ENhance Initiation and Retention in Isoniazid Preventive Therapy (IPT) Care for HIV Study (ENRICH Study)

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.

Conditions

• HIV
• Tuberculosis

Interventions

BEHAVIORAL

Combination intervention components

The CIP will contain programmatic, structural, and psychosocial components, including: 1. use of a clinical algorithm by providers; 2. identification of HIV-infected family members eligible for IPT, using an ICAP-developed family care enrollment form (ICAP - International Center for AIDS Care and Treatment Programs); 3. review of monitoring data on IPT initiation and adherence during monthly multidisciplinary team meetings; 4. reimbursement of transportation costs for monthly clinic visits; and 5. real-time adherence support using IVR via mobile phones and trained Peer Educators.

DRUG

Isoniazid Prevention Therapy

Standard of care involves Isoniazid Prevention Therapy (IPT) - the administration of Isoniazid (INH) to individuals with latent infection with M. tuberculosis in order to prevent progression to active TB disease.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Andrea A Howard, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2016-02-29

Completion

2021-05-07

Countries

• Ethiopia

Study Locations