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Strengths and Limitations | ADVERSE EVENTS, RECRUITMENT | Strengths of the study included multicountry representation from a diversity of clinical settings, good per protocol intervention completion rates (83% NICU MT, 60% postdischarge MT), high study retention rates (95%), and use of a wide array of psychometrically strong measurement tools. Lack of adverse events or longer-term detrimental outcomes linked to the intervention and high intervention completion suggest that the treatment was safe, consistent with tenets of individualized developmental care,This study had several limitations, including a potential lack of sensitivity in the PBQ to detect improvements for mothers who report good mother-infant bonding at baseline, and the possibility of a floor effect where low scores on baseline PBQ precluded the ability to detect changes over time. In addition, we relied on parental self-report, which may have led to social desirability bias, particularly with the PBQ. We cannot exclude the possibility of contamination effects in the NICU phase, as 6 of our 8 participating NICUs had at least some number of shared rooms. We encouraged fathers to engage in MT sessions as we hoped doing so would contribute to infant outcomes and paternal well-being; however, fathers participated in only 25% of MT sessions in both phases. Although all music therapists were trained in neonatal care and in the study protocol, they had differing lengths of NICU experience. The onset of the COVID-19 pandemic in March 2020 affected our final recruitment and led to a small number of postdischarge MT sessions being held online (eTables 1 and 2 in Our results suggest that risk of problematic mother-infant bonding may vary across cultural contexts and may not be an appropriate target of intervention for all preterm mothers. | PMC10220519 | |
Conclusions | In this RCT, parent-led, infant-directed singing facilitated by a music therapist did not have clinically important effects on parental mental health or infant development. Parent-led music therapy supported by a music therapist was safe and well-accepted by parents. Building on qualitative findings | PMC10220519 | ||
Objectives | JIA, genicular nerve block, pain | JUVENILE IDIOPATHIC ARTHRITIS, UNILATERAL KNEE ARTHRITIS | This study aimed at evaluating the effect of genicular nerve block (GNB) in juvenile idiopathic arthritis (JIA) patients with persistent unilateral knee arthritis on pain, inflammatory parameters, function, and range of motion. | PMC9935707 |
Methods | JIA, Swelling, tenderness, pain | UNILATERAL KNEE ARTHRITIS, RHEUMATISM | A total of 104 JIA patients were diagnosed according to the International League Against Rheumatism (ILAR) criteria with persistent unilateral knee arthritis. They were allocated randomly into 2 groups: group 1 treated with GNB, while group 2 was treated with intra-articular triamcinolone (TA) only. Visual analogue scale (VAS) on pain, sonography of large joints in rheumatology (SOLAR) scoring system, and Lysholm scores were assessed at 0-, 2-, and 12-week intervals. Swelling and tenderness were clinically evaluated semi-quantitatively (0-3) at the same time intervals. | PMC9935707 |
Results | tenderness, PD, swelling, pain | VAS pain, tenderness, swelling, and SOLAR grey scale (GS) and power Doppler (PD) scores were significantly reduced after 2 weeks in both groups ( | PMC9935707 | |
Conclusion | inflammation, JIA, pain | INFLAMMATION | GNB was able to control pain and improve function and inflammation of the knee joint in JIA patients. Though steroid attained better results after 2 weeks, GNB achieved an equivalent longer-term improvement after 12 weeks. | PMC9935707 |
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC9935707 | ||
Introduction
| rheumatoid arthritis, JIA, mono-articular knee arthritis, fracture, pain, osteopenia, hemiplegic, Chronic recurrent knee arthritis, RA | RHEUMATOID ARTHRITIS, INFLAMMATORY ARTHRITIS, UNILATERAL KNEE ARTHRITIS, INFLAMMATION, DISEASE, OSTEOPENIA, REMISSION, KNEE ARTHRITIS, ADHESION, JOINT INFLAMMATION | JIA is the commonest chronic inflammatory arthritis in children. Its prevalence is 1/1000. It is characterized by a heterogeneous pattern of joint inflammation for at least 6 weeks. Age at onset is usually < 16 years. The clinical presentation, prognosis, and response to treatment are very heterogeneous. The knee, ankle and wrist are among the commonly involved joints in JIA [JIA is considered a lifelong disease with high morbidity rates. It affects children’s activity level and quality of life. This will later lead to a decrease in muscle power and an increase in osteopenia and fracture risks. The target in JIA is achieving joint remission with full function and range of motion, preventing permanent damage, and maintaining a good quality of life [Chronic recurrent knee arthritis in JIA could lead to cartilage damage and persistent deformity and leg length discrepancy. Furthermore, persistent mono-articular knee arthritis despite remission is relatively common in JIA. Knee arthritis has a great impact on child mobility and quality of life in JIA [The integrity of nerve supply to the joint is essential to keep up the inflammatory cascade in rheumatoid arthritis. Hemiplegia may have a protective effect against the destructive effect of rheumatoid arthritis (RA). The paralyzed limb has lesser perfusion which may also suppress inflammation. It is not clear if this effect is related to impaired vascularity of the hemiplegic side or due to impaired nerve supply or both [There is cumulative evidence that consolidates the anti-inflammatory role of local anesthetics. It is known that local anesthetics can suppress different inflammatory leukocyte functions including adhesion, phagocytosis, and migration [So far, our team has performed one study to evaluate the effect of GNB in adult rheumatoid arthritis. The present study is the first study to test this effect in JIA. The aim of the present clinical trial is to assess the effect of GNB in pediatric patients with JIA who had persistent unilateral knee arthritis regarding pain, range of motion, and inflammation. Furthermore, we attempted to evaluate the sustainability of this effect. | PMC9935707 |
Methods
| PMC9935707 | |||
Patients | JIA | DISEASE | First, we obtained an ethical committee approval from the faculty of Medicine Al-Azhar University (0000016) and then we recruited JIA patients (no condition for disease duration) diagnosed after ILAR criteria [A total of 198 JIA cases were enrolled in the study. Out of them, 87 cases were excluded either due to the presence of one of the exclusion criteria or due to the absence of knee involvement, yielding 111 cases fulfilling the inclusion criteria for this study (see the flow chart in Fig. Flow chart of the included cases in the study | PMC9935707 |
Randomization and blinding | Randomization was done using the 1:1 allocation. For every two participants, the first child selected a group number from a box and the following was allocated to the opposite group. Moreover, participants were also blinded for the nature of the injected substance. Clinical evaluation, initial US evaluation, randomization, and blinding were guaranteed by the 1st author. | PMC9935707 | ||
Study design | Tenderness, Juvenile arthritis disease | HAND SWELLING | Participants were enrolled from the rheumatology clinics in Al-Azhar University Faculty of Medicine. They were monitored at baseline, after 2 weeks, and 12 weeks. The different outcome measures including clinical examination, Lysholm score, SOLAR score, and VAS were assessed in each visit. Juvenile arthritis disease activity score (JADAS)-ESR was used only at baseline. Tenderness and swelling of the affected knee were also scored semi-quantitatively from 0 to 3 [ | PMC9935707 |
