two 30- to 45-minute interviews, 
which we'd like to record and type up for analysis, if you'll let us. We hope that these two interviews 
will happen three months into the program and near the end of the programme (around 6 months). 
If it is okay with you, we would like to have the first interview with you today. If today is not convenient 
for you, we can reschedule the interview for another day as soon as you are ready. You will advise us 
when it is ok for us to conduct this interview with you.   During these interviews, we will ask you about 
your experiences with the ReCharge program that has been supporting your relative and what worked 
and what didn't. These interviews will take place where you feel most comfortable, which could be at 
home or anywhere else in the neighborhood. 
 
Who will participate in the study?  
About 40  people  with relatives who were admitted and discharged from  LMUTH/UTH.  
 
Risks/Discomforts: 
You may feel embarrassed, worried, and/or uncomfortable talking about your opinions and 
experiences. You do not have to take part in every discussion or answer every question. You do not 
have to answer any questions you don’t want to and you may stop participating at any time. Some of 
the questions in the interviews could be potentially stressful to answer. 
 
Benefits: 
Research is designed to benefit society by gaining new knowledge. You may not receive any direct 
benefit from being in this research study, but we believe it will help us to provide better treatment 
around the time of hospitalization. 
 
Alternatives: 
You may choose not to take part in this study. Also, you can choose to participate now and decide to 
stop later at any time. If you choose not to participate in this study, this will not affect how you or 
your relatives access health services or benefits you receive from this health facility.  
 
Confidentiality: 
Every effort will be made to keep your personal information confidential and only the research team 
will have access to the audio recording from the interview. Your name will not be revealed to further 
minimize any breach of confidentiality. Forms or recordings will be given a code. Summary results 
from this study will be reported on clinicaltrials.gov. However, results published for scientific and 
programming purposes will not contain any identifying information. Your records may be reviewed by 
representatives of the University of Zambia Biomedical Research Ethics Committee, the University of 
Maryland Institutional Review Board, the study sponsor (NIH), the U.S. Office for Human Research 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
52 
 
Protections (OHRP), the Zambian Ministry of Health, or the Office for Human Research Protections. 
However, this information will be kept confidential and will only be used to ensure that the study is 
being conducted properly and that your records are being stored appropriately.  
 
Cost: It will not cost you anything to be in this study but your time.   
 
Reimbursement: 
We will reimburse you at K100.00 today, and at the final visit at 6 months. 
Questions: If you have any questions, concerns, or complaints about this study, you may contact the 
Principal Investigator, Dr. Cassidy Claassen, at University of Maryland at Baltimore, 31C Bishops Road, 
Kabulonga Area, Lusaka, Zambia; Phone: +260 971075439; Email: cclaassen@ihv.umaryland.edu 
 
Questions about participants rights: 
If you have questions about your rights as a research participant, you may contact the people listed 
above. You can also contact the UNZABREC Chairperson for the Institutional Review Board (IRB) 
and/or the UMB Institutional Review Board: 
UNZA Biomedical Research Ethics Committee 
Ridgeway Campus, Nationalist Road, Lusaka 
University of Maryland Baltimore IRB 
620 W. Lexington St., 2nd Floor 
Landline Phone: 0211 256 067 
Other Phones: 0955 155 633, 0955 155 634 
Baltimore, Maryland, USA 21201 
Phone: +1 410 706 5037 
Email: unzarec@unza.zm 
Email: hrpo@umaryland.edu 
 
Statement of voluntariness: 
You are free to withdraw from the study at any time. You are also free to refuse to answer any 
questions that make you feel uncomfortable or that you deem private or otherwise. Just let the 
interviewer know that you prefer not to answer that question. Whether or not you take part in this 
study is your choice. There will be no penalty if you decide not to be in the study. You will not lose any 
benefits you are otherwise owed. Your choice to leave the study will not affect your access to 
healthcare now or in the future.  You will be given any new information gained during the course of 
the study that might affect your willingness to continue to take part.  
 
