Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Phase: NA
Conditions: Suicide, Suicidal Ideation, HIV Infections, Adherence, Medication, Treatment Adherence and Compliance, Stigma, Social, Disclosure, Quality of Life
Sponsor: Duke University

 
 
Official Title:  Telehealth to Reduce Suicidality and Improve HIV Care Engagement 
in Tanzania     
 
NCT:  NCT04696861 
 
IRB Document Date:  5/13/2024 

Standard Research Summary
Purpose of the Study
Objectives & hypotheses to be tested
The 
 of the proposed research are to develop a brief telehealth counseling intervention to 
overall objectives
provide support for suicidality and HIV care engagement, and to reduce the mental health treatment gap 
in Tanzania. Duke has longstanding collaborations with Kilimanjaro Christian Medical Centre and affiliated 
HIV clinics, making this an ideal environment for this work.  
The investigators hypothesize that a brief telehealth counseling intervention for people living with HIV and 
experiencing suicidal ideation will be safe (participants in the clinical trial will not have increased risk of 
suicidal behavior), acceptable (high patient retention and satisfaction, high fidelity), and will demonstrate 
preliminary efficacy of the intervention (reduced suicidal ideation, improved care engagement, improved 
mental well-being).
DUHS IRB Application (Version 1.15)
Approval Date 05/13/2024
NCT04696861
General Information
*Please enter the full title of your protocol:
Telehealth to Reduce Suicidality and lmprove HIV Care Engagement in Tanzania
*Please enter the Short Title you would like to use to reference the study:
Suicidality and Care Engagement in Tanzania
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.

Background & Significance
Should support the scientific aims of the research
Mental health comorbidities, particularly depression, are key drivers of the global HIV epidemic, 
contributing to substandard HIV care engagement, reduced quality of life, increased transmission risk, and 
lower life expectancy among people living with HIV (PLWH).
 Depression is exceedingly prevalent among 
1–3
PLWH
 and suicidal ideation is a common response to an HIV diagnosis, making suicide a leading cause 
4–6
of death among PLWH worldwide.
 However, when PLWH have access to mental health treatment that 
7,8
includes adherence counseling, both mental health and HIV outcomes improve.
 Thus, there is an 
9,10
urgent need to enhance access to quality mental health treatment that addresses the unique needs of 
PLWH.11,12
Throughout much of the world, mental health services are inadequate to meet the needs of the population. 
In Tanzania, fewer than 300 mental health workers are tasked with providing care coverage for 58 million 
people, placing it among the world’s most underserved nations for mental health care.
 Counseling 
13
services in Tanzania are rare and difficult to access, while inpatient treatment is reserved almost 
exclusively for severe psychosis, leaving few options for people with suicidal ideation.
 Meanwhile, rates 
14
of death by suicide are extremely high, and more than double among PLWH.
 In the context of such 
15,16
challenges, new approaches are emerging to bridge the mental health treatment gap, including the use of 
telehealth-delivered counseling.
Phone-based interventions for mental health (telehealth) have expanded rapidly in the COVID-19 era, and 
are promising approaches for increasing access to care.
 In Tanzania, mobile phone use is widespread 
17,18
and rapidly expanding, with 75% of the population owning a mobile phone and 38% using mobile Internet.
 These advances create opportunities to extend the reach of health services that are otherwise 
19
unavailable to large swaths of the population, including programs to improve HIV care engagement
, 
20
reduce HIV stigma
, and treat depression and suicidality.
 However, few studies have attempted to 
21
22
integrate these areas by developing mobile technology interventions for mental health screening and 
support in the context of HIV treatment.
 
