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Background: Screening for tuberculosis (TB) and providing TB preventive treatment (TPT) along with antiretroviral therapy is key components of human immune deficiency virus (HIV) care. The uptake of TPT during the coronavirus disease 2019 (COVID-19) period has not been adequately assessed in Addis Ababa City Administration. This study aimed at assessing TPT uptake status among People living with HIV (PLHIV) newly initiated on antiretroviral therapy during the COVID-19 period at all public hospitals of Addis Ababa City Administration, Ethiopia., Methods: A retrospective data review was conducted from April-July 2022. Routine District Health Information System 2 database was reviewed for the period from April 2020-March 2022. Proportion and mean with standard deviation were computed. Logistic regression analysis was conducted to assess factors associated with TPT completion. A p-value of < 0.05 was considered statistically significant., Results: A total of 1,069 PLHIV, aged 18 years and above were newly initiated on antiretroviral therapy, and of these 1,059 (99.1%) underwent screening for TB symptoms. Nine hundred twelve (86.1%) were negative for TB symptoms. Overall, 78.8% (719) of cases who were negative for TB symptoms were initiated on TPT, and of these 70.5% and 22.8% were completed and discontinued TPT, respectively. Of 719 cases who were initiated on TPT, 334 (46.5%) and 385 (53.5%) were initiated on isoniazid plus rifapentine weekly for three months and Isoniazid preventive therapy daily for six months, respectively. PLHIV who were initiated on isoniazid plus rifapentine weekly for three months were more likely to complete TPT (adjusted odds ratio [AOR],1.68; 95% confidence interval [CI], 1.01, 2.79) compared to those who were initiated on Isoniazid preventive therapy daily for six months., Conclusion: While the proportion of PLHIV screened for TB was high, TPT uptake was low and far below the national target of achieving 90% TPT coverage. Overall a considerable proportion of cases discontinued TPT in this study. Further strengthening of the programmatic management of latent TB infection among PLHIV is needed. Therefore, efforts should be made by the Addis Ababa City Administration Health Bureau authorities and program managers to strengthen the initiation and completion of TPT among PLHIV in public hospitals., (© 2024. The Author(s).)

Background: Tuberculosis preventive therapy for persons with HIV infection is effective, but its durability is uncertain., Objective: To compare treatment completion rates of weekly isoniazid-rifapentine for 3 months versus daily isoniazid for 6 months as well as the effectiveness of the 3-month rifapentine-isoniazid regimen given annually for 2 years versus once., Design: Randomized trial. (ClinicalTrials.gov: NCT02980016)., Setting: South Africa, Ethiopia, and Mozambique., Participants: Persons with HIV infection who were receiving antiretroviral therapy, were aged 2 years or older, and did not have active tuberculosis., Intervention: Participants were randomly assigned to receive weekly rifapentine-isoniazid for 3 months, given either annually for 2 years or once, or daily isoniazid for 6 months. Participants were screened for tuberculosis symptoms at months 0 to 3 and 12 of each study year and at months 12 and 24 using chest radiography and sputum culture., Measurements: Treatment completion was assessed using pill counts. Tuberculosis incidence was measured over 24 months., Results: Between November 2016 and November 2017, 4027 participants were enrolled; 4014 were included in the analyses (median age, 41 years; 69.5% women; all using antiretroviral therapy). Treatment completion in the first year for the combined rifapentine-isoniazid groups ( n  = 3610) was 90.4% versus 50.5% for the isoniazid group ( n  = 404) (risk ratio, 1.78 [95% CI, 1.61 to 1.95]). Tuberculosis incidence among participants receiving the rifapentine-isoniazid regimen twice ( n  = 1808) or once ( n  = 1802) was similar (hazard ratio, 0.96 [CI, 0.61 to 1.50])., Limitation: If rifapentine-isoniazid is effective in curing subclinical tuberculosis, then the intensive tuberculosis screening at month 12 may have reduced its effectiveness., Conclusion: Treatment completion was higher with rifapentine-isoniazid for 3 months compared with isoniazid for 6 months. In settings with high tuberculosis transmission, a second round of preventive therapy did not provide additional benefit to persons receiving antiretroviral therapy., Primary Funding Source: The U.S. Agency for International Development through the CHALLENGE TB grant to the KNCV Tuberculosis Foundation.

