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2.8. Functional Capacity and Physical Fitness Assessment | Functional capacity was assessed by a battery of functional tests, including two versions of the “Sit-to-Stand Tests” (STS-5 and STS-60) and the “Timed Up-and-Go Test” [Maximal oxygen uptake (VO | PMC10386647 | ||
2.9. Statistical Analysis | The Kolmogorov–Smirnov test was used to assess normality of distribution. Repeated measures ANOVA (group × time) were used to analyze the results. Tukey post hoc tests were used to determine pairwise differences wherever repeated measures ANOVA showed statistical significance | PMC10386647 | ||
3. Results | No side effects of the supplementation were reported during the 8-week intervention while all participants showed a compliance of >90%. No differences were found in any examined variable between the two groups at baseline. | PMC10386647 | ||
3.1. Effects on Anthropometry and Body Composition | The results for anthropometry and body composition parameters are presented in | PMC10386647 | ||
3.2. Effects on Resting Metabolic Rate | The results for RMR measurements are demonstrated in | PMC10386647 | ||
3.3. Effects on Respiratory Quotient | The results showed no significant interaction effect between group and time, F | PMC10386647 | ||
3.4. Effects on Thyroid Hormones | The results for the thyroid hormones are presented in | PMC10386647 | ||
3.5. Effects on Selenium and Zinc Serum Levels | Se and Zn serum results are shown in | PMC10386647 | ||
3.6. Effects on Physical Fitness and Functional Capacity | The results for the physical fitness tests and functional capacity are presented in Regarding the Sit-to-Stand 5 test, no significant interaction effect between group and time was found, FFor Sit-to-Stand 30, the analysis showed no significant interaction effect between group and time (FNo significant interaction effec... | PMC10386647 | ||
4. Discussion | obesity, muscle mass, inflammation, mitochondrial dysfunction, weight loss | OBESITY, INFLAMMATION, OXIDATIVE STRESS, MITOCHONDRIAL DYSFUNCTION | In the present study, the Zn/Se co-administration enhanced RMR of the participants and increased Se serum levels and TUG performance. However, compared to the placebo group, there were no additional benefits of Zn/Se co-administration on thyroid hormones, body composition, physical fitness, and the remaining functional... | PMC10386647 |
5. Conclusions | The present study found a significant increase in the RMR after co-administration of 200 mcg of selenium L-selenomethionine and 25 mg of Zn gluconate, with the thyroid function hormones remaining unaffected. Furthermore, significant improvements in Se status and TUG performance were detected in the supplementation grou... | PMC10386647 | ||
Author Contributions | Conceptualization, C.D.G., E.A. and A.Z.; methodology, C.D.G. and E.A.; formal analysis, A.Z., E.A. and C.D.G.; investigation, A.Z, G.A., Z.R. and E.A.; data curation, A.Z. and C.D.G.; writing—original draft preparation, A.Z. and C.D.G.; writing—review and editing, A.Z., G.A., C.D.G., E.A., G.C.B., G.K.S. and Z.R.; sup... | PMC10386647 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and was approved by the Cyprus National Ethics Committee (ΕΕΒΚ/ΕΠ/2020/18). | PMC10386647 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10386647 | ||
Data Availability Statement | All data and materials of this study are available upon request. | PMC10386647 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10386647 | ||
References | Consort 2010 Flow Diagram.Resting metabolic rate changes after the intervention period. * Significant time × group interaction.Basic characteristics and body composition data divided into two groups according to the assigned intervention (bold indicates statistical significance). All data are mean ± SD.Resting metaboli... | PMC10386647 | ||
Objectives: | The CHARM2 (Counseling Husbands and wives to Achieve Reproductive Health and Marital Equity) intervention engages health care providers to deliver gender-equity and family planning sessions to couples using a person-centered shared decision-making approach for contraception counseling. We previously showed that the int... | PMC10695301 | ||
Study design: | REGRESSION, SECONDARY | This is a planned secondary analysis of the effect of the CHARM2 intervention on 1201 married couples in rural Maharashtra, India in a cluster randomized controlled trial completed between 2018 and 2020. We assessed the effect of CHARM2 on perceived quality of care as measured by the Interpersonal Quality of Family Pla... | PMC10695301 | |
Results: | Intervention participants had higher mean IQFP scores than control participants at 9-month follow-up (intervention 3.2, SD 0.6 vs. control 2.3 mean, SD 0.9, | PMC10695301 | ||
