ENhance Initiation and Retention in Isoniazid Preventive Therapy (IPT) Care for HIV Study (ENRICH Study)
Status:
Completed
Trial end date:
2021-05-07
Target enrollment:
Participant gender:
Summary
The purpose of the ENRICH study is to evaluate a combination intervention package (CIP)
designed to improve implementation of Isoniazid Preventive Therapy (IPT) among people living
with HIV (PLWH) in Ethiopia. The study is a two-arm cluster randomized trial, randomized at
the HIV clinic level, which includes 10 HIV clinics in Dire Dawa and Harari, Ethiopia.
Clinics are randomized to deliver the combination intervention package (CIP) or standard of
care (SOC), with stratification by facility size (<80 or >80 patients enrolled in HIV care
per year). The experimental intervention will be delivered to all patients in HIV clinics
randomly assigned to CIP who initiated HIV care at the CIP site on or after January 1, 2013
and initiated IPT on or after date of study initiation, July 1, 2013. In HIV clinics assigned
to SOC, usual care procedures for provision of IPT will be delivered.
Study Aims and Hypotheses
Aim 1. Characterize and compare the effectiveness of a combination intervention package with
standard of care for IPT provision in Ethiopia.
Hypothesis 1.1: IPT initiation for new patients enrolling in HIV care at CIP clinics will be
higher than that for newly enrolled patients at SOC clinics.
Hypothesis 1.2: Adherence to and completion of IPT for participants initiating IPT at CIP
clinics will be higher than that for those initiating IPT at SOC clinics.
Aim 1a. Assess acceptability of CIP among participants enrolled in HIV care and healthcare
providers at CIP clinics. Acceptability will include: 1) perceived barriers and facilitators
of uptake and delivery of the intervention package among healthcare providers, and 2)
acceptability and utilization of intervention components as well as the overall intervention
package among IPT initiators and non-initiators.
Aim 2. Assess the impact of CIP compared with SOC on HIV-related outcomes.
Hypothesis 2: HIV-related outcomes for participants receiving IPT at CIP clinics will be
superior to outcomes in participants receiving care at SOC clinics. HIV-related outcomes to
be assessed include retention in care and, among those participants receiving antiretroviral
therapy (ART), adherence to ART and CD4+ count.
Aim 3. Assess the safety and tolerability of IPT among HIV-infected individuals under routine
program conditions in Ethiopia.
Aim 4. Identify patient and program characteristics associated with IPT adherence and
completion at SOC sites.
Hypothesis 4.1: IPT adherence and completion will be associated with modifiable patient
characteristics, including ART status; knowledge and attitudes about IPT; and social support.
Hypothesis 4.2: IPT adherence and completion will be associated with modifiable program
characteristics, including provider/patient ratio, patient tracking, and patient support
groups.
Phase:
N/A
Details
Lead Sponsor:
Columbia University
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)