21
1.
Mayston R, Kinyanda E, Chishinga N, Prince M, Patel V. Mental disorder and the outcome of HIV
/AIDS in low-income and middle-income countries: a systematic review. 
. 2012;26:S117-S135. doi:
AIDS
10.1097/QAD.0b013e32835bde0f
2.
Parcesepe AM, Bernard C, Agler R, et al. Mental health and HIV: research priorities related to the
implementation and scale up of “treat all” in sub-Saharan Africa. 
. 2018;4(Suppl 2):16-25.
J Virus Erad
3.
Yehia BR, Stephens-Shield AJ, Momplaisir F, et al. Health Outcomes of HIV-Infected People with
Mental Illness. 
. 2015;19(8):1491-1500. doi:10.1007/s10461-015-1080-4
AIDS Behav
4.
Chibanda D, Benjamin L, Weiss H, Abas M. Mental, Neurological, and Substance Use Disorders in
People Living With HIV/AIDS in Low- and Middle-Income Countries. 
.
Jaids J Acquir Immune Defic Syndr
2014;67. doi:10.1097/QAI.0000000000000258
5.
Kempf M-C, Huang C-H, Savage R, Safren SA. Technology-Delivered Mental Health Interventions
for People Living with HIV/AIDS (PLWHA): a Review of Recent Advances. 
. 2015;12(4):
Curr HIV/AIDS Rep
472-480. doi:10.1007/s11904-015-0292-6
6.
Rooks-Peck CR, Adegbite AH, Wichser ME, et al. Mental Health and Retention in HIV Care: A
Systematic Review and Meta-Analysis. 
. 2018;37
Health Psychol Off J Div Health Psychol Am Psychol Assoc
(6):574-585. doi:10.1037/hea0000606
7.
Croxford S, Kitching A, Desai S, et al. Mortality and causes of death in people diagnosed with HIV
in the era of highly active antiretroviral therapy compared with the general population: an analysis of a
national observational cohort. 
. 2017;2(1):e35-e46. doi:10.1016/S2468-2667(16)
Lancet Public Health
30020-2
8.
Smith CJ, Ryom L, Weber R, et al. Trends in underlying causes of death in people with HIV from
1999 to 2011 (D:A:D): a multicohort collaboration. 
. 2014;384(9939):241-248. doi:
Lancet Lond Engl
10.1016/S0140-6736(14)60604-8
9.
Chuah FLH, Haldane VE, Cervero-Liceras F, et al. Interventions and approaches to integrating
HIV and mental health services: a systematic review. 
. Published online 2017. doi:
Health Policy Plan
10.1093/heapol/czw169
10.
Safren SA, Bedoya CA, O’Cleirigh C, et al. Cognitive behavioural therapy for adherence and
depression in patients with HIV: a three-arm randomised controlled trial. 
. 2016;3(11):e529-
Lancet HIV
e538. doi:10.1016/S2352-3018(16)30053-4
11.
Abas M, Nyamayaro P, Bere T, et al. Feasibility and Acceptability of a Task-Shifted Intervention
to Enhance Adherence to HIV Medication and Improve Depression in People Living with HIV in Zimbabwe,

a Low Income Country in Sub-Saharan Africa. 
. 2018;22(1):86-101. doi:10.1007/s10461-016-
AIDS Behav
1659-4
12.
Kaaya S, Eustache E, Lapidos-Salaiz I, Musisi S, Psaros C, Wissow L. Grand Challenges:
Improving HIV Treatment Outcomes by Integrating Interventions for Co-Morbid Mental Illness. 
.
PLOS Med
2013;10(5):e1001447. doi:10.1371/journal.pmed.1001447
13.
WHO. 
. World Health Organization; 2018. http://www.who.int
Mental Health Atlas 2017
/mental_health/evidence/atlas/mental_health_atlas_2017/en/
14.
Knettel BA, Rugira J, Tesha F. "They will start believing in counseling”: Provider perceptions of
the presentation and treatment of mental illness in northern Tanzania. Int Perspect Psychol Res Pract
. 2018;7(1):4-18. doi:10.1037/ipp0000078
Consult
15.
Maris RW. 
. Guilford Publications; 2019.
Suicidology: A Comprehensive Biopsychosocial Perspective
16.
Mgaya E, Kazaura MR, Outwater A, Kinabo L. Suicide in the Dar es Salaam region, Tanzania,
2005. 
. 2008;15(3):172-176. doi:10.1016/j.jflm.2007.06.002
J Forensic Leg Med
17.
Long L-A, Pariyo G, Kallander K. Digital Technologies for Health Workforce Development in Low- 
and Middle-Income Countries: A Scoping Review. 
. 2018;6(Suppl 1):S41-S48. doi:
Glob Health Sci Pract
10.9745/GHSP-D-18-00167
18.
Mahmood S, Hasan K, Colder Carras M, Labrique A. Global Preparedness Against COVID-19: We
Must Leverage the Power of Digital Health. 
. 2020;6(2). doi:10.2196/18980
JMIR Public Health Surveill
19.
TCRA. 
. Tanzania Communications Regulatory
Quarterly Communications on Internet Usage
Authority; 2019.
20.
Jongbloed K, Parmar S, van der Kop M, Spittal PM, Lester RT. Recent Evidence for Emerging
Digital Technologies to Support Global HIV Engagement in Care. 
. 2015;12(4):451-461.
Curr HIV/AIDS Rep
doi:10.1007/s11904-015-0291-7
21.
Gimbel S, Kawakyu N, Dau H, Unger JA. A Missing Link: HIV-/AIDS-Related mHealth
Interventions for Health Workers in Low- and Middle-Income Countries. 
. 2018;15(6):
Curr HIV/AIDS Rep
414-422. doi:10.1007/s11904-018-0416-x
Design & Procedures
Describe the study, providing details regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Study Setting. The study will be located in 4 health centers in Moshi, Tanzania: 1) Kilimanjaro Christian 
Medical Center (KCMC), a large tertiary hospital, 2) Mawenzi Hospital, a public facility housing the region’s 
only inpatient psychiatry unit, 3) Majengo Health Center, a small urban health clinic, and 4) Pasua Health 
Centre, a small urban health clinic. KCMC and Mawenzi are the primary referral hospitals for the Northern 
Zone of Tanzania, covering an area of 122,000 km  and 7.7 million people. The adult Care and Treatment 
2
Clinics (CTCs) for HIV at these three hospitals currently test more than 300 people for HIV each month 
and provide HIV care for more than 6,000 PLWH in the region.
IRB and Informed Consent: The study will use Informed Consent forms approved by both the Duke and 
KCMC IRBs. Because KCMC is the primary government referral hospital in the Kilimanjaro region, the four 
health centres that will participate in this study all rely on the KCMC IRB for research approvals. Consent 
forms will be developed and translated in accordance with KCMC's established template and procedures, 
and will be approved by the KCMC IRB prior to use. Consent forms will be written in English and translated 
to Kiswahili by a trained bilingual translator, back-translated to English by a second translator, and the 
forms will be compared and revised to ensure clarity and equivalence in both languages.
Guiding Theoretical Frameworks for the Intervention. Intervention development will be guided by an 
experimental therapeutic approach
 targeting untreated suicidal ideation as a contributor to substandard 
23
HIV care engagement. The details of the intervention will emerge through Aims 1 and 2 of the proposed 
research, and will be guided by two theoretical frameworks: cognitive behavioral therapy for depression 
with adherence counseling (CBT-AD) and MI-SafeCope, a brief model for suicide prevention. The 
intervention will be culturally-informed, designed for telehealth delivery, and pilot tested in a Stage I pilot 
feasibility trial.
CBT-AD was developed to treat depression and enhance antiretroviral treatment adherence among PLWH, 
with promising results in Zimbabwe and South Africa. The intervention involves CBT-based HIV education 
and problem-solving, isolating unique contributors to depressive symptoms among PLWH to facilitate HIV 
care engagement. However, CBT-AD is time-intensive at 6 sessions or more, and was not designed to 
specifically address suicidality. The Duke PI proposes to develop a telehealth intervention that will retain 

