Village-based vs Clinic-based ART Care - a Cluster Randomized Controlled Trial in Lesotho

Summary

This cluster-randomized trial tests a differentiated care model for HIV-positive individuals not on ART during a home-based HIV testing campaign in rural Lesotho, Southern Africa. In intervention clusters, patients are offered a differentiated ART delivery package with two features. Firstly, drug-refill and follow-up are provided by village health workers (VHW), reducing clinic visits to twice a year for laboratory assessment. Secondly, participants have the option of receiving individually tailored adherence reminders and viral load result notifications via SMS.

Conditions

• HIV/AIDS

Interventions

OTHER

Standard of Care

Clinic-based HIV care

OTHER

Village-based ART refill

Option to get ART refill and care by the village health worker

Sponsors & Collaborators

• Ministry of Health, Lesotho

  collaborator OTHER_GOV

• SolidarMed

  collaborator OTHER

• University of Basel

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Niklaus Labhardt

  lead OTHER

Principal Investigators

• Niklaus D Labhardt, MD · University Hospital Basel & Swiss Tropical and Public Health Institute

• Tracy R Glass, PhD · Swiss Tropical & Public Health Institute

• Manuel Battegay, MD · University Hospital, Basel, Switzerland

• Josephine Muhairwe, MD · SolidarMed - Swiss Organization for Health in Africa

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-16

Primary Completion

2020-12-08

Completion

2020-12-08

Countries

• Lesotho

Study Locations