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Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru (CASA)

This study is currently recruiting participants.
Verified June 2012 by Brigham and Women's Hospital
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Partners In Health
Harvard School of Public Health
Harvard University
Information provided by (Responsible Party):
Sonya Sunhi Shin, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01070017
First received: February 16, 2010
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru.


Condition Intervention Phase
HIV
AIDS
HIV Infections
 Other: DOT-HAART
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group. [ Time Frame: 18 and 24 months ] [ Designated as safety issue: No ]
  • Compare social capital among community members in DOT-HAART versus control communities [ Time Frame: 12 months and study completion ] [ Designated as safety issue: No ]
  • Cost-effectiveness of community-based DOT-HAART. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify mediating mechanisms of CASA effect on individual outcomes. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Identify subgroups who respond best to CASA intervention. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1244
Study Start Date: February 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention: DOT-HAART
Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.
 Other: DOT-HAART
For 8 months, DOT-HAART of all doses in the participant's home or alternate location. DOT worker ensures that HIV medications are taken as indicated and witnesses ingestion of all medications including other medications prescribed by physician. The worker will be trained to identify, triage and notify providers of any psychosocial and medical problems/complications. Transition to self-administration begins in months 9-12 when DOT will be tapered and greater participation of treatment supporter to prepare patients for self-administration.
No Intervention: No DOT-HAART
Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.

Detailed Description:

Community-based accompaniment with directly observed antiretroviral therapy (DOT-HAART) may improve adherence and clinical outcomes among impoverished individuals starting HAART in resource-poor settings. Furthermore, the utilization of community health workers may build social capital. This is cluster-randomized trial, with randomization at the level of health centers. Individuals in both intervention and control clusters will receive community-based adherence support (monthly adherence visits) and standard care. In addition, individuals residing in intervention clusters will receive 12 months of community-based DOT-HAART. We will enroll patients as well as community members (health providers, treatment supporters, and community health workers) to assess individual and community-level outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Patient Cohort:

  • Age greater than or equal to 18;
  • Diagnosis if HIV and meeting criteria for HAART;
  • Lives in poverty;
  • EITHER: 1) HAART naïve or 2) starting salvage therapy due to virologic failure;
  • Documentation of baseline CD4 cell count and HIV load;
  • Residence and receipt of HIV healthcare within the study catchment area

Exclusion Criteria for Patient Cohort:

- Imprisoned or cannot give informed consent.

Inclusion Criteria for Community Cohort:

  • Working in a health establishments in study region;
  • If health personnel, contracted employee caring for people living with HIV/AIDS.

Exclusion Criteria for Community Cohort:

- Cannot give informed consent

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070017

Contacts
Contact: Sonya Shin, MD, MPH sshin@partners.org
Contact: Adolfo Caldas, MSW 617-432-6948 acaldas@partners.org

Locations
Peru
Socios En Salud Recruiting
Lima, Peru
Contact: Maribel Munoz, RN     011-51-547-0999        
Principal Investigator: Jaime Bayona, MD, MPH            
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Mental Health (NIMH)
Partners In Health
Harvard School of Public Health
Harvard University
Investigators
Principal Investigator: Sonya Shin, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Sonya Sunhi Shin, Dr., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01070017     History of Changes
Other Study ID Numbers: 1-R01-MH-083550-01A2, 1R01MH083550-01A2
Study First Received: February 16, 2010
Last Updated: June 26, 2012
Health Authority: United States: Federal Government
Peru: Ministry of Health
Peru: Instituto Nacional de Salud

Keywords provided by Brigham and Women's Hospital:
Peru
DOT
HIV
 AIDS
Community based
social capital

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013