the foundational components of CBT-AD while integrating a crisis-based model of suicide prevention, a 
condensed form of care focused on treating acute symptoms and securing the patient’s immediate safety.
There are very few brief, validated models for suicide prevention and none have been used in Africa. One 
promising model with an emerging evidence base is MI-SafeCope, a Motivational Interviewing (MI) 
intervention that has shown potential to reduce depressive symptoms and increase coping for suicidality in 
U.S hospitals. The components of MI-SafeCope are 1) developing an individualized safety plan, 2)
facilitating social support, and 3) a telephone session to reinforce earlier content. These have direct
relevance to my study given the suicide focus, brief delivery model, and precedent for telephone delivery.
Together, CBT-AD and MI-SafeCope, adapted to the context of HIV care in Tanzania, will provide a solid 
foundation for developing a brief telehealth intervention for suicide prevention, HIV education, and 
adherence counseling. A preliminary model is described below.
Preliminary Telehealth Model for Intervention Delivery. The proposed intervention will begin with 
implementing routine screening for depression and suicidality in adult HIV care at the 3 study sites. The 
screening tools, the PHQ-2 and Columbia-Suicide Severity Rating Scale (C-SSRS), contain 8 items 
assessing depression and suicidality in the past month, including thoughts, intent, plan, and actions. The 
PHQ has been validated in Tanzania. We propose to validate several additional study measures in a 
preliminary validation study with 80 patients living with HIV and experiencing suicidal ideation: the HIV 
Stigma Scale (HSS), Beliefs About Medicines Questionnaire (BMQ), Illness Cognition Questionnaire (ICQ), 
Columbia-Suicide Severity Rating Scale (C-SSRS), Self-Efficacy to Avoid Suicidal Action Scale (SEASA), 
Beck Hopelessness Scale-Short Form (BHS-SF), and Brief Reasons for Living Scale (BRFL). 
Patients who endorse depressive symptoms only will receive brief supportive counseling to identify coping 
strategies and a referral for mental health services. Patients who screen positive for suicidal ideation 
(respond “yes” to any C-SSRS item) will be eligible for enrollment in the pilot clinical trial. 
Once consented, the study team will assist patients to make a video call to the telehealth hub using a 
mobile phone. Video calls will be made using WhatsApp, a freely available, secure, and widely used mobile 
application with end-to-end encryption. Calls will be made free of charge (without data charges) using Wi-
Fi hotspots made available at each study clinic. Patients who do not have an Internet-equipped phone will 
use study-owned phones. Private space will be provided in the research offices at each clinic for video calls
The telehealth hub will be located in the KCMC Psychiatry Clinic and will be staffed by two trained research 
nurses. The two study nurses will answer calls using study-provided tablets and will document patient care 
electronically, saved on a secure, password-protected electronic database. Nurses provide the majority of 
health care in Tanzania, including HIV and mental health care, and Moshi is home to many skilled nurses 
seeking career opportunities. In a setting where specialized mental health training is extremely rare, 
nurses are a natural fit to deliver a sustainable intervention. The telehealth model will allow for the 
delivery of all sessions by nurse-counselors at the central hub to efficiently reach patients at subsidiary 
regional HIV clinics.
Before the first call, the research assistant will gather patients’ contact information, preferences for 
outreach in the event of a missed session, and information for an emergency contact. They will then 
connect to the telehealth hub and the nurse will begin the first of three counseling sessions. The initial 
intervention session will be approximately one hour in length, and the second and third sessions will each 
be approximately 30 minutes in length. Sessions will be held every two weeks to mirror the frequency of 
HIV clinic appointments for newly diagnosed patients. Patients unable to come to the clinic for follow-up 
sessions will be given the option to connect via video call or telephone call from the location of their 
choice. Additional support will be offered through weekly text message check ins and optional phone 
contacts and booster sessions. At the end of each session, the counselor will re-administer the C-SSRS and 
patients at acute risk of suicide will be accompanied to a mental health provider for further assessment. If 
the patient is unwilling to see a provider, the consulting psychiatrist and emergency contact will be called 
for support. 
Aim 1: Identify the desired characteristics of a telehealth intervention for suicidality and HIV care 
engagement in the Tanzanian clinical context. To refine the intervention model and assess experiences 
with suicide risk screening and counseling, study personnel will conduct in-depth interviews (IDIs) with 
stakeholders including PLWH (n=36), clinic administrators (n=20), nurses (n=12), study counsellors 
(n=4), mental health workers (n=16), and religious leaders (n = 20). For the patient interviews, clinic 
nurses will assist in identifying adults in HIV care at the study clinics who previously experienced suicidal 
ideation or completed screening. All study staff will be trained in suicide assessment and safety planning. 
Administrators and health workers will be recruited from the study clinics. In-depth interviews with 
healthcare administrators will help inform strategies for future integration of the intervention into the 
healthcare system, and in-depth interviews with religious leaders will provide insight into their 
perspectives on the role of religion and spirituality in mental health and suicide prevention, and ways these 
perspectives might be integrated into the intervention.

Interview guides will be developed with user-centered design in collaboration with the Tanzanian research 
team and informed by CFIR domains. Participants will first be presented with the core characteristics of the 
intervention and asked to provide feedback on its adaptability (e.g., potential for tailoring to individual 
patients, local setting, and acute crisis format), complexity (difficulty of implementation), feasibility 
(telehealth model), and sustainability (integration into current models of care). Interviews will also explore 
the outer setting of patient needs and resources, the relative advantage of the intervention compared to 
other approaches, and external policies and incentives that could impact its scalability. We will also 
conduct interviews with participants who have completed screening for the study and study counsellors to 
explore the acceptability of screening, assessment, and counseling. All participants will receive 
compensation of 10,000 Tanzanian shillings ($4.50) for their time and costs of participation. Interviews will 
be conducted in Kiswahili or English by a trained research assistant in a private office and audio recorded 
for later transcription.
Supplementary Aim: First, all study measures will undergo a thorough process of translation, back-
translation, and discussion to consensus with a team of bilingual researchers. Using the same recruitment 
procedures and eligibility criteria described in Aim 1, nurses will implement suicide screening during HIV 
clinic appointments. Patients (n=80) who screen positive for suicidality (i.e., respond “yes” to any C-SSRS 
item) will be notified of the research and, if interested, provide informed consent. Eligible participants who 
are not interested in participating will receive referrals and resources for mental health support. After 
providing consent, participants will complete the translated survey measures administered by trained 
study staff. These data will be used to validate the study measures in the Tanzanian clinical context 
through evaluation of internal consistency (Cronbach’s alpha and item-scale correlation), convergent 
validity among related measures, and confirmatory factor analysis. Participants will receive an incentive of 
10,000 TZ shillings ($4.50) to compensate for time and transport. Data collection for this Aim was 
completed in October 2022.
Aim 2: Refine content for the telehealth intervention with support from a study advisory board in Tanzania. 
The Duke PI will form an advisory board consisting of PLWH, nurses, mental health workers, 
administrators and local and regional government officials, to assist in refining the intervention. The 
advisory board will have approximately 15 members and will convene 3 times: 1) at the conclusion of Aim 
1 to assist in refining the intervention prior to piloting by interacting with a prototype model, 2) midway 
through the clinical trial to review progress, and 3) at the conclusion of the trial to review and assist in 
interpreting findings. Key members of our previous KCMC advisory boards would be invited to continue 
their involvement for the current study.
Employing principles of user-centered design and an experimental therapeutic approach, study personnel 
will invite advisory board members to experience the intervention as a study participant would, by 
interacting with the intervention technology, counselors, and study surveys. The process will include 
eliciting continual, iterative feedback on the hypothesized mechanisms of change, to adapt the intervention 
model to the study-specific context. Board members will observe as a mock patient completes screening 
and informed consent procedures, then uses a mobile phone to connect with an off-site counselor to 
participate in a mock counseling session. The board will give feedback on the process and perceived 
effectiveness of the session, as well as potential drawbacks. Through this process, we will reshape the 
intervention in real time, identifying opportunities to improve the intervention and increase potential 
acceptability for both clinic staff and patients.
Using advisory board feedback, the study team will develop a detailed study protocol and intervention 
manual. Counselors will be trained research nurses with an understanding of mental health and counseling 
skills. Counselor training will be provided by the Duke PI (a licensed psychologist) and the consulting 
psychiatrist and will consist of 3 weeks of didactic and mock intervention sessions. This will include 
instruction in counseling skills, the intervention model, and ethical/safety considerations for research and 
counseling. During mock sessions, counselor skills and fidelity to the intervention will be assessed by the 
supervisors using an adapted Therapy Quality Scale (TQS), interrater reliability will be calculated, and 
disagreement > 1 point will be discussed to consensus. Counselors will be required to attain mean TQS 
scores ≥ 3 (on a 0-4 scale) in mock sessions prior to contact with participants. They will then complete 
supervised trial runs with 5 patients from the study clinics, which will be used to refine and finalize the 
intervention prior to starting enrollment in the clinical trial.
Aim 3: Pilot test the telehealth intervention in a randomized controlled trial to assess feasibility, 
acceptability, and potential efficacy for reducing suicidality and enhancing HIV care engagement. To 
evaluate the intervention, the study team will enroll 60 PLWH in a Stage I pilot feasibility trial. Participants 
will be adults who experienced suicidal ideation in the past month seeking HIV care at one of the 3 study 
clinics. Using the same recruitment procedures and eligibility criteria described in Aim 1, nurses will 
implement depression and suicide screening during HIV clinic appointments. Patients who screen positive 
for depression, but not suicidality, will not be eligible for the clinical trial but will receive a brief supportive 
counseling module based on WHO’s Problem Management+  and a referral for further mental health 
support. Patients who screen positive for suicidality (i.e., respond “yes” to any C-SSRS item) will be 
referred to study staff, notified of the research and, if interested, provide informed consent. Eligible 
participants who are not interested in participating will receive referrals and resources for mental health 
support.

