scholarly journals 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 Medicine ◽  
2021 ◽  
Vol 18 (12) ◽  
pp. e1003875
Author(s):  
Fred C. Semitala ◽  
Jillian L. Kadota ◽  
Allan Musinguzi ◽  
Juliet Nabunje ◽  
Fred Welishe ◽  
...  

Background 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 The 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. Trial registration ClinicalTrials.gov NCT03934931.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jill K. Gersh ◽  
Ruanne V. Barnabas ◽  
Daniel Matemo ◽  
John Kinuthia ◽  
Zachary Feldman ◽  
...  

Abstract Background People living with HIV (PLHIV) who reside in high tuberculosis burden settings remain at risk for tuberculosis disease despite treatment with anti-retroviral therapy and isoniazid preventive therapy (IPT). The performance of the World Health Organization (WHO) symptom screen for tuberculosis in PLHIV receiving anti-retroviral therapy is sub-optimal and alternative screening strategies are needed. Methods We enrolled HIV-positive adults into a prospective study in western Kenya. Individuals who were IPT-naïve or had completed IPT > 6 months prior to enrollment were eligible. We evaluated tuberculosis prevalence overall and by IPT status. We assessed the accuracy of the WHO symptom screen, GeneXpert MTB/RIF (Xpert), and candidate biomarkers including C-reactive protein (CRP), hemoglobin, erythrocyte sedimentation rate (ESR), and monocyte-to-lymphocyte ratio for identifying pulmonary tuberculosis. Some participants were evaluated at 6 months post-enrollment for tuberculosis. Results The study included 383 PLHIV, of whom > 99% were on antiretrovirals and 88% had received IPT, completed a median of 1.1 years (IQR 0.8–1.55) prior to enrollment. The prevalence of pulmonary tuberculosis at enrollment was 1.3% (n = 5, 95% CI 0.4–3.0%): 4.3% (0.5–14.5%) among IPT-naïve and 0.9% (0.2–2.6%) among IPT-treated participants. The sensitivity of the WHO symptom screen was 0% (0–52%) and specificity 87% (83–90%). Xpert and candidate biomarkers had poor to moderate sensitivity; the most accurate biomarker was CRP ≥ 3.3 mg/L (sensitivity 80% (28–100) and specificity 72% (67–77)). Six months after enrollment, the incidence rate of pulmonary tuberculosis following IPT completion was 0.84 per 100 person-years (95% CI, 0.31–2.23). Conclusions In Kenyan PLHIV treated with IPT, tuberculosis prevalence was low at a median of 1.4 years after IPT completion. WHO symptoms screening, Xpert, and candidate biomarkers were insensitive for identifying pulmonary tuberculosis in antiretroviral-treated PLHIV.


PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251944
Author(s):  
Kate Alford ◽  
Stephanie Daley ◽  
Sube Banerjee ◽  
Jaime H. Vera

Quality of life (QoL) is recognized as an essential end point in the disease management of chronic conditions such as HIV with calls to include good QoL as a ‘fourth 90’ in the 90-90-90 testing and treatment targets introduced by World Health Organization in 2016. Cognitive impairments impact a broad spectrum of experiences and are a common issue effecting people living with HIV (PLWH). Despite this, few studies have examined QoL in PLWH who also have a cognitive disorder. This study aimed to synthesize and describe what is known about QoL in those living with HIV-associated neurocognitive disorders (HAND). A scoping review of peer-reviewed literature was conducted to identify how QoL has been investigated and measured in PLWH with HAND, and how PLWH with HAND report and describe their QoL. We searched PsychInfo, Medline, Scopus, and Web of Science along with hand-searching reference lists from relevant studies found. Included studies were those published in English after 1st January 2003 which included PLWH with cognitive impairment not due to other pre-existing conditions. Fifteen articles met criteria for inclusion. Two studies measured QoL as a primary aim, with others including QoL assessment as part of a broader battery of outcomes. The MOS-HIV and SF-36 were the most commonly used measures of overall QoL, with findings generally suggestive of poorer overall QoL in PLWH with HAND, compared to PLWH without cognitive impairment. Studies which examined dimensions of QoL focused exclusively on functionality, level of independence, and psychological QoL domains. There is a considerable dearth of research examining QoL in PLWH with HAND. The initiatives which advocate for healthy aging and improved QoL in PLWH must be extended to include and understand the experiences those also living with cognitive impairment. Research is needed to understand the broad experiential impacts of living with these two complex, chronic conditions, to ensure interventions are meaningful to patients and potential benefits are not missed.


