Trial Outcomes & Findings for Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania (NCT NCT03858998)

NCT ID: NCT03858998

Last Updated: 2025-04-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 500 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-04-23

Participant Flow

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.

Participant milestones

Measure	Linkage Case Management Intervention A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care Current routine HIV care in Tanzania.
Overall Study STARTED	250	250
Overall Study COMPLETED	250	250
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Total n=500 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 12 • n=5 Participants	36 years STANDARD_DEVIATION 11 • n=7 Participants	37 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	194 Participants n=7 Participants	384 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	56 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	250 Participants n=5 Participants	250 Participants n=7 Participants	500 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Tanzania	250 participants n=5 Participants	250 participants n=7 Participants	500 participants n=5 Participants
HIV/ART status Newly diagnosed HIV	211 Participants n=5 Participants	191 Participants n=7 Participants	402 Participants n=5 Participants
HIV/ART status Previously diagnosed HIV and discontinued ART (≥ 7 days)	39 Participants n=5 Participants	59 Participants n=7 Participants	98 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Number of Participant Deaths in the First 12 Months Post-hospitalization	43 Participants	42 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Number of Participants Who Attended HIV Clinic 3 months	215 Participants	187 Participants	—
Number of Participants Who Attended HIV Clinic 6 months	190 Participants	160 Participants	—
Number of Participants Who Attended HIV Clinic 9 months	180 Participants	158 Participants	—
Number of Participants Who Attended HIV Clinic 12 months	180 Participants	158 Participants	—
Number of Participants Who Attended HIV Clinic 24 months	161 Participants	143 Participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
ART Adherence 3 months	95.1 percentage of ART adherence Standard Deviation 21.5	94.6 percentage of ART adherence Standard Deviation 22.0	—
ART Adherence 6 months	95.7 percentage of ART adherence Standard Deviation 19.5	91.6 percentage of ART adherence Standard Deviation 27.1	—
ART Adherence 9 months	90.9 percentage of ART adherence Standard Deviation 28.2	93.0 percentage of ART adherence Standard Deviation 25.0	—
ART Adherence 12 months	86.9 percentage of ART adherence Standard Deviation 33.3	77.8 percentage of ART adherence Standard Deviation 41.5	—
ART Adherence 24 months	85.0 percentage of ART adherence Standard Deviation 35.5	72.1 percentage of ART adherence Standard Deviation 44.7	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Viral Suppression 12 months	162 Participants	139 Participants	—
Viral Suppression 24 months	153 Participants	134 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Traditional Health Beliefs Baseline	0.53 score on a scale Standard Deviation 0.80	0.44 score on a scale Standard Deviation 0.79	—
Traditional Health Beliefs 12 months	0.81 score on a scale Standard Deviation 0.80	0.89 score on a scale Standard Deviation 0.93	—
Traditional Health Beliefs 24 months	1.10 score on a scale Standard Deviation 1.05	1.31 score on a scale Standard Deviation 1.34	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Self-Efficacy Baseline	22.42 score on a scale Standard Deviation 2.72	22.39 score on a scale Standard Deviation 2.86	—
Self-Efficacy 12 months	22.65 score on a scale Standard Deviation 3.68	21.47 score on a scale Standard Deviation 5.39	—
Self-Efficacy 24 months	22.48 score on a scale Standard Deviation 4.96	20.50 score on a scale Standard Deviation 6.64	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Stigma Baseline	2.32 score on a scale Standard Deviation 0.92	2.28 score on a scale Standard Deviation 0.91	—
Stigma 12 months	2.12 score on a scale Standard Deviation 0.87	2.24 score on a scale Standard Deviation 0.88	—
Stigma 24 months	2.16 score on a scale Standard Deviation 0.94	2.27 score on a scale Standard Deviation 0.92	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Social Support Baseline	34.84 score on a scale Standard Deviation 4.66	34.74 score on a scale Standard Deviation 4.35	—
Social Support 12 months	33.02 score on a scale Standard Deviation 5.14	32.59 score on a scale Standard Deviation 4.60	—
Social Support 24 months	33.16 score on a scale Standard Deviation 4.74	31.66 score on a scale Standard Deviation 5.78	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Perceived Need for HIV Services Baseline	1.90 score on a scale Standard Deviation 0.30	1.94 score on a scale Standard Deviation 0.30	—
Perceived Need for HIV Services 12 months	1.85 score on a scale Standard Deviation 0.37	1.86 score on a scale Standard Deviation 0.41	—
Perceived Need for HIV Services 24 months	1.90 score on a scale Standard Deviation 0.31	1.91 score on a scale Standard Deviation 0.36	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
SF-12 Health Survey: Physical and Mental Health Physical component score (PCS )- Baseline	37.52 score on a scale Standard Deviation 9.13	37.15 score on a scale Standard Deviation 9.04	—
SF-12 Health Survey: Physical and Mental Health Mental component score (MCS) - Baseline	45.08 score on a scale Standard Deviation 11.87	44.76 score on a scale Standard Deviation 11.92	—
SF-12 Health Survey: Physical and Mental Health PCS - 12 months	50.59 score on a scale Standard Deviation 8.31	51.15 score on a scale Standard Deviation 8.06	—
SF-12 Health Survey: Physical and Mental Health MCS - 12 months	49.64 score on a scale Standard Deviation 12.79	50.42 score on a scale Standard Deviation 11.85	—
SF-12 Health Survey: Physical and Mental Health PCS - 24 months	50.91 score on a scale Standard Deviation 8.23	50.92 score on a scale Standard Deviation 7.59	—
SF-12 Health Survey: Physical and Mental Health MCS - 24 months	51.13 score on a scale Standard Deviation 12.98	51.29 score on a scale Standard Deviation 11.85	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Linkage Case Management Intervention n=20 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=20 Participants Current routine HIV care in Tanzania.	Health Care Workers n=20 Participants Health care workers involved with care of hospitalized people with HIV.
Acceptability Acceptability -12 months	20 Participants	20 Participants	20 Participants
Acceptability Acceptability - 24 months	20 Participants	20 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Linkage Case Management Intervention n=250 Participants A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.	Enhanced Standard of Care n=250 Participants Current routine HIV care in Tanzania.	Health Care Workers Health care workers involved with care of hospitalized people with HIV.
Incremental Cost of the Intervention Year 1 costs, per client	22 US dollar	0 US dollar	—
Incremental Cost of the Intervention Annual sustainment costs, per client	17 US dollar	0 US dollar	—

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome data not reported

Adverse Events

Linkage Case Management Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 43 deaths

Enhanced Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 42 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Peck

Weill Cornell Medicine

Phone: (646) 962-8140

Email: rnp2002@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place