Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01070017

Acronym

CASA

Enrollment

1244

Registered

2010-02-17

Start date

2010-02-28

Completion date

2014-08-31

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV, HIV Infections

Keywords

Peru, DOT, HIV, AIDS, Community based, social capital

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.

Interventions

OTHERDOT-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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.	18 and 24 months

Secondary

Measure	Time frame
Identify mediating mechanisms of CASA effect on individual outcomes.	24 months
Identify subgroups who respond best to CASA intervention.	24 months

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026