2020 ◽  

Histoplasmosis is a disease caused by the fungus Histoplasma capsulatum. This disease is highly endemic in some regions of North America, Central America, and South America and is also reported in certain countries of Asia and Africa. It often affects people with impaired immunity, including people living with HIV, among whom the most frequent clinical presentation is disseminated histoplasmosis. The symptoms of disseminated histoplasmosis are non-specific and may be indistinguishable from those of other infectious diseases, especially disseminated tuberculosis (TB), thus complicating diagnosis and treatment. Histoplasmosis is one of the most frequent opportunistic infections caused by fungal pathogens among people living with HIV in the Americas and may be responsible for 5–15% of AIDS-related deaths every year in this Region. These guidelines aim to provide recommendations for the diagnosis, treatment, and management of disseminated histoplasmosis in persons living with HIV. Although the burden of disease is concentrated in the Americas, the recommendations presented within these guidelines are applicable globally. These guidelines were produced in accordance with the World Health Organization (WHO) handbook for guideline development. The Guideline Development Group elaborated the final recommendations based on a systematic review of scientific literature and critical evaluation of the evidence available using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. These guidelines are intended for health-care providers, HIV program managers, policy-makers, national treatment advisory boards, researchers, and other professionals involved in caring for people who either have or may be at risk of developing disseminated histoplasmosis.


Author(s):  
Rosyadi Aziz Rahmat ◽  
Devy Lestari Nurul Aulia

Background : According to the World Health Organization (WHO) HIV continues to be a global public health problem, claiming more than 70 million people are infected with the HIV virus and around 35 million people have died. In 2015, approximately 1.1 (940 000-1300000) million people have died due to being infected with the HIV virus. There were an estimated 36.7 (34.0-39.8) million people living with HIV at the end of 2016. Globally, Sub-Saharan Africa is the most affected region, with nearly 1 in 25 adults living with HIV. (WHO 2016). The purpose of this study was to determine the compliance of commercial sex workers on using condoms in the localization of Teluk Bakau, Batam City. Method : This study used a descriptive research design. The location of this research was carried out in the localization of Teluk Bakau, Batam City. The population in this study were all commercial sex workers (CSWs) in the Teluk Bakau brothels with a total of 95 people. The sample is an object under study and is considered to represent the entire population, here the writer uses a purposive technique, namely by means of sampling based on criteria. The measuring instrument in this study using a questionnaire. This analysis was carried out on each variable. These results are in the form of distribution and percentage of each variable. Data analysis was carried out in a univariate manner by looking at the results of the frequency calculation and the presentation of the results which could later be used as benchmarks for discussion and conclusions. Results and conclusions : It can be seen that the compliance of CSWs using condoms in the Bakau Bay brothel, Batam City is the majority of the majority behave obediently as many as 46 respondents (93.9%)


2014 ◽  
Vol 22 (6) ◽  
pp. 994-1000 ◽  
Author(s):  
Ana Cristina de Oliveira e Silva ◽  
Renata Karina Reis ◽  
Jordana Almeida Nogueira ◽  
Elucir Gir

OBJECTIVES: to assess the quality of life of people living with HIV/AIDS and verify its association with clinical characteristics and treatment adherence.METHOD: cross-sectional study conducted in a hospital in the state of Paraíba, Brazil. A questionnaire was used to collect socio-demographic and clinical data. The quality of life scale proposed by the World Health Organization and a questionnaire to measure treatment adherence were used.RESULTS: of the 314 interviewees, 190 (60.5%) were male, aged 43 years on average, 121 (38.5%) had attended up to five years of schooling, 108 (34.4%) received up to two times the minimum wage, and 112 (35.7%) were on sick leave. In regard to clinical variables, individuals with an undetectable viral load scored higher in all the domains concerning quality of life, with statistically significant differences in three domains. Regarding treatment adherence, 235 (73.8%) presented poor adherence and those who strictly adhered to treatment obtained better scores in quality of life. The results show that quality of life is better among individuals adherent to ART. Supporting people to adhere to the antiretroviral treatment should be a persistent task of healthcare workers and other people participating in the treatment, such as family members and friends.


