Developing and Assessing a Community Based Model of Antiretroviral Care

NCT02337504 | Unknown DMC

• 1 other identifier: GH000765
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tremendous efforts and resources have been expended by the global community to ensure that antiretroviral therapy (ART) is available and accessible to all that need it. Despite these, less than a half of Human Immunodeficiency Virus (HIV)-infected patients requiring ART in sub-Saharan Africa (SSA) are receiving it. Some of the most significant barriers to attaining universal access to ART in this region include large distances that patients have to travel to clinic, time spent in accessing care and a significant shortage of human resources. In order to address these challenges the World Health Organization (WHO) advocates alternative care models especially those that incorporate task-shifting to lower cadre health care workers and lay persons. Unfortunately, few such alternative care models have been identified and very little data exist on their long-term outcomes. With this project we will develop and assess an alternative care model that is established on the platform of a HIV-infected peer-group (ART Co-op) and facilitated by community health workers (CHW's). This model of care is intended to decentralize ART services and bring them closer to the patients. Specifically, we will:

1. 1.Develop an acceptable and sustainable model for extending HIV care and treatment into the community.
2. 2.Perform a pilot study comparing the outcomes of patients enrolled in the ART Co-ops program to those receiving standard of care.
3. 3.Determine the cost savings and cost effectiveness of ART Co-ops.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• ART durability

  Durability of ART regimen (ART failure). This is defined as the need to change ART regimens based on clinical (new or recurrent WHO 3 or 4 event), immunologic (CD4 count\< pre-ART; ≥50% CD4 decrease from peak; persistent CD4\<100) or virologic failure (VL\>10,000 copies/mL). Durability of the patient's ART regimen (requiring no change to second line for failure) will remain equivalent to those seen in clinic regularly.

  48 weeks

Secondary Outcomes (4)

• Retention in care

  48 weeks

• HIV VL (copies/mL)

  48 weeks

• Quality of life

  48 weeks

• stigma

  48 weeks

Study Arms (2)

clinic-based care

NO INTERVENTION

Will receive HIV care at the clinic from the nurses and clinical officer on their regular schedule

Community-based care

ACTIVE COMPARATOR

Will receive HIV care in their community from a community health worker every month as part of a group of 6-10 people

Other: community-based care

Interventions

community-based care OTHER

Will receive HIV care in the community and not in the clinic which is the normal standard of care

Community-based care

Eligibility Criteria

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

You may qualify if:

• HIV-infected
• ≥18 years old
• Have a current cluster of differentiation 4 (CD4)count ≥200cells/µl
• Have an undetectable VL
• Are clinically stable on ART for ≥ 6 months
• A resident of a sub-location within the AMPATH Kitale clinic catchment area
• Are willing to consent to participate

You may not qualify if:

• Pregnant
• Active opportunistic infection (OI)
• Unable to consent for study participation due to physical or mental incapacity

Sponsors & Collaborators

• Moi University: lead
• Centers for Disease Control and Prevention: collaborator

MeSH Terms

Interventions

Delivery of Health Care

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Abraham M Siika, MD,MMED,MS

  Moi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abraham M Siika, MD,MMED,MS

CONTACT

(+254) 532033471; amsiika@africaonline.co.ke

Suzanne Goodrich, MD,MS

CONTACT

(+254) 532033471; spgoodri@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 13, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2015

Record last verified: 2015-01