Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
2 other identifiers
interventional
500
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Mar 2019
Longer than P75 for not_applicable hiv-infections
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedStudy Start
First participant enrolled
March 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedResults Posted
Study results publicly available
May 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedApril 23, 2025
April 1, 2025
4.2 years
February 14, 2019
March 7, 2024
April 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (12)
Number of Participants Who Attended HIV Clinic
3, 6, 9,12, and 24 months
ART Adherence
3, 6, 9, 12, and 24 months
Viral Suppression
12 and 24 months
Traditional Health Beliefs
Baseline,12, and 24 months
Self-Efficacy
Baseline, 12, and 24 months
- +7 more secondary outcomes
Study Arms (2)
Case Management Intervention
EXPERIMENTALA 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
Control
OTHERCurrent routine HIV care in Tanzania.
Interventions
A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Busisi Health Center
Busisi, Mwanza Region, Tanzania
Magu District Hospital
Magu, Mwanza Region, Tanzania
Nyamilama Health Center
Nyamilama, Mwanza Region, Tanzania
Sengerema Health Center
Sengerema, Mwanza Region, Tanzania
Bugando Medical Center
Mwanza, Tanzania
Bukumbi Hospital
Mwanza, Tanzania
Buzuruga Health Center
Mwanza, Tanzania
Evangelical Lutheran Church in Tanzania (ELCT) Health Centre
Mwanza, Tanzania
Igoma Health Centre
Mwanza, Tanzania
Karume Health Centre
Mwanza, Tanzania
Kwimba District Hospital
Mwanza, Tanzania
Misungwi District Hospital
Mwanza, Tanzania
Nyamagana District Hospital
Mwanza, Tanzania
Sekou Toure Hospital
Mwanza, Tanzania
Sengerema District Hospital
Mwanza, Tanzania
Seventh Day Adventist (SDA) Health Centre
Mwanza, Tanzania
Related Publications (4)
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. 2025 Nov 11:10.1007/s10461-025-04917-2. doi: 10.1007/s10461-025-04917-2. Online ahead of print.
PMID: 41214254DERIVEDOkello 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.
PMID: 39773172DERIVEDPeck 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.
PMID: 38446792DERIVEDKisigo 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.
PMID: 35032664DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Peck
- Organization
- Weill Cornell Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Peck, MD
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2019
First Posted
March 1, 2019
Study Start
March 5, 2019
Primary Completion
May 31, 2023
Study Completion
May 31, 2024
Last Updated
April 23, 2025
Results First Posted
May 2, 2024
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Beginning 3 months and ending 5 years following article publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal to achieve aims in the protocol. Proposals should be directed to the Principal Investigator (rnp2002@med.cornell.edu).
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.