After providing consent, participants will complete a baseline survey administered by trained study staff. 
Participants will receive an incentive of 10,000 TZ shillings ($4.50) for each session at the clinic to 
compensate for time and transport. Participants who connect to calls from a location other than the clinic 
will receive 10,000 TZ shillings if connecting via video call (to compensate for time and data costs) and 
5,000 TZ shillings if connecting by telephone call (as incoming calls will not incur costs to participants). 
Data collected at baseline will include measures of suicidality, HIV care engagement, and covariates such 
as stigma, social support, and quality of life. For measures not previously validated in Tanzania, the study 
team will complete a thorough linguistic and cultural translation process as established by Beaton et al., 
including back translation, validity checks, and piloting.
Assignment to condition. Upon completion of the baseline survey, participants will be individually 
randomized to receive either a brief Safety Planning Intervention (n=30), or the 3-session telehealth 
intervention (n=30). Participants will be randomized at a 1:1 ratio using a block randomization method (4 
per block) to ensure equal sample sizes in each condition and to manage the flow of participants to the 
intervention condition. The allocation sequences will be prepared ahead of time using an online 
randomization program.
Intervention and control procedures. After randomization, participants will be guided to a private space 
and assisted to connect by video call to the nurse-counselor (based at KCMC). Upon connecting, control 
participants will receive the brief (20 minute) Safety Planning Intervention and intervention participants 
will complete the first of 3 telehealth-delivered counseling sessions. For intervention participants, the 
remaining sessions will be scheduled at two-week intervals. Patients unable to come to the clinic for follow-
up sessions will be given the option to connect via video call or telephone call from the location of their 
choice. For participants in both conditions, prior to ending the call, the counselor will re-administer the C-
SSRS and those at risk of suicide will be directly referred for psychiatric assessment and treatment to 
ensure their safety. Participants in both conditions will receive text message check ins from the counselors 
to inquire about their well-being and connect them to additional support as needed. Participants in both 
conditions will also have the opportunity to contact the telehealth counselors at any time during normal 
business hours for additional support throughout their participation in the study. These ‘booster sessions’ 
will be focused on assessing suicide risk, safety planning, and reinforcing prior session content.
It was clear in the feedback from NIMH that, given all trial participants will have screened positive for 
suicidal ideation, the study team would need to provide additional support for the control condition and not 
just “treatment as usual” or a referral for services. A brief safety planning intervention is the most 
common brief intervention for suicidal ideation. It involves identifying internal coping strategies, external 
resources for support, and planning formaking the environment safe: https://www.sprc.org/sites/default
/files/SafetyPlanningGuide%20Quick%20Guide%20for%20Clinicians.pdf. Safety planning has a strong 
global evidence base.
Duke's role in the research. As the home institution of the PI, Dr. Knettel, Duke will provide office space 
and IT services, consultative services, grants and finance management, and library support for the 
research study. Duke students and postdoctoral associates may take on supportive roles in the reserch 
and will be added to the IRB protocol as appropriate. Duke IT will assist with procurement and software 
needs for research computers and tablets. Statistical support will be provided by Duke statisticians at Duke 
Global Health Institute and the Duke University School of Nursing.
Dr. Knettel's role in the research will be to lead the training of study personnel, including the study 
coordinator and research assistants and nurse interventionists. Dr. Knettel will help to establish research 
offices at the clinic sites, establish procedures for data collection and intervention delivery, oversee 
intervention delivery and data collection to monitor data quality, lead data analysis, and dissemination and 
reporting of research findings.
Selection of Subjects
List inclusion/exclusion criteria and how subjects will be identified.
For Aims 1 and 2, clinic nurses will assist in identifying adults in HIV care at the study clinics who 
previously experienced suicidal ideation. Administrators, nurses and mental health workers will be 
recruited from the study clinics. 
For the supplemental validation study and the Aim 3 clinical trial, clinic nurses will implement screening for 
suicidality in the clinics using the Columbia-Suicide Severity Rating Scale (C-SSRS), which contains 6 items 
assessing suicidal thoughts, intent, plan, and actions. Patients who screen positive for suicidality (i.e., 
respond “yes” to any C-SSRS item) will be notified of the research and, if interested, provide informed 

