Feasibility of a randomized clinical trial evaluating a community intervention for household tuberculosis child contact management in Cameroon and Uganda
Authors: Vasiliu Anca , Tiendrebeogo Georges , Awolu Muhamed Mbunka , Akatukwasa Cecilia , Tchakounte Boris Youngui , Ssekyanzi Bob , Tchounga Boris Kevin , Atwine Daniel , Casenghi Martina , Bonnet Maryline ,   on behalf of the CONTACT study group, Bonnet Maryline , Vasiliu Anca , Chauvet Savine , de Carvalho Elisabete , Ouedraogo Sayouba , Tiendrebeogo Georges , Casenghi Martina , Cohn Jennifer , Tchounga Boris K. , Tchakounté Boris Y. , Sih Collette , Kana Rogacien , Youm Eric , Tchengou Patrice , Simo Léonie , Manguele Paul W. , Bindzi Paul , Ndongo Marie-Louise A. , Kombou Doline Ndjang , Guedem Nekame Jinette L. , Kaptue Narcisse Sitamze , Tsigaing Philippe N. , Awolu Muhamed M. , Seuleu Ndjamakou Leticia G. , Ndum Naomi Chi , Atwine Daniel , Ssekyanzi Bob , Arinaitwe Rinah , Otai David , Akatukwasa Cecilia , Tebulwa Joanita B. , Kamanzi Hamidah , Natukunda Agnes , Natukunda Eva , Kyarimpa Rose , Kyomuhendo Doreen , Sanyu Scovia , Ssemanya John , Okello Richard , Kuate Albert Kuate , Turyahabwe Stavia , Graham Stephen M. , Dodd Peter J. , Mafirakureva Nyashadzaishe , Mukherjee Sushant 
Published: February 2022

Abstract
Background
One of the main barriers of the management of household tuberculosis child contacts is the necessity for parents to bring healthy children to the facility. We assessed the feasibility of a community intervention for tuberculosis (TB) household child contact management and the conditions for its evaluation in a cluster randomized controlled trial in Cameroon and Uganda.

Methods
We assessed three dimensions of feasibility using a mixed method approach: (1) recruitment capability using retrospective aggregated data from facility registers; (2) acceptability of the intervention using focus group discussions with TB patients and in-depth interviews with healthcare providers and community leaders; and (3) adaptation, integration, and resources of the intervention in existing TB services using a survey and discussions with stakeholders.

Results
Reaching the sample size is feasible in all clusters in 15 months with the condition of regrouping 2 facilities in the same cluster in Uganda due to decentralization of TB services. Community health worker (CHW) selection and training and simplified tools for contact screening, tolerability, and adherence of preventive therapy were key elements for the implementation of the community intervention. Healthcare providers and patients found the intervention of child contact investigations and TB preventive treatment management in the household acceptable in both countries due to its benefits (competing priorities, transport cost) as compared to facility-based management. TB stigma was present, but not a barrier for the community intervention. Visit schedule and team conduct were identified as key facilitators for the intervention.

Conclusions
This study shows that evaluating a community intervention for TB child contact management in a cluster randomized trial is feasible in Cameroon and Uganda.

Trial registration
Clini calTr ials. gov NCT03832023. Registered on February 6th 2019.