HIV InfectionsNCT03858998
Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
A study testing Case Management Intervention in people with HIV Infections, run by Weill Medical College of Cornell University at 16 sites in Tanzania.
Trial summary
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Case Management Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 16 sitesTanzania
- Study dates
- 5 Mar 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- HIV-infected
- ART (anti-retroviral therapy) naïve or have been on ART but have not used ART for > 7 days
- Lives in the region of Mwanza
- Able to be referred to an HIV clinic inside the region of Mwanza
- Has mobile phone or access to mobile phone
Show all 11Show fewer
- Planning to stay in the region of Mwanza for the next 24 months
- Able to speak Kiswahili or English
- Capable and willing to provide informed consent
- Willing to provide locator information and two designated contact persons
- Willing to have a home visits from a study team member
Who cannot join
- Pregnant
- On anti-retrovirals at hospital admission and already linked to an HIV clinic
- Medical, psychiatric or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Tanzania16 sites
Busisi Health Center
Busisi, Mwanza Region
Magu District Hospital
Magu, Mwanza Region
Bugando Medical Center
Mwanza
Bukumbi Hospital
Mwanza
Buzuruga Health Center
Mwanza
Evangelical Lutheran Church in Tanzania (ELCT) Health Centre
Mwanza
Igoma Health Centre
Mwanza
Karume Health Centre
Mwanza
Kwimba District Hospital
Mwanza
Misungwi District Hospital
Mwanza
Nyamagana District Hospital
Mwanza
Sekou Toure Hospital
Mwanza
Sengerema District Hospital
Mwanza
Seventh Day Adventist (SDA) Health Centre
Mwanza
Nyamilama Health Center
Nyamilama, Mwanza Region
Sengerema Health Center
Sengerema, Mwanza Region
About this study
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults.
Read the detailed description
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults. The study is being conducted at hospitals in Mwanza, Tanzania. 500 participants will be enrolled: 250 will be randomized to the case management intervention and 250 will randomized to routine clinical care. The case management intervention consists of 5 sessions over 90 days, and is designed to link hospitalized, HIV-infected patients to long term care at an HIV clinic. Participants will be followed for two years in order to evaluate primary and secondary study objectives.
Secondary outcome measures time frames have been updated to add the 24-month time point for consistency with the pre-specified endpoints in the study protocol.
- Conditions
- HIV Infections
- Being tested
- Case Management Intervention, Control
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case Management InterventionOther
A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
ControlOther
Current routine HIV care in Tanzania.
| Study group | Role | What they receive |
|---|---|---|
| Case Management Intervention | Experimental | A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. Receives: Other: Case Management Intervention; Other: Control |
| Control | Other | Current routine HIV care in Tanzania. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant Deaths in the First 12 Months Post-hospitalization
The number of participants who die in the first 12 months post-hospitalization will be recorded. Death will be determined by phone calls to relatives and will be confirmed by verbal autopsies, obituaries, hospital records, or death certificates.
Measured: 12 months
Secondary outcomes (12)
Number of Participants Who Attended HIV Clinic
HIV clinic attendance will be monitored by review of HIV clinic records. HIV clinic attendance is defined as alive and attended clinic within a window of 90 days (+/- 45 days) around the time points.
Measured: 3, 6, 9,12, and 24 months
ART Adherence
ART adherence will be assessed using the ACTG 4-Day ART Recall Questionnaire. Adherence will be calculated as a percentage, using 1 - (number of missed doses/number of prescribed doses).
Measured: 3, 6, 9, 12, and 24 months
Viral Suppression
Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level <1000 copies/µl.
Measured: 12 and 24 months
Traditional Health Beliefs
Traditional health beliefs will be assessed at baseline and after 12 months using the HIV Insights and Beliefs Scale, scored from 0 to 6, where higher scores indicate more traditional health beliefs. The minimum value is 0 and the maximum value is 6.
Measured: Baseline,12, and 24 months
Self-Efficacy
Self-efficacy will be assessed at baseline and after 12 months using the HIV Adherence Self-Efficacy Scale, scored from 0 to 25, where higher scores indicate a higher level of self-efficacy.
Measured: Baseline, 12, and 24 months
Stigma
Stigma will be assessed at baseline and after 12 months using questions based off the AIDS-Related Stigma Scale, scored from 0 to 8, where higher scores indicate a higher level of perceived stigma.
Measured: Baseline, 12, and 24 months
Social Support
Social support will be assessed at baseline and after 12 months using the SPS-10 Scale, scored from 0 to 40, where higher scores indicate a higher level of social support.
Measured: Baseline, 12, and 24 months
Perceived Need for HIV Services
Perceived need for HIV services will be assessed at baseline and after 12 months using the ART Medications Attitude Scale, scored from 0 to 4, where higher scores indicate a lower perceived need for HIV services.