GNB | PD | PERIOSTEUM | Participants were asked to sit supine with a pillow supporting the popliteal fossa. The examined part was sterilized, and a 12 MHz linear probe (Toshiba Aplio 400 US system) was arranged. The transducer was turned sagittal at the front of the distal end of the femur. The probe was moved from medial or lateral to detect the femoral epicondyle. The genicular artery was identified near the periosteum and confirmed by PD. The genicular nerve is next to the artery. We targeted 3 genicular nerves: the superior medial, lateral, and inferior medial genicular nerves. The in-plane technique was considered and aspiration was done first to avoid intra-vascular injections [ | PMC9935707 |
Intra-articular steroid injection | knee flexion | STERILE, INFILTRATION | The participant was supine, with 30° knee flexion. The probe was directed axially, and the quadriceps tendon was recognized with the suprapatellar recess below. The sterile technique was considered for injection. The needle was introduced from the lateral side to medial one after infiltration anesthesia using 2 ml 1% lidocaine hydrochloride (Xylocaine, AstraZeneca). After proper setting of the needle, the injection of 1 mL of TA 40 mg (Kenacort, Bristol Myers Squibb) was done. Doppler was used to confirm the accuracy of the injection [ | PMC9935707 |
Outcome measures | PMC9935707 | |||
VAS on pain | pain | VAS for the involved knee was also done at the same intervals. The VAS was mounted from 0 to 10. Grade 0 equals no pain and 10 signifies the worst possible pain [ | PMC9935707 | |
Semi-quantitative score for swelling and tenderness | tenderness, swelling, Swelling | Swelling and tenderness were measured using a semi-quantitative score graded from 0 to 3; a score of 0 means no swelling nor tenderness and a score of 3 means maximum swelling and tenderness [ | PMC9935707 | |
JADAS-ESR | interphalangeal joints, JIA, active joints, metacarpophalangeal joints | DISEASE | JADAS includes 4 domains: physician global assessment of disease activity (0 means no activity and 10 means maximum activity), parent/patient global assessment of well-being (0 means very well and 10 means very poor), number of active joints, and an inflammatory marker ESR. We used JADAS27 version. The JADAS27 includes a selected count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints, hips, knees, and ankles. This is based on previous analysis that showed that the 27-joint reduced count is a good surrogate for the whole joint count in JIA [ | PMC9935707 |
Lysholm score | It was used for knee function assessment at 0-, 2-, and 12-week intervals. This questionnaire has 8 subsets. A score between 95 and 100 means excellent functional performance, good 84–94, fair 65–83, and poor < 64 (Fig. Comparison of the outcome between the two study groups: | PMC9935707 | ||
SOLAR score | PD, GS | We considered the SOLAR score for sonographic evaluation of the knee in active and control groups at 0-, 2-, and 12-week intervals. A semi-quantitative 0–3 grey GS and PD scores were used. The suprapatellar midline longitudinal scan, medial longitudinal scan, lateral longitudinal scan, and posterior longitudinal scan were considered for GS, and a sagittal infrapatellar scan was added for PD score. For the GS score, the range was from 0 to 12 and for PD the score ranged from 0 to 15 [ | PMC9935707 | |
Statistical analysis | Quantitative data were expressed as means and standard deviations (SD). We used the Shapiro–Wilk test as numerical means of assessing normality of the quantitative values. Qualitative data were stated as frequencies (No.) and percentages (%). Independent sample Regarding the sample size, we planned a study of a continuous response variable from matched pairs of study subjects, and we found that at least 48 pairs of subjects were needed to reject the null hypothesis with a probability (power) of 0.99. The type I error probability associated with this test of this null hypothesis is 0.95. We used the “Power and Sample Size Calculations software, version 3.1.2” for this purpose.The interobserver Cohen’s kappa value ( | PMC9935707 | ||
Discussion | JIA, active joints, knee arthritis, oligoarticular JIA, capsular calcification, synovitis, arthritis, pain, avascular necrosis, atrophy, ankle arthritis, rheumatoid | KNEE ARTHRITIS, SYNOVITIS, OSTEOARTHRITIS, DISEASE, HYPOPIGMENTATION, ARTHRITIS, OSTEOARTHRITIS KNEE, AVASCULAR NECROSIS, ATROPHY, BLIND, ANKLE ARTHRITIS, DISEASES, COMPLICATIONS | Persistent knee arthritis in JIA was always considered a difficult situation. In many patients, escalating systemic treatment failed to control arthritis. Local therapy was considered a practical alternative, as it can control arthritis without change in systemic treatment plans [It was known that GNB is effective in alleviating pain for 2 weeks on average and for function for 1 week only in osteoarthritis knee [In another systemic review for lower limb intra-articular in JIA, the authors found that the evidence about the role of intra-articular steroid injection is weak. This effect is more apparent in persistent oligoarticular JIA. Furthermore, the improvement was noticed in only few outcome measures. They could not reach a clear conclusion about the duration of improvement. One major obstacle they noticed is the lack of randomized clinical trials in the previous studies. They confirmed that US-guided injection is superior to blind injection with respect to accuracy and post-injection complications [In another comprehensive review, Gotte noticed that more than half of the injected knees with persistent arthritis in oligoarticular JIA could achieve complete resolution of arthritis after steroid injections. The question about the duration of improvement was answered partially in this study. They recorded a mean duration of improvement of between 28 and 74 weeks. The quality, blinding, and level of evidence of the included studies were questionable. They found that good responders had higher ESR and shorter disease duration whereas the effect of sex and age at onset was controversial. Furthermore, the knee showed the longest improvement among different injected joints in some studies, and in other studies, the upper limb joints achieved a longer improvement. Regarding the complications of steroid injections, they found capsular calcification, avascular necrosis (especially for weight-bearing joints), subcutaneous atrophy with or without hypopigmentation, steroid-induced synovitis, and systemic absorption. These side effects depend on the dose, the type of injected steroid, and the frequency of the injection [Iversen et al. reported that patients with JIA and ankle arthritis with disturbed gait dynamics failed to return to normal gait after intra-articular steroid injection for 3 months. This was attributed to pain. This shortcoming of steroid injections highlights the necessity of treating pain in active joints in JIA especially in weight-bearing joints to restore normal gait [Habib et al. reviewed the effect of intra-articular steroid injection in different diseases. They remarked that the duration of improvement depends on the type of arthritis. The duration of improvement was only 3 weeks in osteoarthritis, whereas this improvement extended to 8 weeks in adult rheumatoid and 6 months in JIA. In the listed studies in their review, the systemic treatment changes were not registered. Another essential finding is that they recorded that a single steroid injection has no effect on cartilage size [The elimination half-life of lidocaine is nearly 2 h [ | PMC9935707 |
Limitations of the study | KNEE ARTHRITIS | The small sample size is considered the chief shortcoming of the study. This can be attributed to the inclusion criteria which emphasized persistent knee arthritis. Gait analysis before and after injection should be considered in the study, but unfortunately, there is no expert for gait analysis in the university. TA hexacetanoid is better than TA acetanoide and has a longer-lasting effect. Unfortunately, TA hexacetanoid is not available in Egypt. In addition, we used a relatively small dose of TA. This can be justified by the cartilage damage noticed with using larger TA doses in previous studies [ | PMC9935707 | |
Conclusion | JIA, knee arthritis, knee joints, nerve block | INFLAMMATORY ARTHRITIS, DISEASE, KNEE ARTHRITIS, COMPLICATIONS | GNB could be considered a promising therapy for persistent knee arthritis in JIA patients. It can control disease activity in the knee joints based on different clinical and sonographic outcome measures. Its effect is comparable to intra-articular medications (steroid in particular) with an even better carry-on effect. It is feasible, economic, and with acceptable complications. It could limit steroid use and intensify treatment plans. This study adds more evidence that supports the anti-inflammatory effect of anesthesia. Further research is warranted to test the effect of different nerve block techniques on inflammatory arthritis. | PMC9935707 |
Author contribution | All the authors have read, reviewed, taken part in writing, and approved this trial. The 1st author guaranteed blinding. The 3rd and last authors performed GNB and intra-articular injections. The 2nd, 4th, and 5th authors applied the outcome measures. | PMC9935707 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC9935707 | ||
Data availability | Yes. | PMC9935707 | ||
Declarations | PMC9935707 | |||
Ethics approval and consent to participate | This study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice and was approved by the appropriate institutional review boards. Written informed consent to participate in the study was obtained from the patients’ parents or legal guardians. | PMC9935707 | ||
Disclosures | None related to the study. | PMC9935707 | ||
References
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Background | Physical activity behavioral interventions to change individual-level drivers of activity, like motivation, attitudes, and self-efficacy, are often not sustained beyond the intervention period. Interventions at both environmental and individual levels might facilitate durable change. This community-based study seeks to test a multilevel, multicomponent intervention to increase moderate intensity physical activity among people with low incomes living in U.S. public housing developments, over a 2 year period. | PMC10470135 | ||
Methods | The study design is a prospective, cluster randomized controlled trial, with housing developments ( | PMC10470135 | ||
Discussion | We hypothesize participants living in developments in any of the three intervention groups (E only, I only, and E+I combined) will increase minutes of moderate intensity physical activity more than participants in control group developments. We expect delivery of an intervention package targeting environmental and social factors to become active, combined with the individual level intervention, will improve overall physical activity levels to recommended guidelines at the development level. If effective, this trial has the potential for implementation through other federal and state housing authorities. | PMC10470135 | ||
Trial registration | Clinical Trails.gov PRS | PMC10470135 | ||
Keywords | PMC10470135 | |||
Background | Half of all U.S. adults do not participate in regular physical activity and women consistently report less activity than men [Evidence suggests that characteristics of the environments in which people live can facilitate or inhibit physical activity [On the other end of the spectrum, individual level interventions delivered one-on-one can also be efficacious in changing physical activity behaviors [A limitation of past research is the under-recognition that individual-level programs may be most effective when delivered in environments that support and maintain the promoted physical activity changes, thus prompting calls for intervention programs that combine individual- and environmental-level changes [We propose to evaluate the effects of a multilevel community-based intervention package to increase moderate intensity physical activity using a cluster randomized design, using public housing developments as the unit of randomization. We expect that delivery of an intervention package targeted to the environmental and individual levels will improve overall physical activity levels to recommended guidelines at the housing development level [ | PMC10470135 | ||
Methods/design | PMC10470135 | |||
Participants | The study setting is family-designated public housing developments in the City of Boston managed by the Boston Housing Authority ( | PMC10470135 | ||
Design of the Community Walks study | SECONDARY, ADVERSE EVENT, EVENT | The design of this study, called Community Walks, is a prospective, cluster randomized controlled trial with housing developments as the unit of randomization. A total of 12 developments (8 managed by Boston Housing Authority and 4 privately managed) will be recruited to participate. Four arms will be compared: environmental intervention alone (E) (To evaluate our outcomes, a subset of participants from each development will be recruited to serve in an evaluation cohort. The cohort will be assessed at baseline, at one-year, and at two-year follow-up time points. Primary and secondary outcomes will be assessed at these times. Baseline data collection is anticipated to finish at the end of 2023, and final results are expected in 2025. Community Walks has received approval from the Boston Medical Center/Boston University Medical Campus Institutional Review Board. When research staff learn of an adverse event, they report the event to the PI who then assesses details of the event and relatedness to study procedures and fulfills reporting requirements as necessary. | PMC10470135 | |
Formative research | fatigue | From August 2020 to February 2021, we conducted four videoconference meetings with our established community advisory board comprised of Spanish- and English-speaking residents from Boston public housing developments. The first meeting was used to introduce the individual-level telephone physical activity program and ask members to elaborate on what they see as barriers to physical activity among public housing residents and to comment on barriers previously identified in the literature (e.g., lack of time, familial influences and responsibilities, lack of basic knowledge related to physical activity, lack of transportation, lack of resources and inadequate places to participate in physical activity, increased fatigue and lack of energy, and barriers related to body image). We also shared potential message content and asked for feedback on message acceptability and desired changes. In subsequent meetings, we provided revised content and received further feedback. Overall, members suggested simplifying information and sentence structure to aid understanding. They offered tips for making the telephone content more engaging, and suggested ways to recruit participants in their developments. We incorporated these suggestions into script development. Scripts were developed in English, translated into Spanish, and then reviewed and revised for cultural appropriateness by two bilingual team members. Meetings of the community advisory board continued to occur 2-3 times a year to provide updates and obtain feedback on study progress. | PMC10470135 | |
Recruitment – public housing developments and residents | PMC10470135 | |||
Recruiting public housing developments | Developments are eligible for selection as one of our study sites if they have at least 100 units. A statistician conducted the randomization stratified by management company (Boston Housing Authority/Private) using a computer program, such that 3 developments went to the E group, 3 developments went to the I group, 3 developments went to the E+I group, and 3 developments went to the control. | PMC10470135 | ||
Recruitment and screening of the evaluation cohort | RECRUITMENT | We propose to recruit 50 participants per development in the evaluation cohort. Eligibility criteria include being able to speak English or Spanish, being 18 years old or older, being a public housing resident from one of our study sites, not planning to move within the next 2 years, having access to a phone, not currently participating in another physical activity study, being able to walk independently without regular need for special equipment (wheelchair, scooter, or walker), ability to provide informed consent, and willingness to complete the accelerometer-based device measurement. By design, the entire cohort will be low-income.Recruitment will take place at the developments, using common sampling rules and a direct household door-knocking approach [ | PMC10470135 | |
Intervention overview: role of the HLA | In all intervention developments, community health workers (termed Healthy Living Advocates or HLAs in this program) serve as intervention delivery agents and have been a successful way to partner with public housing communities for engagement activities and clinical trials [ | PMC10470135 | ||
Intervention overview | PMC10470135 | |||
Environmental level intervention: improving the walkability of the public housing development environment | These activities aim to change multiple aspects of the housing development to enable walking as an easy, natural part of life. Our IRB determined that informed consent is not required of people who join environmental-level activities. | PMC10470135 | ||
Walking trails and maps | EVENTS, -20 | WalkMassachusetts, a non-profit walkability and pedestrian safety advocacy organization serving the Commonwealth of Massachusetts, will mark walking trails surrounding each of the intervention developments with signage indicating walking trail status, duration, directions, and distance. There will be at least one short (15-20 min), one medium (25-30 min), and one longer (40-45 min) trail in each E and E+I development neighborhood, to accommodate walkers of various levels. HLAs will distribute maps of the walking trails and other highlights at every walk, at community events, and in the development’s management office. In addition to the walking trails, maps contain brief tips about physical activity and are available in both English and Spanish. | PMC10470135 | |
The process of developing the walking routes | Neighborhood walkability (obtained by assessment using the MAPS tool section 2.7.1) plus feedback from meetings with the managers, local community meetings, and the HLAs with lived experience in these neighborhoods, was used to inform the construction of the walking routes, and subsequent maps created by a professional graphic designer. These walking routes are designed to be used in the E and E+I intervention developments. With authorization from the City of Boston, wayfinding signage will be placed on poles and free-standing displays to instruct HLAs to accompany the walking routes illustrated on the maps. | PMC10470135 | ||
Structured walking groups | EVENTS, RECRUITMENT | HLAs will organize walking groups and adjust scheduling around work and childcare commitments of participants. Groups will begin meeting twice weekly and will occur more frequently as participation increases. The main recruitment strategies employed for these groups will be from flyers, from tables with posterboard displays, and by word-of-mouth referrals. Flyers will be distributed in a variety of ways including door-to-door, posting in high traffic areas, placing in mailboxes, and distributing at community events. Walk group participants will gather at a meeting place, such as a community room, within their development. Children are welcome to attend the walks with their parent/guardian to promote family participation and because improvised day care is not sustainable in the long run. Well behaved pets are also invited. All walking sessions will begin with light stretching. The groups then proceed with their walks. After each walk, they return to the meeting place for a post-walk stretching session. In case of inclement weather, all public housing developments have access to a large group room where they will lead indoor exercise classes, such as dance classes like Zumba or dances to upbeat popular music like Soca. | PMC10470135 | |
Advocacy training meetings | Leaders at WalkMassachusetts will host a 2-session advocacy training meeting at least once per year in each E and E+I development for the HLAs and interested residents. Residents will receive a $25 gift card for attending. The topics covered will be how to: evaluate the walkability of their neighborhood, report issues with sidewalks and other pedestrian infrastructure, and elevate issues to city officials, state agencies, and other advocate groups. Short-term results of this advocacy training could include cleaning up the development, restriping pavement markings, and installing pedestrian signage. Long-term changes might result from calling for city officials to improve sidewalks, adding trees, benches, incorporating complete street designs and traffic calming measures. Residents will know of and be able to connect with WalkMassachusetts for ongoing advocacy support after the training. | PMC10470135 | ||
Individual level intervention: automated ehealth phone program for physical activity | Phone2Health is based upon a previously tested telephone program designed to increase physical activity among urban African American adults [HLAs will facilitate access to the Phone2Health program for residents who live in developments randomized to receive the I and E+I intervention. The HLAs will obtain verbal informed consent from interested residents and set them up to use the telephone program by entering their phone number, preferred call days/times, and preferred language into a study-specific website. During enrollment, participants will indicate specific times and days they would like to be contacted. If a call is missed, the system will call back 15 minutes later. If that call is missed, the system will call on the second preferred day. After 2 weeks of missed calls, the HLA will contact the participant to troubleshoot any issues the participant is having (e.g., missed calls). Once completed, residents could re-enroll in the 12-week program if they wish to. | PMC10470135 | ||
Combined intervention (environmental plus individual level) | The environmental plus individual intervention combines all activities of the environmental intervention and all activities of the Phone2Health program. | PMC10470135 | ||
Environment-level assessments | We will conduct two types of assessments of the built environment at all study public housing developments. First, we will measure access to physical activity resources and walkability at all 12 public housing developments using the Microscale Audit for Pedestrian Streetscapes-abbreviated tool [ | PMC10470135 | ||
Individual-level measures: evaluation cohort | All eligible and consented participants will be sent a link to complete the surveys; if needed, the Research Assistant will administer surveys in person or over the phone. The Research Assistant will conduct the screening and baseline surveys and will also conduct the follow-up surveys at 12 months and 24 months for each enrolled participant. Standard socio-demographic measures will be assessed. All participants will receive a $40 pre-paid debit card at each completed assessment. | PMC10470135 | ||
Primary outcome measurement: physical activity | Our primary outcome is minutes of moderate intensity daily physical activity. Participants will wear an ActiGraph GT3X+ accelerometer-based device on their hip and the device will be initialized to collect raw data at 30 Hz. The participant will be instructed to wear the device during waking hours every day for 7 days, except during water activities. At minimum, the GT3X+ must be worn for 10 waking hours/d on at least 4 days. Initially, the raw GT3X+ data will be used to estimate time spent in MVPA (physical activity at ≥ 3.0 metabolic equivalents units) using publicly available algorithms developed for adults [ | PMC10470135 | ||
Process measures | EVENT | Process measures will be evaluated to monitor implementation of the intervention and to document receipt of the intervention. The HLAs will fill out a checklist after each physical activity event or promotion activity of the Phone2Health program. This information will help investigators determine intervention dosage and process. Specific metrics will include: 1) reach: the number of people who completed HLA walks/physical activity sessions or engaged in Phone2Health program; 2) the dose of the intervention: the number of HLA activities delivered and completed Phone2Health calls; and 3) participants’ feedback and perceptions of the intervention activities. | PMC10470135 | |