Conclusion: | Family planning interventions such as CHARM2, which utilize person-centered shared decision-making contraceptive counseling approaches improve women’s perceived quality of care. Effects on quality of care mediate observed effects of the intervention on contraceptive use. | PMC10695301 | ||
Implications: | Contraceptive interventions should focus on improving person-centered outcomes, such as quality of care, rather than contraceptive use targets. By focusing on improving person-centered care, interventions will improve contraceptive use among those who desire a method while meeting the holistic reproductive health needs... | PMC10695301 | ||
Introduction | ’ contraceptive communication | Provision of person-centered, high-quality, contraceptive counseling has the potential to better meet the reproductive needs of women and couples and has been associated with increased contraceptive use [Gender based power dynamics, including traditional gender norms, male control of and even violence against female pa... | PMC10695301 | |
Methods | SECONDARY | This is an a priori planned secondary analysis of the CHARM2 study described elsewhere in detail [In this cluster randomized trial, 1201 young couples across 40 geographic clusters were randomized to the CHARM2 intervention or control condition (standard of care). Inclusion criteria for the CHARM2 study included marrie... | PMC10695301 | |
Analysis | REGRESSION | First, we assessed descriptive statistics including demographics and IQFP at each time point by intervention group. We utilized two-sided We evaluated the IQFP scale as a continuous mean score and as a categorical average response in descriptive analyses, and as a continuous mean score only in unadjusted and adjusted r... | PMC10695301 | |
Results | At baseline, 504 of 1201 women (42%) reported seeing a family planning provider in the previous 9 months; 38% of intervention and 46% of control participants (All five counseling sessions were received by 87.5% of couples in the intervention arm; an additional 7.3% of women and 5.3% of men received at least one session... | PMC10695301 | ||
Discussion | We found that the CHARM2 intervention had a significant effect on women’s perceptions of interpersonal quality of care received from their family planning providers and that this effect on quality of care mediated observed effects of the CHARM2 intervention on contraceptive use. Interestingly, quality of care did not d... | PMC10695301 | ||
Supplementary Material | PMC10695301 | |||
Funding: | This work was supported by the National Institutes of Health, Grants R01HD084453 and K12HD001259. The funder had no role in the design and conduct of the study, collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript; or decision to submit the manuscript f... | PMC10695301 | ||
References | REGRESSION | Interpersonal Quality of Family Planning (IQFP) items.Female participant IQFP item response by CHARM2 intervention group (Mean Interpersonal Quality of Family Planning (IQFP) score over time, by treatment group (Baseline characteristics of CHARM2 intervention participants who provided IQFP scale response for at least o... | PMC10695301 | |
Background | DSD, viral suppression | Of the 8 million people in South Africa living with HIV, 74% of persons living with HIV are on antiretroviral therapy (ART) and 65% are virally suppressed. Detectable viral load results in HIV-associated morbidity and mortality and HIV transmission. Patient barriers to care, such as missed wages, transport costs, and l... | PMC9842495 | |
Methods | DSD | A Sequential Multiple Assignment Randomized Trial will be undertaken in KwaZulu-Natal, South Africa, to test adaptive ART delivery for persons with detectable viral load and/or who are not engaged in care. The types of differentiated service delivery (DSD) which will be examined in this study are clinic-based incentive... | PMC9842495 | |
Discussion | DSD, viral suppression | To increase population-level viral suppression, persons with detectable viral load need responsive DSD interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with “right-sized” interventions for patients m... | PMC9842495 | |
Keywords | PMC9842495 | |||
Introduction | PMC9842495 | |||
Background and rationale {6a} | DSD, viral suppression, HIV better, HIV is a client-centered approach, chronic disease | CHRONIC DISEASE | HIV care programs have evolved into a chronic disease care model in South Africa, where eight million people are living with HIV [Differentiated service delivery (DSD), also known as differentiated care, for HIV is a client-centered approach that simplifies and adapts HIV services across the HIV care continuum, in ways... | PMC9842495 |
Objectives {7} | SECONDARY | Our clinical trial aims to determine whether community-based ART initiation and maintenance increase the proportion of ART-eligible persons living with HIV who achieve viral suppression at 18 months. We will also evaluate as secondary objectives the (1) qualitative preferences of clients and providers for differentiate... | PMC9842495 | |
Trial design {8} | The SMART ART study is a Sequential Multiple Assignment Randomized Trial (SMART) to test an adaptive treatment strategy for persons living with HIV who are not virally suppressed within existing clinic services (Fig. SMART ART trial design | PMC9842495 | ||
Methods: participants, interventions, and outcomes | PMC9842495 | |||
Study setting {9} | Greater Edendale Area within the Umgungundlovu District in KwaZulu-Natal, South Africa. | PMC9842495 | ||
Eligibility criteria {10} | ACTIVE TUBERCULOSIS | To be eligible, participants•Age 18 years or older•Able and willing to provide informed consent for study procedures•Intend to reside in the study community for the duration of follow-up•Living with HIV and eligible for ART by national guidelinesHave a detectable viral load greater than the lower limit of detection and... | PMC9842495 | |
Who will take informed consent? {26a} | ICH | EVENT | A study counselor will review the study information sheets (screen consent and when applicable enrolment consent) with all potential participants and discuss emerging questions with the individual. In the event that informed consent is being discussed with a couple rather than an individual, each partner will be asked ... | PMC9842495 |
Additional consent provisions for collection and use of participant data and biological specimens {26b} | All participants completing the enrollment consent are given the option of agreeing to future contact for either new research protocols or to receive general information about research findings. Participants are also asked whether they agree or not to be contacted by text message or phone for appointment reminders and ... | PMC9842495 | ||
Interventions | PMC9842495 | |||
Explanation for the choice of comparators {6b} | DSD | The innovation advanced in this study is testing adaptive DSD strategies. The “supply (dissemination) – demand (diffusion) – infrastructure (delivery) model” provides a useful framework to organize activities and bridge the translational research-practice gap [ | PMC9842495 | |
Intervention description {11a} | We will conduct a Sequential Multiple Assignment Randomized Trial (SMART) with participants presenting with a viral load above the limit of detection for the assay or who are not engaged in care/lost to follow-up (LFTU). To classify as not engaged, participants must meet one of the following criteria: (1) more than 6 m... | PMC9842495 | ||
Participants randomized to best clinic practices without lottery incentives | AIDS | AIDS | Enrolled participants will first be randomly assigned to low-intensity interventions: either best clinic practices or best clinic practices with a conditional lottery incentive. Participants randomized to the standard of care (SOC) best clinic practice group receive a clinic referral letter including the date of the HI... | PMC9842495 |
Participants randomized to best clinic practices with lottery incentives | Participants randomized to the SOC with lottery incentives group will receive a clinic referral letter including the date of the HIV test, information on the clinical screening, and that they are being referred to the clinic for ART initiation. Participants will be asked to scan their barcode at the clinic or notify th... | PMC9842495 | ||
Six-month study visit to determine eligibility for the second randomization | TB | CRYPTOCOCCAL MENINGITIS | After the initial 6-month stage, a visit will take place at a location of the participant’s choice with options for the visit to take place at home, at a mobile van, a location in the community, or at the clinic. Participants will complete questionnaires to assess engagement in care and barriers to accessing care. To f... | PMC9842495 |
Participants initiating ART at the month 6 visit | ADVERSE EFFECTS | For participants requiring ART initiation, a study nurse will initiate ART at home or in a mobile van. The study nurse will review the participant’s eligibility for ART initiation at home, provide counseling on adherence and adverse effects, and will dispense the first 90 days of medication. The study staff member will... | PMC9842495 | |
Community (smart locker) delivery | If participants are randomized to the community (smart locker) delivery group, they will receive ART refill delivery via a smart locker in a secure location. They will complete their clinical screen via telehealth, including an option for a secure video link, and self-collect specimens for viral load screening. If the ... | PMC9842495 | ||
