Structural and social factors affecting COVID-19 vaccine uptake among healthcare workers and older people in Uganda: A qualitative analysis.

The COVID-19 vaccine rollout programme in Uganda was launched in March 2021 for priority groups: Healthcare Workers (HCWs), older persons (≥50 years), and persons with chronic conditions. Misinformation, distrust in healthcare systems, and cultural beliefs, pose significant challenges to vaccine uptake. We describe the social and structural factors affecting the uptake of COVID-19 vaccines among HCWs and older people in Uganda.

Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study.

Background: The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial.

Methods: We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders.

Perceptions, attitudes, and willingness of healthcare and frontline workers to participate in an Ebola vaccine trial in Uganda.

Background: Understanding the knowledge, perception and attitudes towards Ebola vaccines is an important factor in ensuring future use of these vaccines. A qualitative methods study embedded in an Ebola vaccine immunogenicity and safety trial (NCT04028349) was conducted to explore the knowledge and perceptions of healthcare (HCWs) and frontline workers (FLWs), about Ebola vaccines and their willingness to participate or recommend participation in Uganda.

Method: We carried out focus group discussions and semi-structured interviews before and after vaccination, with 70 HCWs and FLWs who consented to participate in the trial, and in the qualitative component, from August to September 2019.

Contextual, structural, and mental health experiences of children of women engaged in high-risk sexual behaviour in Kampala: a mixed method study.

Children born to women who sell sex for money or commodities may face economic and social insecurity because of their mother's work, particularly in settings where sex work is illegal. From October 2020 to May 2021, we conducted a study with 60 children aged 12-24 years, born to sex workers in Kampala, Uganda. The children took part in 60 semi-structured interviews, 20 life history interviews, and 4 focus group discussions, which were used to explore their social, economic, and mental health experiences and investigate their vulnerabilities and resilience.

Pathways to care with HIV-associated cryptococcal meningitis in Botswana and Uganda: Findings from a qualitative methods study.

HIV-associated cryptococcal meningitis remains a key driver of AIDS-related mortality. Mortality is twice as high in those who present later to care and with severe symptoms such as confusion. We embedded a qualitative methods study within a randomised controlled trial in Gaborone, Botswana and Kampala, Uganda with the aim of understanding pathways to care.

COVID-19 disease and vaccination in pregnancy: understanding knowledge, perceptions and experiences among pregnant women and community leaders in Uganda.

Background: We investigated pregnant women and community leaders' knowledge, perceptions and experiences of the coronavirus disease 2019 (COVID-19) vaccination program during pregnancy in Uganda and how this changed over the course of the pandemic.

Methods: We conducted 20 in-depth interviews (IDIs) and two group discussions (GDs) with pregnant women and four GDs with community leaders in Kawempe division of Kampala, Uganda. The first round of IDIs/GDs were carried out in March 2021.

"They will say you want to make their home die": A mixed methods study to assess modern family planning use in partnered South Sudanese refugee and host populations in Northern Uganda.

The unmet need for family planning among conflict-affected populations is high globally, leaving girls and women vulnerable to unintended pregnancies and poor sexual and reproductive health outcomes. Ours is the first known mixed-methods study to assess the use of modern family planning (FP) methods amongst married or partnered South Sudanese refugee and host populations in Northern Uganda and to explore differences between them. We conducted a cross-sectional survey in July 2019 which included 1,533 partnered women of reproductive age (15-49 years) from host and South Sudanese refugee communities in Kiryandongo and Arua.

Clinical research for life-threatening illnesses requiring emergency hospitalisation: a critical interpretive synthesis of qualitative data related to the experience of participants and their caregivers.

Background: Research into life-threatening illnesses which require emergency hospitalisation is essential. This group of patients is unique in that they are experiencing an unfolding emergency when they are approached, enrolled, and followed up in a research study. We aimed to synthesise qualitative data from trial participants and surrogate decision-makers to deepen our understanding and inform the design and conduct of future clinical trials for life-threatening illnesses.

Understanding perceptions of schistosomiasis and its control among highly endemic lakeshore communities in Mayuge, Uganda.

Background: Schistosomiasis is a neglected tropical disease and a serious global-health problem with over 230 million people requiring treatment, of which the majority live in Africa. In Uganda, over 4 million people are infected. Extensive parasitological data exist on infection prevalence, intensities and the impact of repeated praziquantel mass drug administration (MDA).

The acceptability of the AMBITION-cm treatment regimen for HIV-associated cryptococcal meningitis: Findings from a qualitative methods study of participants and researchers in Botswana and Uganda.

Background: The AMBITION-cm trial for HIV-associated cryptococcal meningitis demonstrated that a single, high-dose of liposomal amphotericin (AmBisome) plus 14-days of oral flucytosine and fluconazole was non-inferior in terms of all-cause mortality to 7-days of amphotericin B deoxycholate and flucytosine followed by 7-days of fluconazole (Control). The AmBisome regimen was associated with fewer adverse events. We explored the acceptability of the AmBisome regimen from the perspective of participants and providers.

Use of Services among Female Sex Workers Receiving a Comprehensive HIV Enhanced Prevention Intervention in Kampala, Uganda: A Cross-sectional Study.

