A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia

Study Overview
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Brief Summary
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The purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of ART delivery to the standard of care in an urban setting in Zambia.

Detailed Description
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The outcomes of this study will be measured in a prospective cohort of adult patients enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial. The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive ART care in the community every 3 months, and 2) home-based ART delivery in which a community health worker delivers ART care to an individual at home every 3 months. The standard of care is delivery of ART care at the local clinic.

Official Title
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A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Community Adherence Clubs
* Other: Home-Based ART Delivery
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older On first-line ART and retained in care for more than 6 months Virologically suppressed World Health Organization (WHO) stage I and II at time of screening Reside within the clinic catchment area Willing to provide written informed consent and accept Community HIV-care Provider (CHiPs) intervention Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community Adherence Clubs<br>ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker to a club meeting of 20-25 HIV+ patients every three months, with two clinic visits every year for clinical review and laboratory monitoring | Other: Community Adherence Clubs<br>* Provision of ART care in the community to a club of 20-25 HIV+ patients<br>|
| Experimental: Home-Based ART Delivery<br>Individuals receive ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker at their household every three months, with two clinic visits every year for clinical review and laboratory monitoring | Other: Home-Based ART Delivery<br>* Provision of ART care to an individual at their home<br>|
| Other: Standard of Care<br>Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines. | Other: Standard of Care<br>* Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | Viral suppression at 12 months measured using the standard of care viral load testing equipment currently in place. Viral suppression will be defined according to National guidelines. | One year after beginning participation in the program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral suppression at 24 months | Undetectable HIV viral load 24 months after entry into the models of care. This will be done as part of routine laboratory monitoring and measured using routine programmatic data. | Two years after beginning participation in the program |