Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru (CASA)
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|ClinicalTrials.gov Identifier: NCT01070017|
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV AIDS HIV Infections||Other: DOT-HAART||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1244 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||July 31, 2012|
|Actual Study Completion Date :||August 2014|
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.
- 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 ]
- Identify mediating mechanisms of CASA effect on individual outcomes. [ Time Frame: 24 months ]
- Identify subgroups who respond best to CASA intervention. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070017
|Socios En Salud|
|Principal Investigator:||Sonya Shin, MD, MPH||Brigham and Women's Hospital|