HIV/AIDS, Hospitalization, Opportunistic Infections, Transitions of Care
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCommunity Health Worker Post-Discharge Intervention
Clients will be offered a community-based follow-up from a community health worker after hospital discharge.
Sponsors
University Teaching Hospital, Lusaka, Zambia
University of Alabama at Birmingham
University of Maryland, College Park
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Community health worker follow-up after discharge from hospital
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18+ years * HIV-positive * Hospitalized for at least 1 night at study site * Clinically stable and expected to be discharged according to their clinician * Objective evidence of suboptimal HIV outcome, defined as HIV viral load above the lower limit of the assay or T-cell cluster of differentiation 4 count \<=200.
Exclusion criteria
* Unable to provide informed consent * No phone * Planning to reside outside of Lusaka urban district after discharge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Discharge Visits | Through three months post-discharge | Proportion of discharged patients who are successfully visited after discharge. |
| Comprehensive Post-Discharge Visits | Through three months post-discharge | Number of participants that receive a comprehensive discharge follow-up visit from a community health worker |
| Post-Discharge Clinic Visits | Through three months post-discharge | Proportion of initial post-discharge visits to the HIV clinic that are attended by the participant's community health worker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Viral Load Suppression | 6 months post-discharge | Proportion of clients with suppressed HIV viral load at 6 months post-discharge. |
| Antiretroviral Therapy Clinic Visit | 1 month post-discharge | Antiretroviral therapy clinic visit within 1 month of discharge |
| Mortality | 6 months post-discharge | Proportion of clients alive at 6 months post-discharge. |
| Retention in HIV Care | 6 months post-discharge | 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 |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 97 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
Baseline characteristics
| Characteristic | Community Health Worker Post-Discharge Intervention |
|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 12.4 |
| CD4 <200 | 84 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 97 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Zambia | 97 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 97 |
| other Total, other adverse events | 0 / 97 |
| serious Total, serious adverse events | 28 / 97 |
Outcome results
Primary
Comprehensive Post-Discharge Visits
Number of participants that receive a comprehensive discharge follow-up visit from a community health worker
Time frame: Through three months post-discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community Health Worker Post-Discharge Intervention | Comprehensive Post-Discharge Visits | 67 Participants |
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
Time frame: Through three months post-discharge
Primary
Post-Discharge Visits
Proportion of discharged patients who are successfully visited after discharge.
Time frame: Through three months post-discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Community Health Worker Post-Discharge Intervention | Post-Discharge Visits | 92 Participants |
Secondary
Antiretroviral Therapy Clinic Visit
Antiretroviral therapy clinic visit within 1 month of discharge
Time frame: 1 month post-discharge
Secondary
HIV Viral Load Suppression
Proportion of clients with suppressed HIV viral load at 6 months post-discharge.
Time frame: 6 months post-discharge
Secondary
Mortality
Proportion of clients alive at 6 months post-discharge.
Time frame: 6 months post-discharge
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Community Health Worker Post-Discharge Intervention | Mortality | Confirmed Alive | 77 Participants |
| Community Health Worker Post-Discharge Intervention | Mortality | Confirmed Dead | 19 Participants |
| Community Health Worker Post-Discharge Intervention | Mortality | Lost to Follow Up | 1 Participants |
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
Time frame: 6 months post-discharge