The University of Maryland, Baltimore (UMB) is committed to providing participants in its research 
studies all rights due to them under State and federal law.  You give up none of your legal rights by 
signing this consent form or by participating in this study.  This study has been reviewed and 
approved by an Institutional Review Board (IRB).  The IRB is a group of scientists, physicians, experts, 
and community representatives.  The IRB’s membership includes persons who are not affiliated with 
UMB and persons who do not conduct research studies.   
 
 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
53 
 
If you have questions, concerns, complaints, or believe you have been harmed through participation 
in this study as a result of researcher negligence, you can contact members of the IRB or the Human 
Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain 
information, or offer input about your rights as a research participant.  The contact information for 
the IRB and the HRPO is: 
 
University of Maryland, Baltimore 
Institutional Review Board Human Research Protections Office 
620 W. Lexington Street, Baltimore, MD 21201 
410-706-5037 
 
 
STATEMENT OF CONSENT  
 
........................................................................... has described to me what is going to be done, the 
risks, the benefits involved and my rights regarding this study. I understand that my decision to 
participate in this study will not alter my usual medical care. In the use of this information, my identity 
will be concealed. I am aware that I may withdraw at any time. I understand that by signing this form, 
I do not waive any of my legal rights but merely indicate that I have been informed about the research 
study in which I am voluntarily agreeing to participate. A copy of this form will be provided to me. 
 
Name of participant: 
 
 
……………………………………………………….……….….….. 
Signature of participant:  
 
……………………………………….……………………….….….. 
Date (DD/MM/YY): 
 
 
…………………………………………….………………….….….. 
 
Name of witness*: 
 
 
………………………………………………….…………….….….. 
Signature of witness*:   
 
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
Name of study staff member: 
 
…………………………………………………….………….….….. 
Signature of study staff member:  
……………………………………………………….……….….….. 
Date (DD/MM/YY): 
 
 
……………………………………………………….……….….….. 
 
*Note: Witness name, signature and date are required on this consent form only when the consenting volunteer 
is not able to read and/or is illiterate 
 
 
 
 
 
 
 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
54 
 
22. 
Appendix 9: Patient Health Questionnaire 9 (PHQ-9): Nyanja 
 
Pa milonga iwiri yapita, kodi ni kangati kamene munavutisidwa ndi yali mavuto 
aya yokonkapo? 
 
(Chongani mu kabokosi kuti muonese yankho yanu) 
1 
Kukondwera pang’ono kapena kusangalala 
kung’ono mukuchita zinthu 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
2 
Kumvera kuipa, wodidikizidwa mu 
maganizo, kapena  wopanda 
chiyembekezo 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
3 
Kuvutika kugona kapena kusagona, 
kapena kugona kwambiri 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
4 
Kumvera kulema kapena kunkhala ndi 
mphamvu       zing’ono 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
5 
Kunkhala ulibe chilakolako chakudya 
safuna kapena  kudya kwambiri 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
6 
Kumvera kuipa pa za inu mweka -- kapena 
kuti munakangiwa kapena munazilekelela 
kapena kulekelela banja 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
7 
Kuvutika kuika maganizo pamodzi pa 
zinthu, monga kuwerenga nyuzipepa 
kapena kuonelela TV 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
8 
Kuyenda kapena kukamba pang’ono-
pang’ono kwambiri   Kwamene mwina 
munaona? Kapena zosiyanako – kunkhala 
Kusankhazikika kapena kusapumula kuti 
munali kuyenda-yenda kwambiri 
kupambana nthawi zonse 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 

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55 
 
9 
Maganizo yakuti chingankhale bwino kufa 
kapena Kuzichita mweka mu njira iliyonse 
0.Kulibe ngankhale pang’ono 
1.Masiku angapo 
2.Kupambana pa hafu ya masiku 
3.Pafupi-fupi masiku onse 
 
 
 
Score "Masiku angapo”. 
 
 
Score "Kupambana hafu ya masiku": 
 
 
Score "Pafupi-fupi masiku onse": 
 
 
 
 
 
Enter Total Score: 
 
 
 
 
10 
Ngati mwachonga mavuto yali yonse, kodi 
aya mavuto; Yachipanga bwanji kunkhala 
chovuta kwa inu kuchita nchito zanu; 
Kusamalira zinthu pa nyumba kapena 
kumverana ndi anthu ena? with other 
0.Sichokosa ngankhale pang’ono 
1.Nichokosako 
2.Ni chokosa kwambiri difficult 
3.Nichokosa kwambiri 
 
 
 
 
Does the hard copy score match the 
database score? 
Yes 
No 
 
If the scores do not match, please 
comment 
 
 
 
 
Date form completed: (DD/MM/YYYY) 
 
 
Form Completed by (initials): 
 
 
 
 
 
 

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56 
 
23. 
Appendix 10: Patient Health Questionnaire 9 (PHQ-9): Bemba 
 
Pa milungu ibili iyapita bushe miku inga iyo mwacushiwapo namafya ayali fyonse 
ayakonkelepo aya? (Click the circle to indicate your answer) 
1 
Ukutemwa ukunono nangu ukusekelamo 
mukucita ifintu 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
2 
Ukushisansamuka, ukutitikishiwa nangu 
ukushikwata isubilo 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
3 
Ubwafya bwakulala nangu ukulalisha 
nangu ukulalisha sana 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
4 
Ukumfwa uwanaka nangu ukukwata 
amaka ayanono 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
5 
Ukushifwaya ukulya nangu ukulya sana 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
6 
Ukumfwa ububi palwa mwebene mweka 
– nangu ukuti mwalifilwa nangu 
mwaliilekelesha nangu mwalilekesha 
ulupwa 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
7 
Ubwafya bwakubika amaano pa fintu, 
pamo nga ukubelenga nyunshipepa 
nangu ukutamba TV 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
8 
Ukwenda nangu ukulanda panono-
panono sana icakuti; Bambi kuti 
baishiba? Nangu ukupilibula – ukuba 
uushiteka umutima panshi umutima 
panshi icakuti mwaleenda-enda sana 
ukucila lyonse 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 
 3.Mupepi na cila bushiku 
 
9 
Amatontonkanyo ayakuti kuti caba bwino 
nga mwalifwile nangu ukuicena 
mwebene munshila imbi 
 0.Awe nelyo panono 
 1.Inshiku ishingiko 
 2.Ukucila pali hafu ya nshiku 

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57 
 
 3.Mupepi na cila bushiku 
 
 
 
Score "Several days" 
 
 
Score "More than half the days" 
 
 
Score "Nearly every day" 
 
 
 
 
 
Enter Total Score: 
 
 
 
 
10 
Nga cakutila mwaconga amafya ayali 
yonse, bushe aya mafya yalengele ukuba 
icayafya kuli imwe ukucita imilimo, 
Ukusakamana ifintu pa ng’anda, nangu 
ukumfwana nabantu bambi 
0.Sichokosa ngankhale pang’ono 
1.Nichokosako 
2.Ni chokosa kwambiri difficult 
3.Nichokosa kwambiri 
 
 
 
 
Does the hard copy score match the 
database score? 
Yes 
No 
 
If the scores do not match, please 
comment 
 
 
 
 
Date form completed: (DD/MM/YYYY) 
 
 
Form Completed by (initials): 
 
 
 
 
 
 

Claassen, Vinikoor, et al. ReCharge 2 Protocol v2.5, 16 April 2024 
 
58 
 
24. 
Appendix 11: Patient Health Questionnaire 9 (PHQ-9): English 
 
In the past two weeks, how many times have you been bothered by these problems? 
(Click the circle to indicate your answer) 
1 
A little interest or pleasure in doing 
things 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
2 
. Feeling down/bad, depressed, or 
hopeless 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
3 
Difficulty falling asleep or staying asleep, 
or sleeping too much 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
4 
Feeling tired/weak or having little energy 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
5 
Poor appetite or overeating 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
6 
Feeling bad about yourself or that you 
are a failure or let yourself or your family 
down 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
7 
Difficulty/trouble concentrating on 
things, such as reading or watching TV 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
8 
Moving or speaking very slowly that 
other people could have noticed or the 
opposite – being so fidgety or restless 
that you have been moving around a lot 
more than usual 
 
 0.Not at all 
 1.A few days 
 2.More than half a day  
 3.Almost everyday 
 
9 
The idea that it would be better to die or 
to do it yourself in any way 
 0.Not at all 
 1.A few days 
 2.More than half a day  

