Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

NCT01070017 | Completed Phase 3 DMC

• 1 other identifier: 1R01MH083550-01A2
• Study Type: interventional
• Target: 1,244
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; AIDS; HIV Infections

Keywords

Peru; DOT; HIV; AIDS; Community based; social capital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identify mediating mechanisms of CASA effect on individual outcomes.

  24 months

• Identify subgroups who respond best to CASA intervention.

  24 months

Study Arms (2)

Intervention: DOT-HAART

EXPERIMENTAL

Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.

Other: DOT-HAART

No DOT-HAART

NO INTERVENTION

Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.

Interventions

DOT-HAART OTHER

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.

Intervention: DOT-HAART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Imprisoned or cannot give informed consent.
• Working in a health establishments in study region;
• If health personnel, contracted employee caring for people living with HIV/AIDS.
• \- Cannot give informed consent

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Partners in Health: collaborator
• Harvard School of Public Health (HSPH): collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Socios En Salud

Lima, Peru

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sonya Shin, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: July 31, 2012
• Study Completion: August 1, 2014
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

PE (1)