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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: HIV Infections

Treatments: Other: Control; Other: Case Management Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03858998

1804019134

R01MH118107-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Case Management Intervention

Experimental group

Description:

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

Treatment:

Other: Case Management Intervention

Other: Control

Control

Other group

Description:

Current routine HIV care in Tanzania.

Treatment:

Other: Control