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OBJECTIVE: We evaluated the pharmacokinetics of double-dose levonorgestrel implants to overcome the drug-drug interaction with efavirenz-based antiretroviral therapy (ART). STUDY DESIGN: We conducted a non-randomized, open-label, parallel-group, longitudinal pharmacokinetic study among Ugandan women ages 18 to 45 years. Participants with HIV on ART containing efavirenz 600mg received 300mg LNG implants (Jadelle(®), Bayer, New Zealand): 300LNG+ART group. We compared our outcomes with women without HIV using standard dose, 150mg LNG implants: 150LNG group. The implant was placed on day 0 in both groups, and we quantified plasma LNG concentrations over 48 weeks post-implant insertion. LNG pharmacokinetic parameters were estimated using noncompartmental techniques. Our primary outcome was the geometric mean ratio (GMR) with 90% confidence intervals (CI) of LNG area under the concentration-time curve over 24 weeks (AUC(0–24w)) between groups. Demographic data were described as median (interquartile range). A secondary outcome compared between-group percent of levonorgestrel concentrations ≥300 pg/mL, a minimum threshold selected a priori based on observed pregnancies in Ugandan women on standard-dose levonorgestrel implants plus efavirenz. RESULTS: We enrolled 27 women in the 300LNG+ART group [34 (28.0–40.5) years and 61.0 (49.8–66.0) kg] and 19 women in the 150LNG group [33 (30.0–34.5) years and 64.9 (59.0–74.5) kg]. LNG AUC(0–24w) was 34% lower for 300LNG+ART vs. 150LNG [geometric mean 9998 vs. 15,231 pg*week/mL, respectively (GMR 0.66 (90% CI: 0.54–0.80)]. The percentage of participants with LNG concentrations ≥300 pg/mL was not statistically different between groups at week 24 (300LNG+ART: 74.1%; 150LNG: 89.5%; P=0.27). CONCLUSION: Double-dose LNG implant did not completely overcome the drug-drug interaction with efavirenz.

Background Throughout the last decade, tuberculosis (TB) treatment success has not surpassed 90%, the global target. The impact of mobile health interventions (MHIs) on TB treatment outcomes is unknown, especially in low- and middle-income countries (LMICs). MHIs, including interactive voice response technology (IVRT), may enhance adherence and retention in the care of patients with tuberculosis and improve TB treatment outcomes. This study seeks to determine the impact of IVRT-based MHI on TB treatment success (treatment completion and cure rates) in patients with TB receiving care at five public health facilities in Uganda. Methods We used a theory-based and human-centered design (HCD) to adapt an already piloted software to design “Call for life-TB” (CFL-TB), an MHI that utilizes IVRT to deliver adherence and appointment reminders and allows remote symptom reporting. This open-label, multicenter, randomized controlled trial (RCT), with nested qualitative and economic evaluation studies, will determine the impact of CFL-TB on TB treatment success in patients with drug-susceptible TB in Uganda. Participants (n = 274) at the five study sites will be randomized (1:1 ratio) to either control (standard of care) or intervention (adherence and appointment reminders, and health tips) arms. Multivariable regression models will be used to compare treatment success, adherence to treatment and clinic appointments, and treatment completion at 6 months post-enrolment. Additionally, we will determine the cost-effectiveness, acceptability, and perceptions of stakeholders. The study received national ethical approval and was conducted in accordance with the international ethical guidelines. Discussion This randomized controlled trial aims to evaluate interactive voice response technology in the context of resource-limited settings with a high burden of TB and high illiteracy rates. The software to be evaluated was developed using HCD and the intervention was based on the IMB model. The software is tailored to the local context and is interoperable with the MHI ecosystem. The HCD approach ensures higher usability of the MHI by integrating human factors in the prototype development. This research will contribute towards the understanding of the implementation and impact of the MHI on TB treatment outcomes and the health system, especially in LMICs. Trial registration ClinicalTrials.govNCT04709159. Registered on January 14, 2021.

