Browsing by Author "Mujugira, Andrew"
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Item Effect of HIV Self-Testing on PrEP Adherence Among Gender-Diverse Sex Workers in Uganda: A Randomized Trial(Journal of acquired immune deficiency syndromes, 2022) Mujugira, Andrew; Nakyanzi, Agnes; Nabaggala, Maria S.; Muwonge, Timothy R.; Ssebuliba, Timothy; Bagaya, Monica; Nampewo, Olivia; Sapiri, Oliver; Nyanzi, Kikulwe R.; Bambia, Felix; Nsubuga, Rogers; Serwadda, David M.; Ware, Norma C.; Baeten, Jared M.; Haberer, Jessica E.HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) are complementary tools that could empower sex workers to control their HIV protection, but few studies have jointly evaluated PrEP and HIVST in any setting. Methods: The Empower Study was an open-label randomized trial in Uganda. Sex workers were offered F/tenofovir disoproxil fumarate and randomized 1:1 to monthly HIVST and quarterly in-clinic testing (intervention) or quarterly in-clinic HIV testing alone (standard of care) and followed up for 12 months. PrEP adherence was measured using electronic adherence monitoring and tenofovir diphosphate (TFV-DP) levels in dried blood spots. Adherence outcomes and sexual behaviors were compared by arm using generalized estimating equation models. Results: We enrolled 110 sex workers: 84 cisgender women, 14 transgender women, 10 men who have sex with men, and 2 transgender men. The median age was 23 years. The 12-month retention was 75%. Nearly all (99.4%) used $1 HIVST kit. The proportion with TFV-DP levels $700 fmol/punch in the HIVST and standard of care arms at the 3-, 6-, 9-, and 12-month visits was 2.4%, 2.3%, 0%, and 0% and 7.9%, 0%, 0%, and 0%, respectively, with no differences by randomization arm (P . 0.2). Self-reported condomless sex acts with paying partners was similar by arm [adjusted incidence rate ratio 0.70; 95% confidence interval (CI): 0.42 to 1.17; P = 0.18]. One seroconversion occurred (HIV incidence, 0.9/100 person-years); TFV-DP was not detected at any visit. Conclusions: A gender-diverse sample of sex workers in Uganda used HIVST but not daily oral PrEP for HIV protection. Alternate approaches to promote PrEP use, including long-acting formulations, should be considered in this population.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 Factors associated with HIV self‑testing among female university students in Uganda: a cross‑sectional study(AIDS Research and Therapy, 2022) Segawa, Ivan; Bakeera‑Kitaka, Sabrina; Ssebambulidde, Kenneth; Muwonge, Timothy R.; Oriokot, Lorraine; Ouma Ojiambo, Kevin; Mujugira, AndrewAdolescent 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.Item Health Care Worker Perspectives of HIV Pre-exposure Prophylaxis Service Delivery in Central Uganda(Frontiers in Public Health, 2022) Muwonge, Timothy R.; Nsubuga, Rogers; Ware, Norma C.; Wyatt, Monique A.; Pisarski, Emily; Kamusiime, Brenda; Kasiita, Vicent; Kakoola Nalukwago, Grace; Brown, Charles; Nakyanzi, Agnes; Bagaya, Monica; Bambia, Felix; Ssebuliba, Timothy; Katabira, Elly; Kyambadde, Peter; Baeten, Jared M.; Heffron, Renee; Celum, Connie; Mujugira, Andrew; Haberer, Jessica E.Scale-up of HIV pre-exposure prophylaxis (PrEP) services in Uganda is ongoing. However, health care workers (HCWs) may not be aware of PrEP nor what offering this service entails. We explored the impact of standardized HCW training on the knowledge and perspectives of PrEP service delivery in Uganda. Methods: We recruited HCWs from facilities that offered HIV-related services in Central Uganda. Using the Uganda Ministry of Health curriculum, we trained HCWs on PrEP services. We collected data about PrEP knowledge, preparedness, and willingness to deliver PrEP to multiple key populations before the training, immediately after the training, and >6 months later (exit). We additionally conducted 15 qualitative interviews after the exit survey. Quantitative data were analyzed by Fisher exact test, while qualitative interview data were analyzed inductively. Results: We recruited 80 HCWs from 35 facilities in urban (N = 24, 30%), peri-urban (N = 30, 37%), and rural (N = 26, 33%) areas. Most HCWs were nurse counselors (N = 52, 65%) or medical/clinical officers (N = 15, 18%). Surveys indicated that awareness of PrEP increased after the training and remained high. Knowledge of PrEP (i.e., as an effective, short-term antiretroviral medication to use before HIV exposure for people at high risk) generally increased with training, but significant gaps remained, and knowledge decreased with time. Most HCWs recommended PrEP for female sex workers and HIV serodifferent couples, as well as other key populations. We observed increases in the number of HCW who felt their facility was prepared to cater for HIV prevention and provide PrEP, but this view was not universal. HCWs believed in PrEP effectiveness and embraced it as an additional HIV prevention method. Concerns included patient adherence and behavioral risk compensation. HCWs noted challenges in PrEP delivery in terms of inadequate clinic preparedness, infrastructure, staff capacity, and poor attitudes toward key populations by untrained health workers. They felt further training was needed to ensure a smooth scale-up of services without stigmatization. Standardized training improved knowledge, willingness, and preparedness to offer PrEP services among most HCWs in Central Uganda. Ongoing training will be needed to optimize PrEP delivery services and expand delivery to levels needed for population-level impact.Item HIV self-testing and oral pre-exposure prophylaxis are empowering for sex workers and their intimate partners: a qualitative study in Uganda(Journal of the International AIDS Society, 2021) Mujugira, Andrew; Nakyanzi, Agnes; Kasiita, Vicent; Kamusiime, Brenda; Nalukwago, Grace K.; Nalumansi, Alisaati; Twesigye, Chris C.; Muwonge, Timothy R.; Baeten, Jared M.; Wyatt, Monique A.; Haberer, Jessica E.; Ware, Norma C.HIV self-testing (HIVST) and oral pre-exposure prophylaxis (PrEP) are complementary, evidence-based, selfcontrolled HIV prevention tools that may be particularly appealing to sex workers. Understanding how HIVST and PrEP are perceived and used by sex workers and their intimate partners could inform prevention delivery for this population. We conducted qualitative interviews to examine ways in which HIVST and PrEP use influence prevention choices among sex workers in Uganda. Methods: Within a randomized trial of HIVST and PrEP among 110 HIV-negative cisgender women, cisgender men and transgender women sex workers (NCT03426670), we conducted 40 qualitative interviews with 30 sex workers and 10 intimate partners (June 2018 to January 2020). Sex worker interviews explored (a) experiences of using HIVST kits; (b) how HIVST was performed with sexual partners; (c) impact of HIVST on PrEP pill taking; and (d) sexual risk behaviours after HIVST. Partner interviews covered (i) introduction of HIVST; (ii) experiences of using HIVST; (iii) HIV status disclosure; and (iv) HIVST’s effect on sexual behaviours. Data were analysed using an inductive content analytic approach centering on descriptive category development. Together, these categories detail the meaning of HIVST and PrEP for these qualitative participants. Results: Using HIVST and PrEP was empowering for this group of sex workers and their partners. Three types of empowerment were observed: (a) economic; (b) relational; and (c) sexual health. (i) Using HIVST and PrEP made sex without condoms safer. Sex workers could charge more for condomless sex, which was empowering economically. (ii) Self-testing restored trust in partners’ fidelity upon being reunited after a separation. This trust, in combination with condomless sex made possible by PrEP use, restored intimacy, empowering partnered relationships. (iii) HIVST and PrEP enabled sex workers to take control of their HIV prevention efforts and avoid the stigma of public clinic visits. In this way they were empowered to protect their sexual health. Conclusions: In this sample, sex workers’ use of HIVST and PrEP benefitted not only prevention efforts, but also economic and relational empowerment. Understanding these larger benefits and communicating them to stakeholders could strengthen uptake and use of combination prevention interventions in this marginalized population.Item How PrEP delivery was integrated into public ART clinics in central Uganda: A qualitative analysis of implementation processes(Public Library of Science, 2024-03-07) Wyatt, Monique A; Pisarski, Emily E; Nalumansi, Alisaati; Kasiita, Vicent; Kamusiime, Brenda; Nalukwago, Grace K; Thomas, Dorothy; Muwonge, Timothy R; Mujugira, Andrew; Heffron, Renee; Ware, Norma CTailored delivery strategies are important for optimizing the benefit and overall reach of PrEP in sub-Saharan Africa. An integrated approach of delivering time-limited PrEP in combination with ART to serodifferent couples encourages PrEP use in the HIV-negative partner as a bridge to sustained ART use. Although PrEP has been delivered in ART clinics for many years, the processes involved in integrating PrEP into ART services are not well understood. The Partners PrEP Program was a stepped-wedge cluster randomized trial of integrated PrEP and ART delivery for HIV serodifferent couples in 12 public health facilities in central Uganda (Clinicaltrials.gov NCT03586128). Using qualitative data, we identified and characterized key implementation processes that explain how PrEP delivery was integrated into existing ART services in the Partners PrEP Program. In-depth interviews were conducted with a purposefully-selected sub-sample of 83 members of 42 participating serodifferent couples, and with 36 health care providers implementing integrated delivery. High quality training, technical supervision, and teamwork were identified as key processes supporting providers to implement PrEP delivery. Interest in the PrEP program was promoted through the numerous ways health care providers made integrated ART and PrEP meaningful for serodifferent couples, including tailored counseling messages, efforts to build confidence in integrated delivery, and strategies to create demand for PrEP. Couples in the qualitative sample responded positively to providers’ efforts to promote the integrated strategy. HIV-negative partners initiated PrEP to preserve their relationships, which inspired their partners living with HIV to recommit to ART adherence. Lack of disclosure among couples and poor retention on PrEP were identified as barriers to implementation of the PrEP program. A greater emphasis on understanding the meaning of PrEP for users and its contribution to implementation promises to strengthen future research on PrEP scale up in sub-Saharan Africa.Item “I Felt very Small and Embarrassed by the Health Care Provider When I Requested to be Tested for Syphilis”: Barriers And Facilitators of Regular Syphilis and HIV Testing among Female Sex Workers in Uganda(BMC Public Health, 2021) Muhindo, Richard; Mujugira, Andrew; Castelnuovo, Barbara; Sewankambo, Nelson K.; Ratanshi, Rosalind Parkes; Tumwesigye, Nazarius Mbona; Joloba, Edith Nakku; Kiguli, JulietPeriodic testing of female sex workers (FSW) for sexually transmitted infections (STIs) is a core component of global and national responses to achieve population-level STI elimination. We conducted a qualitative study to explore barriers and facilitators of regular syphilis and HIV testing among FSW in Uganda.Within a quasi-experimental study among 436 FSW to assess the effect of peer education and text message reminders on uptake of regular STI and HIV testing among FSW, we conducted 48 qualitative interviews in four cities in Uganda from August–December 2018. We purposively selected FSW who tested for syphilis and HIV every 3–6 months; 12 FSW were interviewed in each city. Sex worker interviews explored: 1) reasons for periodic syphilis and HIV testing; 2) barriers and facilitators of testing; 3) experiences of testing; and 4) challenges faced while seeking testing services. Data were analyzed using thematic content analysis.Thematic analysis revealed individual- and health system-level barriers and facilitators of testing. For syphilis, barriers were a) interpersonal stigma, low perceived severity of syphilis and testing misconceptions (individual); and b) judgmental provider attitudes, paucity of facilities offering syphilis testing, stockouts of test kits and high cost (health system). Facilitators were c) desire to remain healthy, get married and have children, knowing the benefits of early treatment, influence of male partners/clients and normative testing behaviors (individual); and d) sex worker