Advanced HIV DiseaseARCNCT07720128
Advanced HIV Re-engagement in Care
A study testing ARC in people with Advanced HIV Disease, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
Adults who are hospitalized in Lusaka, Zambia, and found to have advanced HIV disease will be enrolled and randomly assigned to receive the ARC intervention or standard of care. All participants will then be followed through the end of the hospitalization and for up to 1 year after discharge from hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HIV Disease
- What is being tested?
- ARC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- 1 siteZambia
- Study dates
- 1 May 2027to 1 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Living with HIV
- Advanced HIV defined as CD4 <350 cells/mm3 or WHO stage 3 or 4 event
- Currently admitted to study hospital's internal medicine department
Who cannot join
- Planning to reside outside Lusaka after discharge
- Too sick to provide informed consent
- Known to have advanced cancer (defined as requiring chemo/radiation therapy or referred to hospice) other than Kaposi Sarcoma
- Known to have end stage kidney disease
- Known to have end stage liver disease
- No access to a telephone
- Currently incarcerated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zambia1 site
University Teaching Hospital
Lusaka
Lottie Hachaambwa, MBChB, 260976435603, lhachaambwa@cihebzambia.org
About this study
Adults who are hospitalized in Lusaka, Zambia, and found to have advanced HIV disease will be enrolled and randomly assigned to receive the ARC intervention or standard of care. All participants will then be followed through the end of the hospitalization and for up to 1 year after discharge from hospital.
Read the detailed description
The ARC intervention includes support from a community health worker that begins during admission and continues after discharge to address gaps in the care cascade for HIV and serious coinfections and comorbidities. ARC components were previously developed and pilot tested at hospitals in Zambia.
- Conditions
- Advanced HIV Disease
- Being tested
- ARC
- Keywords
- HIV/AIDS, Transitions of care, Hospitalization, Community Health Worker, Sub-Saharan Africa, Advanced HIV disease, Tuberculosis, Cryptococcus
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCBehavioural
ARC is a multi-component package of support delivered primarily by a community health worker. It is oriented towards the medical and psychosocial and sociobehavioral challenges of advanced HIV disease and hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Advanced HIV Re-engagement in Care (ARC) | Experimental | In this trial arm, participants will be provided with the ARC intervention package. Receives: Behavioral: ARC |
| Standard of Care (SOC) | No intervention | In this arm, participants will be managed according to the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Mortality will be ascertained as follows. All participants will receive monthly phone check-ins and if they don't respond a study staff member will trace their whereabouts in the community. This process will lead investigators to find out about deaths. In addition, investigators may be informed by a hospital staff member where a participant was admitted and died.
Measured: Enrollment to up to 1 year
Secondary outcomes (3)
HIV viral suppression
HIV RNA concentration in plasma
Measured: Enrollment, 3 months and 1 year
Retention in HIV care
No gap of >28 days without documented possession of antiretroviral therapy medications
Measured: At 3 months and 1 year
Medication possession ratio
Number of days with possession of antiretroviral medications divided by the time interval of interest
Measured: At 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 May 2027 (estimated)
- Primary completion1 May 2031 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced HIV DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- ARC is a multi-component intervention. Clients are linked to a community health worker (CHW) who provides support with healthcare navigation, psychosocial support, health education, and support with adherence to medications. This support begins during hospital admission and continues for 3-6 months after discharge. At discharge, a discharge card is provided to clients and care givers to enhance awareness among clients and staff of the problem list, prescribed medications, and follow-up appointments. After discharge, the client's assigned CHW reinforces the discharge plan and monitor client recovery via home visits, which also includes an assessment of vital and warning signs, medication adherence checks, and phone reminders. CHWs are supported by clinicians at the discharging hospital for issues of medication management and readmission to hospital as needed. Clinicians and CHWs meet periodically at the discharging hospital to discuss active clients and findings from home visits.
