NRU :: Browsing by Author "Semitala, Fred C."

Browsing by Author "Semitala, Fred C."

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Closing the Gap: A Novel Metric of Change in Performance
(East African journal of applied health monitoring and evaluation, 2019) Katuramu, Richard; Wallenta, Jeanna; Semitala, Fred C.; Amanyire, Gideon; Kampiire, Leatitia; Namusobya, Jennifer; Kamya, Moses R.; Havlir, Diane; Geng, Elvin
Interventions to improve performance of global programs in the HIV cascade of care are widespread and increasing the focus of implementation science. At present, however, there is no clear consensus on how to conceptualize their improvement at the program level. The commonly used measures of association, based on ratios of probabilities (or odds), have well-known defects in public health applications. They yield large effect sizes even when the absolute effects, and therefore the public health impact, are small. On the other hand, risk differences create problems because settings with higher baseline values are penalized. We aim to examine ways of quantifying improvement in each health center of a cluster-randomized trial in Uganda to accelerate antiretroviral therapy initiation among HIV-infected adults.
Completion of isoniazid–rifapentine (3HP) for tuberculosis prevention among people living with HIV: Interim analysis of a hybrid type 3 effectiveness–implementation randomized trial
(PLoS Med, 2021) Semitala, Fred C.; Kadota, Jillian L.; Musinguzi, Allan; Nabunje, Juliet; Welishe, Fred; Nakitende, Anne; Akello, Lydia; Kamya, Moses R.; Handley, Margaret A.; Katahoire, Anne; Berger, Christopher A.; Kiwanuka, Noah; Katamba, Achilles; Dowdy, David W.; Cattamanchi, Adithya
Scaling up shorter regimens for tuberculosis (TB) prevention such as once weekly isoniazid–rifapentine (3HP) taken for 3 months is a key priority for achieving targets set forth in the World Health Organization’s (WHO) END TB Strategy. However, there are few data on 3HP patient acceptance and completion in the context of routine HIV care in sub-Saharan Africa. Methods and findings The 3HP Options Trial is a pragmatic, parallel type 3 effectiveness–implementation randomized trial comparing 3 optimized strategies for delivering 3HP—facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), or informed choice between DOT and SAT using a shared decision-making aid—to people receiving care at a large urban HIV clinic in Kampala, Uganda. Participants and healthcare providers were not blinded to arm assignment due to the nature of the 3HP delivery strategies. We conducted an interim analysis of participants who were enrolled and exited the 3HP treatment period between July 13, 2020 and April 30, 2021. The primary outcome, which was aggregated across trial arms for this interim analysis, was the proportion who accepted and completed 3HP (�11 of 12 doses within 16 weeks of randomization). We used Bayesian inference analysis to estimate the posterior probability that this proportion would exceed 80% under at least 1 of the 3HP delivery strategies, a coprimary hypothesis of the trial. Through April 2021, 684 participants have been enrolled, and 479 (70%) have exited the treatment period. Of these 479 participants, 309 (65%) were women, mean age was 41.9 years (standard deviation (SD): 9.2), and mean time on antiretroviral therapy (ART) was 7.8 years (SD: 4.3). In total, 445 of them (92.9%, 95% confidence interval (CI): [90.2 to 94.9]) accepted and completed 3HP treatment. There were no differences in treatment acceptance and completion by sex, age, or time on ART. Treatment was discontinued due to a documented adverse event (AE) in 8 (1.7%) patients. The probability that treatment acceptance and completion exceeds 80% under at least 1 of the three 3HP delivery strategies was greater than 99%. The main limitations are that the trial was conducted at a single site, and the interim analysis focused on aggregate outcome data to maintain blinding of investigators to arm-specific outcomes. Conclusions 3HP was widely accepted by people living with HIV (PLHIV) in Uganda, and very high levels of treatment completion were achieved in a programmatic setting. These findings show that 3HP can enable effective scale-up of tuberculosis preventive therapy (TPT) in high-burden countries, particularly when delivery strategies are tailored to target known barriers to treatment completion.
Diagnostic accuracy and acceptability of rapid HIV oral testing among adults attending an urban public health facility in Kampala, Uganda
(PLoS ONE, 2017) Nangendo, Joanita; Obuku, Ekwaro A.; Kawooya, Ismael; Mukisa, John; Nalutaaya, Annet; Musewa, Angella; Semitala, Fred C.; Karamagi, Charles A.; Kalyango, Joan N.
