NCT01070017

Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,244 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV
• AIDS
• HIV Infections

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-07-31
• Completion: 2014-08-01
• First posted: 2010-02-17
• Last updated: 2017-10-25

Locations

1 site across 1 country: Peru