- Masking
- None (open label)
- Enrolment
- 724 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Ciheb Zambia, University of Maryland, Baltimore
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
- Investigators
- Lottie Hachaambwa, MBChB, Principal investigator, Ciheb ZambiaCassidy Claassen, MD, Principal investigator, University of Maryland, BaltimoreMichael J Vinikoor, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720128
- Sponsor's protocol ID
- IRB-300017004
- Acronym
- ARC
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD is likely to be shared; however, at this time, certain details still need to be clarified in order to align with both sponsor requirements and new data sharing laws in Zambia. Please contact the PIs for more information if required.
Publications
Bwalya C, Stoebenau K, Muchanga G, Mwale M, Maambo C, Banda S, Halwiindi P, Mwango LK, Baumhart C, Mbewe N, Mwitumwa M, Mulenga P, Charurat M, Mutale W, Vinikoor MJ, Claassen CW. Hospitalized with HIV in Zambia: individual and system factors driving the high burden of admissions and post-discharge mortality in the era of HIV epidemic control. AIDS Res Ther. 2025 Feb 24;22(1):22. doi: 10.1186/s12981-024-00689-2.
PubMed 39994735Mbewe N, Vinikoor MJ, Fwoloshi S, Mwitumwa M, Lakhi S, Sivile S, Yavatkar M, Lindsay B, Stafford K, Hachaambwa L, Mulenga L, Claassen CW. Advanced HIV disease management practices within inpatient medicine units at a referral hospital in Zambia: a retrospective chart review. AIDS Res Ther. 2022 Feb 22;19(1):10. doi: 10.1186/s12981-022-00433-8.
PubMed 35193598Ford N, Ehrenkranz P, Jarvis J. Advanced HIV as a Neglected Disease. N Engl J Med. 2024 Feb 8;390(6):487-489. doi: 10.1056/NEJMp2313777. Epub 2024 Feb 3. No abstract available.
PubMed 38314820
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced HIV Re-engagement in Care
- ClinicalTrials.gov ID
- NCT07720128
- Acronym / sponsor ID
- ARC / IRB-300017004
- Conditions
- Advanced HIV Disease
- Keywords
- HIV/AIDS, Transitions of care, Hospitalization, Community Health Worker, Sub-Saharan Africa, Advanced HIV disease, Tuberculosis, Cryptococcus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 724 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Ciheb Zambia, University of Maryland, Baltimore
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adults who are hospitalized in Lusaka, Zambia, and found to have advanced HIV disease will be enrolled and randomly assigned to receive the ARC intervention or standard of care. All participants will then be followed through the end of the hospitalization and for up to 1 year after discharge from hospital.
Detailed description
The ARC intervention includes support from a community health worker that begins during admission and continues after discharge to address gaps in the care cascade for HIV and serious coinfections and comorbidities. ARC components were previously developed and pilot tested at hospitals in Zambia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ARC is a multi-component intervention. Clients are linked to a community health worker (CHW) who provides support with healthcare navigation, psychosocial support, health education, and support with adherence to medications. This support begins during hospital admission and continues for 3-6 months after discharge. At discharge, a discharge card is provided to clients and care givers to enhance awareness among clients and staff of the problem list, prescribed medications, and follow-up appointments. After discharge, the client's assigned CHW reinforces the discharge plan and monitor client recovery via home visits, which also includes an assessment of vital and warning signs, medication adherence checks, and phone reminders. CHWs are supported by clinicians at the discharging hospital for issues of medication management and readmission to hospital as needed. Clinicians and CHWs meet periodically at the discharging hospital to discuss active clients and findings from home visits.
| Arm | Type | Receives |
|---|---|---|
| Advanced HIV Re-engagement in Care (ARC) | Experimental | Behavioral: ARCIn this trial arm, participants will be provided with the ARC intervention package. |
| Standard of Care (SOC) | No intervention | –In this arm, participants will be managed according to the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Living with HIV
- Advanced HIV defined as CD4 <350 cells/mm3 or WHO stage 3 or 4 event
- Currently admitted to study hospital's internal medicine department
Key exclusion criteria (7 listed)
- Planning to reside outside Lusaka after discharge
- Too sick to provide informed consent
- Known to have advanced cancer (defined as requiring chemo/radiation therapy or referred to hospice) other than Kaposi Sarcoma
- Known to have end stage kidney disease
- Known to have end stage liver disease
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 |
|---|---|---|
| ARCARC is a multi-component package of support delivered primarily by a community health worker. It is oriented towards the medical and psychosocial and sociobehavioral challenges of advanced HIV disease and hospitalization. | Behavioural | Advanced HIV Re-engagement in Care (ARC) |
Primary outcome
All-cause mortality
Time frame: Enrollment to up to 1 year
Mortality will be ascertained as follows. All participants will receive monthly phone check-ins and if they don't respond a study staff member will trace their whereabouts in the community. This process will lead investigators to find out about deaths. In addition, investigators may be informed by a hospital staff member where a participant was admitted and died.
3 secondary outcomes
HIV viral suppression
Time frame: Enrollment, 3 months and 1 year
Retention in HIV care
Time frame: At 3 months and 1 year
Medication possession ratio
Time frame: At 3 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 39994735Bwalya C, Stoebenau K, Muchanga G, Mwale M, Maambo C, Banda S, Halwiindi P, Mwango LK, Baumhart C, Mbewe N, Mwitumwa M, Mulenga P, Charurat M, Mutale W, Vinikoor MJ, Claassen CW. Hospitalized with HIV in Zambia: individual and system factors driving the high burden of admissions and post-discharge mortality in the era of HIV epidemic control. AIDS Res Ther. 2025 Feb 24;22(1):22. doi: 10.1186/s12981-024-00689-2.
- Background: PubMed 35193598Mbewe N, Vinikoor MJ, Fwoloshi S, Mwitumwa M, Lakhi S, Sivile S, Yavatkar M, Lindsay B, Stafford K, Hachaambwa L, Mulenga L, Claassen CW. Advanced HIV disease management practices within inpatient medicine units at a referral hospital in Zambia: a retrospective chart review. AIDS Res Ther. 2022 Feb 22;19(1):10. doi: 10.1186/s12981-022-00433-8.
- Background: PubMed 38314820Ford N, Ehrenkranz P, Jarvis J. Advanced HIV as a Neglected Disease. N Engl J Med. 2024 Feb 8;390(6):487-489. doi: 10.1056/NEJMp2313777. Epub 2024 Feb 3. No abstract available.
- Individual participant dataSharing planned: Undecided. IPD is likely to be shared; however, at this time, certain details still need to be clarified in order to align with both sponsor requirements and new data sharing laws in Zambia. Please contact the PIs for more information if required.
Related trials for Advanced HIV Disease
RecruitingPhase 1/2
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
Kaposi Sarcoma
Not yet recruitingObservational study
Tenofovir Exposures in Advanced Kidney Disease Study
Tenofovir, Tenofovir Alafenamide Fumarate
Not yet recruitingPhase 3
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
Cryptococcal Antigenemia, HIV-1-infection
Active, not recruitingPhase 1
Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma
Kaposi Sarcoma
Active, not recruitingPhase 1
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
Advanced Differentiated Thyroid Gland Carcinoma, Advanced Head and Neck Carcinoma
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.
Lottie Hachaambwa, MBChB principal investigator
Ciheb Zambia
Cassidy Claassen, MD principal investigator
University of Maryland, Baltimore
Michael J Vinikoor, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARC in people with Advanced HIV Disease, run by University of Alabama at Birmingham at 1 site 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J Vinikoor, MD (205-996-2416, mjv3@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Enrollment to up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07720128, which also lists 3 linked publications.
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 23 Jul 2026.