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

HIV Prevention Trials Network

Status: Completed

Conditions: HIV Infections

Treatments: Other: Standard of Care; Other: Community Adherence Clubs; Other: Home-Based ART Delivery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03025165

HPTN 071c

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,526 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,526 participants in 3 patient groups

Community Adherence Clubs

Experimental group

Description:

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

Treatment:

Other: Community Adherence Clubs

Home-Based ART Delivery

Experimental group

Description:

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

Treatment:

Other: Home-Based ART Delivery

Standard of Care

Other group

Description:

Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.

Treatment:

Other: Standard of Care