Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania

NCT ID: NCT03858998

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2024-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Case Management Intervention

A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.

Group Type: EXPERIMENTAL

Case Management Intervention

Intervention Type: OTHER

A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.

Control

Intervention Type: OTHER

Current routine HIV care in Tanzania.

Control

Current routine HIV care in Tanzania.

Group Type: OTHER

Control

Intervention Type: OTHER

Current routine HIV care in Tanzania.

Interventions

Case Management Intervention

A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.

Intervention Type: OTHER

Control

Current routine HIV care in Tanzania.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Peck, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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

Countries

Tanzania

References

Okello 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.

Reference Type: DERIVED

PMID: 39773172 (View on PubMed)

Peck 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.

Reference Type: DERIVED

PMID: 38446792 (View on PubMed)

Kisigo 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.

Reference Type: DERIVED

PMID: 35032664 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01MH118107-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1804019134

Identifier Type: -

Identifier Source: org_study_id