Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru (CASA)
Primary Purpose
HIV, AIDS, HIV Infections
Status
Completed
Phase
Phase 3
Locations
Peru
Study Type
Interventional
Intervention
DOT-HAART
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring Peru, DOT, HIV, AIDS, Community based, social capital
Eligibility 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
Sites / Locations
- Socios En Salud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention: DOT-HAART
No DOT-HAART
Arm Description
Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.
Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.
Outcomes
Primary Outcome Measures
Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.
Secondary Outcome Measures
Identify mediating mechanisms of CASA effect on individual outcomes.
Identify subgroups who respond best to CASA intervention.
Full Information
NCT ID
NCT01070017
First Posted
February 16, 2010
Last Updated
October 24, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH), Partners in Health, Harvard School of Public Health (HSPH), Harvard Medical School (HMS and HSDM)
1. Study Identification
Unique Protocol Identification Number
NCT01070017
Brief Title
Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Acronym
CASA
Official Title
Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 31, 2012 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Mental Health (NIMH), Partners in Health, Harvard School of Public Health (HSPH), Harvard Medical School (HMS and HSDM)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS, HIV Infections
Keywords
Peru, DOT, HIV, AIDS, Community based, social capital
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomization of sites assign individuals starting antiretroviral therapy to receive community-based directly observed therapy plus home visits / social support versus home visits / social support alone.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: DOT-HAART
Arm Type
Experimental
Arm Description
Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.
Arm Title
No DOT-HAART
Arm Type
No Intervention
Arm Description
Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.
Intervention Type
Other
Intervention Name(s)
DOT-HAART
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Identify mediating mechanisms of CASA effect on individual outcomes.
Time Frame
24 months
Title
Identify subgroups who respond best to CASA intervention.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonya Shin, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Socios En Salud
City
Lima
Country
Peru
12. IPD Sharing Statement
Learn more about this trial
Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
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