Fred Collins Semitala
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Previous Organizations / Institutes
The organizations / institutes from the scholar's other articles in the past ten years
Research Subjects
Fred Collins Semitala has a total of 279 co-authors. Here are the top co-authors by number of shared publications:
Fred Welishe
Infectious Diseases Research Collaboration Kampala Uganda
10 shared publicationsAdithya Cattamanchi
Center for Tuberculosis University of California San Francisco San Francisco California USA
8 shared publicationsMoses R. Kamya
Affiliations School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda, Infectious Diseases Research Collaboration, Kampala, Uganda
8 shared publications- Moses Robert Kamya
School of Medicine, Makerere University, Kampala, Uganda
8 shared publications - Adithya Cattamanchi
Center for Tuberculosis, Institute for Global Health Sciences, University of California San Francisco , San Francisco, California
7 shared publications Anne R. Katahoire
Child Health and Development Centre Department of Medicine Makerere University Kampala Uganda
7 shared publications
Latest Publications
- Open Access
- 22 September 2026
- Published by Public Library of Science (PLoS) in PLOS Global Public Health
- Vol. 6 (9) , e0005431
HIV self-testing preferences among adolescent girls and young women (AGYW) in urban settings in Uganda: A discrete choice experiment
HIV self-testing (HIVST) is a crucial innovation for improving testing coverage, particularly among adolescent girls and young women (AGYW) who are inadequately reached by standard provider-assisted HIV testing approaches. Understanding their preferences for HIVST services is essential for designing models that optimize uptake. We assessed the HIVST preferences among AGYW at a higher risk of acquiring HIV living in urban Uganda. We enrolled AGYW at a higher risk of HIV using a community-based convenience sampling in a discrete choice experiment (DCE). Each participant completed eight choice sets, each comprising of two hypothetical HIVST service alternatives and an opt-out option. The four attributes included level of assistance (assisted versus unassisted), distribution model (facility-based versus community-based), delivery channel (primary versus secondary) and sample type (oral swab versus blood). A mixed logit model was used to estimate the marginal utilities, relative importance (RI), HIVST profile utilities and predicted uptake (compared to opt-out). Between December 2024 and May 2025, 340 participants were enrolled with mean age 19.8 years (standard deviation (SD): 2.6), and 65.9% of them were not in school. In the main effects model, participants preferred; facility-based over community-based distribution model (β = 0.14 (95% confidence interval (CI): 0.06, 0.23)), primary over secondary delivery channel (β = 0.09 (95% CI: 0.00, 0.17)), and unassisted over assisted testing (β = 0.46 (95% CI: 0.37, 0.54). The sample type didn’t significantly influence the preferences of participants to use HIVST (β = 0.05 (95%CI: -0.04, 0.13). The level of assistance emerged as the most important attribute (RI: 60%), followed by facility-based distribution model (RI: 18.9%) and primary delivery channel (RI: 12.2%). There was a significant interaction between delivery channel and level of assistance (β = 0.66 (95% CI: 0.07, 1.24)). Primary delivery was preferred over secondary delivery when testing was unassisted (β = 0.41 (95% CI: 0.11, 0.71), but not when testing was assisted (β = -0.25 (95% CI: -0.56, 0.06). AGYW preferred HIVST models combining primary delivery with unassisted testing while facility-based distribution also increased preference. This highlights the importance of considering both individual attributes and their interaction when designing HIV delivery models.
- 22 September 2026
- Published by Public Library of Science (PLoS) in PLOS Global Public Health
- Vol. 6 (9) , e0005431
Open AccessHIV self-testing preferences among adolescent girls and young women (AGYW) in urban settings in Uganda: A discrete choice experiment
HIV self-testing (HIVST) is a crucial innovation for improving testing coverage, particularly among adolescent girls and young women (AGYW) who are inadequately reached by standard provider-assisted HIV testing approaches. Understanding their preferences for HIVST services is essential for designing models that optimize uptake. We assessed the HIVST preferences among AGYW at a higher risk of acquiring HIV living in urban Uganda. We enrolled AGYW at a higher risk of HIV using a community-based convenience sampling in a discrete choice experiment (DCE). Each participant completed eight choice sets, each comprising of two hypothetical HIVST service alternatives and an opt-out option. The four attributes included level of assistance (assisted versus unassisted), distribution model (facility-based versus community-based), delivery channel (primary versus secondary) and sample type (oral swab versus blood). A mixed logit model was used to estimate the marginal utilities, relative importance (RI), HIVST profile utilities and predicted uptake (compared to opt-out). Between December 2024 and May 2025, 340 participants were enrolled with mean age 19.8 years (standard deviation (SD): 2.6), and 65.9% of them were not in school. In the main effects model, participants preferred; facility-based over community-based distribution model (β = 0.14 (95% confidence interval (CI): 0.06, 0.23)), primary over secondary delivery channel (β = 0.09 (95% CI: 0.00, 0.17)), and unassisted over assisted testing (β = 0.46 (95% CI: 0.37, 0.54). The sample type didn’t significantly influence the preferences of participants to use HIVST (β = 0.05 (95%CI: -0.04, 0.13). The level of assistance emerged as the most important attribute (RI: 60%), followed by facility-based distribution model (RI: 18.9%) and primary delivery channel (RI: 12.2%). There was a significant interaction between delivery channel and level of assistance (β = 0.66 (95% CI: 0.07, 1.24)). Primary delivery was preferred over secondary delivery when testing was unassisted (β = 0.41 (95% CI: 0.11, 0.71), but not when testing was assisted (β = -0.25 (95% CI: -0.56, 0.06). AGYW preferred HIVST models combining primary delivery with unassisted testing while facility-based distribution also increased preference. This highlights the importance of considering both individual attributes and their interaction when designing HIV delivery models.
- Open Access
- 23 February 2026
- Published by Public Library of Science (PLoS) in PLOS Global Public Health
- Vol. 6 (2) , e0005857
Acceptability of HIV self-testing among HIV high-risk Adolescent Girls and Young Women (AGYW) in urban settings in Uganda
Adolescent Girls and Young Women (AGYW) bear a disproportionate burden of HIV in Sub-Saharan Africa, but HIV testing in this sub-population is sub-optimal. HIV self-testing (HIVST) is an evidence-based intervention that has been shown to improve testing rates among AGYW; however, its acceptability in this sub-population remains under-explored. We assessed the acceptability of HIVST and associated factors among HIV high-risk AGYW. We enrolled HIV high-risk AGYW consecutively from Kampala and Wakiso districts in a community-based cross-sectional study. A structured questionnaire was used to collect data. Acceptability was defined as willingness to use HIVST services if provided, and was measured as a composite outcome using the seven constructs of the Theoretical Framework of Acceptability (TFA) where each construct was assessed using one 5-level Likert item question weighted 1–5. The sum of scores was computed and participants with a score >21 was regarded as accepting HIVST. Descriptive statistics were used to summarize the data and a mixed effects modified Poisson was used to assess factors associated with acceptability of HIVST. Between December 2024 and May 2025, 377 HIV high-risk AGYW of mean age 19.7 years (standard deviation (SD): 2.7) were enrolled in the study of which 55.2% reported having a sexually transmitted infection in the past six months. The acceptability of HIVST was 90.2% (95%CI: 86.7, 92.8). Adjusted analysis showed that having multiple sexual partners, consistent condom use, no history of sexual violence and PrEP use in the past six months, and HIV testing in the past 12 months were significantly associated with greater willingness to use HIVST. HIVST is highly acceptable among the AGYW studied, and this presents a potential opportunity that can be leveraged to scale-up HIVST services. Future implementation efforts could consider strategies that address both behavioral risks and psychological vulnerabilities to optimize uptake and impact of HIVST.
- 23 February 2026
- Published by Public Library of Science (PLoS) in PLOS Global Public Health
- Vol. 6 (2) , e0005857
Open AccessAcceptability of HIV self-testing among HIV high-risk Adolescent Girls and Young Women (AGYW) in urban settings in Uganda
Adolescent Girls and Young Women (AGYW) bear a disproportionate burden of HIV in Sub-Saharan Africa, but HIV testing in this sub-population is sub-optimal. HIV self-testing (HIVST) is an evidence-based intervention that has been shown to improve testing rates among AGYW; however, its acceptability in this sub-population remains under-explored. We assessed the acceptability of HIVST and associated factors among HIV high-risk AGYW. We enrolled HIV high-risk AGYW consecutively from Kampala and Wakiso districts in a community-based cross-sectional study. A structured questionnaire was used to collect data. Acceptability was defined as willingness to use HIVST services if provided, and was measured as a composite outcome using the seven constructs of the Theoretical Framework of Acceptability (TFA) where each construct was assessed using one 5-level Likert item question weighted 1–5. The sum of scores was computed and participants with a score >21 was regarded as accepting HIVST. Descriptive statistics were used to summarize the data and a mixed effects modified Poisson was used to assess factors associated with acceptability of HIVST. Between December 2024 and May 2025, 377 HIV high-risk AGYW of mean age 19.7 years (standard deviation (SD): 2.7) were enrolled in the study of which 55.2% reported having a sexually transmitted infection in the past six months. The acceptability of HIVST was 90.2% (95%CI: 86.7, 92.8). Adjusted analysis showed that having multiple sexual partners, consistent condom use, no history of sexual violence and PrEP use in the past six months, and HIV testing in the past 12 months were significantly associated with greater willingness to use HIVST. HIVST is highly acceptable among the AGYW studied, and this presents a potential opportunity that can be leveraged to scale-up HIVST services. Future implementation efforts could consider strategies that address both behavioral risks and psychological vulnerabilities to optimize uptake and impact of HIVST.
- Open Access
- 1 January 2026
- Published by AOSIS in Journal of Public Health in Africa
- Vol. 17 (1)
Mixed methods assessment of an integrated hypertension and HIV care model: Acceptability, feasibility, and clinical outcomes at primary healthcare clinics in Wakiso District, Uganda
Background: The World Health Organization (WHO) recommends integrating hypertension and human immunodeficiency virus (HIV) care; however, evidence for implementing integrated care in primary healthcare (PHC) HIV clinics remains limited. Aim: To assess the feasibility and acceptability of a pilot model for integrating hypertension care into HIV services and to describe the hypertension care cascade among people living with HIV (PLHIV) and hypertension. Setting: Two PHC HIV clinics in Wakiso district, Uganda. Methods: We conducted a parallel convergent mixed methods study. The pilot intervention included providing blood pressure (BP) cuffs, antihypertensive medications, a treatment algorithm and training healthcare provider (HCP) on hypertension care. Quantitative data were collected from February 2022 to December 2022. Using the consolidated framework for implementation research, we conducted interviews with HCPs (n = 12) and PLHIV with hypertension (n = 8) to explore implementation determinants. We performed descriptive analysis for hypertension care cascades. Qualitative data identified barriers and facilitators to integrating HIV and hypertension care. Results: Of 3802 PLHIV in care, 3502 (92%) were screened for hypertension. Among these, 290 (8.3%) had a chart diagnosis of hypertension, 282 (97.2%) were treated and 128 (50.2%) achieved BP control. Key facilitators included access to medications, BP monitors and improved provider knowledge on management of BP among PLHIV. Barriers included unsynchronised clinic visits and increased provider workload. Conclusion: Integrating hypertension and HIV services in Ugandan HIV clinics is feasible and acceptable. Availability of resources (BP medications and monitors) and trained personnel facilitates integration of these services. Contribution: This pilot study provides evidence that integrating hypertension care into existing PHC HIV in Uganda and other similar settings is both feasible and acceptable but may necessitate additional human resources for health.
- 1 January 2026
- Published by AOSIS in Journal of Public Health in Africa
- Vol. 17 (1)
Open AccessMixed methods assessment of an integrated hypertension and HIV care model: Acceptability, feasibility, and clinical outcomes at primary healthcare clinics in Wakiso District, Uganda
Background: The World Health Organization (WHO) recommends integrating hypertension and human immunodeficiency virus (HIV) care; however, evidence for implementing integrated care in primary healthcare (PHC) HIV clinics remains limited. Aim: To assess the feasibility and acceptability of a pilot model for integrating hypertension care into HIV services and to describe the hypertension care cascade among people living with HIV (PLHIV) and hypertension. Setting: Two PHC HIV clinics in Wakiso district, Uganda. Methods: We conducted a parallel convergent mixed methods study. The pilot intervention included providing blood pressure (BP) cuffs, antihypertensive medications, a treatment algorithm and training healthcare provider (HCP) on hypertension care. Quantitative data were collected from February 2022 to December 2022. Using the consolidated framework for implementation research, we conducted interviews with HCPs (n = 12) and PLHIV with hypertension (n = 8) to explore implementation determinants. We performed descriptive analysis for hypertension care cascades. Qualitative data identified barriers and facilitators to integrating HIV and hypertension care. Results: Of 3802 PLHIV in care, 3502 (92%) were screened for hypertension. Among these, 290 (8.3%) had a chart diagnosis of hypertension, 282 (97.2%) were treated and 128 (50.2%) achieved BP control. Key facilitators included access to medications, BP monitors and improved provider knowledge on management of BP among PLHIV. Barriers included unsynchronised clinic visits and increased provider workload. Conclusion: Integrating hypertension and HIV services in Ugandan HIV clinics is feasible and acceptable. Availability of resources (BP medications and monitors) and trained personnel facilitates integration of these services. Contribution: This pilot study provides evidence that integrating hypertension care into existing PHC HIV in Uganda and other similar settings is both feasible and acceptable but may necessitate additional human resources for health.