The prevalence of HIV in Uganda is 7.3%, and yet nearly 40% of people living with HIV are unaware of their status. The current HIV testing policy which is strictly blood-based poses several challenges including: a need for high level laboratory skills, stringent waste disposal needs, and painful sample collection. It is envisaged that introduction of a rapid, painless HIV oral fluid test as a potential alternative is likely to increase the number of people testing. The aim of this study was to determine the diagnostic accuracy and acceptability of rapid HIV oral testing among adults attending Kisenyi Health Centre IV in Kampala. Methods and findings We conducted a cross-sectional study among 440 adults recruited consecutively at Kisenyi Health Centre IV from January to March 2016. The diagnostic accuracy of the HIV oral test was assessed by comparing to the national HIV serial testing algorithm. We also assessed for acceptability among patients and health care workers (HCWs) by triangulating responses from a structured questionnaire, three focus group discussions and seven key informant interviews. Acceptability was defined as willingness to take the test at the time of the study and intention for future use of the test if it was availed. The prevalence of HIV infection among study participants was 14.8%. The HIV oral fluid test was highly accurate with sensitivity of 100% (95% CI; 94.5±100.0), specificity of 100% (95% CI; 99.0±100.0), positive predictive value (PPV) of 100% (95% CI; 94.5±100.0) and negative predictive value (NPV) of 100% (95% CI; 99.0±100.0). Acceptability of HIV oral testing was also high at 87.0% (95% CI; 83.6±89.9). Participants preferred HIV oral testing because it was: pain free (91%, n = 399) and did not require blood draw (82%, n = 360). Conclusion The HIV oral fluid test has high diagnostic accuracy and acceptability. HIV oral testing is a suitable addition to the national HIV testing strategies with the potential of increasing access to HIV testing services in Uganda.
Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster randomised tria
(The lancet HIV, 2016) Amanyire, Gideon; Semitala, Fred C.; Namusobya, Jennifer; Katuramu, Richard; Kampiire, Leatitia; Wallenta, Jeanna; Chang, Wei; Kamya, Moses
In Africa, up to 30% of HIV-infected patients who are clinically eligible for antiretroviral therapy (ART) do not start timely treatment. We assessed the effects of an intervention targeting prevalent health systems barriers to ART initiation on timing and completeness of treatment initiation. In this stepped-wedge, non-blinded, cluster-randomised controlled trial, 20 clinics in southwestern Uganda were randomly assigned in groups of five clinics every 6 months to the intervention by a computerised random number generator. This procedure continued until all clinics had crossed over from control (standard of care) to the intervention, which consisted of opinion-leader-led training and coaching of front-line health workers, a point-of-care CD4 cell count testing platform, a revised counselling approach without mandatory multiple pre-initiation sessions, and feedback to the facilities on their ART initiation rates and how they compared with other facilities. Treatment-naive, HIV-infected adults (aged ≥18 years) who were clinically eligible for ART during the study period were included in the study population. The primary outcome was ART initiation 14 days after first clinical eligibility for ART. This study is registered with ClinicalTrials.gov, number NCT01810289. Between April 11, 2013, and Feb 2, 2015, 12 024 eligible patients visited one of the 20 participating clinics. Median CD4 count was 310 cells per μL (IQR 179–424). 3753 of 4747 patients (weighted proportion 80%) in the intervention group had started ART by 2 weeks after eligibility compared with 2585 of 7066 patients (38%) in the control group (risk difference 41·9%, 95% CI 40·1–43·8). Vital status was ascertained in a random sample of 208 patients in the intervention group and 199 patients in the control group. Four deaths (2%) occurred in the intervention group and five (3%) occurred in the control group. A multicomponent intervention targeting health-care worker behaviour increased the probability of ART initiation 14 days after eligibility. This intervention consists of widely accessible components and has been tested in a real-world setting, and is therefore well positioned for use at scale.
High viral suppression and low attrition in healthy HIV-infected patients initiated on ART with CD4 above 500 cells/μL in a program setting in Uganda
(Afri Health Sci, 2020) Byonanebye, Dathan M.; Semitala, Fred C.; Katende, Jackson; Bakenga, Alex; Arinaitwe, Irene; Kyambadde, Peter; Musinguzi, Patrick; Andia Biraro, Irene; Byakika-Kibwika, Pauline; Kamya, Moses R.
The World Health Organization recommends antiretroviral therapy (ART) for all HIV-infected patients at all CD4 counts. However, there are concerns that asymptomatic patients may have poorer viral suppression and high attrition. Objectives: We sought to determine attrition and viral suppression among healthy HIV-infected patients initiated on ART in program settings. Methods: This cross-sectional study enrolled ART-experienced patients attending two PEPFAR-supported, high-volume clinics in Kampala, Uganda. Eligible patients were >18 years and had completed at least six months on ART. Participants were interviewed on socio-demographics, ART history and plasma viral load (VL) determined using Abbott Real-time. Predictors of viral suppression (<75 copies/ml) were determined using multivariate logistic regression.
Loss to follow-up and associated factors among adult people living with HIV at public health facilities in Wakiso district, Uganda: a retrospective cohort study
(BMC health services research, 2019) Opio, Denis; Semitala, Fred C.; Kakeeto, Alex; Sendaula, Emmanuel; Okimat, Paul; Nakafeero, Brenda; Nankabirwa, Joaniter I.; Karamagi, Charles; Kalyango, Joan N.