The primary objective of this study was to characterize the pharmacokinetics of etonogestrel (ENG) released from a contraceptive implant in Ugandan women living with HIV who were receiving efavirenz (EFV) or nevirapine (NVP)-based antiretroviral therapy (ART), compared with ART-naive women over 24 weeks.Nonrandomized, parallel-group study with three arms: ART-naive, NVP, or EFV-based ART (N = 20/group).Sparse pharmacokinetic sampling of ENG, NVP, or EFV were performed at screening, entry, and then 1, 4, 12, and 24-week postimplant insertion. The primary endpoint was ENG concentrations at week 24, compared between the ART-naive group and each ART group, using geometric mean ratio (GMR) with 90% confidence intervals.Sixty participants competed the 24-week study and data from 58 participants are included; one participant each was excluded from the NVP group and EFV group because of a sample processing error and ART nonadherence, respectively. At week 24, geometric mean ENG was 362, 341, and 66 pg/ml in the ART-naive, NVP, and EFV groups, respectively [GMR: NVP : ART-naive 0.94 (0.90-1.01); EFV : ART-naive 0.18 (0.17-0.20)]. NVP and EFV concentrations were lower at week 24 compared to preimplant [NVP: geometric mean 5.7 versus 6.8 mg/l, respectively, GMR 0.84 (0.83-0.85); EFV: geometric mean 3.6 versus 4.9 mg/l, respectively, GMR 0.73 (0.69-0.80)].After 24 weeks of combined use, ENG exposure was 82% lower in women using EFV-based ART compared with ART-naive women. In contrast, NVP did not significantly impact ENG exposure. These results raise concerns about reduced effectiveness of implantable contraception for women taking EFV-based ART.

Purpose The aim of this study was to audit the knowledge and practices regarding eye care and eye complications of diabetes mellitus (DM) among diabetic patients 18 years and above in Kampala, Uganda. Methods. A cross-sectional study was done to collect data on the demographics, level of awareness and practices of the 409 diabetic patients regarding eye care and eye complications of DM. Data collected was captured in EPIDATA version 3.1, exported to STATA version 15.0 for further management and analysis. Participants characteristics were summarized using summary statistics and graphs. Using a standard questionnaire, scores for knowledge and practice for diabetes; knowledge and practice on diabetic retinopathy were generated and in all the four scores aforesaid, participants were classified as having good or poor knowledge and practice1. Proportions of participants demonstrating good awareness and good practice were reported. Fishers and Pearson chi- square tests were used to test for associations between patient’s characteristics and knowledge and practice on DM. Bivariable and logistic regression analysis was performed and variables with a p-value of < 0.2 of the unadjusted odds ratio were further analyzed at multivariate logistic regression analysis to find out factors that significantly predict patient’s knowledge and practice on diabetes mellitus. Results. A total of 409 participants were interviewed in the study, majority were females 293 (71.6%) and mean age (SD) was 50 (12) years. A high proportion of participants 314 (76.9%) was aware that DM could affect the eyes but only 24 (5.9%) stated diabetic retinopathy as an eye complication in diabetic patients. Good knowledge about diabetes mellitus was demonstrated by 178 (43.5%) of the study participants. However, only 33.3% had good knowledge on eye care and diabetic retinopathy. It was determined that female diabetic patients and those who stayed with DM for 10 years and beyond were less likely to have good practice on DM compared to male patients and those who had been with DM for less than five years (OR, 95% CI: 0.58, 0.36-0.95, P=0.029: OR, 95% CI: 0.53, 0.32-0.87, P=0.011). It was also found that diabetic patients with good knowledge of DM were at least three times more likely to have good practice compared to those with the poor knowledge (OR, 95% CI: 3.2, 2.1 -4.8, P

Introduction. We aim to describe the time of entry into care and factors associated with being lost to program (LTP) in pregnant women on Option B Plus in an integrated HIV and antenatal care (ANC) clinic in Uganda. Methods. We included all pregnant women enrolled into the integrated HIV-ANC clinic from January 2012 to 31st July 2014, while the follow up period extended up to October 30th 2015. LTP was defined as being out of care for ≥3 months. Results. Overall 856 women were included. Only 36.4% (86/236) of the women were enrolled in the first trimester. Overall 69 (8.1%) were LTP. In the multivariate analysis older women (HR: 0.80 per five-year increase, CI: 0.64–1.0, and P=0.060) and women on ART at the time of pregnancy (0.58, CI: 0.34–0.98, and P=0.040) were more likely not to be LTP. Among women already on ART at the time of pregnancy no factor was associated with LTP. Conclusion. Our results suggest the need for interventions to enhance prompt linkage of HIV positive women to HIV services for ART initiation and for increased retention particularly in young and ART naive women.