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Scale-up of oral pre-exposure prophylaxis (PrEP) for HIV prevention in Uganda began with serodiscordant couples (SDC) and has expanded to other most at-risk populations (MARPs). We explored knowledge, acceptability, barriers and facilitators of PrEP use among potential PrEP users in four MARPs (SDC; men who have sex with men [MSM]; female sex workers [FSW], and fisher folk). We administered quantitative surveys to potential PrEP users in multiple settings in Central Uganda at baseline and approximately 9 months after healthcare worker (HCW) training on PrEP. The survey was completed by 250 potential PrEP users at baseline and 125 after HCW training; 55 completed both surveys. For these 250 participants, mean age was 28.5 years (SD 6.9), 47% were male and 6% were transgender women, with approximately even distribution across MARPs and recruitment locations (urban, peri-urban, and rural). Most (65%) had not heard about PrEP. After HCW training, 24% of those sampled were aware of PrEP, and the proportion of those who accurately described PrEP as \"antiretrovirals to be used before HIV exposure\" increased from 54% in the baseline survey to 74% in the second survey (p<0.001). The proportion of participants who reported HCW as a source of PrEP information increased after training (59% vs 91%, p<0.001). In both surveys, nearly all participants indicated they were willing to take PrEP if offered. The most common anticipated barriers to PrEP were stigma, transportation, accessibility, busy schedules, and forgetfulness. Closeness to home was a common facilitator for all participant categories. Initial awareness of PrEP was low, but PrEP knowledge and interest increased among diverse MARPs after HCW training. Demand creation and HCW training will be critical for increasing PrEP awareness among key populations, with support to overcome barriers to PrEP use. These findings should encourage the acceleration of PrEP rollout in Uganda.

Until recently, community-based antiretroviral therapy (ART) delivery was only available for people living with HIV on ART for ≥6 months with a suppressed viral load. However, early attrition from HIV care is common, particularly in refugee settlements where structural and psychosocial barriers to care are pronounced, and reducing barriers to life-saving ART sooner (e.g., at ART initiation) through community-based ART delivery may improve treatment outcomes. The Head StART study will evaluate the effectiveness, implementation, and health system costs of community ART delivery for individuals newly diagnosed with HIV in refugee settlements in Uganda. In a cluster randomized trial, twelve health centers in five refugee settlements in Uganda were randomized (1:1) to intervention or standard of care (SoC), with stratification to balance site characteristics. Individuals testing positive for HIV are screened for study eligibility (inclusion criteria: diagnosed with HIV < 6 months, on ART ≤ 42 days, ≥ 18 years of age or emancipated minor or mature minor; exclusion criteria: pregnant/breastfeeding, medical reason for requiring facility-based care, concurrent trial participation) aiming to recruit up to 1,560 participants per arm (N = 3,120 total). Eligible individuals are enrolled and monitored longitudinally through abstraction of routinely collected data on HIV care outcomes. At intervention sites, participants are offered community ART delivery (Head StART intervention); at SoC sites, participants receive facility-based care. The primary outcome compares the proportion of participants virally suppressed 12 months post-ART initiation by arm in an intention-to-treat analysis. Qualitative interviews and direct observations will augment quantitative data to evaluate intervention implementation across sites. Micro-costing, time and motion observations, and costing interviews will assess intervention costs, which will inform a budget impact analysis. This trial will generate critical effectiveness, implementation, and budget impact data on community ART delivery for individuals newly diagnosed with HIV in refugee settlements needed to optimize HIV care for humanitarian populations. ClinicalTrials.gov: NCT06126913. Registered 27 September 2023. https://clinicaltrials.gov/study/NCT06126913.