Analysis plan | REGRESSION, SECONDARY | We will “deconstruct” the intervention for the measurement of adherence to the intervention protocol and use these adherence indices in secondary analyses. Adherence data will be collected based on 1) what, how much, and when individual elements were delivered in each development, and 2) what was reported as received by both study staff and HLAs and by residents. We will collect these data for all intervention levels and all components and will enter these data by level into regression models for intervention residents to determine the relative effects of different levels of intervention on physical activity behaviors. These variables will also be used to create cohorts for sensitivity analyses or stratified analyses.Initial descriptive analyses will include an analysis of the baseline characteristics of participants. Data will be stratified with respect to study groups and the randomization assumption checked by comparing demographic characteristics across groups. Unbalanced characteristics will be included in multivariable models to control for any demographic difference between intervention groups. | PMC10470135 | |
Aim 1 (primary aim) | Hypothesis 1: Participants living in developments in any of the three intervention groups will increase minutes of moderate intensity physical activity more than participants in control group developments at 24 month follow up. | PMC10470135 | ||
Within group analysis | Preliminary analysis will examine within group differences in each of the study groups from baseline to the end of the intervention at 2 years. Minutes of moderate or greater intensity activity per week will be examined using paired t-test if the distribution is approximately normal or the nonparametric Wilcoxon signed-rank test if normality cannot be assumed. McNemar’s chi-squared test will be used for a paired analysis of meeting recommended physical activity level (binary outcome) pre and post intervention. | PMC10470135 | ||
Between group analysis | REGRESSION | The between group hypothesis is tested in three separate bivariate analyses comparing each intervention group to the control group in two primary outcomes based on the cluster-randomized design. We examine change in each primary outcome pre-intervention to post-intervention: 1) the number of minutes of moderate or greater intensity physical activity per week (continuous); and 2) meeting the recommended guidelines of >150 minutes of moderate or greater intensity physical activity per week (dichotomous at individual level, proportion at group level). In addition, we will examine this hypothesis controlling for potential confounding factors and any variables that violate the randomization assumption using multilevel multivariable linear (continuous outcomes) and logistic (binary outcomes) regression models.Hypothesis 2: Participants living in developments receiving the combined intervention (E+I) will demonstrate even greater increases in the number of minutes of moderate intensity physical activity per week (individual level) and the proportion meeting the recommended physical activity guidelines (development level) from baseline to 24-month follow-up, compared to either intervention delivered singly. | PMC10470135 | |
Statistical analysis | This hypothesis is tested in two separate bivariate analysis - one comparing the multilevel intervention group (E+I) to the environment intervention only group (E) and the other comparing the multilevel intervention group (E+I) to the individual level intervention only group (I).Hypothesis 3: Participants living in developments receiving the combined intervention (E+I) will demonstrate even greater increases in the number of minutes of moderate intensity physical activity per week (individual level) and the proportion meeting the recommended physical activity guidelines (development level) from baseline to 24-month follow-up, compared to the sum of average change in environmental intervention compared to control and the individual level intervention compared to control (synergistic effect). | PMC10470135 | ||
Statistical analysis | REGRESSION | To examine this hypothesis, we exploit our study design which has a multifactorial design embedded in a cluster randomized controlled trial. Multifactorial experimental designs combine the rigor of experimental design with the ability to produce results on the effectiveness of alternate approaches to multicomponent interventions in a single experiment. We will use multilevel regression analysis and test for an interaction effect between the environmental and individual level interventions (E+I). The presence of a significant interaction between E and I on the primary outcome of physical activity suggests synergy between these components of the intervention. If the effects of the environmental level intervention and individual level intervention are additive there should not be a significant interaction in the model. In this case, we can compare the interaction results to the multilevel intervention group (E+I) to examine the exploratory hypothesis that E+I is more effective than E&I combined. | PMC10470135 | |
Aim 2: mediation/moderation | We will evaluate the mediator effects of motivation, self-efficacy, neighborhood walkability, support from HLAs, and fidelity and moderator effects (i.e., sleep, financial strain, public housing development characteristics, neighborhood social cohesion, and access to physical activity resources) on physical activity behavior. | PMC10470135 | ||
Statistical analysis | Mediation and moderation are examined using variables at both levels, as such we will use multilevel structural equation models and path analysis to examine multilevel mediation and multilevel moderation within and across levels [ | PMC10470135 | ||
Handling missing data | While the mechanism giving rise to the missing data cannot be determined by the observations, the sensitivity of parameter estimates to missing data assumptions can be studied by fitting multiple models that make different assumptions about the missing data process [ | PMC10470135 | ||
Sample size | PMC10470135 | |||
Aim 1 - within group analysis sample size | A sample size of 21 achieves 90% power to detect a mean of paired differences of 3.0 with a significance level of 0.05 using a two-sided paired t-test. A sample size of 34 achieves >90% power to detect a difference of 3.0 with a significance level of 0.05 using a two-sided Wilcoxon Signed-Rank test. Assuming at least 20% of the sample changes between baseline and follow-up a sample size of 115 pairs achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar’s test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 0.10. | PMC10470135 | ||
Aim 1 - between group analysis sample size | We power the multivariable analysis based on test for two means in a 2-level hierarchal design with level 2 randomization. Sample sizes of 96 subjects in each group, which were obtained by sampling 3 clusters with an average of 32 subjects per cluster, achieve >90% power to detect a difference between the group means of at least 5 minutes (or 5 percent difference in meeting recommended levels). A test based on a mixed-model analysis at a significance level of 0.05. | PMC10470135 | ||
Aim 2 – mediation | REGRESSION | The test of mediation effect is based on Sobel’s test. A sample size of 395 achieves 90% power to detect a mediation effect of at least 0.04 as measured by the product of two regression coefficients 0.20 (primary predictor) and 0.20 (mediator) when the significance level is 0.05. | PMC10470135 | |
Aim 2 – moderation | PMC10470135 | |||
RCP method | A total sample size of 480 observations, were obtained by sampling 3 level-2 units (PHD) in the control group, 3 level-2 units (PHD) in I only group, 3 level-2 units (PHD) in the E only group, and 3 level-2 units (PHD) in the E+I group. Finally, 40 level-1 units (individuals with repeated measurements) were obtained from each level-2 unit (PHD). This sample achieves >90% power to detect a three-way interaction among the subject-specific slopes of at least 3.0. A test based on a mixed-model analysis assuming random slopes will be used. This test will be conducted at a significance level of 0.05. | PMC10470135 | ||
