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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.
 
ClinicalTrials.gov Identifier: NCT01070017
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date  ICMJE February 16, 2010
First Posted Date  ICMJE February 17, 2010
Last Update Posted Date October 25, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date July 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
  • 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 ]
  • Compare social capital among community members in DOT-HAART versus control communities [ Time Frame: 12 months and study completion ]
  • Cost-effectiveness of community-based DOT-HAART. [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
  • Identify mediating mechanisms of CASA effect on individual outcomes. [ Time Frame: 24 months ]
  • Identify subgroups who respond best to CASA intervention. [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Official Title  ICMJE Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • HIV
  • AIDS
  • HIV Infections
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention: DOT-HAART
    Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.
    Intervention: Other: DOT-HAART
  • No Intervention: No DOT-HAART
    Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2010)
1244
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date July 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01070017
Other Study ID Numbers  ICMJE 1R01MH083550-01A2( U.S. NIH Grant/Contract )
1R01MH083550-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sonya Sunhi Shin, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Partners in Health
  • Harvard School of Public Health
  • Harvard Medical School
Investigators  ICMJE
Principal Investigator: Sonya Shin, MD, MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP