Browsing by Author "Ngure, Kenneth"
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Item Acceptability and feasibility of long-term, real-time electronic adherence monitoring of HIV pre-exposure prophylaxis (PrEP) use among young women in Kenya: A mixed methods study(Public Library of Science, 2024-03-07) Ogello, Vallery A; Rono, Bernard Kipkoech; Ngure, Kenneth; Sedah, Eric; Thuo, Nicholas B; Musinguzi, Nicholas; Baeten, Jared M; Bukusi, Elizabeth A; Mugo, Nelly R; Haberer, Jessica EReal-time electronic adherence monitoring involves “smart” pill boxes that record and monitor openings as a proxy for pill taking and may be useful in understanding and supporting PrEP use; however, acceptability and/or feasibility for PrEP users is uncertain. We sought to understand the experiences of using a real-time electronic adherence monitor for PrEP delivery among young women in Kisumu and Thika, Kenya. We used the Wisepill device to monitor PrEP use among 18-24-year-old women for two years. Half of the participants were randomized to also receive SMS adherence reminders (daily or as needed for missed doses). We assessed acceptability quantitatively and qualitatively according to the four constructs of Unified Theory of Acceptance and Use of Technology (UTAUT): performance expectancy, effort expectancy, social influence, and facilitating conditions. We assessed feasibility by monitor functionality during periods of PrEP use. We analyzed quantitative data descriptively and compared by site and over time; qualitative data were analyzed inductively and deductively. The median age was 21 years (IQR 19–22), median education was 12 years (IQR 10–13), 182 (53%) had disclosed PrEP use, and 55 (16%) reported recent intimate partner violence. Most participants reported high levels of usefulness and high interest in using the monitor with few problems or worries reported throughout follow-up. Feasibility was high overall with some differences by site (96% functional monitor days in Kisumu vs 88% in Thika). Few monitors were reported lost (N = 29; 8%) or dysfunctional (N = 11; 3%). In qualitative interviews, electronic monitoring was perceived as useful because it supported privacy, confidentiality, easy storage, and PrEP adherence. Effort was generally considered low. Participants expressed some concern for stigma from monitor and/or PrEP use. Facilitating conditions involved the monitor size, color, and battery life. Overall, real-time electronic adherence monitoring was a highly acceptable and feasible approach to understand PrEP adherence among young women in a sub-Saharan African setting.Item Comparison of short messaging service self-reported adherence with other adherence measures in a demonstration project of HIV preexposure prophylaxis in Kenya and Uganda(AIDS (London, England), 2018) Musinguzi, Nicholas; Muwonge, Timothy; Ngure, Kenneth; Katabira, Elly; Mugo, Nelly; O’Rourke Burns, Bridget Frances; Baeten, Jared M.; Heffron, Renee; Haberer, Jessica E.Short messaging service (SMS) can collect adherence data on a frequent basis and is relatively anonymous, and therefore could potentially reduce recall and social desirability biases prevalent in other self-reported measures. Methods: We compared SMS self-reported adherence with three self-reported adherence questions (rating of ability to adhere, frequency of doses taken, percentage of doses taken) and two objective adherence measures [electronic adherence monitoring (EAM) and plasma tenofovir levels] using data from HIV-uninfected members of serodiscordant couples enrolled in a preexposure prophylaxis demonstration project in Kenya and Uganda. Results: Of 373 enrolled participants, 256 (69%) were male and median age at enrolment was 29 years (26, 35). Fifty-two percent were from Kenya and median education at enrolment was 10 years (7,12). Overall, median adherence was 90, 75, 85,94 and 79%, respectively, for self-report by SMS, rating, frequency, percentage and EAM adherence. Spearman’s correlation coefficient between SMS and interviewer- administered self-reported measures was 0.18 for rating and frequency, 0.22 for percentage and 0.14 for EAM (all P< 0.001). The estimated difference in average adherence between SMS and self-reported rating, frequency, percentage adherence and EAM was 8.1 (P < 0.001), 0.3 (P = 0.81), −5.2 (P < 0.001) and 9.5 (P < 0.001), respectively. Area under the receiver-operating curve assessing the ability of SMS self-report to discriminate between detectable and undetectable tenofovir was 0.51. Conclusion: Our study found low correlation between SMS self-report and other self-reported and objective adherence measures and did not discriminate between detectable and undetectable plasma tenofovir levels. Future use of SMS self-report should explore alternative means for reducing potential biases.Item Context matters: PrEP adherence is associated with sexual behavior among HIV serodiscordant couples in East Africa(Journal of acquired immune deficiency syndromes, 2017) Haberer, Jessica E.; Ngure, Kenneth; Muwonge, Timothy; Mugo, Nelly; Katabira, Elly; Heffron, Renee; Musinguzi, Nicholas; Bangsberg, David R.; Celum, Connie; Baeten, Jared M.Short message service (SMS) surveys are a promising tool for understanding whether pre-exposure prophylaxis (PrEP) adherence aligns with risk for HIV acquisition— a concept known as prevention-effective adherence. Methods—The Partners Demonstration Project was an open-label study of integrated PrEP and antiretroviral therapy (ART) delivery among high-risk HIV serodiscordant couples in East Africa. HIV-uninfected partners were offered PrEP until their HIV-infected partner had taken ART for ≥6 months. At 2 study sites, HIV-uninfected partners were offered enrollment into the Partners Mobile Adherence to PrEP (PMAP) sub-study based on ongoing PrEP use, personal cell phone ownership, and ability to use SMS. SMS surveys asked about PrEP adherence and sexual activity in the prior 24 hours; these surveys