This trial is active, not recruiting.

Conditions hiv, aids, hiv infections
Treatment dot-haart
Phase phase 3
Sponsor Brigham and Women's Hospital
Collaborator National Institute of Mental Health (NIMH)
Start date February 2010
End date August 2014
Trial size 1244 participants
Trial identifier NCT01070017, 1-R01-MH-083550-01A2, 1R01MH083550-01A2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
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)
Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.

Primary Outcomes

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
Compare social capital among community members in DOT-HAART versus control communities
time frame: 12 months and study completion
Cost-effectiveness of community-based DOT-HAART.
time frame: 24 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
Principal investigator Sonya Shin, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.