Health Visitors

The isolates used in this study were collected from patients recruited in two studies that were both carried out in peri-urban Kampala-Uganda in sequence. An initial household contact study (HC) was conducted from 1992 to 1999 to describe the epidemiology of TB [population 1.7 million; population density 9400/km² (Uganda Bureau of Statistics; http://www.ubos.org, 2011) and [29 (link),30 (link)]. The second study is the Kawempe Community Health study (KCH) that started in 2000 and is ongoing. The KCH focuses on host factors associated with primary infection, re-infection, reactivation, and progression from MTB infection to active TB clinical disease and also identifies and tracks strains of MTB circulation in households and the local community.
During the conduct of these epidemiologic cohort studies (HC and KCH), adults with sputum smear positive TB were consecutively enrolled as index cases. An index case was defined as the first TB case identified in a household who was ≥ 18 years of age and lived with one or more household contacts. A household was defined as a group of people living within one residence, share meals together and identified a head of family who made decisions for the household. Following the identification of the index cases, home health visitors contacted the household contacts for health education about TB and the study. A household contact was defined as any individual who had resided in the household for at least 7 consecutive days during the 3 months prior to the diagnosis of TB in the index case. Household contacts were screened for both latent (tuberculin skin test) and active disease (sputum smear and culture) on first contact. Those found not to have TB according to the study protocol were followed every three months for a period of two years to identify contacts that later developed active TB. Household contacts were classified as co-prevalent cases if active TB was present at baseline or during three months of household follow-up and as incident cases if active TB developed after three months of follow-up. In both studies (HC and KCH) a total of 1746 isolates were stored from the study area over the period of study (1995–2009). Patients with either latent or active TB were treated with isoniazid (INH) preventive therapy or standard short course combination chemotherapy for active TB in accordance with the Uganda National TB and Leprosy Program guidelines.
At baseline, data of enrolled patients, including age, sex, HIV status, presence of cavity, ethnicity, status of smoking, Body Mass Index (BMI), level of education, alcohol drinking, income, history of diabetes, presence of BCG scar, night sweats, TB in the past, hemoptysis, swollen lymph nodes, extent of disease on chest radiographs and smear grade, were recorded. The extent of disease on chest radiographs was classified as normal, mild, moderate, or far advanced using a validated, standardized scheme [31 ], with lesions recorded by an independent reader who was blinded to smear and culture results. Sputum smear microscopy and culture were performed at either the National TB Reference Laboratory (NTRL) or the Joint Clinical Research Centre (JCRC) TB Laboratory. Isolates were confirmed as MTB using the BACTEC^® para-nitro-acetyl amino-hydroxy-propiophenone (NAP) susceptibility method [32 (link)] and later stored at – 80°C in 7H9 broth supplemented with OADC and glycerol for future analyses.
The institutional review boards and ethics committees at Case Western Reserve University, Makerere University, and the Ugandan AIDS Research Council, and the Uganda National Council for Science and Technology approved the study protocols. All patients gave written informed consent for study participation, including pre- and post-HIV test counseling.

The intervention was developed based on a previous successful study [27 (link)] and on a needs assessment [30 (link)] in a co-creation design with one to two health visitor representatives from each of the intervention clusters. The development was conducted in an iterative manner where health visitors tested aspects of the intervention in their real-world setting after having attended each meeting. The intervention was developed within a two-step approach: first, the contents and major outlines of the intervention were developed (January 2021 – April 2021). Next, co-creation with health visitor representatives from the intervention clusters was conducted following the described iterations (April 2021 – December 2021).
To be able to reduce social inequality in breastfeeding, it is important to investigate how the Breastfeeding Trial works in families who carry a high risk of early breastfeeding cessation, i.e., conceptualised in this study as families in which the mother is young or has a low educational attainment. These characteristics are in many ways stigmatised in high-income settings like Denmark [56 (link), 57 (link)]. Therefore, it is essential that the intervention supports relationship built on trust and provides a sense of security between the health visitor and the family. In an effort to avoid this stigma, recruitment videos developed and employed as part of the intensified intervention were tested among mothers in the target group and revised according to their feedback. Additionally, parents in the risk group participated during the questionnaire development phase with testing of questionnaires, which generated valuable input for the process.
A reference group of parent organisations, practitioners and decision makers will be established in order to contribute knowledge and experience, qualifying the project and in the long term facilitating and ensuring the dissemination of the project and ensuring that the knowledge produced will be targeted the audience including relevant decision makers.
During monthly dialogue meetings, health visitors will have the opportunity to disclose information about any harms or adverse effects. As the intervention aims to strengthen existing standard care, it is not expected to induce harm to the study population, and no data monitoring committee has been established.

The implementation of the intervention will be analysed by process evaluation. The analysis will focus on barriers to and facilitators of the intervention, and on the dose, delivery and fidelity of the delivered intervention. Data utilised for this purpose will be quantitative and qualitative. Quantitative data will include survey data from health visitors, the health visitor records and a survey of organisational structures; and qualitative data will include interviews with families (n = 10), online focus group discussions with health visitors (n = 3), observations of breastfeeding support in the intervention clusters (n = 2–3), and dialogue meetings held with health visitor representatives from intervention clusters (n = 8).
Data from health visitors’ survey and the organisational survey will help us gain insight into any potential contamination between trial arms carried by health visitors changing employment from intervention clusters to control clusters.