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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070017
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : October 25, 2017
National Institute of Mental Health (NIMH)
Partners in Health
Harvard School of Public Health
Harvard Medical School
Information provided by (Responsible Party):
Sonya Sunhi Shin, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
HIV AIDS HIV Infections Other: DOT-HAART Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Study Start Date : February 2010
Actual Primary Completion Date : July 31, 2012
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention: DOT-HAART
Intervention group will receive community-based monthly adherence visits, standard care, and 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.

Primary Outcome Measures :
  1. 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 Measures :
  1. Identify mediating mechanisms of CASA effect on individual outcomes. [ Time Frame: 24 months ]
  2. Identify subgroups who respond best to CASA intervention. [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01070017

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Socios En Salud
Lima, Peru
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Mental Health (NIMH)
Partners in Health
Harvard School of Public Health
Harvard Medical School
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Principal Investigator: Sonya Shin, MD, MPH Brigham and Women's Hospital
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Responsible Party: Sonya Sunhi Shin, Dr., Brigham and Women's Hospital Identifier: NCT01070017    
Other Study ID Numbers: 1R01MH083550-01A2 ( U.S. NIH Grant/Contract )
1R01MH083550-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Keywords provided by Sonya Sunhi Shin, Brigham and Women's Hospital:
Community based
social capital
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases