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Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

NCT ID: NCT01070017

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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HIV AIDS HIV Infections

Keywords

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Peru DOT HIV AIDS Community based social capital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention: DOT-HAART

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

Group Type EXPERIMENTAL

DOT-HAART

Intervention Type OTHER

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.

No DOT-HAART

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* Working in a health establishments in study region;
* If health personnel, contracted employee caring for people living with HIV/AIDS.

Exclusion Criteria

\- Imprisoned or cannot give informed consent.


\- Cannot give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Partners in Health

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sonya Sunhi Shin

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sonya Shin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Socios En Salud

Lima, , Peru

Site Status

Countries

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Peru

Other Identifiers

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1R01MH083550-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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1R01MH083550-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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