clinics offering dual syphilis/HIV testing (health system). For HIV, barriers included: a) internalized stigma (individual); and b) unfavorable clinic hours, stigma, discrimination, and unfriendly provider (health system). Facilitators were a) motivations to stay healthy and attract clients, habitual testing, self-efficacy, doubts about accuracy of negative test results, and use of post-exposure prophylaxis (individual); and d) availability of testing facilities (health system). Syphilis and HIV had similar testing barriers and facilitators.HIV programs are likely to be important entry points for syphilis testing among FSW. Multi-level interventions to address testing barriers should consider focusing on these service delivery points. Extending the dual syphilis and HIV testing approach to FSW may improve testing uptake for both infections at public health facilities and decrease population-level incidence.Item Implementation of gender-based violence screening guidelines in public HIV treatment programs: A mixed methods evaluation in Uganda(Public Library of Science, 2024-05) Thomas, Dorothy; Nalumansi, Alisaati; Reichman, Mira; Metitiri, Mine; Nambi, Florence; Kibuuka, Joseph; Nakabugo, Lylianne; Kamusiime, Brenda; Kasiita, Vicent; Nalukwago, Grace K.; Muwonge, Timothy R; Simoni, Jane; Montgomery, Elizabeth T.; Mujugira, Andrew; Heffron, ReneeBackground HIV and gender-based violence (GBV) intersect to threaten population health. The Uganda Ministry of Health recommends routine GBV screening alongside HIV care but evidence detailing its implementation in HIV care settings is limited. We evaluated screening practices in public HIV clinics to generate evidence supporting GBV screening optimization. Methods To evaluate GBV screening implementation in antiretroviral therapy (ART) clinics, we extracted client data from GBV registers at 12 public ART clinics in Uganda (January 2019-December 2021). We concurrently evaluated perceptions of GBV screening/referral practices by conducting in-depth qualitative interviews with providers (N = 30) and referral partners (N = 10). We contextualized quantitative findings with interview data which were analyzed using a thematic analysis approach. Results During the evaluation period, >90% of providers in participating health facilities implemented GBV screening. Among 107,767 clients served in public ART clinics, providers identified 9,290 (8.6%) clients who experienced past-year physical, sexual and/or emotional GBV of whom 86% received counseling and 19% were referred to support services—most commonly to legal services. Key factors influencing GBV screening implementation included awareness of screening guidelines; client volume; and client’s level of engagement in HIV care. Providers and referral partners identified important benefits to clients (e.g., pursuit of justice and removal from violent environments) when referrals were successful. Key factors influencing referrals included financial constraints that limited referral partners’ ability to provide services at no cost to clients and socio-cultural norms that inhibited client willingness to pursue support services. Conclusions GBV screening implementation in ART clinics supports identification and referral of clients exposed to violence. The effectiveness of GBV screening may be limited by socio-cultural factors that inhibit client capacity to pursue referrals and fragmented and resource-constrained referral networks. Providers and referral partners identified allocating funds to support referrals and collaborative networking meetings as important opportunities for strengthening GBV referrals.Item Leveraging interactive voice response technology to mitigate COVID-19 risk in refugee settlements in Uganda: Lessons learned implementing “Dial-COVID” a toll-free mobile phone symptom surveillance and information dissemination tool(https://doi.org/ 10.1371/journal.pone.0279373, 2023) Klabbers, Robin E.; Muwonge, Timothy R.; Pham, Phuong; Mujugira, Andrew; Vinck, Patrick; Borthakur, Sukanya; Sharma, Monisha; Mohammed, Numan; Parkes-Ratanshi, Rosalind; Celum, Connie; O’Laughlin, Kelli N.