Background: To address the multifaceted challenges associated with tuberculosis (TB) in-person directly observed therapy (DOT), the World Health Organization recently recommended that countries maximize the use of digital adherence technologies. Sub-Saharan Africa needs to investigate the effectiveness of such technologies in local contexts and proactively contribute to global decisions around patient-centered TB care. This study aims to evaluate the effectiveness of pillbox-enabled self-administered therapy (SAT) compared to standard DOT on adherence to TB medication and treatment outcomes in Ethiopia. It also aims to assess the usability, acceptability, and cost-effectiveness of the intervention from the patient and provider perspectives., Methods: This is a multicenter, randomized, controlled, open-label, superiority, effectiveness-implementation hybrid, mixed-methods, two-arm trial. The study is designed to enroll 144 outpatients with new or previously treated, bacteriologically confirmed, drug-sensitive pulmonary TB who are eligible to start the standard 6-month first-line anti-TB regimen. Participants in the intervention arm (n = 72) will receive 15 days of HRZE-isoniazid, rifampicin, pyrazinamide, and ethambutol-fixed-dose combination therapy in the evriMED500 medication event reminder monitor device for self-administration. When returned, providers will count any remaining tablets in the device, download the pill-taking data, and refill based on preset criteria. Participants can consult the provider in cases of illness or adverse events outside of scheduled visits. Providers will handle participants in the control arm (n = 72) according to the standard in-person DOT. Both arms will be followed up throughout the 2-month intensive phase. The primary outcomes will be medication adherence and sputum conversion. Adherence to medication will be calculated as the proportion of patients who missed doses in the intervention (pill count) versus DOT (direct observation) arms, confirmed further by IsoScreen urine isoniazid test and a self-report of adherence on eight-item Morisky Medication Adherence Scale. Sputum conversion is defined as the proportion of patients with smear conversion following the intensive phase in intervention versus DOT arms, confirmed further by pre-post intensive phase BACTEC MGIT TB liquid culture. Pre-post treatment MGIT drug susceptibility testing will determine whether resistance to anti-TB drugs could have impacted culture conversion. Secondary outcomes will include other clinical outcomes (treatment not completed, death, or loss to follow-up), cost-effectiveness-individual and societal costs with quality-adjusted life years-and acceptability and usability of the intervention by patients and providers., Discussion: This study will be the first in Ethiopia, and of the first three in sub-Saharan Africa, to determine whether electronic pillbox-enabled SAT improves adherence to TB medication and treatment outcomes, all without affecting the inherent dignity and economic wellbeing of patients with TB., Trial Registration: ClinicalTrials.gov, NCT04216420. Registered on 2 January 2020.