consent for enrollment in the clinical trial. Eligible participants who are not interested in participating will 
receive referrals and resources for mental health support. Patients who are not eligible for the clinical trial 
but who screen positive for depressive symptoms will provide informed consent and be offered a brief 
counseling session focused on Problem Management. Patients who undergo screening for suicide 
assessment may also be referred for qualitative interviews.
All study participants across all aims will be at least 18 years of age, fluent in Kiswahili or English, and able 
to provide informed consent to participate.
Subject Recruitment and Compensation
Describe recruitment procedures, including who will introduce the study to potential subjects. Describe 
how you will ensure that subject selection is equitable and all relevant demographic groups have access 
to study participation (per 45 CFR 46.111(a) (3)). Include information about approximately how many 
DUHS subjects will be recruited. If subjects are to be compensated, provide specific prorated amounts 
to be provided for expenses such as travel and/or lost wages, and/or for inducement to participate.
For Aims 1 and 2, we will use purposive sampling, asking HIV clinic nurses to identify current clinic 
patients who previously struggled with suicidal ideation and identifying individuals who have undergone 
screening for suicidal ideation. 
For the supplemental Aim and Aim 3, clinic nurses will screen all adults attending HIV clinic appointments, 
and all patients who meet the eligibility criteria and screen positive for suicidal ideation will be eligible to 
be enrolled in the study/clinical trial, with those screening positive for depressive symptoms only being 
referred for Problem Management+. 
All study recruitment will occur in Moshi, Tanzania and will no include DUHS patients. Participants will 
receive an incentive of 10,000 Tanzanian shillings (approximately $4.50) at each study contact at the clinic 
to compensate for their time and transportation costs. Intervention participants who connect to calls from 
a location other than the clinic will receive 10,000 TZ shillings if connecting via video call (to compensate 
for time and data costs) and 5,000 TZ shillings if connecting by telephone call (as incoming calls will not 
incur costs to participants).
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
Clinic nurses will assess the participant's capacity to provide consent prior to referring them to the study. 
Patients who lack the intellectual capacity to give legally effective consent, who are medically unstable, or 
who are in acute psychiatric distress, will not be enrolled and will instead be referred for appropriate care 
within the clinics. These participants will be screened for capacity again at their next HIV appointment, and 
will have the opportunity to enroll at that time if their decisional capacity has improved.
Study Interventions
If not already presented in #4 above, describe study-related treatment or use of an investigational 
drug or biologic (with dosages), or device, or use of another form of intervention (i.e., either physical 
procedures or manipulation of the subject or the subject’s environment) for research purposes.

