Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

HIV Infections Clinical Trial

— CASA  

Official title:

Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070017
• Other study ID #: 1R01MH083550-01A2
• Secondary ID: 1R01MH083550-01A
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2010
• Last updated: October 24, 2017
• Start date: February 2010
• Est. completion date: August 2014

Study information

• Verified date: October 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1244
• Est. completion date: August 2014
• Est. primary completion date: July 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• HIV
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Peru	Socios En Salud	Lima

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Harvard Medical School, Harvard School of Public Health, National Institute of Mental Health (NIMH), Partners in Health

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.		18 and 24 months
Secondary	Identify mediating mechanisms of CASA effect on individual outcomes.		24 months
Secondary	Identify subgroups who respond best to CASA intervention.		24 months