Table 2 Selected case studies at MLW
Case study number & setting | Study type and the main aim | Study population | Study activities | Ad-hoc AC arrangements and provision |
|---|---|---|---|---|
Case study 1 Blantyre—QECH MLW | Challenge study (clinical trial) Feasibility of empirical pneumococcal carriage in Malawi and feasibility of all measures required to determine vaccine response | Healthy adult volunteers within Blantyre (all participants interviewed in our study were healthy volunteers working at QECH) | Inoculation with pneumococcal bacteria Three days observation at an arranged accommodation Follow-up on study participants | Referral for HIV if a participant is diagnosed at recruitment Provision of care for any medical condition, even those unrelated to the study (participants are advised to report at Mwaiwathu—a private tertiary hospital). Not specific to the extent to which the study can provide support for chronic conditions |
Case study 2 Blantyre—QECH | Randomised, factorial, open-label clinical trial To compare the impact on 15-day and one-year mortality of combined systematic empirical treatment against TB and Cytomegalovirus plus standard of care versus standard of care in HIV-infected infants with severe pneumonia | Children less than 12 months old living with HIV (We interviewed mothers with children recruited in this study and were all coming from within Blantyre—participants were identified during follow-up visits) | Treatment and follow-up | Trial physician support with the review of participants when admitted to the ward [direct care] Provide assisted referral Provision of other social support such as food for the participant (infant milk) and clothes (diapers) [this was considered as AC by researchers, and they thought it is an important part of care] Provide TB screening to mothers, and samples are tested at KUHeS/MLW laboratory |
Case study 3 Blantyre—QECH | Cross-sectional study To investigate the impact of HIV infection on the frequency and function of Mtb-specific Polycytotoxic T cells (P-CTLs) in the lung and peripheral blood in humans | Healthy, HIV-uninfected adults Asymptomatic adults living with HIV TB patients both living with and not living with HIV | Bronchoscopy sample collection and follow-up | Provision of direct care for other conditions unrelated to the study Provide assisted referral for conditions that require a specialist opinion For example, the study team had a participant with severe anaemia, and they facilitated her admission and transfusion |
Case study 4 Chikwawa—community | A prospective serological community cohort study To understand the acquisition of immunity to Non-typhoidal salmonella (NTS) and epidemiology of enteric NTS and how this immunity varies with risk factors (malaria, anaemia, malnutrition, and sickle cell disease) and geographical setting | Under-five children (we interviewed mothers who had their children recruited in the study, and they were all from Chikwawa district) | Sample collection and follow-up on participants | Support with the provision of diagnostic and treatment for non-study related conditions such as anaemia and malaria Support with the referral of children diagnosed with sickle cell disease and malnutrition to QECH and Chikwawa district hospital, respectively |
Case study 5 Blantyre—health centres | Phase 3 Clinical trial To assess the efficacy in the prevention of severe rotavirus Gastroenteritis of the NRRV vaccine in comparison to Rotarix To evaluate the safety of the Non-Replicating Rota Vaccine (NRRV) vaccine in healthy infants and compare it with that of Rotarix | Healthy infants, ≥ 6 weeks and < 8 weeks of age at the time of 1st study vaccination. (We interviewed mothers who had their children recruited in the study, they were all from Blantyre and identified during recruitment day at either Zingwangwa or Limbe health centre) | Vaccination at visits 1- 4 and a blood draw at the 4th visit Active surveillance of Gastroenteritis throughout the study through weekly contacts | Support participants with referrals for critical conditions Provide assisted referral in cases where a participant requires to meet a specialist [when they are also sick from other diseases] after a study follow-up visit Provide care (medical care and treatment) to participants, their mother, father, and other siblings when they are sick Provide food to participants at their scheduled visits |