LMS method | REGRESSION | A total sample size of 492 level-1 units (individuals), which were obtained by sampling 3 level-2 units (PHD) in the control group, 3 level-2 units (PHD) in I only group, 3 level-2 units (PHD) in the E only group, and 3 level-2 units (PHD) in the E+I group, with an average of 41 level-1 units (individuals) per level-2 unit (PHD), achieve >85% power to detect an interaction difference among the group means of at least 3.75. A test based on a mixed-model regression analysis at a significance level of 0.05. | PMC10470135 | |
Aim 3 - qualitative interviews | We will conduct qualitative interviews with 40 key informants to explore the future implementation of the multilevel physical activity intervention using the Consolidated Framework for Implementation Research as our conceptual model [Interviewers will follow a semi-structured interview guide with sections corresponding to each of the five CFIR domains: Outer Setting, Inner Setting, Intervention Characteristics, Characteristics of Individuals, and Process. The guide will allow for structured questions to be asked in all interviews, while allowing flexibility to probe or follow up on emerging topics. Interviews will be audiotaped, transcribed verbatim, and systematically read as they are being conducted to determine if information saturation has been reached. We will conduct a content analysis of the transcripts [Interview themes will also be compared among those public housing developments in which key informants gave higher and lower organizational readiness ratings during the housing manager interviews conducted at baseline. Then, following team-based coding, the preliminary coding structure will be shown to the entire research team to review our analysis decisions. Codes will be added, refined, and deleted during this process. To enhance the trustworthiness of the analysis, we will hold at least two peer debriefing meetings with the entire research team to show them the transcripts and the codes applied and ask for their feedback [ | PMC10470135 | ||
Discussion | The Community Walks study addresses a gap in the literature to test multilevel interventions in low-income populations and is nearly unique in its focus on this population, on a layered multilevel design, and on walking as the main form of physical activity. The environmental level intervention will be delivered by community residents trained as HLAs for leading walks using newly designed and marked walking trails around the development. Among residents randomized to the I and E+I condition, we will enroll interested residents to a more intensive individual level eHealth phone intervention to further promote motivation and self-efficacy for physical activity.As described by Hall and colleagues, a continuum exists ranging from fundamental multilevel research to multilevel intervention research [The interviews we have planned at the conclusion of the trial will help us understand barriers and facilitators to intervention reach, adoption, implementation and maintenance, which will inform future intervention efforts. Other research teams have also included qualitative methods of intervention evaluation, including participatory evaluation (e.g., Ripple Effects Mapping) to elucidate factors most important to participants and other stakeholders [Limitations of our study should be considered. Because our primary outcome is measured by actigraphy, those who are not able to ambulate independently are not included in the evaluation cohort. However, we do allow those using certain assistive devices (such as walkers) to participate in the evaluation cohort, as we thought actigraphy would be appropriate in these instances. In addition, only those willing to participate are included in the evaluation cohort. These may create bias in our sampling frame. Our program is available in English and Spanish, which represents most languages spoken in public housing developments. However, while people who speak other languages will be welcome to participate in E level intervention activities, they may not feel as welcome or be able to participate fully. Finally, the study is conducted in only one city, which may limit external generalizability.In conclusion, a multilevel, multicomponent community-based study is being conducted to test whether individual- and environmental-level intervention programming promotes moderate intensity physical activity among urban public housing residents. | PMC10470135 | ||
Trial status | MAY | Protocol Version 1.8, June 7, 2023.Recruitment Start Date: May 2, 2022.Recruitment Approximate End Date: September 4, 2023. | PMC10470135 | |
Acknowledgements | The authors wish to express gratitude to Gianna Fernandez and Charmaine King, Healthy Living Advocates, for their guidance in intervention implementation. This paper is dedicated to the memory of Dr. Deborah Bowen. | PMC10470135 | ||
Authors’ contributions | LQ is the Principal Investigator, she conceived the study, led the proposal and protocol development. JD, MG, and SC contributed to the study design and evaluation plan. MA, MS, DR, JM, SM, JK, DC, IS and TW led aspects of program design and development. All authors read and approved the final manuscript. | PMC10470135 | ||
Funding | Funding Source: GovernmentFunding Details: NIH/National Institute on Minority Health & Health Disparities (NIMHD), Federal-NIH, Grant, 1R01MD015165.The funding source does not have a role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. | PMC10470135 | ||
Availability of data and materials | RECRUITMENT | Lisa Quintiliani, Julien Dedier, and Melody Goodman have Access to the final trial dataset. No contractual agreements limit access to dataset. The datasets generated and/or analyzed during the current study are not publicly available due to the research is still ongoing, but are available from the corresponding author on reasonable request. Participant recruitment for this trial is not completed and is still ongoing. | PMC10470135 | |
Declarations | PMC10470135 | |||
Ethics approval and consent to participate | Boston University, Institutional Review Board (IRB), H-42219.Written, informed consent to participate is obtained from all participants. The research study staff member reviews the informed consent document, discuss risks and possible benefits of study participation, answer any questions that arise, and conclude by asking whether they agree to participate. The research study staff member obtains the participant’s signature either in person or when they next meet in person (if done over the telephone). The consent process is the same between English and Spanish-speaking participants. All experimental protocols were approved by Boston University Medical Campus and Boston Medical Center: Institutional Review Board. All methods were carried out in accordance with relevant guidelines and regulations. | PMC10470135 | ||
Consent for publication | Not applicable. | PMC10470135 | ||
Competing interests | TW is the President of IEQ Technology, Inc., the company that deployed the Phone2Health program described in this study. All other authors declare that they have no conflicts of interests/competing interests. | PMC10470135 | ||
References | PMC10470135 | |||