As pre-exposure prophylaxis (PrEP) becomes more widely used in heterosexual populations, an important consideration is its safety in infants who are breastfed by women taking PrEP. We investigated whether tenofovir and emtricitabine are excreted into breast milk and then absorbed by the breastfeeding infant in clinically significant concentrations when used as PrEP by lactating women. We conducted a prospective short-term, open-label study of daily oral emtricitabine-tenofovir disoproxil fumarate PrEP among 50 HIV-uninfected breastfeeding African mother-infant pairs between 1-24 wk postpartum (ClinicalTrials.gov Identifier: NCT02776748). The primary goal was to quantify the steady-state concentrations of tenofovir and emtricitabine in infant plasma ingested via breastfeeding. PrEP was administered to women through daily directly observed therapy (DOT) for ten consecutive days and then discontinued thereafter. Non-fasting peak and trough samples of maternal plasma and breast milk were obtained at drug concentration steady states on days 7 and 10, and a single infant plasma sample was obtained on day 7. Peak blood and breast milk samples were obtained 1-2 h after the maternal DOT PrEP dose, while maternal trough samples were obtained at the end of the PrEP dosing interval (i.e., 23 to 24 h) after maternal DOT PrEP dose. Tenofovir and emtricitabine concentrations were quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays. Of the 50 mother-infant pairs enrolled, 48% were ≤12 wk and 52% were 13-24 wk postpartum, and median maternal age was 25 y (interquartile range [IQR] 22-28). During study follow-up, the median (IQR) daily reported frequency of infant breastfeeding was 15 times (12 to 18) overall, 16 (14 to 19) for the ≤12 weeks, and 14 (12 to 17) for the 13-24 wk infant age groups. Overall, median (IQR) time-averaged peak concentrations in breast milk were 3.2 ng/mL (2.3 to 4.7) for tenofovir and 212.5 ng/mL (140.0 to 405.0) for emtricitabine. Similarly, median (IQR) time-averaged trough concentrations in breast milk were 3.3 ng/mL (2.3 to 4.4) for tenofovir and 183.0 ng/mL (113.0 to 250.0) for emtricitabine, reflecting trough-to-peak breast milk concentration ratios of 1.0 for tenofovir and 0.8 for emtricitabine, respectively. In infant plasma, tenofovir was unquantifiable in 46/49 samples (94%), but emtricitabine was detectable in 47/49 (96%) (median [IQR] concentration: 13.2 ng/mL [9.3 to 16.7]). The estimated equivalent doses an infant would ingest daily from breastfeeding were 0.47 μg/kg (IQR 0.35 to 0.71) for tenofovir and 31.9 μg/kg (IQR 21.0 to 60.8) for emtricitabine, translating into a <0.01% and 0.5% relative dose when compared to the 6 mg/kg dose that is proposed for therapeutic treatment of infant HIV infection and for prevention of infant postnatal HIV infection; a dose that has not shown safety concerns. No serious adverse effects were recorded during study follow-up. The key study limitation was that only a single infant sample was collected to minimize venipunctures for the children. However, maternal daily DOT and specimen collection at drug concentration steady state provided an adequate approach to address the key research question. Importantly, there was minimal variation in breast milk concentrations of tenofovir and emtricitabine (respective median trough-to-peak concentration ratio ~1), demonstrating that infants were exposed to consistent drug dosing via breast milk. In this short-term study of daily directly observed oral PrEP in HIV-uninfected breastfeeding women, the estimated infant doses from breast milk and resultant infant plasma concentrations for tenofovir and emtricitabine were 12,500 and >200-fold lower than the respective proposed infant therapeutic doses, and tenofovir was not detected in 94% of infant plasma samples. These data suggest that PrEP can be safely used during breastfeeding with minimal infant drug exposure. ClinicalTrials.gov, Identifier: NCT02776748.

Persons living in refugee settlements in sub-Saharan Africa may be at increased risk for COVID-19 and experience barriers to accessing COVID-19 information. We aimed to evaluate the implementation of \"Dial-COVID\" a multi-lingual, toll free, telephone platform that uses interactive voice response (IVR) to track COVID-19 symptoms/exposure and disseminate COVID-19 health information in refugee settlements in Uganda. We hypothesized that IVR could provide an alternative way to screen for COVID-19 and communicate public health information to humanitarian populations when physical access and testing capacity were limited. The Dial-COVID IVR platform was created in ten languages and advertised by community health workers in refugee settlements for participants to call into toll free. In a recorded IVR symptom survey, participants were screened for COVID-19 symptoms/exposures and based on their responses, received tailored public health messages about COVID-19 risk mitigation in accordance with Uganda Ministry of Health guidelines. Here we report the challenges and lessons learned implementing this research during the pandemic. Between February 2021 and March 2022, 15,465 calls were received by the Dial-COVID platform from all 31 refugee settlements in Uganda through which 6,913 symptom surveys were completed and 10,411 public health messages were disseminated in all study languages. Uptake of Dial-COVID fluctuated with the national COVID-19 caseload and was impacted by phone ownership and connectivity in refugee settlements. Intensified advertising efforts promoted Dial-COVID uptake. Flexibility to adapt IVR messages was contingent on translation capacity. Refugees living in refugee settlements across Uganda accessed Dial-COVID to share and obtain COVID-19 information suggesting that IVR holds potential for rapid information dissemination and screening of humanitarian populations during future infectious disease outbreaks and may be a valuable tool for routine public health programs. IVR adaptation flexibility and reach are influenced by language constraints and by contextual factors related to platform access. World Pandemic Research Network- 490652.