- Open Access
- 26 November 2025
- Published by Springer Nature in BMC Infectious Diseases
- Vol. 25 (1)
High prevalence and atypical genotype distribution of oral human Papillomavirus in an East African HIV cohort: a cross-sectional study
Globally, Human Papillomavirus type 16 (HPV-16) is the predominant genotype associated with oropharyngeal cancers. However, little is known about the preva
- 26 November 2025
- Published by Springer Nature in BMC Infectious Diseases
- Vol. 25 (1)
Open AccessHigh prevalence and atypical genotype distribution of oral human Papillomavirus in an East African HIV cohort: a cross-sectional study
Globally, Human Papillomavirus type 16 (HPV-16) is the predominant genotype associated with oropharyngeal cancers. However, little is known about the preva
- Open Access
- 7 July 2025
- Published by Wiley in Journal of the International AIDS Society
- Vol. 28 (S3) , e26499
Early findings from the integration of hypertension care into differentiated service delivery models for HIV in Uganda: a mixed‐method study
Introduction: Uganda's national guidelines recommend integrated HIV and hypertension care; however, integration of hypertension care into HIV differentiated service delivery (DSD) models has not been extensively described. We aimed to describe trends in DSD models for people living with HIV (PLHIV) with hypertension and to qualitatively describe the experiences of healthcare providers (HCPs) and PLHIV with hypertension after implementing integrated care.Methods: We conducted a parallel convergent mixed methods study nested in an ongoing stepped wedge cluster randomised trial in Kampala and Wakiso districts. Quantitative data (age, sex, blood pressure, DSD model, medication prescriptions) were collected from routine medical records at eight clinics implementing the enhanced care package between March 2023 and July 2024. Additionally, structured interviews were conducted at two clinics with HCPs (n = 6, 3 per clinic) and PLHIV with hypertension (n = 8, 4 per clinic). Our quantitative outcome variable was enrolment in intensive DSD models (facility‐based individual and group models) versus other DSDs. A generalised estimation equation was used to account for within clinic correlation and repeated measures within participants over time. Inductive thematic analysis was applied to the qualitative data using the Consolidated Framework for Implementation Research.Results: Overall, 3164 PLHIV with hypertension accessed care at the eight clinics. Median age was 46 years (IQR 38–56); more than two‐thirds were female. There was considerable heterogeneity across clinics in the use of DSD models during the study period. Overall, use of intensive models increased over time (OR 1.127 [1.059−1.199] per month). However, two clinics showed significant time interaction effects (Wald test χ2 (7) = 69.94, p < 0.001), with a decrease in the intensive models over time. HCPs and PLHIV observed that integrating hypertension care was easily adaptable in some models, while more challenging in others. The availability of resources and synchronisation of HIV and hypertension visits facilitated the integration of hypertension care within the HIV DSD models.Conclusions: The integration of hypertension management into HIV DSD models is both feasible and adaptable; however, it requires transitioning PLHIV between various models based on clinical needs. To facilitate this process, comprehensive client education by the HCPs is necessary.Clinical Trial Number: clinicaltrials.gov # NCT05609513
- 7 July 2025
- Published by Wiley in Journal of the International AIDS Society
- Vol. 28 (S3) , e26499
Open AccessEarly findings from the integration of hypertension care into differentiated service delivery models for HIV in Uganda: a mixed‐method study
