ENhance Initiation and Retention in Isoniazid Preventive Therapy (IPT) Care for HIV Study (ENRICH Study)
Information source: Columbia University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; Tuberculosis
Intervention: Combination Intervention Package (Other); Standard of Care (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s): Andrea A Howard, MD, Principal Investigator, Affiliation: Columbia University
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 Harar, 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 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 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.
Clinical Details
Official title: A Combination Intervention Package for Isoniazid Preventive Therapy in Ethiopia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Percentage of patients enrolled in HIV care who initiate IPTPercentage of patients who are administered at least 180 doses of IPT within 9 months of IPT initiation
Secondary outcome: Percentage of participants who attended their most recent HIV clinic appointment 6 months after initiating IPTPercentage of total prescribed ART (antiretroviral therapy) doses ingested for each month of ART treatment for the first 6 months after IPT initiation Change in CD4+ count from initiation of IPT to 6 months later Safety and tolerability of IPT measured by side effects and adverse events experienced by patients during IPT, as identified through monthly questionnaires and chart review Percentage of total prescribed IPT doses ingested for each month of IPT treatment
Detailed description:
The study intervention, combination intervention package (CIP), will contain programmatic,
structural and psychosocial components including: 1) health care provider training and
mentorship in IPT provision using a clinical algorithm; 2) identification of HIV-infected
family members eligible for IPT using a family care enrollment form; 3) review of monitoring
data on IPT initiation and adherence during monthly multidisciplinary team meetings; 4)
reimbursement of transportation costs to patients for monthly clinic visits; and 5)
real-time adherence support using interactive voice response (IVR) via mobile phones and
trained peer educators.
Data will be collected from all HIV-infected patients enrolled in HIV care at study sites on
or after January 1, 2013; from a subset of patients who initiate IPT and enroll into a
measurement cohort (MC); and from program characteristics surveys conducted at the study
sites. Routine clinic data from all HIV-infected patients enrolled in HIV care at the 10
participating clinics on or after January 1, 2013 will be used to measure the following
outcomes: IPT initiation, completion of IPT, and retention in HIV care. These data will be
collected by Research Assistants (RA) by abstracting the following information from the
clinic Pre-ART, ART (antiretroviral therapy) and IPT registers during the period of
observation on all HIV patients who enrolled in care at a study site on or after January 1,
2013: date of enrollment in HIV care; IPT initiation (yes/no); date of ART initiation (if
applicable); IPT outcomes (completion, default, death, stopped, transferred out); TB
screening results; TB treatment (yes/no); TB treatment outcomes (if applicable); and
retention in HIV care.
A measurement cohort of 500 HIV-infected patients initiating IPT on or after July 1, 2013
will be recruited from the 10 clinics (n=250 per study arm). MC participants will be
assessed at baseline (enrollment) and monthly intervals for six to nine months, depending on
the duration of IPT. Outcomes to be measured among MC participants include: adherence to
IPT; adherence to ART (if applicable); change in CD4+ count; and side effects/adverse
events. MC participants at both SOC and CIP sites will receive the same assessments. RAs
will administer assessments on the day of regularly scheduled clinic visits, including a
Baseline interview administered on the day of enrollment (which coincides with the day the
participant initiates IPT), monthly follow-up interviews completed throughout IPT, and an
end of treatment interview that is completed on the day the participant ends IPT.
Participants who miss a study visit will be contacted by study staff and administered the
questionnaire over the phone within a 1-week window period of the scheduled clinic visit.
RAs will also call the MC participants between clinic visits to conduct unannounced pill
counts to assess medication adherence. In addition, 30 MC participants from CIP sites will
participate in a qualitative interview to assess feasibility and acceptability of the
Interactive Voice Response (IVR) system, one of the interventions in place at CIP sites.
RAs will conduct an assessment of programmatic activities at each HIV clinic prior to study
implementation and on a monthly basis thereafter throughout the study period. Clinics in
both conditions will receive the same assessments. The RA will administer a brief
semi-structured Program Characteristics survey to the ART nurse, who will be most familiar
with the day-to-day operations of the HIV clinic. The survey will assess nurse training and
mentorship in IPT initiation and HIV treatment; availability and use of an IPT clinical
algorithm, IPT and ART adherence training for peer educators (PEs); IPT health education for
patients; availability and use of an IPT treatment literacy curriculum, including a
flipchart used by PEs; reimbursement for transportation costs for patients; provision of
mobile phones, SIM cards and airtime vouchers for HIV patients on IPT; use of IVR messages
for medication and appointment reminders and assessment of medication adherence and side
effects; and provision of community-based adherence and side effect monitoring by PEs.
These data will be used to assess fidelity with the intervention at CIP sites, as well as to
measure any potential contamination at SOC sites.
All clinical care will be performed by the clinic staff (nurses and PEs). All study
procedures, including participant interviews, pill counts, medical record abstraction, and
program characteristics surveys will be performed by study staff (research assistants).
Following routine clinic visits, clinic staff will refer patients initiating IPT to study
staff, who will screen for eligibility, obtain informed consent, and enroll consenting
eligible patients into the MC. In addition, RAs at CIP sites will provide parts of the
intervention, including disbursement of mobile phones, SIM cards, airtime vouchers, and
cash for transportation reimbursement to eligible patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Measurement Cohort (MC) Eligibility Criteria:
MC Inclusion Criteria:
1. Enrolled in HIV care at a study site on or after 01 January 2013;
2. 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;
3. Initiates IPT on or after date of study initiation at any study site;
4. Aged 18 or older;
5. Amharic-, Somali-, Oromiffa-, Harari- or English-speaking; and
6. Able and willing to provide informed consent within 3 working days of IPT initiation.
MC Exclusion Criterion:
1. Children under the age of 18 years
Locations and Contacts
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
Additional Information
Starting date: July 2013
Last updated: June 10, 2015
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