Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial

NCT04494516 | Completed

• 1 other identifier: IRB00237243
• Study Type: observational
• Target: 183
• Locations: 2 countries
• Sites: 2

Brief Summary

This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts, to design its implementation strategy and, post intervention, to assess lessons learned for future scale up. Participants will include policy makers and health system managers, nurse and physician providers, community health team members, and child caregivers of TB-exposed children. Stakeholders will be asked to participate in two interviews, one prior to the cluster randomized trial assessing this intervention and one after the cluster randomized trial. Trained interviewers will conduct 1-hour semi-structured in-depth interviews that will be audio-recorded, translated and transcribed for thematic analysis using a priori and emergent domains of interest. Free-listing, ranking exercises and cultural consensus will be used to identify context-specific intervention adaptations and implementation strategies.

Conditions

Tuberculosis Infection; Tuberculosis Prevention

Outcome Measures

Primary Outcomes (4)

• Perception of intervention adaptations as assessed by an in-depth interview

  In-depth, semi-structured interviews will explore perceptions of context-specific adaptations to the community-based TB prevention intervention needed for success.

  Within six months prior to CHIP-TB trial initiation

• Perception of implementation strategies as assessed by an in-depth interview

  In-depth, semi-structured interviews will explore perceptions of context-specific implementation strategies for the community-based TB prevention intervention needed for success.

  Within six months prior to CHIP-TB trial initiation

• Perception of the social context of the community-based health teams as assessed by an in-depth interview

  In-depth, semi-structured interviews will explore the social context and inner setting of the community health teams.

  Within six months prior to CHIP-TB trial initiation

• Perception of the lessons learned as assessed by an in-depth interview

  In-depth, semi-structured interviews will explore lessons learned for the future scale up and dissemination of the community-based TB prevention intervention.

  Within four months after CHIP-TB Trial completion

Study Arms (2)

Pre-trial

This cohort of participants will be recruited preceding evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with design of the intervention and implementation strategy. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites.

Post-trial

This cohort of participants will be recruited after evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with future scale up and dissemination of the intervention. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include key stakeholders from the target communities in South Africa (Ekurhuleni, Gauteng Province) and Ethiopia (East Shewa Zone of the Oromia regional state), including caregivers of TB-exposed children, community health teams including nurses and community health workers, clinic-based nurse and clinic/hospital-based physician providers, program managers and policy makers.

You may qualify if:

• Adult caregiver (18 years of age or older) of a child (\<15 years of age) who was exposed to TB in the last two years where at least one child was evaluated for and offered either TB preventive therapy or TB treatment.
• Community health team members from one of the Ethiopian or South African clinics in which the CHIP-TB trial will be conducted.
• TB nurse from one of the 16 Ethiopian or South African clinics in which the study will be conducted
• Pediatrician or medical officer working in pediatrics at the relevant Ethiopian or South African District Hospital who sees outpatient pediatric consultations including TB-exposed children
• Program manager or policy maker in the relevant Ethiopian or South African district or provincial office who manages TB, PMTCT, and/or other pediatric programming

You may not qualify if:

• Any adult caregivers, community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who are unable or unwilling to provide informed consent for both the interview and audio-recording
• Any community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who participated in the program for at least 3 months
• Any adult caregiver whose child participated in the community-based TB prevention program
• Any adult caregivers, community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who are unable or unwilling to provide informed consent for both the interview and audio-recording

Sponsors & Collaborators

• Johns Hopkins University: lead
• UNITAID: collaborator
• Aurum Institute: collaborator
• KNCV Tuberculosis Foundation: collaborator

Study Sites (2)

KNCV Tuberculosis Foundation

Addis Ababa, Ethiopia

Location

The Aurum Institute

Johannesburg, South Africa

Location

Related Publications (1)

• Salazar-Austin N, Bergman AJ, Mulder C, Tudor C, Mulatu F, Conradie G, Chaisson RE, Golub JE, Churchyard G, Bedru A, Kerrigan D. Improving access to tuberculosis preventive treatment for children in Ethiopia: designing a home-based contact management intervention for the CHIP-TB trial through formative research. BMC Health Serv Res. 2024 Sep 10;24(1):1043. doi: 10.1186/s12913-024-11451-9.

  PMID: 39252005 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Nicole Salazar-Austin, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 31, 2020
• Study Start: June 4, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1); ZA (1)