Introduction: Uganda's national guidelines recommend integrated HIV and hypertension care; however, integration of hypertension care into HIV differentiated service delivery (DSD) models has not been extensively described. We aimed to describe trends in DSD models for people living with HIV (PLHIV) with hypertension and to qualitatively describe the experiences of healthcare providers (HCPs) and PLHIV with hypertension after implementing integrated care.Methods: We conducted a parallel convergent mixed methods study nested in an ongoing stepped wedge cluster randomised trial in Kampala and Wakiso districts. Quantitative data (age, sex, blood pressure, DSD model, medication prescriptions) were collected from routine medical records at eight clinics implementing the enhanced care package between March 2023 and July 2024. Additionally, structured interviews were conducted at two clinics with HCPs (n = 6, 3 per clinic) and PLHIV with hypertension (n = 8, 4 per clinic). Our quantitative outcome variable was enrolment in intensive DSD models (facility‐based individual and group models) versus other DSDs. A generalised estimation equation was used to account for within clinic correlation and repeated measures within participants over time. Inductive thematic analysis was applied to the qualitative data using the Consolidated Framework for Implementation Research.Results: Overall, 3164 PLHIV with hypertension accessed care at the eight clinics. Median age was 46 years (IQR 38–56); more than two‐thirds were female. There was considerable heterogeneity across clinics in the use of DSD models during the study period. Overall, use of intensive models increased over time (OR 1.127 [1.059−1.199] per month). However, two clinics showed significant time interaction effects (Wald test χ2 (7) = 69.94, p < 0.001), with a decrease in the intensive models over time. HCPs and PLHIV observed that integrating hypertension care was easily adaptable in some models, while more challenging in others. The availability of resources and synchronisation of HIV and hypertension visits facilitated the integration of hypertension care within the HIV DSD models.Conclusions: The integration of hypertension management into HIV DSD models is both feasible and adaptable; however, it requires transitioning PLHIV between various models based on clinical needs. To facilitate this process, comprehensive client education by the HCPs is necessary.Clinical Trial Number: clinicaltrials.gov # NCT05609513
- Open Access
- 26 November 2024
- Published by Wiley in Journal of the International AIDS Society
- Vol. 27 (12) , e26390
Preferences of people living with HIV for features of tuberculosis preventive treatment regimens in Uganda: a discrete choice experiment
Introduction: Tuberculosis (TB) preventive treatment (TPT) is recommended for people living with HIV (PLHIV) in high TB burden settings. While 6 months of daily isoniazid remains widely used, shorter regimens are now available. However, little is known about preferences of PLHIV for key features of TPT regimens.Methods: From July to November 2022, we conducted a discrete choice experiment among adult PLHIV engaged in care at an urban HIV clinic in Kampala, Uganda. Participants chose between two hypothetical TPT regimens with five different features (pills per dose, frequency, duration, need for adjusted antiretroviral therapy [ART] dosage and side effects), organized across nine random choice tasks. We analysed preferences using hierarchical Bayesian estimation, latent class analysis and willingness‐to‐trade simulations.Results: Of 400 PLHIV, 392 (median age 44, 72% female, 91% TPT‐experienced) had high‐quality choice task responses. Pills per dose was the most important attribute (relative importance 32.4%, 95% confidence interval [CI] 31.6–33.2), followed by frequency (20.5% [95% CI 19.7–21.3]), duration (19.5% [95% CI 18.6–20.5]) and need for ART dosage adjustment (18.2% [95% CI 17.2–19.2]). Latent class analysis identified three preference groups: one prioritized less frequent, weekly dosing (N = 222; 57%); another was averse to ART dosage adjustment (N = 107; 27%); and the last prioritized short regimens with fewer side effects (N = 63; 16%). All groups highly valued fewer pills per dose. Overall, participants were willing to accept a regimen of 2.8 months’ additional duration [95% CI: 2.4–3.2] to reduce pills per dose from five to one, 3.6 [95% CI 2.4–4.8] months for weekly rather than daily dosing and 2.2 [95% CI 1.3–3.0] months to avoid ART dosage adjustment.Conclusions: To align with preferences of PLHIV in Uganda, decision‐makers should prioritize the development and implementation of TPT regimens with fewer pills, less frequent dosing and no need for ART dosage adjustment, rather than focus primarily on duration of treatment.