Background Adolescent girls and young women (AGYW) at institutions of higher learning are at high risk of HIV, and conventional HIV testing services may not reach them sufficiently. HIV self-testing (HIVST) scalability can be informed by identifying AGYW who have used or are interested in using HIVST. We aimed to determine factors associated with use and willingness to use HIVST among female university students. Methods An online cross-sectional survey was conducted among 483 female students at Makerere University, Uganda. Proportions of students who have used or are willing to use HIVST and their associated factors were determined. Modified Poisson regression models were used to estimate prevalence ratios (PR) and their 95% confidence intervals (CI). Results The median age of the participants was 22 (Interquartile range [IQR] 21–23) years, and 21% had never tested for HIV. Over 93% were willing to utilize HIVST, and 19% had ever used HIV self-test kits. Increasing age (adjusted prevalence ratio [aPR] 1.23 per year, 95% CI 1.07–1.43) was significantly associated with HIVST use. Predictors of willingness to self-test for HIV were college type (arts vs. science-based, aPR 0.92, 95% CI 0.88–0.97), number of sexual partners (one, aPR 1.07, 95% CI 1.03–1.12 or ≥ 2, aPR 1.08, 95% CI 1.04–1.19, vs. none), alcohol (aPR 1.04, 95% CI: 1.00–1.09) or injection drug (aPR 1.04, 95% CI 1.00–1.09) use, a history of sexually transmitted infections in past 12 months (aPR 1.05, 95% CI 1.01–1.09), and HIV testing experience (tested in past 12 months, aPR 1.12, 95% CI 1.02–1.22 or over 12 months, aPR 1.13, 95% CI 1.03–1.24, vs. never tested). Conclusion HIVST was highly acceptable despite its limited use. This study demonstrates female student characteristics that can be leveraged to scale up HIVST programs in higher institutions of learning.

Background Perspectives on COVID-19 risk and the willingness and ability of persons living in refugee settlements to adopt COVID-19 prevention strategies have not been rigorously evaluated. The realities of living conditions in Ugandan refugee settlements may limit the extent to which refugees can uptake strategies to mitigate COVID-19 risk. Methods In-depth qualitative interviews were conducted between April 2021 and April 2022 to assess COVID-19 knowledge, risk perception, prevention strategy adoption including COVID-19 vaccination, and COVID-19 impact on living conditions in refugee settlements in Uganda. Interview participants included 28 purposively selected refugees who called into “Dial-COVID”, a free telephone COVID-19 information collection and dissemination platform that was advertised in refugee settlements by community health workers. Interviews were analyzed using a combination of deductive and inductive content analysis. Emerging themes were mapped onto the Theoretical Domains Framework to identify domains influencing prevention behavior. Results were synthesized to provide intervention and policy recommendations for risk mitigation in refugee settlements for COVID-19 and future infectious disease outbreaks. Results The COVID-19 pandemic detrimentally impacted economic and food security as well as social interactions in refugee settlements. Youth were considered especially impacted, and participants reported incidents of child marriage and teenage pregnancy following school closures. Participants displayed general knowledge of COVID-19 and expressed willingness to protect themselves and others from contracting COVID-19. Risk mitigation strategy uptake including COVID-19 vaccination was influenced by COVID-19 knowledge, emotions surrounding COVID-19, the environmental context and resources, personal goals, beliefs about the consequences of (non)adoption, social influences, and behavior reinforcement. Resource constraints, housing conditions, and competing survival needs challenged the adoption of prevention strategies and compliance decreased over time. Conclusions Contextual challenges impact the feasibility of COVID-19 risk mitigation strategy uptake in refugee settlements. Pre-existing hardships in this setting were amplified by the COVID-19 pandemic and related lockdowns. Targeted dispelling of myths, alignment of information across communication mediums, supporting survival needs and leveraging of respected role models are strategies that may hold potential to mitigate risk of infectious diseases in this setting. Registration details World Pandemic Research Network – 490,652.

Background HIV serodifferent couples where one partner is living with HIV and the other is not, remain a key population for HIV prevention. Maintaining an undetectable viral load eliminates the risk of sexual HIV transmission, this principle is often summarised as undetectable = untransmittable (U = U). However, the extent to which this principle is understood and utilised by serodifferent couples remains unclear. This study aimed to explore both partners’ perceptions, experiences and adoption of U = U within their relationships. Methods We conducted an exploratory qualitative study using in-depth interviews with 20 serodifferent couples (40 participants) between July and August 2023 in Ifakara, Tanzania and Kasangati, Uganda. Each partner was interviewed separately. Interviews explored: (1) Awareness of U = U, (2) Lived experiences related to U = U, and (3) Social perceptions of U = U and HIV serodifference. The interviews were audio-recorded, transcribed, and analysed using thematic analysis with Atlas.ti for coding. Results All participants were in a heterosexual serodifferent relationship and had mutually disclosed their status. The average age was 25 years, and couples had been partnered for approximately 3.5 years. All 40 participants (100%) had basic knowledge of U = U or treatment as prevention. The qualitative analysis identified four key themes that were broadly consistent in both settings: (1) Knowledge of U = U facilitated adoption, with initial doubts giving way to trust over time as partners remained HIV-negative; (2) Disclosure triggered emotional responses, which were alleviated through counselling, with U = U influencing relationship confidence and fertility decisions; (3) Use of additional prevention (PrEP, condoms) reinforced trust in U = U, addressing residual concerns about adherence and fidelity; (4) Persistent stigma and limited community awareness constrained U = U’s potential impact. Themes were largely consistent across Uganda and Tanzania, though Ugandan participants more frequently reported detailed provider counselling and PrEP use. Conclusion This study highlights how understanding experiences of U = U among HIV serodifferent couples in Tanzania and Uganda are shaped by personal, relational, and contextual factors. Our findings suggest that U = U communication strategies should be strengthened through context-specific counselling, improved access to viral load testing, and community education. Further research is needed to explore how U = U is perceived and adopted in more diverse settings.