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59 
 
 3.Almost everyday 
 
 
 
Score "Several days" 
 
 
Score "More than half the days" 
 
 
Score "Nearly every day" 
 
 
 
 
 
Enter Total Score: 
 
 
 
 
10 
If you checked off any problems, how 
difficult has these problems made it for 
you to do your job, take care of things at 
home, or get along with other people? 
0. Not difficult at all 
1. A bit difficult 
2. Difficult  
3. Very difficult 
 
 
 
 
Does the hard copy score match the 
database score? 
Yes 
No 
 
If the scores do not match, please 
comment 
 
 
 
 
Date form completed: (DD/MM/YYYY) 
 
 
Form Completed by (initials): 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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60 
 
25. 
Appendix 12: English - Modified Alcohol Use Disorders Identification Test-
Consumption  
 
Modified Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) 
PART ONE: pre-admission alcohol use 
Questions 
0 points 
1 point 
2 points 
3 points 
4 points 
In the 3 months before you 
were admitted to the hospital, 
on average, how often did you 
have a drink containing 
alcohol?# 
Never 
 
Monthly 
or less 
2-4 times 
a month 
2-3 times a 
week 
4+ times a 
week 
When you were drinking 
alcohol, on average, how many 
drinks did you have?* 
0-2 
3-4 
5-6 
7-9 
10 or more 
When you were drinking 
alcohol, on average, how often 
did you have 6 or more drinks* 
in one day? 
0 
Less than 
monthly 
Monthly 
Weekly 
Daily or 
almost daily 
PART TWO: post-discharge alcohol use 
Questions 
0 points 
1 point 
2 points 
3 points 
4 points 
Since discharge, on average, 
how often have you had a 
drink containing alcohol? 
Never 
 
Monthly 
or less 
2-4 times 
a month 
2-3 times a 
week 
4+ times a 
week 
 
When to refer for counseling for unhealthy alcohol use:  
• 
Score of 3 or more pre-admission and 2 or more post-discharge 
• 
Score of 3 or more post-discharge, regardless of pre-admission score 
 
 
Footnotes: 
#If the person reports never drinking (i.e., abstinence), leave next two blank (skip them) 
*Standard drink units can be determined as follows:  
• 
1 lager (12-ounce bottle, Mosi/Castle, 3% alcohol) = 1 unit 
• 
1 glass of wine (5-ounce, 10% alcohol) = 1 unit 
• 
1 container of opaque beer (1-liter, Chibuku Shake Shake, etc., 4% alcohol) = 4 units 
• 
1 bottle of spirits including gin, vodka, ‘junta’, ‘twojilijili’ (200 ml bottle; 40% alcohol) = 8 units 
• 
1 bottle of Cachasu (200 ml bottle; >40% alcohol) = 10 units   
 
 
 
 
 
 
 
 
 
 

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61 
 
26. Appendix 13: Nyanja - Modified Alcohol Use Disorders Identification Test-
Consumption 
 
 
Kuyesa Kugwiritsa Ntchito Mowa Wosinthidwa (AUDIT-C) 
(Modified Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)) 
GAWO LOYAMBA: kumwa mowa musanalowe 
Mafunso 
0 points 
1 point 
2 points 
3 points 
4 points 
M'miyezi itatu musanalowe 
m'chipatala, pafupifupi, ni 
kangati pomwe mumamwa 
chili conse comwe kuli 
mowa? 
Ayi 
Mwezi 
uliwonse 
kapena 
kuchepera 
2-4 pa 
mwezi 
2-3 pa 
sabata 
4+ pa sabata 
Mwenze kumwa mabotolo 
angati ya mowa ngati muli pa 
tsiku lakumwa mowa? 
0-2 
3-4 
5-6 
7-9 
10 kapena 
kuposa 
Ndi nthawi ziti zimene 
mumwa zakumwa zofikira 
mabotolo yali 6 kapena 
zopitilila pa nthawi imodzi? 
Ayi 
Pasanathe 
mwezi 
uliwonse 
Mwezi 
uliwonse 
Mlungu 
uliwonse 
Tsiku lililonse 
kapena 
pafupifupi 
tsiku lililonse 
GAWO LACHIWIRI: kumwa mowa mutasiya 
Mafunso 
0 points 
1 point 
2 points 
3 points 
4 points 
Kuyambira kumasulidwa, ni 
kangati pomwe mumamwa 
chili conse comwe kuli 
mowa? 
    Ayi  
Mwezi 
uliwonse 
kapena 
kuchepera 
2-4 pa 
mwezi 
2-3 pa 
sabata 
4+ pa sabata 
 