Objectives: This study aimed to assess the evolution of body mass index (BMI) of HIV-positive adults on second-line antiretroviral therapy (ART) over time and factors affecting it in north-west Ethiopia., Design: An institution-based retrospective follow-up study was conducted using data extracted from 1016 patient cards from February 2008 to February 2016., Setting: Eight referral hospitals from Amhara region, Ethiopia were included., Participants: HIV patients who started second-line ART., Outcome Measures: Change in BMI since starting second-line ART., Results: Five hundred and thirty-eight (52.95%) participants were males and the median age of the participants was 33 years (IQR: 28; 39). The median follow-up time was 18 months (IQR: 5.2; 32.2). The average change of BMI showed linear increase over time. The amount of BMI increment or decrement according to each variable was shown as β coefficients. Treatment duration (β=0.013, 95% CI 0.004 to 0.022), isoniazid prophylaxis (β=0.87, 95% CI 0.32 to 1.42), cotrimoxazole prophylaxis (β=0.63, 95% CI 0.08 to 1.19), ambulatory functional status (β=-1.16, 95% CI -1.95 to 1.31), bedridden functional status (β=-1.83, 95% CI -2.47 to 1.21), WHO stage III (β=-0.42, 95% CI -0.65 to 0.20), WHO stage IV (β=-0.62, 95% CI -1.02 to 0.22), CD4 count (β=0.001, 95% CI 0.0008 to 0.0015), and time interaction of variables like tertiary educational status (β=0.02, 95% CI 0.01 to 0.04), ambulatory functional status (β=0.03, 95% CI 0.01 to 0.05) and WHO stages III (β=0.01, 95% CI 0.007 to 0.02) were found to be significant predictors., Conclusion: The BMI of patients has shown linear increment over the treatment time. Factors affecting it have been identified but its effect on cardiovascular disease needs further study., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Mortality of adult patients who are on antiretroviral therapy (ART) is higher in low-income than in high-income countries. After the failure of standard first-line treatment, patients switch to second-line regimens. However, there are limited data about the outcome of patients after switching to a second-line regimen in the study area. This study aimed to measure the rate of mortality and its determinants among HIV patients on second-line ART regimens., Methods: Multicenter institution based retrospective follow up study was conducted among 1192 adult patients who started second-line ART between 2008 and 2016 in eight selected hospitals of Amhara region. Patients who started second-line treatment after the failure of first-line treatment were included. Patient medical records, registration books, and computer database were used to collect the data. Time to death after a switch to second-line ART was the primary outcome of interest. Cox proportional hazard model was fitted to identify determinant factors of mortality., Results: Among 1192 patients who were on second-line ART, 136 (11.4%) died with 3,157 person-years of follow up. Over the study period, the mortality rate was 4.33 per 100 person-years. Not taking isoniazid preventive therapy (IPT) (Adjusted Hazard Ratio (AHR): 6.6; 95% CI: 2.9, 15.0), did not make modification on second-line regimen (AHR: 4.4; 95% CI: 2.8, 6.8), poor clinical adherence (AHR: 2.5; 95% CI: 1.4, 4.5), functional status of bedridden (AHR: 2.7; 95% CI: 1.5, 4.8), and having attained a tertiary level of education (AHR: 0.4; 95% CI: 0.2, 0.8) were independent determinants of mortality., Conclusion: The incidence rate of mortality was high and most of the deaths occurred within 12 months after switching to second-line ART. Higher mortality among adult HIV-infected patients was associated with poor adherence, no formal education, not taking IPT, being bedridden at the time of the switch, and not modifying second-line treatment. Improving treatment adherence of patients by providing consistent adherence counseling, providing INH prophylaxis and monitoring patient's regimen more closely during the first twelve months after switch could decrease mortality of HIV patients on a second-line regimen., Competing Interests: The authors declare no competing interests.

Setting: Sixty-seven government health facilities providing tuberculosis (TB) and human immunodeficiency virus (HIV) services across Ethiopia., Objective: To examine clinician barriers to implementing isoniazid preventive therapy (IPT) among people living with HIV., Design: A cross-sectional study to evaluate the provider-related factors associated with high IPT coverage at the facility level., Results: On bivariate analysis, the odds of high IPT implementation were lower when clinicians felt patients were negatively affected by the side effects of IPT (OR 0.18, 95%CI 0.04-0.81) and perceived that IPT increased multidrug-resistant TB (MDR-TB) rates (OR 0.66, 95%CI 0.44-0.98). The presence of IPT guidelines on site (OR 2.93, 95%CI 1.10-7.77) and TB-HIV training (OR 3.08, 95%CI 1.11-8.53) had a positive relationship with high IPT uptake. In the multivariate model, clinician's perception that active TB was difficult to rule out had a negative association with a high IPT rate (OR 0.93; 95%CI 0.90-0.95)., Conclusions: Clinician impression that ruling out active TB among HIV patients is difficult was found to be a significant barrier to IPT uptake. Continued advancement of IPT relies greatly on improving the ability of providers to determine IPT eligibility and more confidently care for patients on IPT. Improved clinician support and training as well as development of new TB diagnostic technologies could impact IPT utilization among providers.

