Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02662829 |
| Other study ID # |
AAAN7358 |
| Secondary ID |
K01AI104351 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2015 |
| Est. completion date |
January 2019 |
Study information
| Verified date |
April 2022 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Lesotho, a small, landlocked country completely surrounded by South Africa, is among the
world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB)
and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV
coinfected. Data from similar settings suggest that TB incidence in children is approximately
50% of adult TB incidence. The Lesotho National TB Program has adopted World Health
Organization's (WHO) isoniazid preventive therapy (IPT) recommendations for child contacts;
however, as in other countries in the region, implementation of IPT in children is limited,
no clear strategies guide child contact tracing and screening, and no clear methods ensure
provision of IPT in children. Thus, it is important to evaluate novel methods to prevent TB
in child contacts of adult TB cases.
The purpose of the PREVENT Study is to identify an effective and acceptable intervention that
addresses programmatic, structural and psychosocial barriers to contact tracing, screening,
and IPT for child contacts of TB patients, with the ultimate goal of improving health
outcomes among children in Lesotho. The study is a two-arm cluster randomized trial,
randomized at the TB clinic level, which includes ten TB clinics in Berea district. Clinics
are randomized to deliver the community-based intervention (CBI) or standard of care (SOC),
with stratification by facility type. The experimental intervention will be delivered to all
child contacts of adult TB patients in TB clinics randomly assigned to CBI. In TB clinics
assigned to SOC, usual care procedures for contact tracing and IPT will be delivered.
Description:
The study intervention, community-based intervention (CBI), will contain multiple components,
including: 1) Facility Providers. Providers will be trained on study interventions; job aids
will be provided. Nurses will use a clinical algorithm based on national guidelines for
intensive case finding and screening of child contacts for TB to assess patients without TB
symptoms for IPT eligibility; to initiate IPT; and to monitor for side effects, TB symptoms,
and adherence. If a child contact develops TB symptoms during IPT, national guidelines will
be followed. HIV testing will be strongly promoted in child contacts. Use of simple available
clinic IPT registers will be promoted. The PI will establish systems to track IPT use at
monthly multi-disciplinary team meetings; clinic staff will review IPT monitoring data for
prior months, identify challenges, and develop solutions. IPT registers will link IPT outcome
data to TB register data for index cases. 2) Patients and Guardians. Nurses will explain to
patients and guardians that IPT can prevent TB, promote IPT initiation, assess IPT adherence
and side effects, and encourage follow-up with village health workers (VHW). Nurses will
emphasize HIV testing for children. The VHW role will encompass social support, system
navigation, referrals, and advocacy. VHW will follow up with guardians of children who miss
appointments or report nonadherence, using scripted, illustrated flipcharts targeting
children and guardians. VHW will emphasize to guardians the importance of IPT, encourage IPT
and visit adherence, offer support and empathy, provide referrals, and advocate for patients.
3) Community Outreach. To investigate household contacts, VHW will visit homes of all adult
TB cases at facilities assigned to CBI. All HIV-infected children and children under 5,
regardless of HIV status, will be referred to health facilities. VHW will administer TB
symptom screening in child contacts in the community, accompany them and their guardians to
the clinic, and provide education sessions, support groups, and adherence counseling.
Study assessments include: 1) outcome data via medical records; 2) pre- and post-intervention
interviews with providers; 3) post-intervention guardian interviews; and 4) program
characteristics data. Stakeholders and policy makers will be engaged early in the process to
help ensure successful integration of findings in programmatic contexts. A dissemination
strategy will be developed in consultation with stakeholders and will help ensure scaling up
of the intervention, if found effective.
All clinical care, including implementation of the combination intervention package at sites
randomized to CIP, will be performed by Lesotho Ministry of Health clinic staff (nurses and
VHW). All study procedures, including participant interviews, medical record abstraction, and
program characteristics surveys will be performed by study staff.
