Browsing by Author "Ssali, Agnes"
Now showing 1 - 9 of 9
Results Per Page
Sort Options
Item Ethical and Practical Considerations Arising from Community Consultation on Implementing a Controlled Human Infection Studies using Schistosoma Mansoni in Uganda(Global Bioethics, 2022) Egesa, Moses; Ssali, Agnes; Tumwesige, Edward; Kizza, Moses; Driciru, Emmanuella; Luboga, Fiona; Roestenberg, Meta; Seeley, Janet; Elliott, Alison M.Issues related to controlled human infection studies using Schistosoma mansoni (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. With both groups, a mock consent process was conducted. Fourteen in-depth key informant interviews and three group discussions were held to explore perceptions towards participating in a CHI-S. Most of the participants had not heard of the CHI-S. Willingness to take part depended on understanding the study procedures and the consenting process. Close social networks were key in deciding to take part. The worry of adverse effects was cited as a possible hindrance to taking part. Volunteer time compensation was unclear for a CHI-S. Potential volunteers in these communities are willing to take part in a CHI-S. Community engagement is needed to build trust and time must be taken to share study procedures and ensure understanding of key messages.Item Ethical and Practical Considerations arising from Community Consultation on Implementing Controlled Human Infection Studies using Schistosoma Mansoni in Uganda(Global Bioethics, 2022) Egesa, Moses; Ssali, Agnes; Tumwesige, Edward; Kizza, Moses; Driciru, Emmanuella; Luboga, Fiona; Roestenberg, Meta; Seeley, Janet; Elliott, Alison M.Issues related to controlled human infection studies using Schistosoma mansoni (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. With both groups, a mock consent process was conducted. Fourteen in-depth key informant interviews and three group discussions were held to explore perceptions towards participating in a CHI-S. Most of the participants had not heard of the CHI-S. Willingness to take part depended on understanding the study procedures and the consenting process. Close social networks were key in deciding to take part. The worry of adverse effects was cited as a possible hindrance to taking part. Volunteer time compensation was unclear for a CHI-S. Potential volunteers in these communities are willing to take part in a CHI-S. Community engagement is needed to build trust and time must be taken to share study procedures and ensure understanding of key messages.Item Experiences of research ethics committee members and scientists of the research protocol review process in Uganda: a case study(International Health, 2020) Ssali, Agnes; Poland, Fiona; Seeleya, JanetWe 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. Results: How much to compensate for time, the amount of study information shared with volunteers and sample storage for future unknown research were areas of concern for REC members. Delays in getting feedback concerned scientists. Conclusions: Researchers and REC members need to hold regular discussions to ensure the review process is relevant and responsive.Item A Mixed Methods and Triangulation Model for Increasing the Accuracy of Adherence and Sexual Behaviour Data: The Microbicides Development Programme(PLoS ONE, 2010) Pool, Robert; Montgomery, Catherine M.; Morar, Neetha S.; Mweemba, Oliver; Ssali, Agnes; Gafos, Mitzy; Lees, Shelley; Stadler, Jonathan; Crook, Angela; Nunn, Andrew; Hayes, Richard; McCormack, SheenaThe collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIVrelated) 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. In a companion paper some of the results from this model are presented. Methodology/Principal Findings: Data were collected from a random subsample of 725 women (7.7% of the trial population) using structured interviews, coital diaries, in-depth interviews, counting returned gel applicators, focus group discussions, and ethnography. The core of the model was a customised, semi-structured in-depth interview. There were two levels of triangulation: first, discrepancies between data from the questionnaires, diaries, in-depth interviews and applicator returns were identified, discussed with participants and, to a large extent, resolved; second, results from individual participants were related to more general data emerging from the focus group discussions and ethnography. A democratic and equitable collaboration between clinical trialists and qualitative social scientists facilitated the success of the model, as did the preparatory studies preceding the trial. The process revealed some of the underlying assumptions and routinised practices in ‘‘clinical trial culture’’ that are potentially detrimental to the collection of accurate data, as well as some of the shortcomings of large qualitative studies, and pointed to some potential solutionsItem Pregnancy in HIV Clinical Trials in Sub Saharan Africa: Failure of Consent or Contraception?(PLoS ONE, 2013) Ssali, Agnes; Namukwaya, Stella; Bufumbo, Leonard; Seeley, Janet; Lalloo, David G.; Parkes-Ratanshi, Rosalind; Kamali, AnatoliHigher 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. The trials were a phase III microbicide efficacy trial among HIV negative women using vaginal gel (MDP); and a trial of primary prevention prophylaxis for invasive cryptococcal disease using fluconazole among HIV infected men and women in Uganda (CRYPTOPRO). 