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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03858998

Enrollment

500

Registered

2019-03-01

Start date

2019-03-05

Completion date

2024-05-31

Last updated

2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

OTHERCase Management Intervention

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

OTHERControl

Current routine HIV care in Tanzania.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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
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.

Countries

Tanzania

Participant flow

Recruitment details

Hospitalized people with HIV who were either not treated (antiretroviral-naïve) or had discontinued ART and were hospitalized for any reason were enrolled between March 2019 and February 2022.

Participants by arm

Arm	Count
Linkage Case Management Intervention A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	250
Enhanced Standard of Care Current routine HIV care in Tanzania.	250
Total	500

Baseline characteristics

Characteristic	Enhanced Standard of Care	Total	Linkage Case Management Intervention
Age, Continuous	36 years STANDARD_DEVIATION 11	37 years STANDARD_DEVIATION 11.5	38 years STANDARD_DEVIATION 12
HIV/ART status Newly diagnosed HIV	191 Participants	402 Participants	211 Participants
HIV/ART status Previously diagnosed HIV and discontinued ART (≥ 7 days)	59 Participants	98 Participants	39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	250 Participants	500 Participants	250 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Region of Enrollment Tanzania	250 participants	500 participants	250 participants
Sex: Female, Male Female	194 Participants	384 Participants	190 Participants
Sex: Female, Male Male	56 Participants	116 Participants	60 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	43 / 250	42 / 250
other Total, other adverse events	0 / 250	0 / 250
serious Total, serious adverse events	0 / 250	0 / 250

Outcome results

Primary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Linkage Case Management Intervention	Number of Participant Deaths in the First 12 Months Post-hospitalization	43 Participants
Enhanced Standard of Care	Number of Participant Deaths in the First 12 Months Post-hospitalization	42 Participants

p-value: 0.9195% CI: [-0.06, 0.07]Chi-squared

Secondary

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

Population: We assessed the acceptability of the Daraja intervention across the study groups through qualitative interviews. The subset of participants for qualitative interviews were purposively selected from the list of participants who had completed 12 months from enrollment. We selected 20 intervention participants, 20 control participants and 20 healthcare workers providing care to people with HIV. Health care workers were not enrolled as participants in the trial nor randomized to a study arm.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Linkage Case Management Intervention	Acceptability	Acceptability - 24 months	20 Participants
Linkage Case Management Intervention	Acceptability	Acceptability -12 months	20 Participants
Enhanced Standard of Care	Acceptability	Acceptability -12 months	20 Participants
Enhanced Standard of Care	Acceptability	Acceptability - 24 months	20 Participants
Health Care Workers	Acceptability	Acceptability -12 months	20 Participants
Health Care Workers	Acceptability	Acceptability - 24 months	20 Participants

Secondary

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Linkage Case Management Intervention	ART Adherence	6 months	95.7 percentage of ART adherence	Standard Deviation 19.5
Linkage Case Management Intervention	ART Adherence	12 months	86.9 percentage of ART adherence	Standard Deviation 33.3
Linkage Case Management Intervention	ART Adherence	9 months	90.9 percentage of ART adherence	Standard Deviation 28.2
Linkage Case Management Intervention	ART Adherence	24 months	85.0 percentage of ART adherence	Standard Deviation 35.5
Linkage Case Management Intervention	ART Adherence	3 months	95.1 percentage of ART adherence	Standard Deviation 21.5
Enhanced Standard of Care	ART Adherence	24 months	72.1 percentage of ART adherence	Standard Deviation 44.7
Enhanced Standard of Care	ART Adherence	3 months	94.6 percentage of ART adherence	Standard Deviation 22
Enhanced Standard of Care	ART Adherence	6 months	91.6 percentage of ART adherence	Standard Deviation 27.1
Enhanced Standard of Care	ART Adherence	9 months	93.0 percentage of ART adherence	Standard Deviation 25
Enhanced Standard of Care	ART Adherence	12 months	77.8 percentage of ART adherence	Standard Deviation 41.5

Secondary

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

Population: This measure could not be calculated because it assumed an outcome that was not observed.

Secondary

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

Arm	Measure	Group	Value (NUMBER)
Linkage Case Management Intervention	Incremental Cost of the Intervention	Year 1 costs, per client	22 US dollar
Linkage Case Management Intervention	Incremental Cost of the Intervention	Annual sustainment costs, per client	17 US dollar
Enhanced Standard of Care	Incremental Cost of the Intervention	Year 1 costs, per client	0 US dollar
Enhanced Standard of Care	Incremental Cost of the Intervention	Annual sustainment costs, per client	0 US dollar

Secondary

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Linkage Case Management Intervention	Number of Participants Who Attended HIV Clinic	6 months	190 Participants
Linkage Case Management Intervention	Number of Participants Who Attended HIV Clinic	12 months	180 Participants
Linkage Case Management Intervention	Number of Participants Who Attended HIV Clinic	9 months	180 Participants
Linkage Case Management Intervention	Number of Participants Who Attended HIV Clinic	24 months	161 Participants
Linkage Case Management Intervention	Number of Participants Who Attended HIV Clinic	3 months	215 Participants
Enhanced Standard of Care	Number of Participants Who Attended HIV Clinic	24 months	143 Participants
Enhanced Standard of Care	Number of Participants Who Attended HIV Clinic	3 months	187 Participants
Enhanced Standard of Care	Number of Participants Who Attended HIV Clinic	6 months	160 Participants
Enhanced Standard of Care	Number of Participants Who Attended HIV Clinic	9 months	158 Participants
Enhanced Standard of Care	Number of Participants Who Attended HIV Clinic	12 months	158 Participants

Secondary

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.