1. Introduction | cancer, CIN | VIRUS, HPV INFECTION, CERVICAL LESIONS, CANCER, DISEASE, CIN, CERVICAL CANCER, CERVICAL CANCER, REGRESSION | In Uganda, the uptake of cervical cancer (CC) screening services is low, at 46.7%, among HIV-infected women, and only 9% of these women adhere to annual CC screening. Some studies have evaluated the possibility of community or home-based human papillomavirus (HPV) self-collected vaginal swabs, but not clinic-based HPV self-collected vaginal swabs. Therefore, we propose a study to determine the efficacy of clinic-based versus home-based HPV DNA self-sampling among HIV-infected women attending a rural HIV clinic in Uganda. We believe that a randomized, single-blinded trial would achieve this objective, and so we have chosen it to guide the study. Including a total of 382 participants from a rural HIV clinic, randomized into a ratio of 1:1 for clinic- and home-based HPV self-sampling, would allow us to appropriately ascertain the difference in the uptake of HPV self-sampling between the two arms. The Integrated Biorepository of H3 Africa Uganda Laboratory would be used as a reference laboratory for the HPV DNA extraction, typing, and sequencing. At baseline, modified Poisson regression models would be used to measure factors associated with the prevalence of HPV and uptake in both arms at baseline. Visual inspection under acetic acid (VIA), as a gold-standard test for CC to grade for CIN, would be performed at 0 and 6 months among a random sample of 75 women with a self-collected HPV sample. The difference in uptake could be determined using the intention-to-treat analysis. The difference in the groups by each variable would be summarized as the standardized mean difference (i.e., the mean difference divided by the pooled standard deviation). The predictors of the time for which participants would continue with HPV self-sampling in both arms, recovery, and Cox proportional hazards regression would be used. At the bivariate level, the associations between each independent variable and time, with the time of continuing HPV self-sampling, would be computed. Crude hazard ratios and their 95% confidence interval would be used in the presentation of the results, with The highest burden of cervical cancer (CC) disease is mainly observed in Sub-Saharan Africa [Cervical cancer is the commonest cancer among Ugandan women. Annually, 3915 women in Uganda are afflicted by CC and, of these, 2160 die [Cervicography, Pap smears, and VIA are mainly performed by health providers via a colposcopy [Uganda faces many barriers to provider-led CC screening, and these include health workers who do not know the importance of CC screening [HPV testing is globally recommended instead of Pap testing, because it is also conducted on patient-collected samples [Countries in SSA, such as Uganda, bear a high burden of the HIV/AIDS epidemic, and 50% of HIV-infected women barely access CC screening. Repeated HPV infection, and the cervix’s inability to shade off the HPV virus due to reduced immunity, occur mostly in HIV-positive women. As a result, they easily progress to pre-invasive cervical lesions [This increased risk among HIV-infected women requires them to screen for CC annually. However, there is a paucity of studies that have determined the effectiveness of clinic-based versus home-based HPV self-sampling approaches among HIV-infected women. It is anticipated that HPV patient-led CC screening would be effective, and would increase the uptake of CC screening and, hence, the early detection and treatment of CC. Additionally, there is no clear policy or organized structure for a nationwide cervical cancer screening program in Uganda. Therefore, there is an opportunity to increase the interest among rural HIV-infected women in going for HPV testing, through the promotion of programs that involve self-sampling approaches to HPV sampling among women. This could contribute to a reduction in the incidence of invasive CC, and in the health and community consequences of the disease. There is a lack of studies determining the effectiveness of patient-led HPV screening at an HIV clinic, compared to home-based vaginal HPV self-sampling, among HIV-infected women. We predict that if HIV-infected women conducted self-sampling at the HIV clinic using a vaginal collection kit method that was reliable, efficient, and acceptable, it would reduce the waiting time to access CC screening from the HW, enhance the prompt receipt of results, reduce attrition, and further address barriers to CC screening in rural communities. The results from the study will direct us to the appropriate HPV self-sampling approach for disease stratification, which will be published, and used to design policy briefs. Additionally, the findings will also be used to develop health promotion programs related to the prevention of HPV and CC among women. | PMC10454402 |
2. The Health Promotion Model for the Clinic-Based HPV Self-Sampling Approach | DISEASE, SECONDARY, CERVICAL CANCER | The health promotion model (HPM) has been chosen as the conceptual framework to guide this study, because health-promoting behavior is interpreted as a broad conceptualization, including the secondary prevention of CC. The theory could be used to interpret the effectiveness of clinic-based HPV self-sampling, in comparison with home-based HPV self-sampling approaches. It could be used to assess the difference in the uptake, HPV prevalence, associated factors, performance of clinic-based screening among HIV-infected women and their experiences, and costs related to patient-led HPV screening. The HPM would be used to interpret the factors affecting the uptake of clinic-based versus home-based HPV self-sampling among HIV-infected women. It was chosen because it suits the tailoring of public health interventions and dissemination [The three concepts that were chosen to guide this study were the concept of personal factors, the concept of situational influences, and the concept of health-promoting behavior. The concept of personal factors could be used to identify the demographic characteristics (age, parity, level of education, CD4 count, viral load, knowledge of CC screening, screening preference, ART status, WHO stage, STI status, ART adherence status, fear of finding disease, type of HPV 16/18 by sample), knowledge, sexual history, reproductive health history, social factors, economic factors, and culture, concerning the prevention of HPV and eventually cervical cancer. The concept of situational influences could support the identification of the personal, family, community (perceived embarrassment of the screening procedure, knowledge of the disease, family support, peer support groups), and health system factors (distance to the health facility, waiting time, appointment scheduling, counseling status, peer support group, trained HWs, referral, the return of laboratory tests), and the cost-effectiveness, of the clinic-based versus home-based HPV self-sampling approach.Health-promoting behavior could be interpreted as activities related to HPV self-sampling, at the clinic or at home, among HIV-infected women. The model could also examine the relationship between personal factors and health-promoting behavior; situational influences and health-promoting behavior; and personal factors and health promotion. Additionally, the HPM has been widely used in health promotion research involving people of different age groups regarding participation in HPV self-sampling and CC screening [ | PMC10454402 | |
3. Research Implications | PMC10454402 | |||
3.1. Study Site | Geographical areas where women have multiple sexual partners are key risk factors for HIV and HPV transmission. Luwero district is found in the central region of Uganda, where 19% of women have multiple sexual partners, which is a key risk factor for HIV and HPV transmission (UDHS, 2016). This provides the basis used to justify the HIV clinic at Luweero Hospital, Luweero district ( | PMC10454402 | ||
3.2. The Intervention | As shown in | PMC10454402 | ||
3.3. The Study Population | The study approach would be to enroll all women attending the HIV clinic aged 25–49 years who had never been screened, had not been screened within the last year (those who had screened for >1 year with normal results), or had abnormal screening results at the clinic, and to obtain their consent to participate. | PMC10454402 | ||
3.4. The Phased Approach to Study Implementation | We propose using a phased approach, to allow step-by-step learning, as we implement the study procedures to determine the effectiveness of the clinic-based HPV self-sampling approach. The three phases that would guide this study are detailed below. | PMC10454402 | ||
