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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-07-22

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.

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Community Adherence Clubs

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

Group Type EXPERIMENTAL

Community Adherence Clubs

Intervention Type OTHER

Provision of ART care in the community to a club of 20-25 HIV+ patients

Home-Based ART Delivery

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

Group Type EXPERIMENTAL

Home-Based ART Delivery

Intervention Type OTHER

Provision of ART care to an individual at their home

Standard of Care

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

Group Type OTHER

Standard of Care

Intervention Type OTHER

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

Interventions

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Community Adherence Clubs

Provision of ART care in the community to a club of 20-25 HIV+ patients

Intervention Type OTHER

Home-Based ART Delivery

Provision of ART care to an individual at their home

Intervention Type OTHER

Standard of Care

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

Intervention Type OTHER

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