Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Andrea Howard, Columbia University
ClinicalTrials.gov Identifier:
NCT01926379
First received: August 5, 2013
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
HIV
Tuberculosis
Behavioral: Combination intervention components
Drug: Isoniazid Prevention Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Combination Intervention Package for Isoniazid Preventive Therapy in Ethiopia

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Percentage of patients enrolled in HIV care who initiate IPT [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of patients who are administered at least 180 doses of IPT within 9 months of IPT initiation [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    IPT completion is defined as at least 180 doses administered within 9 months.


Secondary Outcome Measures:
  • Percentage of participants who attended their most recent HIV clinic appointment 6 months after initiating IPT [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Retention in HIV care will be measured by percentage of participants who attended their most recent HIV clinic appointment 6 months after initiating IPT.

  • Percentage of total prescribed ART (antiretroviral therapy) doses ingested for each month of ART treatment for the first 6 months after IPT initiation [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    ART adherence will be measured by percentage of total prescribed ART doses ingested, averaged across medications for each month of treatment, from unannounced pill counts and monthly interviews.

  • Change in CD4+ count from initiation of IPT to 6 months later [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Change in CD4 count over 6 months (from initiation of IPT to 6 months later). Routine clinical CD4 test results will be used by study staff and no additional blood draw will be required.

  • Incidence of adverse events experienced by patients during IPT, as identified through monthly questionnaires and chart review [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Safety and tolerability will be measured through 1) monthly questionnaires about perceived side effects; and 2) chart review to determine side effects and adverse events requiring discontinuation of isoniazid, as well as cases of TB diagnosed while on IPT.

  • Percentage of total prescribed IPT doses ingested for each month of IPT treatment [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    IPT adherence will be measured by percentage of total prescribed doses ingested for each month of treatment, from data collected from the unannounced pill counts and monthly interviews.


Enrollment: 338
Study Start Date: July 2013
Estimated Study Completion Date: May 2017
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Intervention Package (CIP)
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

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.
Other Name: IPT
Standard Of Care (IPT alone)
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
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.
Other Name: IPT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926379

Locations
Ethiopia
Addis Ketema Health Center
Dire Dawa, Ethiopia
Dire Dawa Health Center
Dire Dawa, Ethiopia
Gende Gerada Health Center
Dire Dawa, Ethiopia
Gende Kore Health Center
Dire Dawa, Ethiopia
Goro Health Center
Dire Dawa, Ethiopia
Legehare Health Center
Dire Dawa, Ethiopia
Melka-Jebdu Health Center
Dire Dawa, Ethiopia
Sabian Health Center
Dire Dawa, Ethiopia
Arategna Health Center
Harar, Ethiopia
Jinela Health Center
Harar, Ethiopia
Sponsors and Collaborators
Columbia University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Andrea A Howard, MD Columbia University
  More Information

Responsible Party: Andrea Howard, Associate Professor of Clinical Epidemiology (in ICAP), Columbia University
ClinicalTrials.gov Identifier: NCT01926379     History of Changes
Other Study ID Numbers: AAAK3163  1R01AI100044-01 
Study First Received: August 5, 2013
Last Updated: May 17, 2016
Health Authority: United States: Federal Government
Ethiopia: Ethiopia Science and Technology Commission
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Columbia University:
Ethiopia
TB
tuberculosis
HIV
IPT
isoniazid
adherence
combination intervention package
retention

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 02, 2016