The intervention is described in "Design & Procedures" above.
Risk/Benefit Assessment
Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant individuals, imprisoned persons or 
cognitively impaired adults), what special precautions will be used to minimize risks to these subjects? 
Also identify what available alternatives the person has if he/she chooses not to participate in the 
study. Describe the possible benefits to the subject. What is the importance of the knowledge expected 
to result from the research?
Ethical considerations for the study will be grounded in recent NIMH guidance on Conducting Research with 
Participants at Elevated Risk for Suicide. All participants will provide written informed consent prior to 
participation and a decision not to participate will in no way influence the patient’s eligibility for standard 
care at the clinic. We will continually monitor safety indicators, including suicide attempts and suicide 
deaths. In the unlikely event of (a) increases in suicidal behavior or (b) greater suicidality in the 
intervention condition as compared to control, the trial will be discontinued.
Given this close monitoring of safety, we anticipate the risk to participants to be minimal. Potential risks to 
participants in this study include: 1) negative consequences if confidentiality of information obtained in the 
study are compromised (including subject identity as a research participant, information collected during 
assessments, or abstracted information from the medical record review); 2) unintended consequences (e.
g., stigma and inadvertent HIV disclosure) resulting from participation in the telehealth intervention; and 
3) distress or emotional reactions related to the study assessments or intervention sessions.
Confidentiality is of critical importance, and we will take many precautions to protect against the possibility 
of a breach of confidentiality. Our research team is very aware of the importance of maintaining strict 
confidentiality and has extensive experience dealing with sensitive information. All study staff will be well 
trained and will receive ongoing supervision in confidentiality and data security procedures, specifically in 
ethical conduct, confidentiality protection, review of medical records, mandated reporting, and other topics 
of human participant protection. Steps to protect against risks will be implemented as follows:
Prior to any data collection, all study staff will be trained in the protection of human subjects. As this study 
is specifically enrolling patients who are experiencing suicidal ideation, additional protections will be 
implemented to minimize risk of suicide. At the conclusion of all Aim 1 interviews and Aim 3 counseling 
sessions in both conditions (intervention or enhanced standard of care), the nurse-counselor will re-
administer the C-SSRS measure of suicide risk. At the first study visit, we will provide all participants with 
a list of local resources for additional mental health support, including contact information for the health 
system’s inpatient and outpatient psychiatry services.
Any participants at acute risk of harm will be directly referred for further assessment by the study’s 
consulting psychiatrists, Dr. Judith Boshe and Dr. Kim Madundo, or by qualified mental health staff at 
Majengo Health Centre or Mawenzi Hospital. For participants at acute risk of harm who refuse further 
assessment or treatment, we will contact the clinic nurse and the participant’s emergency contact to 
inform them of the concern, following the procedures agreed upon by the participant at study enrollment. 
Dr. Boshe and Dr. Madundo will be available for consultation by mobile phone during all assessment and 
intervention times, and to see all at-risk participants in the outpatient clinic at KCMC, which offers 
psychotherapy and psychotropic medication, including antidepressant medication, as well as referral for 
inpatient treatment at Mawenzi Hospital’s Psychiatry Unit if necessary.
Adverse events will be reported to the IRBs according to IRB and NIH policies and appropriate action will 
be taken to ensure patient safety to the extent of our ability.
The study will not enroll vulnerable subjects. According to Tanzanian healthcare policy, pregnant women 
living with HIV are seen at a separate Prevention of Mother-to-Child Transmission of HIV (PMTCT) clinic. 
Prisoners living with HIV receive care within the prison system.
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.

There will be no costs for subjects to participate in the research. Participants will offer their time, and may 
incur transportation costs to reach the clinic or data costs if they choose to receive follow-up intervention 
sessions via video call at a location other than the clinic. To defray these costs, participants will receive an 
incentive of 10,000 Tanzanian shillings (approximately $4.50) at each study contact at the clinic. 
Participants who connect to calls from a location other than the clinic will receive 10,000 TZ shillings if 
connecting via video call (to compensate for time and data costs) and 5,000 TZ shillings if connecting by 
telephone call (as incoming calls will not incur costs to participants).
Data Analysis & Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.
Qualitative data will be analyzed using a thematic approach based on grounded theory and the constant 
comparative method, a rigorous set of inductive procedures to identify and examine themes from textual 
data in a way that is transparent and reproducible. Interview transcripts will first be summarized in a 
qualitative memo, including representative quotes, and organized around 
 domains reflecting the 
a priori
components of the interview guides and CFIR. Next, the memos will be uploaded to NVivo software for 
coding. Within the broader domains, emerging themes from the interviews will be identified and added to a 
codebook to develop a coding structure. Each memo will be coded by 2 team members, inter-coder 
agreement will be calculated, and disagreements will be reconciled via consensus discussion with a 3rd 
team member. After coding, we will produce NVivo queries and analytic memos to synthesize content, 
compare participant characteristics, and draw deeper meaning on themes. Qualitative results will be 
synthesized with the input of the Tanzanian research team, developed into at least one research 
manuscript, and submitted for publication.
Scale validation will include evaluation of internal consistency of each instrument (Cronbach’s alpha and 
item-scale correlation), convergent validity among related measures, and confirmatory factor analysis to 
assess whether the factor structure of the English version of manuscript is retained in the Tanzaniain 
clinical sample.
Feasibility and acceptability of the intervention will be described by retention patterns, participant 
satisfaction, fidelity, and implementation cost. 
 will be measured using the Client 
Participant satisfaction
Satisfaction Questionnaire
 at the 3-month survey and defined as a mean score ≥ 3 on a 1-4 scale.
93
 Fidelit
 to the manual will be measured by TQS and deemed acceptable if mean scores are ≥ 3 on a 0-4 scale. 
y
Co
 of the intervention will be tracked, including the time for training, supervision, and actual costs incurred. 
st
Potential efficacy will be assessed by analyzing differences by condition in primary outcomes (suicidality, 
HIV care engagement, viral load) and secondary outcomes (depression, social support, quality of life). The 
trial will not be powered to detect significant intervention effects or stable effect sizes; however, we will 
conduct these analyses to examine the potential for effects in a larger trial. Mixed-effects regression will 
be used to model pre-post differences within and between arms using a time by condition model 
specification (time, condition, and time*condition). Individual-level random intercepts will be used to 
account for correlation due to repeated measurement. This mixed-effects regression approach allows us to 
control for baseline outcome values that may not be balanced between groups due to small sample size, 
and may improve precision of treatment effect estimates. We will also generate parameter estimates and 
ranges of values to estimate power for a future larger clinical trial study.
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
The Duke PI Dr. Knettel will receive guidance on research with patients at-risk of suicide in monthly 
mentoring meetings with Dr. David Goldston, a recognized expert in the field of suicide prevention 
research. During these meetings, Drs. Knettel and Goldston will review safety data from the study, 
including trends in suicidal ideation and any reported instances of suicidal behavior or death by suicide 

among participants. In the unlikely event of (a) increases in suicidal behavior from baseline to follow-up 
survey or (b) greater suicidality in the intervention condition as compared to control as measured in the 
follow-up survey, the trial will be discontinued.
Participants identified to be in acute crisis at any of the research sites will be referred to Dr. Boshe or Dr. 
Madundo at the psychiatry service at KCMC, or to mental health staff at Majengo Health Centre or Mawenzi 
Hospital, in a safe and timely manner.  Study research assistants (RAs) and nurse interventionists will be 
trained in suicide risk assessment using a manual developed by the U.S. Department of Veteran Affairs 
(2013). This framework incorporates considerations of whether the person has a plan to commit suicide, 
intent to carry out the plan, access to the means to carry out the plan, or a history of suicidal behavior. 
Risk assessment will be conducted in each intervention session and whenever emotional distress is 
communicated outside of sessions (e.g., during weekly text message check-ins).
“Acute crisis” will be defined as a participant meeting more than one of these criteria (plan, intent, means, 
history). In the event of an acute crisis assessed by a study RA, we will immediately initiate a contact with 
a psychiatric nurse. If the acute crisis is assessed by a psychiatric nurse, we will notify the consulting 
psychiatrist (Dr. Boshe or Dr. Madundo). Counseling will be provided, and study staff will maintain contact 
with the participant until a plan has been made to protect the participant’s safety, which may include 
accompanying them to the psychiatric unit at KCMC or Mawenzi Hospital or contacting a family member or 
friend to stay with the patient and provide support. If the consulting psychiatrist determines that a 
participant is able to return home with a family member or friend, a drop in session will be scheduled for 
the next day to reevaluate risk and progress.