Clinical trial NCT01070017: Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Official title: Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
AIDS
HIV Infections
Keywords: Peru
DOT
HIV
AIDS
Community based
social capital
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Partners in Health
name: Harvard School of Public Health (HSPH)
name: Harvard Medical School (HMS and HSDM)
First posted: 2010-02-17
Enrollment: 1244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.
timeFrame: 18 and 24 months
Secondary outcomes:
measure: Identify mediating mechanisms of CASA effect on individual outcomes.
timeFrame: 24 months
measure: Identify subgroups who respond best to CASA intervention.
timeFrame: 24 months
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Socios En Salud
Study officials:
affiliation: Brigham and Women's Hospital
name: Sonya Shin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: