Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru (CASA)
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru|
- 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 ] [ Designated as safety issue: No ]
- Compare social capital among community members in DOT-HAART versus control communities [ Time Frame: 12 months and study completion ] [ Designated as safety issue: No ]
- Cost-effectiveness of community-based DOT-HAART. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Identify mediating mechanisms of CASA effect on individual outcomes. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Identify subgroups who respond best to CASA intervention. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Intervention: DOT-HAART
Intervention group will receive community-based monthly adherence visits, standard care, and 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.
No Intervention: No DOT-HAART
Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070017
|Socios En Salud|
|Principal Investigator:||Sonya Shin, MD, MPH||Brigham and Women's Hospital|