Health Trials

Advanced HIV Re-engagement in Care

ConditionAdvanced HIV Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ARC

    Behavioral

    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.

Treatment groups

724 Participants
are divided into 2 treatment groups
Group A: Advanced HIV Re-engagement in Care (ARC)Experimental treatment 1 intervention
Group B: Standard of Care (SOC)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Enrollment to up to 1 year

Secondary outcomes

1

HIV viral suppression

HIV RNA concentration in plasma

Time frame
Enrollment, 3 months and 1 year
2

Retention in HIV care

No gap of \>28 days without documented possession of antiretroviral therapy medications

Time frame
At 3 months and 1 year
3

Medication possession ratio

Number of days with possession of antiretroviral medications divided by the time interval of interest

Time frame
At 3 months and 12 months

Other outcomes

Sponsors and contacts

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University of Alabama at Birmingham

Lead sponsor

Ciheb Zambia

Collaborator

University of Maryland, Baltimore

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: