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Comparison of Facility and Home-based ART Delivery Systems in Uganda

NCT ID: NCT00144365

Last Updated: 2012-09-11

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

PHASE3

Total Enrollment

1453 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2010-12-31

Brief Summary

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The study is a 3-year, randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.

Detailed Description

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The study is a randomized trial to compare ART delivery through two different models: a) ART delivered through health facilities by clinically qualified staff and b) home-based care in which lay workers, i.e. non-medically qualified people, play a major role in the ART delivery and clients are followed up at health facilities less frequently. The primary objective is to measure the effects of these strategies on plasma HIV viral load. We will also examine the effects on treatment failure, disease progression, survival, adherence, family member HIV testing, sexual behavior, and cost-effectiveness.

The trial is conducted with The AIDS Support Organization (TASO) clinic in Jinja, Uganda. Randomization is conducted through geographic clusters, defined using sub-counties in the district, and stratified by distance from fixed health facilities, and urban/rural. Just over 800 participants, living in 40 clusters, will be recruited over a period of 3-6 months and followed-up over a period of 3 years.

Conditions

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AIDS

Keywords

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HIV Africa Adherence HIV viral load Sexual behavior Voluntary counseling and testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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Antiretroviral therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

HIV infection Plan to remain resident in the area for at least 12 months CD4 cell count \<200 cells/mm3 or severe symptomatic HIV (WHO stage 3 or 4) Identify a medicine companion who will assist in adherence to ART treatment Age 18 years or above.

Exclusion Criteria

Abnormal liver and renal function test results (AST or ALT ≥ 5x upper limit of normal Calculated creatinine clearance \< 25 ml/min). The tests are conducted only in individuals in whom they are clinically indicated
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Medical Research Council

OTHER_GOV

Sponsor Role collaborator

The AIDS Support Organization

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heiner Grosskurth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

British Medical Research Council

Rebecca Bunnell, ScD, MEd

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Shabbar Jaffar, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Tropical Medicine and Hygeine

Alex Coutinho, MBChB, MSc

Role: PRINCIPAL_INVESTIGATOR

The AIDS Support Organization

Locations

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The AIDS Support Organization

Jinja, Jinja, Uganda

Site Status

Countries

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Uganda

Other Identifiers

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1U01PS000065-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDC-NCHSTP-4371

Identifier Type: -

Identifier Source: org_study_id