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

NCT01926379 | Completed

• 2 other identifiers: AAAK31631R01AI100044-01
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Ethiopia; TB; tuberculosis; HIV; IPT; isoniazid; adherence; combination intervention package; retention

Outcome Measures

Primary Outcomes (2)

• Percentage of patients enrolled in HIV care who initiate IPT

  IPT initiation is defined as percentage of patients enrolled in HIV care on or after January 1, 2013 who initiate IPT between July 1, 2013 and January 1, 2015. This information will be found through a review of clinic registers.

  up to 2 years

• Percentage of patients who are administered at least 180 doses of IPT within 9 months of IPT initiation

  IPT completion is defined as at least 180 doses administered within 9 months.

  up to 2 years

Secondary Outcomes (5)

• Percentage of participants who attended their most recent HIV clinic appointment 6 months after initiating IPT

  up to 2 years

• Percentage of total prescribed ART (antiretroviral therapy) doses ingested for each month of ART treatment for the first 6 months after IPT initiation

  up to 2 years

• Change in CD4+ count from initiation of IPT to 6 months later

  up to 2 years

• Incidence of adverse events experienced by patients during IPT, as identified through monthly questionnaires and chart review

  up to 2 years

• Percentage of total prescribed IPT doses ingested for each month of IPT treatment

  up to 2 years

Study Arms (2)

Combination Intervention Package (CIP)

EXPERIMENTAL

Patients who enrolled in HIV care at a CIP site on or after January 1, 2013 and initiate Isoniazid Prevention Therapy (IPT) on or after study initiation on July 1, 2013 will receive the combination intervention components that is a part of the Combination Intervention Package (CIP).

Behavioral: Combination intervention components; Drug: Isoniazid Prevention Therapy

Standard Of Care (IPT alone)

OTHER

Patients are screened for tuberculosis (TB) at enrollment in HIV care at a HIV clinic and during each routine clinic visit using a simple symptom questionnaire. Eligible patients will receive the standard of care intervention, Isoniazid Prevention Therapy (IPT), per national guidelines. After IPT initiation, patients return to the HIV clinic monthly for monitoring of side effects, TB symptoms, self-reported 30-day adherence, and to receive a 30-day supply of isoniazid. If adherence problems are noted at any time, the nurse counsels the patient, and if the patient still wants to take IPT, it is continued.

Drug: Isoniazid Prevention Therapy

Interventions

Combination intervention components BEHAVIORAL

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.

Combination Intervention Package (CIP)

Isoniazid Prevention Therapy DRUG

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.

Also known as: IPT

Combination Intervention Package (CIP); Standard Of Care (IPT alone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Children under the age of 18 years

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (10)

Addis Ketema Health Center

Dire Dawa, Ethiopia

Location

Dire Dawa Health Center

Dire Dawa, Ethiopia

Location

Gende Gerada Health Center

Dire Dawa, Ethiopia

Location

Gende Kore Health Center

Dire Dawa, Ethiopia

Location

Goro Health Center

Dire Dawa, Ethiopia

Location

Legehare Health Center

Dire Dawa, Ethiopia

Location

Melka-Jebdu Health Center

Dire Dawa, Ethiopia

Location

Sabian Health Center

Dire Dawa, Ethiopia

Location

Arategna Health Center

Harar, Ethiopia

Location

Jinela Health Center

Harar, Ethiopia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Andrea A Howard, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 20, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: May 7, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ET (10)