Browsing by Author "Kemigisha, Doreen"

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    Ask the Way From Those Who Have Walked It Before – Grandmothers’ Roles in Health-related Decision Making and HIV Pre-exposure Prophylaxis (PrEP) Use Among Pregnant and Breastfeeding Women in Africa
    (Research Square, 2021) Reddy, Krishnaveni; Kemigisha, Doreen; Chitukuta, Miria; Dadabhai, Sufia; Mathebula, Florence; Tenza, Siyanda; Palanee-Phillips, Thesla; Ryan, Julia; van der Straten, Ariane; Musara, Petina; Macagna, Nicole; Ryan, Julia
    HIV acquisition among pregnant and breastfeeding women in sub-Saharan Africa (SSA) and vertical transmission rates remain high despite established strategies for HIV prevention. Methods: We explored grandmothers’ (mothers/mothers-in-law) influence on pregnant and breastfeeding women’s health-related decisions and their potential to support use of HIV prevention products utilizing qualitative data collected from grandmothers, HIV-uninfected, currently/recently pregnant or breastfeeding women and male partners of currently/recently pregnant or breastfeeding women during the MTN-041/MAMMA study. Results: Grandmothers were described as important sources of information, playing both supportive and influencer roles, due to personal maternal experience and generational knowledge. Grandmothers expressed willingness to support pre-exposure prophylaxis (PrEP) use and agreed with other groups that this decision should be made by women themselves and/or with partners. Conclusion: With the right framing and approach, grandmothers’ supportive roles can optimise uptake and adherence to biomedical HIV prevention and reduce HIV acquisition among pregnant and breastfeeding women in these communities.
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    Ethical considerations for involving adolescents in biomedical HIV prevention research
    (BMC Medical Ethics, 2021) Nakalega, Rita; Akello, Carolyne; Gati, Brenda; Nakabiito, Clemensia; Nolan, Monica; Kamira, Betty; Etima, Juliane; Nakyanzi, Teopista; Kemigisha, Doreen; Nanziri, Sophie C.; Nanyonga, Stella; Nambusi, Maria Janine; Mulumba, Emmie; Biira, Florence; Nabunya, Hadijah Kalule; Akasiima, Simon Afrika; Nansimbe, Joselyne; Maena, Joel; Babirye, Juliet Allen; Ngure, Kenneth; Mujugira, Andrew
    Background: Involvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16–17-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving investigational new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda. Methods: From August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions. Results: Most community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo. Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention. Conclusions: Stakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining
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    How Community Education Tools Facilitated Understanding of the ASPIRE Vaginal Ring Study: Kampala Experience
    (AIDS Research and Human Retroviruses, 2014) Ndawula, Patrick; Nakyanzi, Teopista; Etima, Juliane; Kabwigu, Samuel; Matovu, Flavia K.; Nanziri, Sophie C.; Kemigisha, Doreen; Nanyonga, Stella; White, Rhonda; Cokley, Cheryl; Nakabiito, Clemesia
    UNAIDS Good participatory practice guidelines for biomedical HIV prevention trials recommends that sufficient trial information, such as study objectives, procedures, risks, benefits, and what is expected of participants, is provided for potential participants to make informed decisions. We describe how ASPIRE community education tools increased study awareness and enabled literacy regarding research, reproductive health, family planning, and HIV prevention.
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    Impact and experience of participant engagement activities in supporting dapivirine ring use among participants enrolled in the phase III MTN-020/ASPIRE study
    (BMC public health, 2021) Garcia, Morgan; Luecke, Ellen; Mayo, Ashley J.; Scheckter, Rachel; Ndase, Patrick; Matovu Kiweewa, Flavia; Kemigisha, Doreen; Musara, Petina; Singh, Nishanta; Palanee-Phillips, Thesla; Baeten, Jared M.; Torjesen, Kristine; Mansoor, Leila E.
    Low adherence to investigational products can negatively impact study outcomes, limiting the ability to demonstrate efficacy. To continue advancing potential new HIV prevention technologies, efforts are needed to improve adherence among study participants. In MTN-020/ASPIRE, a phase III randomized, double-blind, placebocontrolled study of the dapivirine vaginal ring carried out across 15 sites in sub-Saharan Africa, a multifaceted approach to adherence support was implemented, including a strong focus on participant engagement activities (PEAs). In this manuscript, we describe PEAs and participant attendance, and analyze the potential impact of PEAs on ring use. Methods: All sites implemented PEAs and submitted activity and attendance reports to the study management team throughout the study. Participant demographics were collected via case report forms. Residual dapivirine remaining in the last ring returned by each participant was used to estimate drug released from the ring, which was then adjusted for time participants had the ring to calculate probable use categorized into three levels (low/intermittent/high). Product use was connected to PEA attendance using participant identification numbers. We used multivariate Poisson regression with robust standard errors to explore differences in ring use between PEA attendance groups and reviewed qualitative reports for illustrative quotes highlighting participant experiences with PEAs. Results: 2312 of 2629 study participants attended at least one of 389 PEAs conducted across sites. Participant country and partner knowledge of study participation were most strongly associated with PEA attendance (p < 0.005) with age, education, and income status also associated with event attendance (p <0.05). When controlling for these variables, participants who attended at least one event were more likely to return a last ring showing at least some use (RR = 1.40) than those who never attended an event. There was a stronger correlation between a last returned ring showing use and participant attendance at multiple events (RR = 1.52).
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    Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study
    (HIV Clinical Trials, 2018) Wynne, Joshua; Muwawu, Rosemary; Mubiru, Michael C.; Kamira, Betty; Kemigisha, Doreen; Nakyanzi, Teopista; Kabwigu, Samuel; Nakabiito, Clemensia; Kiweewa Matovu, Flavia
    The success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results. This paper describes the challenges and specific strategies used to retain participants in a Phase 2B safety and effectiveness study of daily oral and vaginal tenofovir formulations for the prevention of HIV-1 infection in the MTN-003 (VOICE) trial in Kampala, Uganda. Once enrolled, participants were seen every 28 days at the research site and their study product was re-filled. Challenges to retention included a mobile population, non-disclosure of study participation to spouse/family, and economic constraints. Strategies used to maintain high participation rates included the use of detailed locator information, a participant tracking database, regular HIV/STI testing, and the formation of close bonds between staff and subjects. We enrolled 322 women out of the 637 screened. The overall retention rate was 95% over a 3 year follow up period. Only 179 (3%) out of the 6124 expected visits were missed throughout study implementation. Reasons for missed visits included: participants thinking that they did not need frequent visits due to their HIV negative status, time constraints due to commercial sex work, and migration for better employment. With the implementation of multi-faceted comprehensive follow-up and retention strategies, we achieved very high retention rates in the MTN-003 study. This paper provides a blueprint for effective participant retention strategies for other longitudinal HIV prevention studies in resource-limited settings in Sub-Saharan Africa.
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    Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site
    (AIDS Research and Human Retroviruses, 2014) Nanziri, Sophie Clare; Ndawula, Patrick; Nakyanzi, Teopista; Gati, Brenda; Matovu, Flavia K.; Etima, Juliane; Kabwigu, Samuel; Kemigisha, Doreen; Nanyonga, Stella; Nakabiito, Cleemensia
    Recruitment of participants is labor intensive and a critical aspect of prevention research. It is important to incorporate early retention techniques into recruitment strategies during the planning phase to ensure that retention targets are met. The Kampala team describes the strategies, process, and challenges in ensuring retainable participants are recruited into the study.