Measured: Baseline, 12, and 24 months
SF-12 Health Survey: Physical and Mental Health
Physical weakness will be assessed at baseline and after 12 months using the SF-12 Health Survey. The SF-12 measures physical health (physical component score (PCS)), scored from 0 to 100, and mental health (mental component score (MCS)), scored from 0 to 100, with higher scores indicating greater physical and mental health.
Measured: Baseline, 12, and 24 months
Acceptability
Qualitative interviews will be conducted with a sub-set of participants to evaluate the acceptability of the intervention. The acceptability of the Daraja intervention was defined as a binary outcome based on the results of the qualitative interviews. The sub-set will be comprised of 20 intervention participants, 20 routine care control participants, and 20 health care workers (nurses and physicians). Health care workers were not enrolled as participants in the trial nor randomized to a study arm.
Measured: 12 and 24 months
Incremental Cost of the Intervention
A microcosting analysis was conducted to identify the resources needed to implement and sustain the Daraja intervention and estimate the associated costs. Resource identification was accomplished primarily through in-person site visits and semi-structured interviews with relevant personnel. Nationally representative unit costs were assigned to the relevant resources. Resources were categorized as fixed start-up, time-dependent, or variable, and contextualized as being required for implementation or sustainment. The intervention implementation period was defined as the first 12 months following start-up, and consisted of the resources in all 3 of the aforementioned categories, and the sustainment period is intended to reflect a typical year following the implementation period, and consists of time-dependent and variable resources, given that the costs associated with fixed start-up resources become negligible over time. Incremental cost was reported as a number in 2023 USD.
Measured: 12 months
Cost Per Life Saved
The difference in costs between the arms from the healthcare perspective will be compared to the observed difference in survival between the arms to calculate incremental cost per life saved. Parametric methods based on parameters obtained from bootstrapping will be used to estimate an acceptability curves, which will illustrate the probability that the intervention is a good value for different willingness-to-pay thresholds
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start5 Mar 2019
- Primary completion31 May 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Robert Peck, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858998
- Sponsor's protocol ID
- 1804019134
- Other IDs
- R01MH118107-01
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2019
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will include de-identified data on demographic characteristics, medical history, psychosocial measures, survival, HIV clinic linkage and retention, ART adherence, HIV viral loads, health economic variables and acceptability. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Therefore, we will make the dataset available to users under a data-sharing agreement that includes the following: a commitment to use the data for research purposes and not participant identification, commitment to securing the data with appropriate password protected IT practices, and a commitment to destroying the data after analyses are completed. For published data, the de-identified individual participant data that underlie the results reported in the article (text, tables, figured, appendices) will be available.
Publications
Ayieko P, Willkens M, Issarow B, Deogratias D, Fitzgerald DW, Grosskurth H, Kisigo G, Okello E, Metsch LR, Peck RN, Kapiga S, Lee MH. Self-Efficacy and One-Year HIV Outcomes for Hospitalized People with HIV in Tanzania: A Mediation Analysis of the Daraja Clinical Trial. AIDS Behav. 2026 Apr;30(4):1022-1029. doi: 10.1007/s10461-025-04917-2. Epub 2025 Nov 11.
PubMed 41214254Okello ES, Peck RN, Issarow B, Kisigo G, Abel K, Malibwa D, Kabakama S, Charles M, Lee M, Rutachunzibwa T, Fitzgerald D, Ayieko P, Grosskurth H, Metsch LR, Kapiga S. "Ashamed of being seen in an HIV clinic": a qualitative analysis of barriers to engaging in HIV care from the perspectives of patients and healthcare workers in the Daraja clinical trial. BMC Public Health. 2025 Jan 7;25(1):69. doi: 10.1186/s12889-024-21231-z.
PubMed 39773172Peck RN, Issarow B, Kisigo GA, Kabakama S, Okello E, Rutachunzibwa T, Willkens M, Deogratias D, Hashim R, Grosskurth H, Fitzgerald DW, Ayieko P, Lee MH, Murphy SM, Metsch LR, Kapiga S. Linkage Case Management and Posthospitalization Outcomes in People With HIV: The Daraja Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1025-1034. doi: 10.1001/jama.2024.2177.
PubMed 38446792Kisigo GA, Issarow B, Abel K, Hashim R, Okello ES, Ayieko P, Lee MH, Grosskurth H, Fitzgerald D, Peck RN, Kapiga S. A social worker intervention to reduce post-hospital mortality in HIV-infected adults in Tanzania (Daraja): Study protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Feb;113:106680. doi: 10.1016/j.cct.2022.106680. Epub 2022 Jan 13.
PubMed 35032664
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
- ClinicalTrials.gov ID
- NCT03858998
- Acronym / sponsor ID
- 1804019134
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults.
Detailed description
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults. The study is being conducted at hospitals in Mwanza, Tanzania. 500 participants will be enrolled: 250 will be randomized to the case management intervention and 250 will randomized to routine clinical care. The case management intervention consists of 5 sessions over 90 days, and is designed to link hospitalized, HIV-infected patients to long term care at an HIV clinic. Participants will be followed for two years in order to evaluate primary and secondary study objectives.