Loss to follow-up (LTFU) from care among people living with HIV (PLHIV) is thought to be more common in the public setting compared to the private health care. It is anticipated that the problem may become worse with the current “test and treat” policy in Uganda due to the likely increases in patient loads and its attendant pressure on health care providers to support patient counseling. This study determined the incidence and factors associated with LTFU from HIV care among adult PLHIV in public health facilities in Wakiso district, Uganda. Methods: This was a retrospective cohort study that involved the review of 646 records of patients initiated on antiretroviral therapy (ART) between January 1st, 2015 and December 31st, 2017 at 13 randomly selected public health facilities in Wakiso district. The cox proportional hazards regression was used to determine the factors associated with LTFU. The results were supported by sequential in-depth and key informant interviews to explore reasons for LTFU. Results: Of the 646 patients enrolled, 391 were female (60.5%), 282 were below 30 years (43.6%) and 207 were married (50.1%). A total of 216 patients (33.4%) had no documented outcomes and were considered LTFU. The incidence of LTFU was 21 per 1000 person months (95% confidence interval (CI): 18–25 per 1000 person months). Factors associated with LTFU included having normal weight compared to underweight (adjusted hazard ratio (aHR) 0.64, 95% CI: 0.45–0.90, p = 0.011), receiving HIV care from hospitals compared to lower level facilities (aHR 0.22, 95% CI: 0.12–0.41, p < 0.001), and no telephone contact compared to those with a telephone contact (aHR 2.16, 95% CI: 1.33–3.51, p = 0.002). Stigmatization and long waiting times were the prominent reasons for LTFU reported from the in-depth and key informant interviews. Conclusions: The incidence of LTFU in public health facilities in Uganda is quite high and is associated with being underweight, not having a telephone contact to receive reminders and receiving care at lower level facilities. Early diagnosis, routine use of patient address locator forms and improved quality of HIV care at lower level health facilities may reduce LTFU among PLHIV.
Prevalence, associated factors and perspectives of HIV testing among men in Uganda
(PLoS ONE, 2020) Nangendo, Joanita; Katahoire, Anne R.; Armstrong-Hough, Mari; Kabami, Jane; Odei Obeng-Amoako, Gloria; Muwema, Mercy; Semitala, Fred C.; Karamagi, Charles A.; Wanyenze, Rhoda K.; Kamya, Moses R.; Kalyango, Joan N.
Despite overall increase in HIV testing, more men than women remain untested. In 2018, 92% of Ugandan women but only 67% of men had tested for HIV. Understanding men’s needs and concerns for testing could guide delivery of HIV testing services (HTS) to them. We assessed the prevalence of testing, associated factors and men’s perspectives on HIV testing in urban and peri-urban communities in Central Uganda. Methods and findings We conducted a parallel-convergent mixed-methods study among men in Kampala and Mpigi districts from August to September 2018. Using two-stage sampling, we selected 1340 men from Mpigi. We administered a structured questionnaire to collect data on HIV testing history, socio-demographics, self-reported HIV risk-related behaviors, barriers and facilitators to HIV testing. We also conducted 10 focus-groups with men from both districts to learn their perspectives on HIV testing. We used modified Poisson regression to assess factors associated with HIV testing and inductive thematic analysis to identify barriers and facilitators. Though 84.0% of men reported having tested for HIV, only 65.7% had tested in the past 12-months despite nearly all (96.7%) engaging in at least one HIV risk-related behavior. Men were more likely to have tested if aged 25–49 years, Catholic, with secondary or higher education and circumcised. Being married was associated with ever-testing while being widowed or divorced was associated with testing in past 12-months.
Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda
(Implementation Science, 2020) Kadota, Jillian L.; Musinguzi, Allan; Nabunje, Juliet; Welishe, Fred; Ssemata, Jackie L.; Bishop, Opira; Berger, Christopher A.; Patel, Devika; Sammann, Amanda; Katahoire, Anne; Nahid, Payam; Belknap, Robert; Phillips, Patrick P. J.; Namusobya, Jennifer; Kamya, Moses; Handley, Margaret A.; Kiwanuka, Noah; Katamba, Achilles; Dowdy, David; Semitala, Fred C.; Cattamanchi, Adithya
Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods: We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectivenessimplementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the costeffectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion: 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion.
Understanding uptake of an intervention to accelerate antiretroviral therapy initiation in Uganda via qualitative inquiry
(Journal of the International AIDS Society, 2017) Semitala, Fred C.; Wallenta, Jeanna; Kampiire, Leatitia; Katuramu, Richard; Amanyire, Gideon; Namusobya, Jennifer; Havlir, Diane V.; Kamya, Moses R.; Geng, Elvin H.
The Streamlined Antiretroviral Therapy Initiation Strategy (START-ART) study found that a theory-based intervention using opinion leaders to inform and coach health care providers about the risks of treatment delay, provision of point of care (POC) CD4 testing machines (PIMA) and reputational incentives, led to rapid rise in ART initiation. We used qualitative research methods to explore mechanisms of provider behaviour change.

Browsing by Author "Semitala, Fred C."

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