3.4.1. Pilot Phase | RECRUITMENT | To understand the dynamics of testing the tools, randomization, and recruitment procedures, and the specimen collection, handling, transportation, and storage before shipment to the central laboratory, it is important to pilot the tools. A three-day pilot of the tools could be conducted at Mukono General Hospital, Mukono District, which is not part of the study. We would aim to pretest 30 questionnaires among 15 HIV-infected women per arm. Per arm, three women would undergo HPV self-sampling and a visual inspection of the cervix under acetic acid (VIA) at the clinic and would also participate in an IDI. The main purpose of the pilot phase would be to test the tools, randomization, and recruitment procedures, and the specimen collection, handling, transportation, and storage before shipment to the central laboratory. | PMC10454402 | |
3.4.2. Baseline Phase | At baseline, a cross-sectional study design would be used to determine the factors associated with the prevalence of, and those associated with the uptake of, HPV testing in both arms. We could, further, estimate the differences in the viability of the samples between the clinic-based and control groups. | PMC10454402 | ||
3.4.3. Effectiveness Phase | SECONDARY, RECRUITMENT | A prospective randomized controlled single-blinded trial has been considered to estimate the efficacy of clinic-based versus home-based HPV self-sampling among HIV-infected women at the HIV clinic. As women came to the HIV clinic, they could prospectively be randomized to clinic-based or home-based HPV self-sampling. This would be a single-blinded randomized controlled trial, in which the study participants would not know the arm to which they had been assigned. After recruitment and consent, a randomization Excel list would be generated, and participants randomized to the two study arms in the ratio of 1:1. However, a random sample of HPV-positive women who took up HPV testing in both arms at baseline could also be subjected to VIA. The women would be followed up at 6 months, to measure their continued uptake rate of HPV self-sampling. The period of six months has been considered as is the time for their refill treatment for ART. As the study is tailored so that the findings could be used to design screening approaches that were public, feasible, and cost-effective, a modified societal perspective could be used to model the cost-effectiveness analysis. Non-medical costs would be obtained from the interviews that we conducted with the women, and from the secondary data analysis of the budgets. However, comparisons for the transport costs, personnel time, patient waiting time, and time spent in the facility would be considered. | PMC10454402 | |
3.5. Recruitment | cancer, CIN, CIN3, Cancer | CANCER, CANCER, CIN | To obtain robust outcomes, all midwives involved in the study would be initially trained in the study procedures. All eligible women attending the HIV clinic would be educated on the different procedures for the collection of samples for HPV testing. Women could prospectively be recruited and randomized as they came to the HIV clinic. The midwives would obtain women’s consent to HPV testing and VIA screening. The women randomized to the clinic-based HPV self-sampling group who had consented to and accepted the screening would be provided with an HPV sample collection kit to collect the vaginal swab and return it to the laboratory for HPV testing. The women randomized to home-based HPV self-sampling, who had consented to, and accepted, the screening, would receive the HPV testing kit from the community linkage personnel (CLP). The CLP could collect all the collected samples from the women and transport them to the laboratory at Luweero Hospital. As recommended by the World Health Organization (WHO,) all women who took up screening in each group would need to first undergo a pregnancy test called human chorionic gonadotropin (HCG). The randomly selected sample of 150 HPV-positive women who took up HPV testing in both arms would further be subjected to a VIA, which is accepted as a gold-standard test for grading CIN in low-income settings such as Uganda. All women with suspected CIN2 and CIN3 could be referred to Uganda Cancer Institute for further management. The study would leverage the existing referral systems for cancer patients. UCI is the only national center for cancer treatment in Uganda and, therefore all identified cases are referred to that center as a norm; hence, there is no need for a memorandum of understanding. This is as shown in | PMC10454402 |
3.6. Sample Size | STIS | It has been estimated that a total of 382 HIV-infected women would determine the effectiveness of the clinic-based HPV sampling approach. In each arm, i.e., the clinic-based and the home-based HPV self-sampling, there would be 191 participants. The required powered sample for this sub-study has been determined based on the formula for comparative studies where the outcome is categorical (or a proportion) (Schlesselman, 1982). To answer the question of the facilitators and barriers to HPV screening in the rural HIV clinic, we would conduct 24 in-depth interviews (IDIs) among women aged 25–35 years and 36–49 years, including women who would decline CC screening, with or without a history of STIs, as indicated in The phenomenology design would be used to explore the deeper facilitators and barriers toward women regarding self-sampling, either at home or in clinical settings, in Luweero District Hospital, Uganda. The in-depth interview (IDI) guide would be translated from English to Luganda. Qualitative data analysis would be guided by content analysis techniques. The transcripts would be coded in NVivo 20.7.0. The coded text would then be used to generate categories of analytically meaningful data that guided the formation of themes, the interpretation of results, and the final write-up. | PMC10454402 | |
3.7. Sampling Procedures | An electronic sampling frame of women aged from 25 to 49 years would be obtained via the Luweero district hospital HIV clinic. The women’s history of CC screening could be reviewed in their files. All women who had not been screened at all, not been screened within the last three years, had abnormal screening results, or had been screened more than 1 year ago with normal results, attending the HIV clinic, could be included in the sampling frame. The first participant would be randomly selected, and the subsequent women would be systematically selected using an interval of 2. Purposive sampling would be used to allocate women for IDIs, and expert opinions would be used to collect cost data from key informants and documents. | PMC10454402 | ||
3.8. Sample Collection Procedures | Those who took up screening in both groups would be educated on the sampling procedure, and given a Qvintip kit to collect their samples. The Qvintip dry-based sample collection kit can be transported at room temperature, and is, therefore, appropriate to use in developing countries, as it does not require cold-chain transportation. Therefore, it would be appropriate to collect samples using the Qvintip kit, because would be is user-friendly in our settings. The samples stored at the HIV clinic lab would be transported to the Integrated Biorepository of H3 Africa Uganda as a reference laboratory for the HPV DNA extraction, PCR amplification, testing, and genotyping. | PMC10454402 | ||
3.9. Data Analysis | REGRESSION, EVENTS | To determine the factors associated with the uptake, and HPV prevalence at baseline (0 months) in clinic-based versus home-based HPV self-sampling from the baseline data, descriptive statistics, as well as univariate, bivariate, and multivariate logistic regression would be considered. The difference in uptake over the study period (effectiveness of clinic-based versus home-based HPV self-sampling) could be determined using the intention-to-treat analysis. We could further determine predictors of the time to continue with HPV self-sampling in both arms, and recovery, and Cox proportional hazards would be used. Content analysis could be used to analyze the qualitative data regarding the facilitators and barriers to HPV self-sampling. To estimate the cost-effectiveness of the clinic-based HPV self-sampling approach, an Excel model could be built and validated to check for the logical flow of events. | PMC10454402 |
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