14 focus group discussions and 8 in-depth interviews were conducted with HIV positive and negative women and their male partners over a six month period. Areas explored were their experiences about why and when one should get pregnant, factors affecting use of contraceptives, HIV status disclosure and trial product use. Results: All respondents acknowledged being advised of the importance of avoiding pregnancy during the trial. Factors reported to contribute to pregnancy included; trust that the investigational product (oral capsules/vaginal gel) would not harm the baby, need for children, side effects that led to inconsistent contraceptive use, low acceptance of condom use among male partners. Attitudes towards getting pregnant are fluid within couples over time and the trials often last for more than a year. Researchers need to account for high pregnancy rates in their sample size calculations, and consider lesser used female initiated contraceptive options e.g. diaphragm or female condoms. In long clinical trials where there is a high fetal or maternal risk due to investigational product, researchers and ethics committees should consider a review of participants contraceptive needs/pregnancy desire review after a fixed period, as need for children, partners and health status of participants may alter over time.Item Reasons for participating in a randomised clinical trial: The volunteers' voices in the COSTOP trial in Uganda(Contemporary clinical trials communications, 2017) Ssali, Agnes; Nunn, Andrew; Mbonyea, Martin; Anywainea, Zacchaeus; Seeleya, JanetIntroduction: 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. One of the objectives of the exit interview was to find out what motivated the participants to join the research. Results: Participants gave personal reasons for joining the trial, frequently linked to their health and well-being as well as reduction of pill burden. Conclusion: We conclude that underlying reasons for joining clinical trials may extend beyond or can be different from the rationale given to the participants before enrolment by the research team. The reasons that motivate enrolment to clinical trials and research in general require further investigation in different settings. Trial registration number: ISRCTN44723643.Item Schistosomiasis messaging in endemic communities: Lessons and implications for interventions from rural Uganda, a rapid ethnographic assessment study(PLoS Negl Trop Dis, 2021) Ssali, Agnes; Pickering, Lucy; Nalwadda, Edith; Mujumbusi, Lazaaro; Seeley, Janet; Lamberton, Poppy H. L.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. However, treatment uptake remains suboptimal, with many people unaware of treatment or thinking it is only for children. Furthermore, people are often rapidly reinfected post-treatment due to continued exposure. In three Schistosoma mansoni high endemicity lake-shore communities in Mayuge district, Eastern Uganda, we investigated the sources of schistosomiasis information, remembered content of information, and the perception of information and related practices towards the control of schistosomiasis.Item Visual inspection with acetic acid (VIA) positivity among female sex workers: a cross-sectional study highlighting one-year experiences in early detection of precancerous and cancerous cervical lesions in Kampala, Uganda(Infectious Agents and Cancer, 2021) Namale, Gertrude; Mayanja, Yunia; Kamacooko, Onesmus; Bagiire, Daniel; Ssali, Agnes; Seeley, Janet; Newton, Robert; Kamali, AnatoliAlthough 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. Methods: Between June 2014 and July 2015, we enrolled FSWs into a cross-sectional study at a research clinic. The women were screened using the VIA method (application of 3–5 % acetic acid to the cervix). All VIA positive women were referred to a tertiary hospital for colposcopy, biopsy, and immediate treatment (if indicated) at the same visit according to national guidelines. Data on socio-demographic, sexual behaviour, sexual reproductive health and clinical characteristics were collected. We used logistic regression to identify factors associated with VIA positivity. Results: Of 842 women assessed for eligibility, 719 (85 %) of median age 30 (IQR 26, 35) were screened, and 40 (6 %) women were VIA positive. Of the 24 histology specimens analysed, 6 showed inflammation, only 1 showed cervical intraepithelial neoplasia (CIN) 1, 13 women showed CIN2/3, while 4 women already had invasive cervical cancer. The overall prevalence of HIV was 43 %, of whom only 35 % were receiving ART. In the age-adjusted analysis, VIA positivity was more likely among women who reported having > 100 life-time partners (aOR = 3.34, 95 %CI: 1.38–8.12), and HIV positive women (aOR = 4.55; 95 %CI: 2.12–9.84).Item Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda(BMC medical ethics, 2015) Ssali, Agnes; Poland, Fiona; Seeley, JanetInformed 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. Methods: Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis. Results: Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.