We estimated the prevalence and factors associated with the use of a dedicated HIV prevention, care, and treatment service for female sex workers (FSWs) in Kampala, Uganda. Between October 2017 to January 2018, we conducted a cross-sectional study among FSWs at a dedicated clinic. We defined use as the use of the HIV prevention, care, and treatment services by FSWs at least once within the past six months.

Ethical and practical considerations arising from community consultation on implementing controlled human infection studies using in Uganda.

Issues related to controlled human infection studies using (CHI-S) were explored to ensure the ethical and voluntary participation of potential CHI-S volunteers in an endemic setting in Uganda. We invited volunteers from a fishing community and a tertiary education community to guide the development of informed consent procedures. Consultative group discussions were held to modify educational materials on schistosomiasis, vaccines and the CHI-S model and similar discussions were held with a test group.

Decision making in a clinical trial for a life-threatening illness: Therapeutic expectation, not misconception.

Potential participants for clinical trials which aim to define treatments for life-threatening conditions are often extremely unwell. When exploring why individuals participate in clinical trials one common observation is a misplaced expectation of personal benefit - a therapeutic misconception. The care offered in some clinical trials is of a higher standard than is routinely available and this has led to criticism around the freedom of choice to enrol - structural coercion.

Schistosomiasis messaging in endemic communities: Lessons and implications for interventions from rural Uganda, a rapid ethnographic assessment study.

Background: Over 240 million people are infected with schistosomiasis, the majority in sub-Saharan Africa. In Uganda, high infection rates exist in communities on the shores of Lake Victoria. Praziquantel mass drug administration (MDA) delivered by village health teams is the mainstay of schistosomiasis control.

Visual inspection with acetic acid (VIA) positivity among female sex workers: a cross-sectional study highlighting one-year experiences in early detection of pre-cancerous and cancerous cervical lesions in Kampala, Uganda.

Background: Although cervical cancer is preventable, most women in sub-Saharan Africa (SSA) do not receive routine screening and few treatment options exist. Female Sex Workers (FSWs) are among the Ugandan female population at highest risk of acquiring sexually transmitted infections (STIs) including HIV and human papilloma viruses (HPV), the cause of cervical cancer. We report one-year experiences of visual inspection with acetic acid (VIA) positivity among FSWs in the early detection of pre-cancerous and cancerous cervical lesions in Kampala, Uganda.

The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD): protocol for an in-depth qualitative study within a multisite randomised controlled trial for HIV-associated cryptococcal meningitis.

Introduction: Individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable. This is especially true in low-income settings. The decision to enrol may be influenced by existing inequalities, poor healthcare infrastructure and fear of death.

Experiences of research ethics committee members and scientists of the research protocol review process in Uganda: a case study.

Background: We investigated how relevant and responsive scientists and research ethics committee (REC) members considered the research protocol review processes for health research practice in Uganda.

Methods: Interviews were conducted with five scientists and five REC members. Data were analysed thematically.

Reasons for participating in a randomised clinical trial: The volunteers' voices in the COSTOP trial in Uganda.

Introduction: The reasons why research participants join clinical trials remains an area of inquiry especially in low and middle income countries.

Methods: We conducted exit interviews with participants who took part in a trial which aimed to evaluate whether long term prophylaxis with cotrimoxazole can be safely discontinued among adults who have been stabilised on antiretroviral therapy (ART). Participants were all reported to be stable on ART and had been participating in the trial for between 12 and 36 months; at the end of the trial participants were interviewed using a semi-structured questionnaire.

Exploring informed consent in HIV clinical trials: A case study in Uganda.

Introduction: In settings with low literacy levels ensuring that participants are fully-informed before they consent to participate in clinical trials is a challenge. We explored the experiences and concerns of key actors in the informed consent process in two HIV clinical trials.

Method: Semi-structured interviews were conducted with 46 respondents including trial participants, research study team and research ethics committee members about their experiences during the informed consent process.

Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda.

Background: Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team.

Pregnancy in HIV clinical trials in Sub Saharan Africa: failure of consent or contraception?

Objective: Higher than expected pregnancy rates have been observed in HIV related clinical trials in Sub-Saharan Africa. We designed a qualitative study to explore the factors contributing to high pregnancy rates among participants in two HIV clinical trials in Sub-Saharan Africa.

Methods: Female and male participants enrolled in one of two clinical HIV trials in south-west Uganda were approached.

A mixed methods and triangulation model for increasing the accuracy of adherence and sexual behaviour data: the Microbicides Development Programme.

Background: The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard" the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial.

Assessing the accuracy of adherence and sexual behaviour data in the MDP301 vaginal microbicides trial using a mixed methods and triangulation model.

Background: Accurate data on adherence and sexual behaviour are crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard" the collection of such data relies largely on participant self-reporting. The Microbicides Development Programme has developed a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour.

Re-framing microbicide acceptability: findings from the MDP301 trial.

Microbicides are most usually conceptualised within a disease prevention framework and studies usually define acceptability in terms of product characteristics, willingness to use and risk reduction. This starting point has led to assumptions about microbicides which, rather than being challenged by empirical studies, have tended to foreclose the data and subsequent conceptual models. Few studies take an emic ('insider') perspective or attempt to understand how microbicides fit into the broader context of women's and men's everyday lives.