Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01926379 |
| Other study ID # |
AAAK3163 |
| Secondary ID |
1R01AI100044-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2013 |
| Est. completion date |
May 7, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
(tuberculosis) 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. Also, three groups will be recruited
from CIP clinics to participate in in-depth interviews: IPT initiators, from among
participants in the Measurement Cohort (n =15), IPT non-initiators (n=15), and healthcare
providers (nurses and peer educators, n=13). In-depth interviews will assess acceptability
and preferences of intervention components as well as reasons for IPT non-initiation.
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 flip chart used by
PEs; reimbursement for transportation costs for patients; provision of mobile phones,
subscriber identification module (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.
