Browsing by Author "Muwonge, Timothy"
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Item Adherence to oral HIV pre-exposure prophylaxis among female sex workers in Kampala, Uganda(African Health Sciences, 2021) Kakoola Nalukwago, Grace; Isunju, John Bosco; Muwonge, Timothy; Katairo, Thomas; Bunani, Nelson; Semitala, Fred; Kyambadde, Peter; Matovu, FlaviaIn Kampala Uganda, female sex workers (FSWs) have high HIV prevalence (33%). Oral PrEP is a novel HIV prevention intervention that offers hope to decrease HIV incidence in key populations especially among FSWs. Studies have shown that with poor adherence, oral PrEP has no efficacy, and therefore adherence to PrEP is critical among FSWs to maximize HIV prevention. However, implementation data on adherence to PrEP among FSWs is limited so this study sought to assess adherence to PrEP. Specifically, we sought to 1) determine the level of adherence to PrEP among FSWs, and 2) determine factors associated with PrEP adherence. Methods: This cross-sectional study was conducted from November to December 2018; 126 FSWs using PrEP were interviewed using a questionnaire. Adherence was categorically defined as high adherence and low adherence. Logistic regression was done. Results: Using long-term contraception methods (OR 0.06, 95% CI: 0.04-0.77) and not using condoms with clients (OR 0.07, 95% CI: 0.01-0.42) were negatively associated with high PrEP adherence. Conclusion: Barriers to PrEP adherence need to be addressed for successful PrEP implementation to improve adherence going forward. Service care providers should reinforce positive behaviors such as use of condoms devotedly during PrEP breaks.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 Does Adherence Change When No One is Looking? Comparing Announced and Unannounced Tenofovir Levels in a PrEP Trial(Journal of acquired immune deficiency syndromes, 2017) Musinguzi, Nicholas; Muwonge, Timothy; Thomas, Katherine; Baeten, Jared M.; Bangsberg, David R.; Haberer, Jessica E.Differences between unannounced and announced tenofovir levels as measures of PrEP adherence are not well understood. In an ancillary adherence study involving one urban site (Kampala) and two rural sites (Kabwohe and Tororo) from the Partners PrEP study, 268 specimen pairs from chronologically proximal clinic and home visits were tested for plasma tenofovir levels. Comparing clinic and home specimens, 89 versus 89 % were classified as detectable ([0.31 ng/ml; p = 0.77), 87 versus 86 % as recent dosing ([10 ng/ml; p = 0.80), and 82 versus 80 % as steady-state ([40 ng/ml; p = 0.44). Mean difference between announced and unannounced drug levels, adjusted for specimen collection time was 3.2 ng/ml (p = 0.50) for Kabwohe, 23.2 ng/ml (p = 0.003) for Kampala and -3.3 ng/ml p = 0.69) for Tororo. In the setting of high adherence, plasma tenofovir levels tested at the clinic were categorically similar as levels tested at home; however, differences were seen between urban and rural settings.Item 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 A pragmatic approach to identifying implementation barriers and facilitators for a novel pre-exposure prophylaxis (PrEP) delivery model at public facilities in urban Uganda(Implementation Science Communications, 2022) Thomas, Dorothy; Mujugira, Andrew; Ortblad, Katrina; Namanda, Sylvia; Kibuuka, Joseph; Nakitende, Mai; Nambi, Florence; Nakabugo, Lylianne; Scoville, Caitlin; Muwonge, Timothy; Heffron, ReneeScalable HIV pre-exposure prophylaxis (PrEP) delivery models for resource-limited settings are critical for improving PrEP coverage and interrupting HIV transmission. This research uses technical assistance (TA) reports to evaluate implementation barriers and facilitators for a novel delivery model integrating PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples in public health facilities in Kampala, Uganda. Methods: We used data from the Partners PrEP Program (PPP)—a stepped-wedge cluster randomized trial that is launching PrEP delivery through an integrated model of oral PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples at public health facilities in Kampala and Wakiso, Uganda (NCT03586128). Technical assistance teams, comprised of PPP program staff, conducted monthly TA visits to implementing facilities where they identified and addressed implementation challenges in collaboration with health facility staff. Findings were recorded in TA reports, a standardized form structured using the Consolidated Framework for Implementation Research (CFIR). We used a conceptual content analysis approach to evaluate TA reports completed from January to December 2019 and identify implementation barriers and facilitators. Results: Among 39 reports from the 8 implementing facilities (~ 5 per facility), we identified 11 CFIR constructs. Key implementation facilitators included sensitizing and educating facility staff about PrEP (knowledge and beliefs about the innovation); establishing formal and informal feedback and accountability mechanisms (reflecting and evaluating); and empowering facility staff to address implementation challenges (self-efficacy). Key implementation barriers were