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. Methods 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. Results 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. Conclusion 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.Item Patients with Advanced HIV Type 1 Infection Initiating Antiretroviral Therapy in Botswana: Treatment Response and Mortality(AIDS research and human retroviruses, 2009) Mujugira, Andrew; Wester, C. William; Kim, Soyeon; Bussmann, Hermann; Gaolathe, TendaniThe response to highly active antiretroviral treatment (HAART) and predictors of mortality among patients with advanced HIV infection (CD4+ cell count <50 cells/mm3) in Botswana are described. Clinical and laboratory data for 349 patients with CD4 <50 cells/mm3 initiating HAART from January 23 to November 18, 2002 at Princess Marina Hospital in Gaborone, Botswana were extracted from clinical charts and electronic patient management systems. The Kaplan–Meier method was used to estimate survival and log-rank tests used for group comparisons. Cox regression was used to identify independent predictors of survival. A total of 349 adults initiated HAART. In all, 78.2% (95% CI: 73.7%, 82.9%) of patients survived 1 year. Among survivors, the mean CD4+ cell count increase was 239.8 cells/mm3 (95% CI: 217.0, 262.8) at 12 months; 92.1% (95% CI: 87.8%, 94.9%) of patients (as treated) had plasma HIV-1 RNA ≤400 copies/ml at 9 months declining to 59.9% (95% CI: 54.7%, 64.9%) (ITT). There was a 2-fold higher mortality rate among patients with CD4+ ≤10 cells/mm3 compared to 11–49 cells/mm3, hazard ratio (HR) = 1.91 (95% CI:1.16, 3.14). A 10 cell/mm3 higher CD4+ cell count corresponded to a 22% decrease in hazard of death (HR = 0.78; 95% CI: 0.64, 0.94). Lower baseline CD4+ cell count (p < 0.001) and WHO clinical stage 4 HR = 2.41 (95% CI:1.32, 4.38) were independent predictors of poorer survival. HAART confers significant benefit even among persons with advanced immunosuppression. Adults with CD4+ cell counts ≤10 cells/mm3 and/or WHO clinical stage 4 disease at the time of HAART initiation have a higher risk of death.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 PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial(EClinicalMedicine, 2022) Heffron, Renee; Muwonge, Timothy R.; Thomas, Katherine K.; Nambi, Florence; Nakabugo, Lylianne; Kibuuka, Joseph; Thomas, Dorothy; Feutz, Erika; Meisner, Allison; Ware, Norma C.; Wyatt, Monique A.; Simoni, Jane M.; Katz, Ingrid T.; Kadama, Herbert; Baeten, Jared M.; Mujugira, AndrewGlobal scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program. Methods Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128. Findings From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses. Interpretation Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV.Item Relationship between socioeconomic status and risk of sexually transmitted infections in Uganda: Multilevel analysis of a nationally representative survey(International journal of STD & AIDS, 2019) Anguzu, Godwin; Flynn, Andrew; Musaazi, Joseph; Kasirye, Ronnie; Atuhaire, Leonard K.; Kiragga, Agnes N.; Kabagenyi, Allen; Mujugira, AndrewSocioeconomic status (SES) appears to have positive and negative associations with sexually transmitted infection (STI) risk in resource-limited settings, but few studies have evaluated nationally representative data. We assessed multiple SES measures and their effect on STI risk. We conducted a secondary analysis of data from the Uganda Demographic and Health Survey (UDHS 2011). The primary outcome (STI risk) was self-reported STIs and/or symptoms in the prior 12 months. We examined associations between multiple SES measures and STI risk using a mixed-effects Poisson regression model. The results showed that of the 9256 sexually active individuals, 7428 women and 1828 men were included in the analysis. At an individual level, middle wealth quintile and disposable income were associated with STI risk, whereas being in the richest wealth quintile was protective. Residence in wealthier regions (adjusted incidence rate ratio [aIRR] 3.92, 3.62, and 2.75, for Central, Western, and Eastern regions; p < 0.01) was associated with increased STI risk. Regional level analysis revealed stochastic variability of STI risk across geographical region (variance 0.03; p = 0.01). The