Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Brigham and Women's Hospital1,244 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

1,244

Conditions

HIV AIDS HIV Infections

Interventions

DOT-HAARTOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Socios En Salud

Lima, Peru

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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