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

Primary Purpose

HIV Infections

Status

Completed

Phase

Not Applicable

Locations

Zambia

Study Type

Interventional

Intervention

Community Adherence Clubs

Home-Based ART Delivery

Standard of Care

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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:

Sites / Locations

Zambart

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Community Adherence Clubs

Home-Based ART Delivery

Standard of Care

Arm 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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03025165

First Posted

January 17, 2017

Last Updated

August 25, 2022

Sponsor

HIV Prevention Trials Network

1. Study Identification

Unique Protocol Identification Number

NCT03025165

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2017 (Actual)

Primary Completion Date

July 22, 2019 (Actual)

Study Completion Date

July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HIV Prevention Trials Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2526 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Community Adherence Clubs

Arm Type

Experimental

Arm Description

Arm Title

Home-Based ART Delivery

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Community Adherence Clubs

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Home-Based ART Delivery

Intervention Description

Provision of ART care to an individual at their home

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

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

Primary Outcome Measure Information:

Title

Viral Suppression

Description

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.

Time Frame

One year after beginning participation in the program

Secondary Outcome Measure Information:

Title

Viral suppression at 24 months

Description

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.

Time Frame

Two years after beginning participation in the program

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed Limbada, MBCHB, MScID

Organizational Affiliation

Zambart

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zambart

City

Lusaka

Country

Zambia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34843674

Citation

Limbada M, Macleod D, Situmbeko V, Muhau E, Shibwela O, Chiti B, Floyd S, Schaap AJ, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) study team. Rates of viral suppression in a cohort of people with stable HIV from two community models of ART delivery versus facility-based HIV care in Lusaka, Zambia: a cluster-randomised, non-inferiority trial nested in the HPTN 071 (PopART) trial. Lancet HIV. 2022 Jan;9(1):e13-e23. doi: 10.1016/S2352-3018(21)00242-3. Epub 2021 Nov 26.

Results Reference

derived

PubMed Identifier

33430928

Citation

Limbada M, Bwalya C, Macleod D, Floyd S, Schaap A, Situmbeko V, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study. Trials. 2021 Jan 12;22(1):52. doi: 10.1186/s13063-020-05010-w.

Results Reference

derived

Learn more about this trial

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

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