HIV Infections
Conditions
Brief summary
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
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.
Interventions
OTHERCommunity Adherence Clubs
Provision of ART care in the community to a club of 20-25 HIV+ patients
OTHERHome-Based ART Delivery
Provision of ART care to an individual at their home
OTHERStandard of Care
Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.
Sponsors
HIV Prevention Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | One year after beginning participation in the program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression at 24 months | Two years after beginning participation in the program | 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. |
Countries
Zambia
Outcome results
None listed