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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
Current routine HIV care in Tanzania.
Busisi Health Center
Busisi, Mwanza Region, Tanzania
Magu District Hospital
Magu, Mwanza Region, Tanzania
Nyamilama Health Center
Nyamilama, Mwanza Region, Tanzania
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.
Time frame: 12 months
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.
Time frame: 3, 6, 9,12, and 24 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).
Time frame: 3, 6, 9, 12, and 24 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.
Time frame: 12 and 24 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. The minimum value is 0 and the maximum value is 6.
Time frame: Baseline,12, and 24 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.
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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
...and 6 more locations
Time frame: Baseline, 12, and 24 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.
Time frame: Baseline, 12, and 24 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.
Time frame: Baseline, 12, and 24 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.
Time frame: Baseline, 12, and 24 months
SF-12 Health Survey: Physical and Mental Health
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.
Time frame: Baseline, 12, and 24 months
Acceptability
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.
Time frame: 12 and 24 months
Incremental Cost of the Intervention
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.
Time frame: 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
Time frame: 12 months