Background: Opportunistic diseases cause morbidity and mortality among human immunodeficiency virus (HIV) infected persons. There is dearth of evidence on the magnitude and predictors of opportunistic diseases among PLHIV in Ethiopia. This study was conducted to determine the magnitude and predictors of opportunistic diseases among adults enrolled in the national HIV/AIDS care and treatment services and generate information for program planning and medicine quantification in the country., Methods: A health facility-based cross-sectional study was conducted. Probability proportional to size and random sampling methods were employed to select health facilities and medical records of adult HIV-infected patients respectively. A total of 7826 medical records were reviewed from 60 health facilities nationwide. Socio-demographic and clinical data including diagnosis of opportunistic diseases were collected from the medical records. Period prevalence of opportunistic diseases over one year period was determined. Bivariate and multivariate logistic regression was used to measure associations between independent variables and the dependent variable, occurrence of opportunistic diseases., Results: Of the total of 7826 study participants, 3748 (47.9%) were from hospitals and 4078 were from health centers. The majority (61.8%) were female. The median age was 32 years with interquartile range (IQR) of 27-40. The median duration of stay in HIV care was 56 (IQR = 28-80) months; 7429 (94.9%) were on antiretroviral treatment. A total of 1665 cases of opportunistic diseases were recorded with an overall prevalence estimated at 21.3% (95% confidence interval (CI): 20.36, 22.18%). Skin diseases (4.1%), diarrhea (4.1%), bacterial pneumonia (3.6%), recurrent upper respiratory tract infections (3.1%) and tuberculosis (2.7%) were the leading opportunistic diseases. Isoniazid preventive therapy coverage among eligible patients was 24.8%. Persons with a CD4 count < 200 cells/mm 3 [adjusted odds ratio (AOR) 1.80, 95% CI: 1.45, 2.23]; and who were bed ridden or ambulatory functional status [AOR (95% CI) = 3.19 (2.32, 4.39)] were independent predictors of diagnosis of opportunistic diseases., Conclusion: Opportunistic diseases were found to be pervasive among HIV infected adults in Ethiopia. Proactive identification and management, and prevention of opportunistic diseases should be strengthened especially among females, ambulatory or bed-ridden, and patients with low CD4 cell count.

Objective: To identify the incidence of and predictors for tuberculosis in children living with HIV in Northern Ethiopia., Design: Observational, retrospective follow-up study., Methods: A total of 645 HIV-infected children were observed between September 2009 and September 2014. Cox regression analysis was used to identify predictors for developing TB., Results: The incidence rate of tuberculosis was 4.2 per 100 child-years. Incidence of tuberculosis was higher for subjects who were not on cotrimoxazole preventive therapy, were not on isoniazid preventive therapy, had delayed motor development, had a CD4 cell count below the threshold, had hemoglobin level less than 10 mg/dl and were assessed as World Health Organization (WHO) clinical stage III or IV., Conclusion: Incidence of TB in children living with HIV was high. This study reaffirmed that isoniazid preventive therapy is one of the best strategy to reduce incidence of TB in children living with HIV. All children living with HIV should be screened for TB but for children with delayed motor development, advanced WHO clinical stage, anemia or immune suppression, intensified screening is highly recommended.

Background: Tuberculosis (TB) is the most common human immunodeficiency virus (HIV) associated opportunistic infection. It is the leading cause of death in HIV-infected individuals in sub-Saharan Africa. Anti-retroviral therapy (ART) and isoniazid preventive therapy (IPT) are the two useful TB preventative strategies available to reduce TB among people living with HIV (PLHIV). Therefore, the aim of this study is to compare mortality associated with IPT taken together with ART, as well as ART alone, among PLHIV., Methods: A retrospective cohort study was undertaken at Tikur Anbessa Specialized Hospital (TASH) and Zewditu Memorial Hospital (ZMH) on 185 patients receiving IPT (6 months) plus ART and 557 patients receiving ART alone. Mortality rates (MR) per 100 person-years (PYs) were used to compare mortality rates amongst the groups. Time-to-death and survival probabilities of the patients were determined using the Kaplan Meier Method. The Cox Proportional Hazard Model was employed to estimate the effect of IPT plus ART on survival of PLHIV., Results: The mortality cases noted in patients treated by IPT plus ART versus ART alone were 18 (4.5 cases/100 PYs) and 116 (10 cases/100 PYs), respectively. In reference to the ART alone, the IPT plus ART reduced the likelihood of death significantly (aHR 0.48; 95% CI 0.38-0.69) and median time to death was about 26 months (IQR 19-34). Moreover, WHO stage IV (aHR 2.42: 95% CI 1.42-4.11), CD4 values ≥350 cells/mm3 (aHR 0.52; 95% CI 0.28-0.94), adherence to ART (aHR 0.12; 95% CI 0.08-0.20), primary levels of education (aHR 2.20; 95% CI 1.07-4.52); and alcohol consumption (aHR 1.71; 95% CI 1.04-2.81) were factors strongly associated with mortality., Conclusion: We found that PLHIV treated by the IPT plus ART had a lower likelihood of mortality and delayed time-to-death when compared to patients treated by ART alone.