Home ART delivery | Participants randomized to the home ART delivery group will receive ART delivery at home or at a location of their choice, such as a community center. At ART delivery visits, a clinical screening questionnaire will be completed, and blood collected for viral load and creatinine tested as indicated by the clinical monit... | PMC9842495 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | tuberculosis | OPPORTUNISTIC INFECTIONS, ADVERSE EVENTS, TUBERCULOSIS, STIS, ADVERSE EFFECTS, ADVERSE EVENT | Participants will be encouraged to visit the clinic for medical concerns outside of ART monitoring and adherence counseling. During participant ART resupply and monitoring visits, they will complete a standardized symptom screening questionnaire for adverse effects of ART, tuberculosis, opportunistic infections, and ST... | PMC9842495 |
Strategies to improve adherence to interventions {11c} | Participants will receive a non-identifying text message within 1 week of viral load testing to communicate that “all is going well” (i.e., if their viral load is suppressed), contacting them to have additional adherence counseling—“contact us for more information” (i.e., if first viral load not suppressed), or asking ... | PMC9842495 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | ART, TPT, and other chronic meds will be dispensed. | PMC9842495 | ||
Provisions for post-trial care {30} | Participants who suffer harm from participating in this study will be offered a referral to one of the study site’s referral partners or, if appropriate, care at the HSRC site clinic, free of charge. No monetary compensation will be provided. If a participant requires medical care that the study clinic cannot provide, ... | PMC9842495 | ||
Outcomes {12} | viral suppression | SECONDARY | The primary outcome of this trial is viral suppression at 18 months, comparing (i) all individuals randomized to clinic-based care with or without lottery incentives for the full 18 months and (ii) nonresponding individuals rerandomized to home- or community-based care to those rerandomized to clinic-based care. The se... | PMC9842495 |
Participant timeline {13} | The flow of participants through the study at associated time points is presented in Fig. The flow of participants through the study at associated time points | PMC9842495 | ||
Sample size {14} | With a sample size of | PMC9842495 | ||
Recruitment {15} | RECRUITMENT | Prior to recruitment, community mobilizers will visit communities to provide details about the study including the community-based HIV testing and approximate dates available in that community and at the clinic. Site teams are experienced in HTC and are well known to the clinic staff and community leaders. We will iden... | PMC9842495 | |
Recruitment at HIV clinics | RECRUITMENT | Outreach for recruitment will be conducted by study staff at HIV clinics to identify persons living with HIV who are presenting at the clinic for the first time and are not yet engaged in care. Participants recruited at the clinic will be eligible to continue with study procedures outlined below. For Clinic Outreach Te... | PMC9842495 | |
Community-based HTC | PMC9842495 | |||
Home HTC | Counseling and testing in home HTC is conducted in a private environment either inside the participant’s home or outside. During community mobilization, mobilizers will inform household members of the day and time of home HTC visits. For the home HTC visit, trained counselors will visit contiguous homes within the comm... | PMC9842495 | ||
Mobile HTC | RECRUITMENT | Counseling and testing in mobile HTC is conducted in mobile testing centers in a private environment either inside the testing van or outside. Mobile HTC will be provided from mobile counseling and testing units and within suitable community venues identified during the community entry and consultation process. The com... | PMC9842495 | |
HIV self-testing (HIVST) | EVENTS | In order to further identify persons, particularly men, in the community who are less likely to participate in community-based HTC, we will provide HIV testing kits for self-administered testing and clear guidance for follow-up of persons electing to use the test kits. Persons who have a positive test using the kits wi... | PMC9842495 | |
Assignment of interventions: allocation | PMC9842495 | |||
Sequence generation {16a} | RECRUITMENT | We plan to enrol approximately 900 participants and randomize them initially at a ratio of 1:1 using varying size block randomization. At 6 months into the study, rerandomization of eligible participants will take place at a ratio of 2:1:1 again using varying size block randomization. Due to the intermittent availabili... | PMC9842495 | |
Concealment mechanism {16b} | The randomization sequence will be predetermined and available through sealed envelopes for each participant/household enrolled. The randomization group will not be determined until the participant has completed all screening procedures. The randomization will be designed at the University of Washington International C... | PMC9842495 | ||
Implementation {16c} | The allocation sequence will be generated by the unblinded biostatistician. The screening and enrolling nurse will assign participants who are eligible to the available interventions. | PMC9842495 | ||
