5 results on '"David MacLeod"'
Search Results
2. A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study
- Author
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Mohammed Limbada, Chiti Bwalya, David Macleod, Sian Floyd, Ab Schaap, Vasty Situmbeko, Richard Hayes, Sarah Fidler, Helen Ayles, and on behalf of the HPTN 071 (PopART) Study Team
- Subjects
HIV ,Anti-retroviral therapy ,Home-based ART delivery ,Adherence clubs ,Zambia ,Medicine (General) ,R5-920 - Abstract
Abstract Background Following the World Health Organization’s (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges. Methods A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as “stable” on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data. Discussion This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings. Trial registration ClinicalTrials.gov NCT03025165 . Registered on 19 January 2017
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- 2021
- Full Text
- View/download PDF
3. Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial
- Author
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Hillary Rono, Andrew Bastawrous, David Macleod, Emmanuel Wanjala, Stephen Gichuhi, and Matthew Burton
- Subjects
Eye problems ,Visual impairement ,Access ,Primary eye care ,Community Eye Health system ,Community volunteers ,Medicine (General) ,R5-920 - Abstract
Abstract Background Globally, eye care provision is currently insufficient to meet the requirement for eye care services. Lack of access and awareness are key barriers to specialist services; in addition, specialist services are over-utilised by people with conditions that could be managed in the community or primary care. In combination, these lead to a large unmet need for eye health provision. We have developed a validated smartphone-based screening algorithm (Peek Community Screening App). The application (App) is part of the Peek Community Eye Health system (Peek CEH) that enables Community Volunteers (CV) to make referral decisions about patients with eye problems. It generates referrals, automated short messages service (SMS) notifications to patients or guardians and has a program dashboard for visualising service delivery. We hypothesise that a greater proportion of people with eye problems will be identified using the Peek CEH system and that there will be increased uptake of referrals, compared to those identified and referred using the current community screening approaches. Study design A single masked, cluster randomised controlled trial design will be used. The unit of randomisation will be the ‘community unit’, defined as a dispensary or health centre with its catchment population. The community units will be allocated to receive either the intervention (Peek CEH system) or the current care (periodic health centre-based outreach clinics with onward referral for further treatment). In both arms, a triage clinic will be held at the link health facility four weeks from sensitisation, where attendance will be ascertained. During triage, participants will be assessed and treated and, if necessary, referred onwards to Kitale Eye Unit. Discussion We aim to evaluate a M-health system (Peek CEH) geared towards reducing avoidable blindness through early identification and improved adherence to referral for those with eye problems and reducing demand at secondary care for conditions that can be managed effectively at primary care level. Trial registration The Pan African Clinical Trials Registry (PACTR), 201807329096632. Registered on 8 June 2018.
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- 2019
- Full Text
- View/download PDF
4. The effect of visual support strategies on the quality of life of children with cerebral palsy and cerebral visual impairment/perceptual visual dysfunction in Nigeria: study protocol for a randomized controlled trial
- Author
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Roseline Duke, Komomo Eyong, Kathryn Burton, David MacLeod, Gordon N. Dutton, Clare Gilbert, and Richard Bowman
- Subjects
Cerebral palsy ,Cerebral visual impairment ,Perceptual visual dysfunction ,Insight Questions Inventory ,Visual support strategies ,Paediatric quality of life ,Medicine (General) ,R5-920 - Abstract
Abstract Background Cerebral visual impairment (CVI), including perceptual visual dysfunction (PVD), is common in children with cerebral palsy (CP). Inventories of questions relating to practical aspects of visual perception in everyday life, in particular the closed-ended Insight Questions Inventory (IQI), can be used to assess CVI/PVD. Studies linking responses to the inventory with specific visual support strategies, aimed at modifying the child’s environment and/or behaviour to minimize the impact of the CVI/PVD, have been piloted. The IQI and tailored strategies have not been used in an African population, nor have they been tested in a controlled trial. This trial will compare the effectiveness of the IQI and linked visual support strategies versus general supportive treatments on the quality of life of children with CVI/PVD and CP through a randomized controlled trial. Methods/design This is a prospective, double-blind, parallel-arm, randomized controlled trial. The primary outcome is change in quality of life scores between the two arms of the trial at 6 weeks, assessed using the Paediatric Quality of Life Inventory (PedsQL) generic 4.0 and CP 3.0 module. All children will undergo baseline assessment including the Open Questions Inventory, IQI, PedsQL 3.0, PedsQL 4.0 generic, and the Strengths and Difficulties Questionnaire (SDQ). Eligible children with CP aged 4 years to
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- 2019
- Full Text
- View/download PDF
5. The effect of visual support strategies on the quality of life of children with cerebral palsy and cerebral visual impairment/perceptual visual dysfunction in Nigeria: study protocol for a randomized controlled trial
- Author
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David Macleod, KI Eyong, Clare Gilbert, Gordon N. Dutton, Roseline Duke, Richard Bowman, and Kathryn Burton
- Subjects
Male ,Visual perception ,Time Factors ,Medicine (miscellaneous) ,law.invention ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,Quality of life ,law ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Prospective Studies ,Perceptual visual dysfunction ,Child ,Randomized Controlled Trials as Topic ,Visual Cortex ,lcsh:R5-920 ,Standard treatment ,Age Factors ,Gross Motor Function Classification System ,Strengths and Difficulties Questionnaire ,Disabled Children ,Treatment Outcome ,Child, Preschool ,Visual Perception ,Paediatric quality of life ,Female ,lcsh:Medicine (General) ,Visually Impaired Persons ,medicine.medical_specialty ,Adolescent ,Vision Disorders ,Nigeria ,Visual support strategies ,Cerebral visual impairment ,Cerebral palsy ,03 medical and health sciences ,Double-Blind Method ,Humans ,business.industry ,Cerebral Palsy ,Insight Questions Inventory ,medicine.disease ,Clinical trial ,Physical therapy ,Quality of Life ,business ,030217 neurology & neurosurgery - Abstract
Background Cerebral visual impairment (CVI), including perceptual visual dysfunction (PVD), is common in children with cerebral palsy (CP). Inventories of questions relating to practical aspects of visual perception in everyday life, in particular the closed-ended Insight Questions Inventory (IQI), can be used to assess CVI/PVD. Studies linking responses to the inventory with specific visual support strategies, aimed at modifying the child’s environment and/or behaviour to minimize the impact of the CVI/PVD, have been piloted. The IQI and tailored strategies have not been used in an African population, nor have they been tested in a controlled trial. This trial will compare the effectiveness of the IQI and linked visual support strategies versus general supportive treatments on the quality of life of children with CVI/PVD and CP through a randomized controlled trial. Methods/design This is a prospective, double-blind, parallel-arm, randomized controlled trial. The primary outcome is change in quality of life scores between the two arms of the trial at 6 weeks, assessed using the Paediatric Quality of Life Inventory (PedsQL) generic 4.0 and CP 3.0 module. All children will undergo baseline assessment including the Open Questions Inventory, IQI, PedsQL 3.0, PedsQL 4.0 generic, and the Strengths and Difficulties Questionnaire (SDQ). Eligible children with CP aged 4 years to
- Published
- 2018
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