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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Isoniazid

Criteria

Measurement Cohort (MC) Eligibility Criteria

Inclusion Criteria:

• Enrolled in HIV care at a study site on or after 01 January 2013

• Eligible per Ethiopia Federal Ministry of Health guidelines for IPT (without symptoms suggestive of tuberculosis, active hepatitis, regular and heavy alcohol use or peripheral neuropathy) and ready to initiate IPT

• Initiates IPT on or after date of study initiation at any study site

• Aged 18 or older

• Amharic-, Somali-, Oromo/Oromiffa-, Harari- or English-speaking

• Able and willing to provide informed consent within 3 working days of IPT initiation

Exclusion Criteria:

• Children under the age of 18 years