- 26 November 2024
- Published by Wiley in Journal of the International AIDS Society
- Vol. 27 (12) , e26390
Open AccessPreferences of people living with HIV for features of tuberculosis preventive treatment regimens in Uganda: a discrete choice experiment
Introduction: Tuberculosis (TB) preventive treatment (TPT) is recommended for people living with HIV (PLHIV) in high TB burden settings. While 6 months of daily isoniazid remains widely used, shorter regimens are now available. However, little is known about preferences of PLHIV for key features of TPT regimens.Methods: From July to November 2022, we conducted a discrete choice experiment among adult PLHIV engaged in care at an urban HIV clinic in Kampala, Uganda. Participants chose between two hypothetical TPT regimens with five different features (pills per dose, frequency, duration, need for adjusted antiretroviral therapy [ART] dosage and side effects), organized across nine random choice tasks. We analysed preferences using hierarchical Bayesian estimation, latent class analysis and willingness‐to‐trade simulations.Results: Of 400 PLHIV, 392 (median age 44, 72% female, 91% TPT‐experienced) had high‐quality choice task responses. Pills per dose was the most important attribute (relative importance 32.4%, 95% confidence interval [CI] 31.6–33.2), followed by frequency (20.5% [95% CI 19.7–21.3]), duration (19.5% [95% CI 18.6–20.5]) and need for ART dosage adjustment (18.2% [95% CI 17.2–19.2]). Latent class analysis identified three preference groups: one prioritized less frequent, weekly dosing (N = 222; 57%); another was averse to ART dosage adjustment (N = 107; 27%); and the last prioritized short regimens with fewer side effects (N = 63; 16%). All groups highly valued fewer pills per dose. Overall, participants were willing to accept a regimen of 2.8 months’ additional duration [95% CI: 2.4–3.2] to reduce pills per dose from five to one, 3.6 [95% CI 2.4–4.8] months for weekly rather than daily dosing and 2.2 [95% CI 1.3–3.0] months to avoid ART dosage adjustment.Conclusions: To align with preferences of PLHIV in Uganda, decision‐makers should prioritize the development and implementation of TPT regimens with fewer pills, less frequent dosing and no need for ART dosage adjustment, rather than focus primarily on duration of treatment.
- Open Access
- 30 October 2024
- Published by Oxford University Press (OUP) in Open Forum Infectious Diseases
- Vol. 11 (11) , ofae667
Adverse Events Reported During Weekly Isoniazid-Rifapentine (3HP) Tuberculosis Preventive Treatment Among People With Human Immunodeficiency Virus in Uganda
Background: Short-course tuberculosis (TB) prevention regimens, including 12 weeks of isoniazid and rifapentine (3HP), are increasingly used in high-TB-burden countries. Despite established safety and tolerability in efficacy trials, 3HP-related adverse events (AEs) could differ in routine settings. Real-world data on AE type, frequency, and timing are crucial for health systems considering 3HP programmatic scale-up. Methods: We reviewed AEs among people with human immunodeficiency virus (HIV) participating in a pragmatic implementation trial of facilitated 3HP taken by directly observed therapy (DOT) or self-administered therapy (SAT) in Kampala, Uganda, and classified them using the Common Terminology Criteria for Adverse Events. We assessed AE timing and summarized related clinical actions including laboratory tests, diagnoses made, medications prescribed, and treatment interruptions. Results: Among 1655 people with HIV treated between July 2020 and September 2022, 270 (16.3%) reported 451 events; main issues included general (7%), nervous system (6%), musculoskeletal (5%), gastrointestinal (5%), and dermatologic (3%) disorders. Most (61%) occurred within 6 weeks of initiating 3HP. Among those with events, 211 (78%) required further clinician evaluation, 202 (75%) required laboratory testing, 102 (38%) had medications prescribed, 40 (15%) had treatment paused, and 14 (5%) discontinued 3HP. Women, those multidimensionally impoverished, and DOT recipients were more likely to report an AE. SAT users and later enrollees were more likely to have 3HP interrupted or stopped due to an AE. Conclusions: In a routine setting, 3HP was safe, with 16% of people with HIV reporting AEs and only 3% requiring temporary or permanent treatment interruption. These findings support 3HP expansion in routine HIV/AIDS care settings for TB prevention. Clinical Trials Registration. NCT03934931.
- 30 October 2024
- Published by Oxford University Press (OUP) in Open Forum Infectious Diseases
- Vol. 11 (11) , ofae667
Open AccessAdverse Events Reported During Weekly Isoniazid-Rifapentine (3HP) Tuberculosis Preventive Treatment Among People With Human Immunodeficiency Virus in Uganda
Background: Short-course tuberculosis (TB) prevention regimens, including 12 weeks of isoniazid and rifapentine (3HP), are increasingly used in high-TB-burden countries. Despite established safety and tolerability in efficacy trials, 3HP-related adverse events (AEs) could differ in routine settings. Real-world data on AE type, frequency, and timing are crucial for health systems considering 3HP programmatic scale-up. Methods: We reviewed AEs among people with human immunodeficiency virus (HIV) participating in a pragmatic implementation trial of facilitated 3HP taken by directly observed therapy (DOT) or self-administered therapy (SAT) in Kampala, Uganda, and classified them using the Common Terminology Criteria for Adverse Events. We assessed AE timing and summarized related clinical actions including laboratory tests, diagnoses made, medications prescribed, and treatment interruptions. Results: Among 1655 people with HIV treated between July 2020 and September 2022, 270 (16.3%) reported 451 events; main issues included general (7%), nervous system (6%), musculoskeletal (5%), gastrointestinal (5%), and dermatologic (3%) disorders. Most (61%) occurred within 6 weeks of initiating 3HP. Among those with events, 211 (78%) required further clinician evaluation, 202 (75%) required laboratory testing, 102 (38%) had medications prescribed, 40 (15%) had treatment paused, and 14 (5%) discontinued 3HP. Women, those multidimensionally impoverished, and DOT recipients were more likely to report an AE. SAT users and later enrollees were more likely to have 3HP interrupted or stopped due to an AE. Conclusions: In a routine setting, 3HP was safe, with 16% of people with HIV reporting AEs and only 3% requiring temporary or permanent treatment interruption. These findings support 3HP expansion in routine HIV/AIDS care settings for TB prevention. Clinical Trials Registration. NCT03934931.