were sent daily for the 7 days prior and 7 days after routine study visits in the Partners Demonstration Project. Results—The PMAP sub-study enrolled 373 HIV-uninfected partners; 69% were male and mean age was 31 years. Participants completed 17,030 of 23,056 SMS surveys sent (74%) with a mean of 47 surveys per participant over 9.8 months of follow-up. While HIV-infected partner use of ART was <6 months, mean reported PrEP adherence was 92% on surveys concurrently reporting sex within the serodiscordant partnership and 84% on surveys reporting no sex (p<0.001). Discussion—SMS surveys provided daily assessment of concurrent PrEP adherence and sexual behavior. Higher PrEP adherence was temporally associated with increased risk for HIV acquisition.Item 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, AndrewBackground: 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 retainingItem Intimate partner violence and self-reported pre-exposure prophylaxis (PrEP) interruptions among HIV-negative partners in HIV serodiscordant couples in Kenya and Uganda(Journal of acquired immune deficiency syndromes, 2018) Cabral, Alejandra; Baeten, Jared; Ngure, Kenneth; Velloza, Jennifer; Odoyo, Josephine; Haberer, Jessica; Celum, Connie; Muwonge, Timothy; Asiimwe, Stephen; Heffron, ReneeOral pre-exposure prophylaxis (PrEP) is effective for HIV prevention and PrEP delivery studies are investigating ways to deliver PrEP with high adherence. However, in many settings with high HIV burden, intimate partner violence (IPV) is reported often and could be a barrier to effective PrEP use. We examined the association between IPV and interruptions in PrEP use. Methods—We analyzed data from 1,013 serodiscordant heterosexual couples enrolled in a large PrEP demonstration project in Kenya and Uganda, the Partners Demonstration Project. At quarterly study visits, HIV-negative participants receiving PrEP were asked about interruptions in their PrEP use and experiences with IPV. The association between IPV and PrEP interruptions was analyzed using multivariable generalized estimating equations. Results—At baseline and follow-up there were 53 visits with reports of abuse by 49 HIV-negative partners, including physical, economic, and verbal IPV. Interruptions in PrEP use were reported at 328 visits (7.1% of all visits) by 249 people. The median length of PrEP interruption was 28 days (interquartile range [IQR]: 7–45). The frequency of PrEP interruptions among those reporting IPV was 23.8% and those without IPV was 6.9%. PrEP interruption was significantly associated with IPV after adjustment for age and frequency of sexual intercourse (adjusted OR=2.6, 95% CI 1.2–6.0). Conclusion—IPV was more likely to be reported at visits when PrEP interruptions were also reported, which may have implications for sustained adherence to PrEP. Within PrEP delivery programs, there may be opportunities to assess individual safety and well-being in order to bolster adherence.Item Sexual behavior and perceived HIV risk among HIV-negative members of serodiscordant couples in East Africa(AIDS and Behavior, 2020) Wanga, Valentine; Baeten, Jared M.; Bukusi, Elizabeth A.; Mugo, Nelly R.; Asiimwe, Stephen; Ngure, Kenneth; Mujugira, Andrew; Muwonge, Timothy; Odoyo, Josephine B.; Haberer, Jessica E.; Celum, Connie; Heffron, ReneeHIV risk perception may influence the use of HIV prevention interventions. Using data from HIV-negative adults enrolled in a study of pre-exposure prophylaxis (PrEP) and antiretroviral therapy for HIV-serodiscordant couples in Kenya and Uganda, we examined associations between: 1) condom use and risk perception and 2) risk perception and PrEP adherence. Two-thirds of HIV-negative partners reported condomless sex with their HIV-positive partner or another partner in the month prior to study enrollment. Compared to those who reported no condomless sex, participants who reported condomless sex during the month prior to study visit had 5-fold higher odds of reporting “high risk” vs “no risk” perception (36.3 versus 10.9%: aOR=4.9, 95% CI: 3.4–6.9). Reporting condomless sex in the most recent sex act was associated with increased odds of perceiving some HIV risk (aOR for high risk=7.3, 95% CI 4.9–10.8; aOR for moderate risk=4.8, 95% CI 3.5–6.7; aOR for low risk=3.5, 95% CI 2.7–4.6). We found no significant association between risk perception and PrEP adherence. Sexual behavior aligned with perceived HIV risk, which can facilitate an HIV-negative individual’s decisions about PrEP use.Item Short message service (SMS) surveys assessing pre-exposure prophylaxis (PrEP) adherence and sexual behavior are highly acceptable among HIV-uninfected members of serodiscordant couples in East Africa: A mixed methods study(AIDS and Behavior, 2019) Muwonge, Timothy R.; Ngure, Kenneth; Katabira, Elly; Mugo, Nelly; Kimemia, Grace; O'Rourke Burns, Bridget Frances; Musinguzi, Nicholas; Bambia, Felix; Baeten, Jared M.; Heffron, Renee; Haberer, Jessica E.Short message service (SMS) surveys are a promising data collection method and were used to measure sexual behavior and adherence to HIV pre-exposure prophylaxis (PrEP) among HIV-uninfected partners of serodiscordant couples enrolled in a sub-study of the Partners Demonstration Project (an open-label study of integrated antiretroviral therapy and PrEP for HIV prevention in Kenya and Uganda). Questionnaires were completed by 142 participants after study exit. Median age was 29 years; 69% were male. Ninety-five percent (95%) felt SMS surveys were “easy” or “very easy”, 74% reported no challenges, and 72% preferred SMS surveys over in-person study visits. Qualitative interviews involving 32 participants confirmed the ease of responding to SMS surveys. Participants also indicated that surveys acted as reminders for adherence to PrEP and condom use and were experienced as support from the study. SMS surveys were generally found to be acceptable in this population and provided real-time context of PrEP use.