Assignment of interventions: blinding | PMC9842495 | |||
Who will be blinded {17a} | Because of the difficulty masking study team and study participants to group allocation, the study is unblinded. However, staff assessing the primary outcome will be masked to the allocation of participants, as will study investigators. | PMC9842495 | ||
Procedure for unblinding if needed {17b} | This study is unblinded with respect to the study group. | PMC9842495 | ||
Data collection and management | PMC9842495 | |||
Plans for assessment and collection of outcomes {18a} | PMC9842495 | |||
Screening and baseline | PMC9842495 | |||
Screening questionnaire | HIV testing behavior | After consent is obtained and locator information documented, the core set of risk assessment questions will be administered, including socio-demographic information; sexual and risk behavior; hypothetical risk and Belief in Medicines questionnaires; quality of life survey; knowledge, attitudes, and practices of HIV te... | PMC9842495 | |
Testing | hypertension, diabetes | BLOOD, HYPERTENSION, DIABETES | Home testing and counseling (HTC) and mobile HTC will be conducted in communities in South Africa. Additional health services, specifically measurement of blood pressure and hemoglobin A1C testing for hypertension and diabetes screening, may be offered to all participants following local screening guidelines. Blood pre... | PMC9842495 |
HIV counseling and testing | EVENT | Subsequently, the counselor will conduct individual counseling and HIV testing according to national guidelines. HIV results will be recorded. If necessary, for quality assurance (QA) of rapid HIV tests, dried blood spots will be collected. In the event that two individuals within a partnership test, the study staff wi... | PMC9842495 | |
Screening for persons living with HIV not on ART | HIV infection | HIV INFECTION, RECRUITMENT | Persons living with HIV identified through home HTC, mobile HTC, or clinic recruitment and who are not on ART will be screened to stage their HIV infection by CD4 testing and the World Health Organization (WHO) symptomatic screen. To minimize the time to ART initiation, costs, and loss to follow-up, point-of-care tests... | PMC9842495 |
CD4 testing | The CD4 test is a measure of immune function and is used to determine eligibility into SMART ART. Participants will be offered a point-of-care (POC) CD4 test, which will be obtained from a fingertip sample by lancet. If necessary for quality assurance (QA) of POC CD4 testing under field settings or if the POC CD4 test ... | PMC9842495 | ||
WHO symptom screen and HIV engagement in care questionnaire | PCP pneumonia, tuberculosis | CRYPTOCOCCAL MENINGITIS, SEXUALLY TRANSMITTED INFECTIONS, OPPORTUNISTIC INFECTIONS, TUBERCULOSIS | Participants will be screened for symptoms of tuberculosis, opportunistic infections (e.g., cryptococcal meningitis, PCP pneumonia), sexually transmitted infections, and clinical HIV through a set of standard WHO questions. Persons living with HIV will complete an HIV engagement in care questionnaire on previous HIV te... | PMC9842495 |
Pregnancy testing | A urine pregnancy test will be performed, with urine collection done in a private setting. Women who have a positive pregnancy test will be eligible to participate in the study and will be linked to antenatal care at the clinic and followed until they link. | PMC9842495 | ||
Creatinine testing | TAF | Persons living with HIV who are ART eligible will receive a point-of-care creatinine (Cr) test (using a lancet for finger-stick blood collection) to evaluate renal function for the common first-line regimens that include tenofovir (TDF) or tenofovir alafenamide (TAF). If an alternate first-line regimen is available fol... | PMC9842495 | |
Tuberculosis (TB) testing | TB | AMPLIFICATION | For persons reporting symptoms consistent of active TB, we will use a point-of-care TB test once available. The Cepheid GeneXpert test (Sunnyvale, CA) is approved for use in South Africa, and a portable version (Omni) is expected to be available. Both the GeneXpert and the Omni systems use sputum specimens (2 mL unproc... | PMC9842495 |
Cryptococcal testing | cryptococcal infection, cryptococcal disease, co-infections | While ART is recommended for all persons living with HIV, for participants who have co-infections, ART initiation may be delayed with cryptococcal disease, which is most commonly seen when the CD4 count is ≤100 cells/μL. A point-of-care assay for cryptococcal infection is currently being evaluated and will be included ... | PMC9842495 | |
Screening viral load and ART testing | Two dried blood spot (DBS) cards will be collected at screening and stored for testing for HIV viral load and antiretroviral therapy. The maximum volume of blood to be collected is 0.5mL [2 spots on the first card and three spots on the second]. The cards will be stored at the study sites under appropriate conditions. ... | PMC9842495 | ||
