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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Case Management Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case Management Intervention<br>A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. | Other: Case Management Intervention<br>* A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.<br>Other: Control<br>* Current routine HIV care in Tanzania.<br>|
| Other: Control<br>Current routine HIV care in Tanzania. | Other: Control<br>* Current routine HIV care in Tanzania.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who attended HIV clinic | 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. | 3, 6, 9, and 12 months | 
| ART adherence | 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). | 3, 6, 9, and 12 months | 
| Viral suppression | 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. | 12 months | 
| Traditional Health Beliefs | 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. | Baseline and 12 months | 
| Self-Efficacy | 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. | Baseline and 12 months | 
| Stigma | 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. | Baseline and 12 months | 
| Social Support | 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. | Baseline and 12 months | 
| Perceived Need for HIV Services | 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. | Baseline and 12 months | 
| Physical Weakness | Physical weakness will be assessed at baseline and after 12 months using the SF-12 Health Survey. The SF-12 measures physical health, scored from 0 to 100, with higher scores indicating greater physical health. | Baseline and 12 months | 
| Acceptability | Qualitative interviews will be conducted with a sub-set of participants to evaluate the acceptability of the intervention. The sub-set will be comprised of 20 intervention participants, 20 routine care control participants, and 20 healthcare workers (nurses and physicians). The interviews will be conducted by trained qualitative research assistants and will focus on the issues central to the intervention including traditional health beliefs, self-efficacy, stigma, social support, and perceived need for HIV services. | 12 months | 
| Incremental cost of the intervention | Healthcare service utilization will be summarized for each arm as descriptive counts such as number of HIV care visits, home visits, laboratory tests, medications, and hospitalizations. Unit costs will be determined for each type of service unit by applying labor rates and materials costs available from the study hospital, and other expense costs available from previous studies. Unit costs will be multiplied by service utilization to calculate healthcare costs. Resources spent on research activities will be excluded. Costs will be reported from the healthcare sector perspective. All data will be analyzed under an intent-to-treat principle. | 12 months | 
| Cost per life saved | 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 | 12 months |