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

NCT00144365 | Completed Phase 3

• 2 other identifiers: CDC-NCHSTP-43711U01PS000065-01
• Study Type: interventional
• Target: 1,453
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AIDS

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HIV viral load

Secondary Outcomes (7)

• Medication adherence

• Treatment failure

• Morbidity

• Survival

• Sexual behavior

Interventions

Antiretroviral therapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• British Medical Research Council: collaborator
• The AIDS Support Organization: collaborator

Study Sites (1)

The AIDS Support Organization

Jinja, Jinja, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexual Behavior

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Heiner Grosskurth, MD, PhD

  British Medical Research Council

  PRINCIPAL INVESTIGATOR

• Rebecca Bunnell, ScD, MEd

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Shabbar Jaffar, PhD

  London School of Tropical Medicine and Hygeine

  PRINCIPAL INVESTIGATOR

• Alex Coutinho, MBChB, MSc

  The AIDS Support Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

UG (1)