Volume of specimens | For most participants for whom point-of-care tests will be used, 1.5 mL of blood will be collected. A maximum of 12mL of blood will be collected for testing for CD4, creatinine, DBS, and viral load including specimens for QA/QC. The specimens will be disposed of after testing. | PMC9842495 | ||
Chart abstraction | For all study groups, engagement in care (clinic visits, ART initiation, and pharmacy refills) may be abstracted from clinic records or ART refills confirmed by participant report and/or staff member confirming ART supplies either in person or via phone/telehealth. | PMC9842495 | ||
Six-month visit | PMC9842495 | |||
Specimen collection | Participants will have specimens collected for ART monitoring at the month 6 visit, specifically creatinine and viral load. Volumes and frequency of laboratory monitoring are described below. | PMC9842495 | ||
Community (smart locker) delivery | If participants are randomized to the community (smart locker) delivery group, they will receive ART refill delivery via a smart locker in a secure location. They will complete their clinical screen via telehealth, including an option for a secure video link, and self-collect specimens for viral load screening. If the ... | PMC9842495 | ||
Home ART delivery | Participants randomized to the home ART delivery group will receive ART delivery at home or at a location of their choice, such as a community center. At ART delivery visits, a clinical screening questionnaire will be completed, and blood collected for viral load and creatinine tested as indicated by the clinical monit... | PMC9842495 | ||
Follow-up (9, 12, and 15 months) | PMC9842495 | |||
Follow-up procedures for participants in the home ART group | ADVERSE EVENTS, ADVERSE EVENT | Follow-up visits at months 9, 12, and 15 will take place at the home or a location of the participant’s choice. Appointments for the home delivery, i.e., date and time that it will be available at home or a location easily accessible to the participants for follow-up, will be made at the time of ART initiation. Appoint... | PMC9842495 | |
Follow-up procedures for participants in the community (smart locker) group | tuberculosis | TUBERCULOSIS | Follow-up visits at months 9, 12, and 15 will take place via telehealth with ART provided at the smart locker and the participant depositing their self-collected specimens at the smart locker for collection. Smart locker ART pick-up windows will be made for ART refills and monitoring prior to their ART supply running o... | PMC9842495 |
Follow-up procedures for ART monitoring in the community (smart locker) and home delivery groups | BLOOD | Blood specimens will be collected for viral load and creatinine monitoring according to national guidelines. In the smart locker group, participants will self-collect DBS for viral load testing. In the home ART delivery group, specimens will either be collected by staff or, for no contact deliveries, by participants. F... | PMC9842495 | |
Follow-up procedures for the SOC clinic group (with and without lottery incentives) | ADVERSE EVENTS, OPPORTUNISTIC INFECTIONS | Participants will initiate ART at the clinic and, if feasible, receive quarterly chart review (either paper charts or through electronic medical records (EMRs) where available) to review safety labs (creatinine at 3, 6, and 12 months after ART initiation, for participants on TDF, and viral load 6 and 12 months after AR... | PMC9842495 | |
Procedures for 18-month or exit visit for all participants | Examination of HIV care documentation | ADVERSE EVENTS | Follow-up visits at month 18 or exit will take place in person at the mobile van, home, or clinic, by participant choice. At the follow-up visits, counselors will answer questions and provide support for HIV care. Participants will complete a questionnaire on their experience accessing care, including barriers to care,... | PMC9842495 |
Plans to promote participant retention and complete follow-up {18b} | TB | ADVERSE EFFECTS, PNEUMOCYSTIS PNEUMONIA, TUBERCULOSIS (TB) | Screening and enrolment will be conducted in person and will be followed by quarterly visits thereafter for 18 months. Participants will also receive a phone call 7 days and 30 days after initiating ART to complete a standard symptom screen for ART adverse effects and referred to clinic care if necessary. If indicated,... | PMC9842495 |
Data management {19} | VIRUS, EVENT | Screening and enrolment questionnaires will be administered to all participants using REDCap (Research Electronic Data Capture). REDCap was developed through a National Institutes of Health grant to Vanderbilt University. It is free and consists of a secure web-based application and associated mobile phone app. It is u... | PMC9842495 |
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