Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Conditions
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HIV, AIDS, HIV Infections

Intervention / Treatment
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* Other: DOT-HAART


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: DOT-HAART<br>Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART. | Other: DOT-HAART<br>* 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.<br>|
| No Intervention: No DOT-HAART<br>Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify mediating mechanisms of CASA effect on individual outcomes. |  | 24 months | 
| Identify subgroups who respond best to CASA intervention. |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peru, DOT, HIV, AIDS, Community based, social capital