Clinical trial NCT03858998: Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
Official title: Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participant Deaths in the First 12 Months Post-hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Who Attended HIV Clinic
timeFrame: 3, 6, 9,12, and 24 months
measure: ART Adherence
timeFrame: 3, 6, 9, 12, and 24 months
measure: Viral Suppression
timeFrame: 12 and 24 months
measure: Traditional Health Beliefs
timeFrame: Baseline,12, and 24 months
measure: Self-Efficacy
timeFrame: Baseline, 12, and 24 months
measure: Stigma
timeFrame: Baseline, 12, and 24 months
measure: Social Support
timeFrame: Baseline, 12, and 24 months
measure: Perceived Need for HIV Services
timeFrame: Baseline, 12, and 24 months
measure: SF-12 Health Survey: Physical and Mental Health
timeFrame: Baseline, 12, and 24 months
measure: Acceptability
timeFrame: 12 and 24 months
measure: Incremental Cost of the Intervention
timeFrame: 12 months
measure: Cost Per Life Saved
timeFrame: 12 months
Other outcomes:
Locations:
city: Busisi
country: Tanzania
facility: Busisi Health Center
state: Mwanza
city: Magu
country: Tanzania
facility: Magu District Hospital
state: Mwanza
city: Nyamilama
country: Tanzania
facility: Nyamilama Health Center
state: Mwanza
city: Sengerema
country: Tanzania
facility: Sengerema Health Center
state: Mwanza
city: Mwanza
country: Tanzania
facility: Bugando Medical Center
city: Mwanza
country: Tanzania
facility: Bukumbi Hospital
city: Mwanza
country: Tanzania
facility: Buzuruga Health Center
city: Mwanza
country: Tanzania
facility: Evangelical Lutheran Church in Tanzania (ELCT) Health Centre
city: Mwanza
country: Tanzania
facility: Igoma Health Centre
city: Mwanza
country: Tanzania
facility: Karume Health Centre
city: Mwanza
country: Tanzania
facility: Kwimba District Hospital
city: Mwanza
country: Tanzania
facility: Misungwi District Hospital
city: Mwanza
country: Tanzania
facility: Nyamagana District Hospital
city: Mwanza
country: Tanzania
facility: Sekou Toure Hospital
city: Mwanza
country: Tanzania
facility: Sengerema District Hospital
city: Mwanza
country: Tanzania
facility: Seventh Day Adventist (SDA) Health Centre
Study officials:
affiliation: Weill Medical College of Cornell University
name: Robert Peck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.