HIV/AIDSReCharge2NCT05694546
Re-engagement at Discharge 2
A study testing Community Health Worker Post-Discharge Intervention in people with HIV/AIDS and Hospitalization, run by University of Maryland, Baltimore at 2 sites in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Hospitalization, Transitions of Care
- What is being tested?
- Community Health Worker Post-Discharge Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesZambia
- Study dates
- 18 Aug 2023to 13 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to provide informed consent
- No phone
- Planning to reside outside of Lusaka urban district after discharge
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Levy Mwanawasa University Teaching Hospital
Lusaka
University Teaching Hospital
Lusaka
About this study
Official title: Re-engagement at Discharge 2: Improving Post-hospital Outcomes for Adults With HIV in Zambia
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.
Read the 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.
- Being tested
- Community Health Worker Post-Discharge Intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker Post-Discharge InterventionBehavioural
Clients will be offered a community-based follow-up from a community health worker after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Post-Discharge Intervention | Experimental | This group will be offered a community-based visit from a community health worker following hospital discharge. Receives: Behavioral: Community Health Worker Post-Discharge Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Discharge Visits
Proportion of discharged patients who are successfully visited after discharge.
Measured: 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
Measured: 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
Measured: Through three months post-discharge
Secondary outcomes (4)
HIV Viral Load Suppression
Proportion of clients with suppressed HIV viral load at 6 months post-discharge.
Measured: 6 months post-discharge
Mortality
Proportion of clients alive at 6 months post-discharge.
Measured: 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
Measured: 6 months post-discharge
Antiretroviral Therapy Clinic Visit
Antiretroviral therapy clinic visit within 1 month of discharge
Measured: 1 month post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start18 Aug 2023
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Community health worker follow-up after discharge from hospital
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia, University of Alabama at Birmingham, University of Maryland, College Park
- Responsible party
- Principal investigator, Cassidy Claassen, University of Maryland, Baltimore
- Investigators
- Cassidy Claassen, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694546
- Sponsor's protocol ID
- R34MH122265
- Acronym
- ReCharge2
- Status last verified
- Aug 2025
- First submitted
- 7 Jan 2022
- Last updated
- 7 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-engagement at Discharge 2: Improving Post-hospital Outcomes for Adults With HIV in Zambia
- ClinicalTrials.gov ID
- NCT05694546
- Acronym / sponsor ID
- ReCharge2 / R34MH122265
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia, University of Alabama at Birmingham, University of Maryland, College Park
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Community health worker follow-up after discharge from hospital
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Post-Discharge Intervention | Experimental | Behavioral: Community Health Worker Post-Discharge InterventionThis group will be offered a community-based visit from a community health worker following hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- No phone
- Planning to reside outside of Lusaka urban district after discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker Post-Discharge InterventionClients will be offered a community-based follow-up from a community health worker after hospital discharge. | Behavioural | Community Health Worker Post-Discharge Intervention |
Primary outcome
Post-Discharge Visits
Time frame: Through three months post-discharge
Proportion of discharged patients who are successfully visited after discharge.
Comprehensive Post-Discharge Visits
Time frame: 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
Time frame: 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
4 secondary outcomes
HIV Viral Load Suppression
Time frame: 6 months post-discharge
Mortality
Time frame: 6 months post-discharge
Retention in HIV Care
Time frame: 6 months post-discharge
Antiretroviral Therapy Clinic Visit
Time frame: 1 month post-discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassidy Claassen, MD principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Post-Discharge Intervention in people with HIV/AIDS and Hospitalization, run by University of Maryland, Baltimore at 2 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Discharge Visits (time frame: Through three months post-discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.