Secondary outcome measures time frames have been updated to add the 24-month time point for consistency with the pre-specified endpoints in the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Management Intervention | Experimental | Other: Case Management Intervention, Other: ControlA 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. |
| Control | Other | Other: ControlCurrent routine HIV care in Tanzania. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age or older
- HIV-infected
- ART (anti-retroviral therapy) naïve or have been on ART but have not used ART for > 7 days
- Lives in the region of Mwanza
- Able to be referred to an HIV clinic inside the region of Mwanza
Key exclusion criteria (3 listed)
- Pregnant
- On anti-retrovirals at hospital admission and already linked to an HIV clinic
- Medical, psychiatric or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case Management InterventionA 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. | Other | Case Management Intervention |
| ControlCurrent routine HIV care in Tanzania. | Other | Case Management Intervention, Control |
Primary outcome
Number of Participant Deaths in the First 12 Months Post-hospitalization
Time frame: 12 months
The number of participants who die in the first 12 months post-hospitalization will be recorded. Death will be determined by phone calls to relatives and will be confirmed by verbal autopsies, obituaries, hospital records, or death certificates.
12 secondary outcomes
Number of Participants Who Attended HIV Clinic
Time frame: 3, 6, 9,12, and 24 months
ART Adherence
Time frame: 3, 6, 9, 12, and 24 months
Viral Suppression
Time frame: 12 and 24 months
Traditional Health Beliefs
Time frame: Baseline,12, and 24 months
Self-Efficacy
Time frame: Baseline, 12, and 24 months
Stigma
Time frame: Baseline, 12, and 24 months
Social Support
Time frame: Baseline, 12, and 24 months
Perceived Need for HIV Services
Time frame: Baseline, 12, and 24 months
SF-12 Health Survey: Physical and Mental Health
Time frame: Baseline, 12, and 24 months
Acceptability
Time frame: 12 and 24 months
Incremental Cost of the Intervention
Time frame: 12 months
Cost Per Life Saved
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41214254Ayieko P, Willkens M, Issarow B, Deogratias D, Fitzgerald DW, Grosskurth H, Kisigo G, Okello E, Metsch LR, Peck RN, Kapiga S, Lee MH. Self-Efficacy and One-Year HIV Outcomes for Hospitalized People with HIV in Tanzania: A Mediation Analysis of the Daraja Clinical Trial. AIDS Behav. 2026 Apr;30(4):1022-1029. doi: 10.1007/s10461-025-04917-2. Epub 2025 Nov 11.
- Derived from this study: PubMed 39773172Okello ES, Peck RN, Issarow B, Kisigo G, Abel K, Malibwa D, Kabakama S, Charles M, Lee M, Rutachunzibwa T, Fitzgerald D, Ayieko P, Grosskurth H, Metsch LR, Kapiga S. "Ashamed of being seen in an HIV clinic": a qualitative analysis of barriers to engaging in HIV care from the perspectives of patients and healthcare workers in the Daraja clinical trial. BMC Public Health. 2025 Jan 7;25(1):69. doi: 10.1186/s12889-024-21231-z.
- Derived from this study: PubMed 38446792Peck RN, Issarow B, Kisigo GA, Kabakama S, Okello E, Rutachunzibwa T, Willkens M, Deogratias D, Hashim R, Grosskurth H, Fitzgerald DW, Ayieko P, Lee MH, Murphy SM, Metsch LR, Kapiga S. Linkage Case Management and Posthospitalization Outcomes in People With HIV: The Daraja Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1025-1034. doi: 10.1001/jama.2024.2177.
- Derived from this study: PubMed 35032664Kisigo GA, Issarow B, Abel K, Hashim R, Okello ES, Ayieko P, Lee MH, Grosskurth H, Fitzgerald D, Peck RN, Kapiga S. A social worker intervention to reduce post-hospital mortality in HIV-infected adults in Tanzania (Daraja): Study protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Feb;113:106680. doi: 10.1016/j.cct.2022.106680. Epub 2022 Jan 13.
- Individual participant dataSharing planned: Yes. The final dataset will include de-identified data on demographic characteristics, medical history, psychosocial measures, survival, HIV clinic linkage and retention, ART adherence, HIV viral loads, health economic variables and acceptability. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Therefore, we will make the dataset available to users under a data-sharing agreement that includes the following: a commitment to use the data for research purposes and not participant identification, commitment to securing the data with appropriate password protected IT practices, and a commitment to destroying the data after analyses are completed. For published data, the de-identified individual participant data that underlie the results reported in the article (text, tables, figured, appendices) will be available.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Peck, MD principal investigator
Weill Medical College of Cornell University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management Intervention in people with HIV Infections, run by Weill Medical College of Cornell University at 16 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant Deaths in the First 12 Months Post-hospitalization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858998, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.