Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

Phase 3

Completed

• Conditions: HIV; AIDS; HIV Infections
• Interventions: Other: DOT-HAART

• Registration Number: NCT01070017
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2012-07-31
• Study Completion: 2014-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1244

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Identify mediating mechanisms of CASA effect on individual outcomes.	24 months
Identify subgroups who respond best to CASA intervention.	24 months

Trial Locations

Locations (1)

Socios En Salud; 🇵🇪 Lima, Peru