- Open Access
- 24 October 2024
- Published by Public Library of Science (PLoS) in PLOS Global Public Health
- Vol. 4 (10) , e0003347
Evaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial
Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We used thematic analysis (inductive and deductive) to align the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as needed enabled acceptance of patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, prior TPT experience with daily isoniazid, and few 3HP-related serious adverse events enabled adoption, whereas initial concerns about 3HP safety among HCPs, and COVID-19 treatment disruptions delayed 3HP adoption. Refresher training and collaboration among HCPs enabled implementation whereas limited diagnostic facilities for adverse events at the clinic hindered implementation. SAT was modified post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up. Trial registration: ClinicalTrials.gov (NCT03934931); Registered 2nd May 2019; https://clinicaltrials.gov/study/NCT03934931?id = NCT03934931&rank = 1.
- 24 October 2024
- Published by Public Library of Science (PLoS) in PLOS Global Public Health
- Vol. 4 (10) , e0003347
Open AccessEvaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial
Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We used thematic analysis (inductive and deductive) to align the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as needed enabled acceptance of patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, prior TPT experience with daily isoniazid, and few 3HP-related serious adverse events enabled adoption, whereas initial concerns about 3HP safety among HCPs, and COVID-19 treatment disruptions delayed 3HP adoption. Refresher training and collaboration among HCPs enabled implementation whereas limited diagnostic facilities for adverse events at the clinic hindered implementation. SAT was modified post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up. Trial registration: ClinicalTrials.gov (NCT03934931); Registered 2nd May 2019; https://clinicaltrials.gov/study/NCT03934931?id = NCT03934931&rank = 1.
- Open Access
Evaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial.
Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We conducted an inductive thematic analysis and aligned the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as required enabled acceptance for patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, and collaboration among HCPs enabled, whereas initial concerns about 3HP safety among HCPs delayed 3HP adoption and implementation. SAT was maintained post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up.
Open AccessEvaluating the implementation of weekly rifapentine-isoniazid (3HP) for tuberculosis prevention among people living with HIV in Uganda: A qualitative evaluation of the 3HP Options Trial.
Three months of isoniazid-rifapentine (3HP) is being scaled up for tuberculosis (TB) preventive treatment (TPT) among people living with HIV (PLHIV) in high-burden settings. More evidence is needed to identify factors influencing successful 3HP delivery. We conducted a qualitative assessment of 3HP delivery nested within the 3HP Options Trial, which compared three optimized strategies for delivering 3HP: facilitated directly observed therapy (DOT), facilitated self-administered therapy (SAT), and patient choice between facilitated DOT and facilitated SAT at the Mulago HIV/AIDS clinic in Kampala, Uganda. We conducted 72 in-depth interviews among PLHIV purposively selected to investigate factors influencing 3HP acceptance and completion. We conducted ten key informant interviews with healthcare providers (HCPs) involved in 3HP delivery to identify facilitators and barriers at the clinic level. We used post-trial 3HP delivery data to assess sustainability. We conducted an inductive thematic analysis and aligned the emergent themes with the RE-AIM framework dimensions to report implementation outcomes. Understanding the need for TPT, once-weekly dosing, shorter duration, and perceived 3HP safety enhanced acceptance overall. Treatment monitoring by HCPs and reduced risk of HIV status disclosure enabled DOT acceptance. Dosing autonomy enabled SAT acceptance. Switching between DOT and SAT as required enabled acceptance for patient choice. Dosing reminders, reimbursement for clinical visits, and social support enabled 3HP completion; pill burden, side effects, and COVID-19-related treatment restrictions hindered completion. All HCPs were trained and participated in 3HP delivery with high fidelity. Training, care integration, and collaboration among HCPs enabled, whereas initial concerns about 3HP safety among HCPs delayed 3HP adoption and implementation. SAT was maintained post-trial; DOT was discontinued due to inadequate ongoing financial support beyond the study period. Facilitated delivery strategies made 3HP treatment convenient for PLHIV and were feasible and implemented with high fidelity by HCPs. However, the costs of 3HP facilitation may limit wider scale-up.
