NCT02662829

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
562

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

3.1 years

First QC Date

January 15, 2016

Last Update Submit

April 4, 2022

Conditions

Tuberculosis

Keywords

LesothotuberculosisTBHIVadherencecommunity-based interventionretention

Outcome Measures

Primary Outcomes (3)

  • Yield of child contacts

    Number of child contacts per pulmonary TB case screened, based on review of clinic registers

    3 years

  • Percentage of IPT initiation

    Percentage of child contacts identified through contact tracing of new adult TB cases during observation period who initiate IPT, based on review of clinic registers

    3 years

  • Percentage of IPT completion

    Percentage of child contacts who complete IPT of those who initiate as determined by provider and recorded in clinic charts

    Up to 9 months after IPT initiation

Secondary Outcomes (1)

  • Percentage of HIV testing

    3 years

Study Arms (2)

Community-based intervention (CBI)

EXPERIMENTAL

1. Nurse training and mentorship in TB prevention using clinical algorithm based on national guidelines. 2. Health education using a treatment literacy curriculum for parents and guardians. 3. Community outreach by trained village health workers.

Behavioral: Community-based intervention

Standard of Care (SOC)

ACTIVE COMPARATOR

At SOC clinics, patients will receive usual care for management of contact tracing, screening, and IPT provision. Childhood TB in Lesotho is managed by nurses in health centers. Per national guidelines, TB patients are asked to bring in child contacts, who are screened using a simple symptom questionnaire. Children who screen negative are assessed for IPT eligibility. Absent contra-indications (eg, active hepatitis, regular alcohol consumption, peripheral neuropathy), nurses counsel children and guardians on IPT benefits, potential side effects, and importance of adherence. Children requiring chest x-rays or gastric lavage and HIV-infected children under age 1 are referred to the hospital. After initiation, patients and guardians return to the clinic monthly for monitoring for side effects, TB symptoms, adherence, and 30-day supply of isoniazid. If adherence problems are noted, the nurse counsels patient and guardian as appropriate.

Other: Standard of care

Interventions

Community-based interventionBEHAVIORAL
Also known as: CBI
Community-based intervention (CBI)
Standard of careOTHER
Also known as: SOC
Standard of Care (SOC)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nurse or village healthcare worker(VHW) working in a CBI clinic or VHW working in the community and affiliated with CBI clinic
  • Aged 18 or older
  • English- or Sesotho speaking
  • Capable of informed consent
  • Guardian of a child contact
  • Aged 18 or older
  • English- or Sesotho speaking
  • Capable of informed consent
  • Two groups of guardians will be enrolled: guardians who brought their children for TB screening, and guardians who did not bring their children for TB screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Berea Hospital

Berea, Berea, Lesotho

Location

Holy Family Health Center

Berea, Berea, Lesotho

Location

Khubetsoana Health Center

Berea, Berea, Lesotho

Location

Koali Health Center

Berea, Berea, Lesotho

Location

Kolojane Health Center

Berea, Berea, Lesotho

Location

Maluti Hospital

Berea, Berea, Lesotho

Location

Pilot Health Center

Berea, Berea, Lesotho

Location

St Magdalena Health Center

Berea, Berea, Lesotho

Location

St. David Health Center

Berea, Berea, Lesotho

Location

St. Theresa Health Center

Berea, Berea, Lesotho

Location

Related Publications (1)

  • Hirsch-Moverman Y, Howard AA, Frederix K, Lebelo L, Hesseling A, Nachman S, Mantell JE, Lekhela T, Maama LB, El-Sadr WM. The PREVENT study to evaluate the effectiveness and acceptability of a community-based intervention to prevent childhood tuberculosis in Lesotho: study protocol for a cluster randomized controlled trial. Trials. 2017 Nov 21;18(1):552. doi: 10.1186/s13063-017-2184-0.

    PMID: 29157275DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Yael Hirsch-Moverman, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 26, 2016

Study Start

December 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 6, 2022

Record last verified: 2022-04

Locations

LE(10)