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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT01926379
• Date of registration: 05/08/2013
• Prospective Registration: No
• Primary sponsor: Columbia University
• Public title: ENhance Initiation and Retention in Isoniazid Preventive Therapy (IPT) Care for HIV Study (ENRICH Study) ENRICH
• Scientific title: A Combination Intervention Package for Isoniazid Preventive Therapy in Ethiopia
• Date of first enrolment: July 2013
• Target sample size: 338
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01926379
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Ethiopia

Contacts

• Name: Andrea A Howard, MD
• Affiliation: Columbia University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Tuberculosis

Intervention(s)

Behavioral: Combination intervention components

Drug: Isoniazid Prevention Therapy

Primary Outcome(s)

Percentage of patients enrolled in HIV care who initiate IPT [Time Frame: up to 2 years]

Percentage of patients who are administered at least 180 doses of IPT within 9 months of IPT initiation [Time Frame: up to 2 years]

Secondary Outcome(s)

Incidence of adverse events experienced by patients during IPT, as identified through monthly questionnaires and chart review [Time Frame: 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 [Time Frame: up to 2 years]

Change in CD4+ count from initiation of IPT to 6 months later [Time Frame: up to 2 years]

Percentage of participants who attended their most recent HIV clinic appointment 6 months after initiating IPT [Time Frame: up to 2 years]

Percentage of total prescribed IPT doses ingested for each month of IPT treatment [Time Frame: up to 2 years]

Secondary ID(s)

AAAK3163

1R01AI100044-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)