- Open Access
Adverse events reported during weekly isoniazid-rifapentine (3HP) tuberculosis preventive treatment among people living with HIV in Uganda
Background: Short-course tuberculosis (TB) prevention regimens, including 12 weeks of isoniazid and rifapentine (3HP), are increasingly used in high TB-burden countries. Despite established safety and tolerability in efficacy trials, 3HP-related adverse events (AE) could differ in routine settings. Real-world data on AE type, frequency, and timing is crucial for health systems considering 3HP programmatic scale-up. Methods: We reviewed AEs among people living with HIV (PLHIV) participating in a pragmatic implementation trial of facilitated 3HP taken by directly observed therapy (DOT) or self-administered therapy (SAT) in Kampala, Uganda, and classified them using the Common Terminology Criteria for Adverse Events. We assessed AE timing and summarized related clinical actions including lab tests, diagnoses made, medications prescribed, and treatment interruptions. Results: Among 1655 PLHIV treated between July 2020-September 2022, 270 (16.3%) reported 451 events; main issues included general (7%), nervous system (6%), musculoskeletal (5%), gastrointestinal (5%), and dermatologic (3%) disorders. Most (61%) occurred within 6 weeks of initiating 3HP. Among those with events, 211 (78%) required further clinician evaluation, 202 (75%) required laboratory testing, 102 (38%) had medications prescribed, 40 (15%) had treatment paused, and 14 (5%) discontinued 3HP. Women, those multidimensionally impoverished, and DOT recipients were more likely to report an AE. SAT users and later enrollees were more likely to have 3HP interrupted or stopped due to an AE. Conclusions: In a routine setting, 3HP was safe with 16% of PLHIV reporting AEs and only 3% requiring temporary or permanent treatment interruption. These findings support 3HP expansion in routine HIV/AIDS care settings for TB prevention. Summary: 3HP is being rolled out for TB prevention in high burden countries. We describe the incidence and clinical management of adverse events in a real-world clinical setting among people living with HIV participating in a pragmatic implementation study in Uganda.
Open AccessAdverse events reported during weekly isoniazid-rifapentine (3HP) tuberculosis preventive treatment among people living with HIV in Uganda
Background: Short-course tuberculosis (TB) prevention regimens, including 12 weeks of isoniazid and rifapentine (3HP), are increasingly used in high TB-burden countries. Despite established safety and tolerability in efficacy trials, 3HP-related adverse events (AE) could differ in routine settings. Real-world data on AE type, frequency, and timing is crucial for health systems considering 3HP programmatic scale-up. Methods: We reviewed AEs among people living with HIV (PLHIV) participating in a pragmatic implementation trial of facilitated 3HP taken by directly observed therapy (DOT) or self-administered therapy (SAT) in Kampala, Uganda, and classified them using the Common Terminology Criteria for Adverse Events. We assessed AE timing and summarized related clinical actions including lab tests, diagnoses made, medications prescribed, and treatment interruptions. Results: Among 1655 PLHIV treated between July 2020-September 2022, 270 (16.3%) reported 451 events; main issues included general (7%), nervous system (6%), musculoskeletal (5%), gastrointestinal (5%), and dermatologic (3%) disorders. Most (61%) occurred within 6 weeks of initiating 3HP. Among those with events, 211 (78%) required further clinician evaluation, 202 (75%) required laboratory testing, 102 (38%) had medications prescribed, 40 (15%) had treatment paused, and 14 (5%) discontinued 3HP. Women, those multidimensionally impoverished, and DOT recipients were more likely to report an AE. SAT users and later enrollees were more likely to have 3HP interrupted or stopped due to an AE. Conclusions: In a routine setting, 3HP was safe with 16% of PLHIV reporting AEs and only 3% requiring temporary or permanent treatment interruption. These findings support 3HP expansion in routine HIV/AIDS care settings for TB prevention. Summary: 3HP is being rolled out for TB prevention in high burden countries. We describe the incidence and clinical management of adverse events in a real-world clinical setting among people living with HIV participating in a pragmatic implementation study in Uganda.