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

Not Applicable

Completed

Conditions: HIV Infections

Interventions: Other: Control
Other: Case Management Intervention

Registration Number: NCT03858998

Lead Sponsor: Weill Medical College of Cornell University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Current routine HIV care in Tanzania.
Case Management Intervention	Control	A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
Case Management Intervention	Case Management Intervention	A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.

Primary Outcome Measures

Name	Time	Method
Number of Participant Deaths in the First 12 Months Post-hospitalization	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Attended HIV Clinic	3, 6, 9,12, and 24 months	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.
ART Adherence	3, 6, 9, 12, and 24 months	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).
Viral Suppression	12 and 24 months	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.
Traditional Health Beliefs	Baseline,12, and 24 months	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.
Self-Efficacy	Baseline, 12, and 24 months	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.
Stigma	Baseline, 12, and 24 months	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.
Social Support	Baseline, 12, and 24 months	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.
Perceived Need for HIV Services	Baseline, 12, and 24 months	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.
SF-12 Health Survey: Physical and Mental Health	Baseline, 12, and 24 months	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.
Acceptability	12 and 24 months	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.
Incremental Cost of the Intervention	12 months	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.
Cost Per Life Saved	12 months	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

Trial Locations

Locations (16): Busisi Health Center
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Busisi, Mwanza, Tanzania
Magu District Hospital
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Magu, Mwanza, Tanzania
Nyamilama Health Center
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Nyamilama, Mwanza, Tanzania
Igoma Health Centre
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Mwanza, Tanzania
Sengerema Health Center
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Sengerema, Mwanza, Tanzania
Evangelical Lutheran Church in Tanzania (ELCT) Health Centre
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Mwanza, Tanzania
Bugando Medical Center
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Mwanza, Tanzania
Bukumbi Hospital
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Mwanza, Tanzania
Buzuruga Health Center
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Mwanza, Tanzania
Karume Health Centre
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Mwanza, Tanzania
Kwimba District Hospital
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Mwanza, Tanzania
Misungwi District Hospital
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Mwanza, Tanzania
Sengerema District Hospital
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Mwanza, Tanzania
Sekou Toure Hospital
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Mwanza, Tanzania
Nyamagana District Hospital
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Mwanza, Tanzania
Seventh Day Adventist (SDA) Health Centre
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Mwanza, Tanzania