Nthawi yolozera upangiri wogwiritsa ntchito mowa mosayenera: 
• 
Zigoli za 3 kapena kupitilira apo alowetsedwa kale ndi 2 kapena kupitilira apo atasiya 
• 
Zigoli zitatu kapena kupitilira apo mutangotulutsidwa, posatengera kuti munalandira 
bwanji 
 
Mawu a M'munsi: 
#Ngati munthuyo anena kuti samamwa (mwachitsanzo, kudziletsa), siyani ziwiri zotsatirazi 
(zidumphani) Zakumwa zokhazikika zitha kuzindikirika motere:  
• 1 lager (botolo la 12-ounce, Mosi / Castle, 3% mowa) = 1 unit 
• 1 galasi la vinyo (5-ounce, 10% mowa) = 1 unit 
• Chidebe chimodzi cha mowa wosawoneka bwino (1-lita, Chibuku Shake Shake, etc., 4% mowa) 
= mayunitsi 4 
• Botolo limodzi la mizimu kuphatikizapo gin, vodka, 'junta', 'twojilijili' (botolo la 200 ml; 40% 
mowa) = mayunitsi 8 
• 1 botolo la Cachasu (200 ml botolo;> 40% mowa) = mayunitsi 10 
 
 
 
 

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62 
 
27. Appendix 14: Bemba - Modified Alcohol Use Disorders Identification Test-
Consumption 
 
 
 
 
 
 
 
 
 
Modified Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) 
PART ONE: pre-admission alcohol use 
Questions 
0 points 
1 point 
2 points 
3 points 
4 points 
Mu myeshi shitatu lintu 
tabalami teka mu chipatala, 
miku inga mumona ukuti 
mwina mwenu alenwo 
bwalwa? 
Never 
 
Monthly 
or less 
2-4 times 
a month 
2-3 times a 
week 
4+ times a 
week 
Umwina mwenu, nga cakuti 
lelo alenwa, miku inga alenwa 
ifikali ifya bwalwa?  
0-2 
3-4 
5-6 
7-9 
10 or more 
Miku inga mumwene umwina 
mwenu alenwa imiku 6 no 
kuya pantanshi mu kulongana 
kumo kwine? 
0 
Less than 
monthly 
Monthly 
Weekly 
Daily or 
almost daily 
PART TWO: post-discharge alcohol use 
Questions 
0 points 
1 point 
2 points 
3 points 
4 points 
 Ukufuma epo mwafumine mu 
chipatala, miku inga mumona 
ukuti mwina mwenu alenwo 
bwalwa? 
Never 
 
Monthly 
or less 
2-4 times 
a month 
2-3 times a 
week 
4+ times a 
week 
 
When to refer for counseling for unhealthy alcohol use:  
• 
Score of 3 or more pre-admission and 2 or more post-discharge 
• 
Score of 3 or more post-discharge, regardless of pre-admission score 
 
Footnotes: 
#If the person reports never drinking (i.e., abstinence), leave next two blank (skip them) 
*Standard drink units can be determined as follows:  
• 
1 lager (12-ounce bottle, Mosi/Castle, 3% alcohol) = 1 unit 
• 
1 glass of wine (5-ounce, 10% alcohol) = 1 unit 
• 
1 container of opaque beer (1-liter, Chibuku Shake Shake, etc., 4% alcohol) = 4 units 
• 
1 bottle of spirits including gin, vodka, ‘junta’, ‘twojilijili’ (200 ml bottle; 40% alcohol) = 8 units 
• 
1 bottle of Cachasu (200 ml bottle; >40% alcohol) = 10 units   

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28. Appendix 15: Letter of Permission to Conduct Research at UTH