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| Name | Class |
|---|---|
| University Teaching Hospital, Lusaka, Zambia | OTHER |
| University of Alabama at Birmingham | OTHER |
| University of Maryland, College Park | OTHER |
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Early post-discharge mortality is high among Zambians living with HIV admitted to the hospital. This may be due to missed opportunities in post-discharge care, such as inadequate follow-up and treatment. In this study the investigators will develop and pilot a new approach to post-discharge HIV care to improve care coordination and treatment adherence.
Many people living with HIV (PLHIV) have poor outcomes following hospitalization, including high mortality, readmission, and gaps in HIV care engagement. This is likely multi-factorial and not all etiologies may be modifiable. While high mortality may due to incurable cancer, the majority of deaths in PLHIV are thought to be caused by infectious diseases for which treatments exist. However, succumbing to these life-threatening infections after discharge may be due to poor understanding of discharge instructions, lack of post hospital care, and poor understanding of required follow up. Psychosocial support also plays a role in the mental and physical health of these sick patients.
In ReCharge 1, the investigators gathered formative data and identified at least three major factors that undermine HIV clinical outcomes after hospital discharge. First, there are gaps in continuity of care between the discharging facility and outpatient. Second, support from family is often suboptimal due to lack of understanding on the cause of illness, lack of HIV status disclosure, and the cost of care. Third, HIV comorbidities may underpin or complicate the immediate reason for discharge or the post-discharge engagement in care. These data were disseminated to local experts in Zambia including from the Ministry of Health and used to create a new care model for post-discharge HIV care. The care model draws from other successful programs in Zambia. In ReCharge 2 the investigators now propose to pilot the program and assess feasibility, acceptability, and potential for clinical impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Health Worker Post-Discharge Intervention | Experimental | This group will be offered a community-based visit from a community health worker following hospital discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker Post-Discharge Intervention | Behavioral | Clients will be offered a community-based follow-up from a community health worker after hospital discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Discharge Visits | Proportion of discharged patients who are successfully visited after discharge. | Through three months post-discharge |
| Comprehensive Post-Discharge Visits | Number of participants that receive a comprehensive discharge follow-up visit from a community health worker | Through three months post-discharge |
| Post-Discharge Clinic Visits | Proportion of initial post-discharge visits to the HIV clinic that are attended by the participant's community health worker | Through three months post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Viral Load Suppression | Proportion of clients with suppressed HIV viral load at 6 months post-discharge. | 6 months post-discharge |
| Mortality | Proportion of clients alive at 6 months post-discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cassidy Claassen, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levy Mwanawasa University Teaching Hospital | Lusaka | Zambia | ||||
| University Teaching Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Community Health Worker Post-Discharge Intervention | This group will be offered a community-based visit from a community health worker following hospital discharge. Community Health Worker Post-Discharge Intervention: Clients will be offered a community-based follow-up from a community health worker after hospital discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Community Health Worker Post-Discharge Intervention | This group will be offered a community-based visit from a community health worker following hospital discharge. Community Health Worker Post-Discharge Intervention: Clients will be offered a community-based follow-up from a community health worker after hospital discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post-Discharge Visits | Proportion of discharged patients who are successfully visited after discharge. | Posted | Count of Participants | Participants | Through three months post-discharge |
|
|
6 months
No difference
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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 | Community Health Worker Post-Discharge Intervention | This group will be offered a community-based visit from a community health worker following hospital discharge. Community Health Worker Post-Discharge Intervention: Clients will be offered a community-based follow-up from a community health worker after hospital discharge. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Readmission | Surgical and medical procedures | Non-systematic Assessment | Readmission to hospital |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cassidy Claassen | University of Maryland Baltimore | 316-727-6185 | cclaassen@ihv.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 16, 2024 | May 30, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D009894 | Opportunistic Infections |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Community health worker follow-up after discharge from hospital
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| 6 months post-discharge |
| Retention in HIV Care | Retention in HIV care after discharge defined by no gap of >28 days off antiretroviral therapy from discharge date to 6 months post-discharge date | 6 months post-discharge |
| Antiretroviral Therapy Clinic Visit | Antiretroviral therapy clinic visit within 1 month of discharge | 1 month post-discharge |
| Lusaka |
| Zambia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4 <200 | Count of Participants | Participants |
|
|
|
| Primary | Comprehensive Post-Discharge Visits | Number of participants that receive a comprehensive discharge follow-up visit from a community health worker | Posted | Count of Participants | Participants | Through three months post-discharge |
|
|
|
| Primary | Post-Discharge Clinic Visits | Proportion of initial post-discharge visits to the HIV clinic that are attended by the participant's community health worker | Not Posted | Through three months post-discharge | Participants |
| Secondary | HIV Viral Load Suppression | Proportion of clients with suppressed HIV viral load at 6 months post-discharge. | Not Posted | 6 months post-discharge | Participants |
| Secondary | Mortality | Proportion of clients alive at 6 months post-discharge. | Posted | Count of Participants | Participants | 6 months post-discharge |
|
|
|
| Secondary | Retention in HIV Care | Retention in HIV care after discharge defined by no gap of >28 days off antiretroviral therapy from discharge date to 6 months post-discharge date | Not Posted | 6 months post-discharge | Participants |
| Secondary | Antiretroviral Therapy Clinic Visit | Antiretroviral therapy clinic visit within 1 month of discharge | Not Posted | 1 month post-discharge | Participants |
| 19 |
| 97 |
| 28 |
| 97 |
| 0 |
| 97 |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |