Browsing by Author "Nakalega, Rita"

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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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    Viral Load suppression after intensive adherence counselling among HIV infected adults at Kiswa Health Centre, Kampala: A retrospective cohort study. Secondary data analysis
    (Research Square, 2022) Nakaye, Catherine; Mukiza, Nelson; Mawanda, Denis; Kataike, Hajira; Kaganzi, Hellen; Ahimbisibwe, Grace Miriam; Businge, Gerald Bright; Kyambadde, Raymonds Crespo; Nakalega, Rita
    The Joint United Nations Programme on HIV/AIDS through the 95-95-95 target requires 95% of people with HIV infection (PWHIV) on antiretroviral treatment (ART) to be virally suppressed. Viral Load (VL) non-suppression has been found to be associated with suboptimal ART adherence, and Intensive Adherence Counselling (IAC) has been shown to lead to VL re-suppression by over 70% in PWHIV on ART. Currently, there is data paucity on VL suppression after IAC in adult PWHIV in Uganda. This study aimed to evaluate the proportion of VL suppression after IAC and associated factors among adult PWHIV on ART at Kiswa Health Centre in Kampala, Uganda. Methods Study was a retrospective cohort design and employed secondary data analysis to review routine program data. Medical records of adult PWHIV on ART for at least six months with VL non-suppression from January 2018 to June 2020 at Kiswa HIV clinic were examined in May 2021. Descriptive statistics were applied to determine sample characteristics and study outcome proportions. Multivariable modified Poisson regression analysis was employed to assess predictors of VL suppression after IAC. Results Analysis included 323 study participants of whom 204 (63.2%) were female, 137 (42.4%) were between the age of 30 and 39 years; and median age was 35 years (interquartile range [IQR] 29–42). Participant linkage to IAC was 100%. 48.6% (157/323) of participants received first IAC session within 30 days or less after unsuppressed VL result. 66.78% (205/307) of participants who received recommended three or more IAC sessions achieved VL suppression. 34% of participants completed three IAC sessions in recommended 12 weeks. Receipt of three IAC sessions (ARR = 1.33, 95%CI: 1.16–1.53, p < 0.001) and having baseline VL of 1,000–4,999 copies/ml (ARR = 1.47, 95%CI: 1.26–1.73, p < 0.001) was significantly associated with VL suppression after IAC. Conclusion VL suppression proportion of 66.78% after IAC in this population was comparable to 70%, the percentage over which adherence interventions have been shown to cause VL re-suppression. However, timely IAC intervention is needed from receipt of unsuppressed VL results to IAC process completion. Resistance testing should be performed for PWHIV with persistent VL non-suppression after IAC for apt ART regimen switch.