bilateral association between SES and STI risk underscores the need for multi-sectoral interventions to address the upstream effects of poverty on STI risk and downstream effects of STIs on health and economic productivity.Item Relationship between socioeconomic status and risk of sexually transmitted infections in Uganda: Multilevel analysis of a nationally representative survey(International journal of STD & AIDS, 2019) Anguzu, Godwin; Flynn, Andrew; Musaazi, Joseph; Kasirye, Ronnie; Atuhaire, Leonard K.; Kiragga, Agnes N.; Kabagenyi, Allen; Mujugira, AndrewSocioeconomic status (SES) appears to have positive and negative associations with sexually transmitted infection (STI) risk in resource-limited settings, but few studies have evaluated nationally representative data.We assessed multiple SES measures and their effect on STI risk. We conducted a secondary analysis of data from the Uganda Demographic and Health Survey (UDHS 2011). The primary outcome (STI risk) was self-reported STIs and/or symptoms in the prior 12 months. We examined associations between multiple SES measures and STI risk using a mixed-effects Poisson regression model. The results showed that of the 9256 sexually active individuals, 7428 women and 1828 men were included in the analysis. At an individual level, middle wealth quintile and disposable income were associated with STI risk, whereas being in the richest wealth quintile was protective. Residence in wealthier regions (adjusted incidence rate ratio [aIRR] 3.92, 3.62, and 2.75, for Central, Western, and Eastern regions; p<0.01) was associated with increased STI risk. Regional level analysis revealed stochastic variability of STI risk across geographical region (variance 0.03; p¼0.01). The bilateral association between SES and STI risk underscores the need for multi-sectoral interventions to address the upstream effects of poverty on STI risk and downstream effects of STIs on health and economic productivity.Item Re‑engagement in HIV care following a missed visit in rural Uganda(BMC research notes, 2018) Nabaggala, Maria Sarah; Parkes‑Ratanshi, Rosalind; Kasirye, Ronnie; Kiragga, Agnes; Castlenuovo, Barbara; Ochaka, Ian; Nakakawa, Lilian; Asiimwe Bena, Diana; Mujugira, AndrewWe conducted a retrospective cohort study to assess the effect of tracking People Living with HIV (PLHIV) after missed clinic visits and factors associated with return to care in rural Uganda. We assessed retention in care among 650 HIV-infected women and men. We used univariable and multivariable generalized linear models to assess demographic and self-reported factors associated with re-engagement in HIV care. Results: Of 381 PLHIV who ever missed a scheduled appointment, 68% were female and most (80%) had initiated ART. Most (70%) of those tracked returned to care. Relative to men, women (adjusted risk ratio [ARR] 1.23; 95% confidence interval (CI) 1.05–1.43; p = 0.009) were more likely to return to care after active tracking. PLHIV who missed scheduled visits for other reasons (forgetting, adequate drug supplies, or long distance to clinic) had reduced odds of return to care (ARR 0.41; 95% CI 0.28–0.59; p < 0.001). These data support close monitoring of patient retention in HIV care and active measures to re-engage those who miss an appointment. Furthermore, they highlight the need for targeted interventions to those more resistant to re-engagement such as men.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 Understanding early implementation of pre-exposure prophylaxis for HIV prevention in public health facilities in Uganda using the Consolidated Framework for Implementation Research(Clinics, 2019) Ortblad, Katrina; Brown, Charles; Muwonge, Timothy R.; Scoville, Caitlin; Izizinga, Diego; Namanda, Sylvia; Nambi, Florence; Nakabugo, Lylianne; Mujugira, Andrew; Heffron, ReneeIn sub-Saharan Africa, a number of countries are starting to deliver oral preexposure prophylaxis (PrEP) for HIV prevention in public health facilities. • We are conducting a stepped-wedge cluster-randomized trial in 12 health facilities in Kampala & Wakiso, Uganda to launch delivery of a PrEP program within HIV clinics targeting HIV-negative members of HIV serodiscordant couples and determine the