2018 ◽  
Vol 29 (9) ◽  
pp. 873-883 ◽  
Author(s):  
Reuben Granich ◽  
Somya Gupta

The human immunodeficiency virus (HIV) and Mycobacterium tuberculosis syndemic remains a global public health threat. Separate HIV and tuberculosis (TB) global targets have been set; however, success will depend on achieving combined disease control objectives and care continua. The objective of this study was to review available policy, budgets, and data to reconceptualize TB and HIV disease control objectives by combining HIV and TB care continua. For 22 World Health Organization (WHO) TB and TB/HIV priority countries, we used 2015 data from the HIV90–90–90watch website, UNAIDS AIDSinfo, and WHO 2016 and 2017 Global TB Reports. Global resources available in TB and HIV/TB activities for 2003–2017 were collected from publicly available sources. In 22 high-burden countries, people living with HIV on antiretroviral therapy ranged from 9 to 70%; viral suppression was 38–63%. TB treatment success ranged from 71 to 94% with 14 (81% HIV/TB burden) countries above 80% TB treatment success. From 2003 to 2017, reported global international and domestic resources for HIV-associated TB and TB averaged $2.85 billion per year; the total for 2003–2017 was 43 billion dollars. Reviewing combined HIV and TB targets demonstrate disease control progress and challenges. Using an integrated HIV and TB continuum supports HIV and TB disease control efforts focused on improving both individual and public health.


2018 ◽  
Vol 49 (3) ◽  
pp. 20-29
Author(s):  
George Mamboleo ◽  
George T. Mugoya ◽  
Jonathan Nauser ◽  
Adrionia Molder ◽  
Fais Connor ◽  
...  

The development of highly active antiretroviral therapy (HAART) has shifted human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) from an acute to a chronic condition. Due to reduced fatality, approximately 1.1 million people living with HIV/AIDS (PLWHA) are faced with increased longevity in conjunction with functional consequences associated with chronic disability. Employment has been associated with increased treatment adherence, quality of life (QoL), and mental and physical health for people living with HIV/AIDS. The purpose of this study was to determine the relationship between employment status and QoL for PLWHA. Participants included 115 patients receiving services from two Ryan White HIV/AIDS Program (RWHAP) clinics in a rural Mid Atlantic Appalachian region of the U.S. Findings revealed statistically significant differences in employment status on six domains of the World Health Organization’s Quality of Life scale for PLWHA (WHOQOL-HIV-Bref), except for spirituality/religion/personal beliefs. Implications for practice and research are discussed.


2009 ◽  
Vol 14 (3) ◽  
pp. 493-503 ◽  
Author(s):  
Richard J. Wolitski ◽  
◽  
Daniel P. Kidder ◽  
Sherri L. Pals ◽  
Scott Royal ◽  
...  

10.2196/27013 ◽  
2021 ◽  
Vol 7 (4) ◽  
pp. e27013
Author(s):  
Rena Fukunaga ◽  
David Lowrance ◽  
Adam MacNeil ◽  
Teeb Al-Samarrai ◽  
Joseph Cavanaugh ◽  
...  

The World Health Organization (WHO) recommends providing tuberculosis preventive treatment (TPT) to all persons living with HIV and to all household contacts of persons with bacteriologically confirmed pulmonary tuberculosis disease. Regrettably, the absence of a harmonized data collection and management approach to TPT indicators has contributed to programmatic challenges at local, national, and global levels. However, in April 2020, the WHO launched the Consolidated HIV Strategic Information Guidelines, with an updated set of priority indicators. These guidelines recommend that Ministries of Health collect, report, and use data on TPT completion in addition to TPT initiation. Both indicators are reflected in the WHO’s list of 15 core indicators for program management and are also required by the US President’s Emergency Plan for AIDS Relief’s Monitoring, Evaluation, and Reporting (MER) guidance. Although not perfectly harmonized, both frameworks now share essential indicator characteristics. Aligned indicators are necessary for robust strategic and operational planning, resource allocation, and data communication. “Collect once, use many times” is a best practice for strategic information management. Building harmonized and sustainable health systems will enable countries to successfully maintain essential HIV, tuberculosis, and other health services while combatting new health threats.


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