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Completed

NCT Number: NCT01070017

Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Identify mediating mechanisms of CASA effect on individual outcomes.

    Time frame: 24 months

  2. Identify subgroups who respond best to CASA intervention.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • Harvard School of Public Health (HSPH)
  • National Institute of Mental Health (NIMH)
  • Partners in Health

Registry information

Acronym: CASA

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Feb 17, 2010
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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