Setting: St Peter's TB Specialized Hospital, Addis Ababa, Ethiopia., Objective: To estimate the prevalence of mutations that cause resistance to isoniazid (INH) and rifampicin (RMP) and assess the effects of these mutations on second-line anti-tuberculosis treatment., Design: GenoType(®)MTBDRplus assay results and clinical data documented at St Peter's TB Specialized Hospital over 3 years were retrospectively collected and analysed., Results: The results indicated that 68.7% (n = 470) of RMP-resistant isolates had mutations at codon 531 (S531L) of the rpoB gene, while 93% (n = 481) of the INH-resistant isolates had mutations at codon 315 (S315T1) of the katG gene. The proportion of inhA mutations was 0.8% (n = 481). Treatment outcome was unfavourable in 23.7% (n = 76) of patients treated with second-line anti-tuberculosis drugs. Mutations in other codons of the rpoB gene (P > 0.05) and in the inhA promoter region (P > 0.05) were not associated with unfavourable treatment outcomes., Conclusion: The predominant mutations in RMP and INH resistance were observed at codons 531 and 315 in the rpoB and katG genes, respectively. Mutations in the inhA region were rare, which shows its minimal contribution to the development of resistance to ethionamide. This also suggests that treating multidrug-resistant TB patients with high doses of INH may have little effect.

Objective: To elicit Ethiopian health care providers' understanding of challenges to effectively preventing, diagnosing and treating tuberculosis (TB)., Design: Qualitative data were collected via in-depth interviews and focus group discussions with 73 providers, including physicians, nurses, pharmacists and laboratory technicians, in five hospitals in the Northern Ethiopian regions of Amhara and Tigray. There was no intervention., Results: Focus groups and interviews shared a number of prominent common themes. Respondents identified numerous challenges associated with active case identification, infection control practices, diagnostics, including the absence of TB culture and drug susceptibility testing capacity, and the lack of infrastructure for diagnosing and treating multidrug-resistant TB. Pharmacists noted a need for improved procurement practices and pediatric dosages for TB medications. Providers shared concerns regarding isoniazid preventive therapy, health workforce challenges and the risk of contracting TB in the workplace., Conclusions: Health care providers in the Northern Ethiopian regions of Tigray and Amhara identified many challenges to effectively preventing, diagnosing and treating TB. These challenges are complicated by severe resource constraints and challenges in attracting and retaining providers in government hospitals in centers outside Addis Ababa.

Background: Isoniazide preventive therapy (IPT) is given to individuals with latent infection of tuberculosis (TB) to prevent the progression to active disease. One of the primary reasons for failure of IPT is poor adherence., Methods: A cross sectional study was conducted in four hospitals in Addis Ababa. Data were collected using a pre-tested interviewer-administered structured questionnaire. Bivariate and multivariate analysis was done to identify predictors of IPT., Results: A total of 319 (97.5%) individual participated in this study. Within seven days recall period, self-reported dose adherence rate was 86.5%. Individual who received explanation about IPT from health care providers (OR = 7.74; 95%CI: 3.144, 19.058); who had good feeling/comfortable to take IPT in front of other people [OR = 5.981, 95%CI (2.308, 15.502)] and who attended clinical appointment regularly (OR = 4.0; 95%CI: 1.062, 15.073) were more likely to adhere to IPT. Participants who developed IPT related adverse effect were 93% less likely to adhere to the prescribed doses (OR = 0.065; 95%CI: 0.024, 0.179)., Conclusion: The prevalence of self reported dose adherence over the past 7 days was higher. Non-adherence was observed among respondent who were not provided with sufficient information about IPT. The health care providers need to strengthen their educational and counseling efforts to convince the patient before putting them on IPT. To enhance adherence, health education efforts should focus on the importance of IPT, the details of the regimen and adverse effects.