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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH118107-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Management Intervention | Experimental | A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. |
|
| Control | Other | Current routine HIV care in Tanzania. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Case Management Intervention | Other | A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. |
|
| 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 |
| 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, 9,12, and 24 months |
| ART Adherence |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert Peck, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busisi Health Center | Busisi | Mwanza Region | Tanzania | |||
| Magu District Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41214254 | Derived | Ayieko P, Willkens M, Issarow B, Deogratias D, Fitzgerald DW, Grosskurth H, Kisigo G, Okello E, Metsch LR, Peck RN, Kapiga S, Lee MH. Self-Efficacy and One-Year HIV Outcomes for Hospitalized People with HIV in Tanzania: A Mediation Analysis of the Daraja Clinical Trial. AIDS Behav. 2026 Apr;30(4):1022-1029. doi: 10.1007/s10461-025-04917-2. Epub 2025 Nov 11. | |
| 39773172 | Derived | Okello ES, Peck RN, Issarow B, Kisigo G, Abel K, Malibwa D, Kabakama S, Charles M, Lee M, Rutachunzibwa T, Fitzgerald D, Ayieko P, Grosskurth H, Metsch LR, Kapiga S. "Ashamed of being seen in an HIV clinic": a qualitative analysis of barriers to engaging in HIV care from the perspectives of patients and healthcare workers in the Daraja clinical trial. BMC Public Health. 2025 Jan 7;25(1):69. doi: 10.1186/s12889-024-21231-z. |
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The final dataset will include de-identified data on demographic characteristics, medical history, psychosocial measures, survival, HIV clinic linkage and retention, ART adherence, HIV viral loads, health economic variables and acceptability. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Therefore, we will make the dataset available to users under a data-sharing agreement that includes the following: a commitment to use the data for research purposes and not participant identification, commitment to securing the data with appropriate password protected IT practices, and a commitment to destroying the data after analyses are completed.
For published data, the de-identified individual participant data that underlie the results reported in the article (text, tables, figured, appendices) will be available.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal to achieve aims in the protocol. Proposals should be directed to the Principal Investigator (rnp2002@med.cornell.edu).
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Linkage Case Management Intervention | A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. |
| FG001 | Enhanced Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2019 | Feb 15, 2024 |
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| Control | Other | Current routine HIV care in Tanzania. |
|
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, 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
| Magu |
| Mwanza Region |
| Tanzania |
| Nyamilama Health Center | Nyamilama | Mwanza Region | Tanzania |
| 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 |
| Kwimba District Hospital | Mwanza | Tanzania |
| Misungwi District Hospital | Mwanza | Tanzania |
| Nyamagana District Hospital | Mwanza | Tanzania |
| Sekou Toure Hospital | Mwanza | Tanzania |
| Sengerema District Hospital | Mwanza | Tanzania |
| Seventh Day Adventist (SDA) Health Centre | Mwanza | Tanzania |
| 38446792 | Derived | Peck RN, Issarow B, Kisigo GA, Kabakama S, Okello E, Rutachunzibwa T, Willkens M, Deogratias D, Hashim R, Grosskurth H, Fitzgerald DW, Ayieko P, Lee MH, Murphy SM, Metsch LR, Kapiga S. Linkage Case Management and Posthospitalization Outcomes in People With HIV: The Daraja Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1025-1034. doi: 10.1001/jama.2024.2177. |
| 35032664 | Derived | Kisigo GA, Issarow B, Abel K, Hashim R, Okello ES, Ayieko P, Lee MH, Grosskurth H, Fitzgerald D, Peck RN, Kapiga S. A social worker intervention to reduce post-hospital mortality in HIV-infected adults in Tanzania (Daraja): Study protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Feb;113:106680. doi: 10.1016/j.cct.2022.106680. Epub 2022 Jan 13. |
Current routine HIV care in Tanzania.
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Linkage Case Management Intervention | A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. |
| BG001 | Enhanced Standard of Care | Current routine HIV care in Tanzania. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| HIV/ART status | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 3, 6, 9,12, and 24 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | Posted | Mean | Standard Deviation | percentage of ART adherence | 3, 6, 9, 12, and 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12, and 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12, and 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12, and 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12, and 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12, and 24 months |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12, and 24 months |
|
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| 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. | 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. | Posted | Count of Participants | Participants | 12 and 24 months |
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| 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. | Posted | Number | US dollar | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | This measure could not be calculated because it assumed an outcome that was not observed. | Posted | 12 months |
|
|
12 months
All-cause mortality was the primary outcome of this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Linkage Case Management Intervention | A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics. | 43 | 250 | 0 | 250 | 0 | 250 |
| EG001 | Enhanced Standard of Care | Current routine HIV care in Tanzania. | 42 | 250 | 0 | 250 | 0 | 250 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Peck | Weill Cornell Medicine | (646) 962-8140 | rnp2002@med.cornell.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2023 | Feb 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Previously diagnosed HIV and discontinued ART (≥ 7 days) |
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| Health Care Workers |
Health care workers involved with care of hospitalized people with HIV. |
|
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| Units | Counts |
|---|
| Participants |
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