impact of the PrEP program on HIV viral suppression in partners living with HIV (ClinicalTrials.gov)Item Understanding PrEP Acceptability Among Priority Populations: Results from a Qualitative Study of Potential Users in Central Uganda(AIDS and Behavior, 2022) Sundararajan, Radhika; Wyatt, Monique A.; Muwonge, Timothy R.; Pisarski, Emily E.; Mujugira, Andrew; Haberer, Jessica E.; Ware, Norma C.Daily oral pre-exposure prophylaxis (PrEP) can safely and effectively prevent HIV acquisition in HIV-negative individuals. However, uptake of PrEP has been suboptimal in sub-Saharan Africa. The goal of this qualitative study was to identify facilitators of and barriers to PrEP acceptability among target users not taking PrEP. Fifty-nine individuals belonging to Ugandan priority populations participated in a single in-depth interview. Participants perceived themselves as being at high risk for HIV acquisition, and expressed interest in PrEP as an HIV prevention strategy. Two forms of stigma emerged as potential barriers to PrEP use: (1) misidentification as living with HIV; and (2) disclosure of membership in a priority population. Acceptability of PrEP was dampened for this sample of potential PrEP users due to anticipated stigmatization. Mitigating stigma should be a key component of effective PrEP delivery to reach UNAIDS goal of ending the AIDS epidemic by 2030.Item “You are not a man”: a multi-method study of trans stigma and risk of HIV and sexually transmitted infections among trans men in Uganda(Journal of the International AIDS Society, 2021) Mujugira, Andrew; Kasiita, Vicent; Bagaya, Monica; Nakyanzi, Agnes; Bambia, Felix; Nampewo, Oliva; Kamusiime, Brenda; Mugisha, Jackson; Nalumansi, Alisaati; Twesigye, Collin C.; Muwonge, Timothy R.; Baeten, Jared M.; Wyatt, Monique A.; Tsai, Alexander C.; Ware, Norma C.; Haberer, Jessica E.Transgender (trans) men in sub-Saharan Africa are a hidden and vulnerable population who may engage in sex work due to socio-economic exclusion and lack of alternative employment opportunities. Little is known about HIV and sexually transmitted infection (STI) risk among trans men in this setting. We conducted a multi-method study to characterize HIV/STI risk among trans men in Uganda. Methods: Between January and October 2020, we enrolled 50 trans men into a cross-sectional study through snowball sampling. Data were collected on socio-demographic characteristics, sexual practices and depression. We conducted 20 qualitative interviews to explore: (1) descriptions of sexual practices that could increase HIV/STI exposure; (2) experiences of accessing public healthcare facilities; (3) perceptions of HIV or STI testing; (4) HIV and STI service delivery; and (5) drug and alcohol use. We used an inductive content analytic approach centring on descriptive category development to analyse the data. Results: The median age was 25 years (interquartile range 23–28). The prevalence of HIV, syphilis and hepatitis B was 4%, 6% and 8%, respectively. We observed multiple levels of intersecting individual, interpersonal and structural stigmas. (1) Trans men reported transphobic rape motivated by interpersonal stigma that was psychologically traumatizing to the survivor. The resultant stigma and shame hindered healthcare access. (2) Structural stigma and economic vulnerability led to sex work, which increased the risk of HIV and other STIs. Sex work stigma further compounded vulnerability. (3) Individualized stigma led to fear of disclosure of gender identity and HIV status. Concealment was used as a form of stigma management. (4) Multiple levels of stigma hampered access to healthcare services. Preference for trans-friendly care was motivated by stigma avoidance in public facilities. Overall, the lived experiences of trans men highlight the intertwined relationship between stigma and sexual health. Conclusions: In this sample from Uganda, trans men experienced stigma at multiple levels, highlighting the need for gendersensitive healthcare delivery. Stigma reduction interventions, including provider training, non-discrimination policies, support groups and stigma counselling, could strengthen uptake and utilization of prevention services by this marginalized population.