related to ineffective recruitment and referral of sero-different couples to and from nearby facilities (cosmopolitanism) as well as stockouts of laboratory resources and testing supplies (available resources). Conclusions: This analysis featured a robust implementation science framework to assess the relationship between early implementation determinants and outcomes of this innovative PrEP delivery model. Further, we have provided important descriptions of early implementation barriers and facilitators that will inform scale-up efforts for PrEP delivery within and beyond Uganda. Future work will refine the analysis of pragmatic program data, qualitatively investigate the identified key themes, and explore strategies for addressing implementation barriers.Item Prevalence and risk factors for hypertension and diabetes among those screened in a refugee settlement in Uganda(Conflict and Health, 2021) Kubiak, Rachel W.; Sveum, Elinor M.; Faustin, Zikama; Muwonge, Timothy; Abbas Zaidi, Hussain; Kambugu, Andrew; Masereka, Simon; Kasozi, Julius; Bassett, Ingrid V.; O’Laughlin, Kelli N.Diabetes and hypertension are increasingly prevalent in low and middle income countries, but they are not well documented in refugee settlements in these settings. We sought to estimate the prevalence and associated characteristics of diabetes and hypertension among adults presenting for clinic-based HIV testing in Nakivale Refugee Settlement in Uganda. Methods: HIV-negative adults presenting to outpatient clinics for HIV testing at three health centers in Nakivale Refugee Settlement were enrolled from January 2019 through January 2020. Multi-lingual research assistants administered questionnaires aloud to ascertain medical history and sociodemographic information. The research assistants used standardized procedures to measure participants’ blood pressure to detect hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg), and conduct a point-of-care blood glucose test for diabetes (random blood glucose ≥11.1 mmol/L with self-reported frequent urination or thirst, or fasting blood glucose ≥7.0 mmol/L regardless of symptoms), as per Uganda Ministry of Health guidelines. We used χ- square or Fisher’s exact test to test for differences in disease prevalence by refugee status and log-binomial or Poisson regression models to estimate associations of immigration status and country of origin, respectively, with hypertension and diabetes while controlling for age, sex, education level, and body mass index. Results: Among 2127 participants, 1379 (65%) were refugees or asylum seekers and 748 (35%) were Ugandan nationals. Overall, 32 participants met criteria for diabetes (1.5%, 95% CI 1.1–2.1%) and the period prevalence was 2.3% (95% CI 1.7–3.0). There were 1067 (50%, 95% CI 48.0–52.2%) who met the criteria for pre-hypertension and 189 (9%, 95% CI 7.7–10.1%) for hypertension. These proportions did not vary by immigration status or country of origin in univariate tests or multivariable regression models. Conclusions: Hypertension was common and diabetes was uncommon among those screened in a Ugandan refugee settlement. Routine blood pressure screening should be considered in this setting. Additional research could develop diabetes screening criteria to help identify at risk individuals in this limited resource setting.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 Treatment with Commonly Used Antiretroviral Drugs Induces a Type I/III Interferon Signature in the Gut in the Absence of HIV Infection(Cell Reports Medicine, 2020) Hughes, Sean M.; Levy, Claire N.; Calienes, Fernanda L.; Stekler, Joanne D.; Pandey, Urvashi adik; Vojtech, Lucia; Berard, Alicia R.; Birse, Kenzie; Noel-Romas, Laura; Richardson, Brian; Golden, Jackelyn B.; Cartwright, Michael; Collier, Ann C.; Stevens, Claire E.; Curlin, Marcel E.; Holtz, Timothy H.; Mugo, Nelly; Irungu, Elizabeth; Katabira, Elly; Muwonge, Timothy; Lama, Javier R.; Baeten, Jared M.; Burgener, Adam; Lingappa, Jairam R.; McElrath, M. Juliana; Mackelprang, Romel; McGowan, Ian; Cranston, Ross D.; Cameron, Mark J.; Hladik, FlorianTenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are used for HIV treatment and prevention. Previously, we found that topical rectal tenofovir gel caused immunological changes in the mucosa. Here, we assess the effect of oral TDF/FTC in three HIV pre-exposure prophylaxis trials, two with gastrointestinal and one with cervicovaginal biopsies. TDF/FTC induces type I/III interferon-related (IFN I/III) genes in the gastrointestinal tract, but not blood, with strong correlations between the two independent rectal biopsy groups (Spearman r = 0.91) and between the rectum and duodenum (r = 0.81). Gene set testing also indicates stimulation of the type I/III pathways in the ectocervix and of cellular proliferation in the duodenum. mRNA sequencing, digital droplet PCR, proteomics, and immunofluorescence confirm IFN I/III pathway stimulation in the gastrointestinal tract. Thus, oral TDF/FTC stimulates an IFN I/III signature throughout the gut, which could increase antiviral efficacy but also cause chronic immune activation in HIV prevention and treatment settings.