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

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: AIDS; HIV; HIV Infections

Treatments: Other: DOT-HAART

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01070017

1R01MH083550-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,244 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,244 participants in 2 patient groups

Intervention: DOT-HAART

Experimental group

Description:

Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.

Treatment:

Other: DOT-HAART

No DOT-HAART

No Intervention group

Description:

Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.