IntroductionPre-exposure prophylaxis (PrEP) use among cisgender female sex workers (FSWs), a population at disproportionately high HIV acquisition risk in Uganda, remains suboptimal. Uptake and continued use are constrained by barriers, such as limited clinical hours, long distances to access facility-based PrEP services, and high mobility among FSWs. Community pharmacies may offer a more accessible PrEP delivery model due to extended operating hours and convenient locations. This study aims to evaluate the accessibility and capacity of pharmacies in Kampala, Uganda, to serve as potential sites for PrEP delivery.Methods and analysisWe will conduct a concurrent mixed-methods study combining geospatial mapping, structured surveys, a discrete choice experiment (DCE), and in-depth interviews (IDIs). First, the study will compare the reach and accessibility of PrEP services through community pharmacies versus public healthcare facilities. To highlight PrEP service reach, we will use geospatial analysis to map pharmacies, PrEP clinics, FSW hotspots (i.e., areas where sex is exchanged), and HIV incidence. We will also calculate a PrEP facility needs ratio (number of PrEP facilities/HIV incidence) for each of Kampala’s administrative divisions and estimate travel distance and time to access PrEP services using cost–distance analysis. Perceived accessibility of PrEP services will be assessed through FSW surveys (n=50) and IDIs (n=20–30), guided by Levesque’s framework. Then, we will evaluate pharmacy capacity via surveys (n=274) and IDIs (n=20–30), exploring infrastructure, resources, and staff perspectives, informed by the Consolidated Framework for Implementation Research. Additionally, a DCE will be embedded in the pharmacy survey to elicit staff preferences for delivery approaches and analysed using mixed logit models. Finally, we will integrate quantitative and qualitative findings to provide a broad assessment of whether pharmacies are suitable venues for PrEP delivery to FSWs in Kampala. Enrolment will begin by April 2026 for FSWs and July 2026 for pharmacy staff.Ethics and disseminationEthical approval has been obtained from the Infectious Diseases Institute Research Ethics Committee (IDI-REC-2025-175) and the Uganda National Council for Science and Technology (HS6178ES). Written informed consent will be obtained from all participants. We will disseminate study findings through stakeholder meetings, scientific conferences, and peer-reviewed publications.

Background Long-acting injectable (LAI)-PrEP provides better protection against HIV compared to oral PrEP, which requires taking a daily pill. Our study aimed to assess knowledge about oral and LAI-PrEP and identify factors associated with willingness to use LAI-PrEP among key populations (KPs) in Uganda. Methods We conducted a cross-sectional study at the Most at Risk Populations Initiative (MARPI) clinic between November and December 2021. Participants were recruited through convenience sampling and interviewed using a structured questionnaire by trained interviewers. Participants were categorised into three groups based on their oral PrEP use: those who had not yet initiated PrEP, those who had discontinued oral PrEP, and those currently on oral PrEP. Modified Poisson regression analysis was performed to determine factors associated with the participants’ willingness to use LAI-PrEP. Data was analysed using STATA 14 software. Results Of the 234 participants, 135 (57.7%) were female, 82.5% knew about LAI-PrEP, and 65.8% were willing to use it. The mean age was 28.7 years (standard deviation [SD] 5.8). Willingness to use LAI-PrEP was less likely among divorced, widowed, or separated individuals than singles (i.e., people with no prior marital experience and neither in a romantic relationship) (adjusted prevalence ratio [aPR] 0.65, 95% CI: 0.43–0.98). Relative to current oral PrEP users, willingness to use LAI-PrEP was similar among those who discontinued oral PrEP (aPR 1.39, 95% CI: 0.92–2.11) and those who had not yet initiated PrEP but were at risk for HIV (aPR 1.26, 95% CI: 0.83–1.89). Conclusions This cross-sectional analysis of diverse members of KPs in Uganda revealed that the willingness to use LAI-PrEP was lower among individuals who were divorced, separated, or widowed compared to those who were single. Future studies should investigate effective methods for promoting the uptake of long-acting PrEP formulations among populations at high risk of HIV acquisition.