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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Partners In Health
Harvard School of Public Health
Harvard Medical School
Information provided by (Responsible Party):
Sonya Sunhi Shin, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01070017
First received: February 16, 2010
Last updated: July 31, 2013
Last verified: July 2013

February 16, 2010
July 31, 2013
February 2010
August 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01070017 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • HIV
  • AIDS
  • HIV Infections
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.
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1244
August 2014
August 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT01070017
1-R01-MH-083550-01A2, 1R01MH083550-01A2
Yes
Sonya Sunhi Shin, Brigham and Women's Hospital
Brigham and Women's Hospital
  • National Institute of Mental Health (NIMH)
  • Partners In Health
  • Harvard School of Public Health
  • Harvard Medical School
Principal Investigator: Sonya Shin, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
July 2013

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