HIV/AIDS Infections and Infestations
Conditions
Interventions
Current interventions as of 05/02/2025:
The method of randomisation is cluster randomisation with 1:1 allocation.
ExtraCECI, which will be targeted at both cluster and individual participant levels
then next appointment scheduled at three months at Time 2
sixth month at Time 3
ninth month at Time 4
and final appointment scheduled at twelve month at Time 5.
Standard HIV care:
Clinics randomised to the control arm will continue to
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/02/2025: HIV clinics: 1. Clinics with a minimum travel distance of 3 km apart to minimise treatment ‘contamination’ between the intervention and control arms; 2. The clinic lead must be willing to participate and commit to compliance with ethics requirements 3. At least two HCP per clinic who meet the inclusion criteria must be willing to participate at the time of clinic inclusion. HCP: 1. HCP who regularly provide hands on care for PLWHA; and 2. HCP providing care for PLWHA in eligible clinics for at least 6 months. PLWHA: 1. Adults PLWHA from age 18 years 2. HIV-positive diagnosis and in care for at least 6 months, to ensure that PLWHA has the experience of care to reflect on 3. PLWHA who have cognitive ability to consent to participating in the study as guided by the Mental Capacity Act 4. PLWHA who are clinically well to participate (having >200 cells/mm3 CD4 count/ viral load <200 without complications 5. PLWHA attending clinic for ART refill, adherence counselling, psychosocial & spiritual support, including other services targeted at PLWHA who are in care. _____ Previous inclusion criteria: HIV clinics: 1. There must be a minimum distance of 3 km between clinics 2. The clinic lead must be willing to participate and commit to compliance with ethics requirements 3. At least two HCP who meet the inclusion criteria must be willing to participate at the time of clinic inclusion HCP: 1. HCP including doctors, nurses, pharmacists, counsellors, social workers, and care assistants who regularly provide care to PLWHA; 2. HCP who has been providing care for PLWHA in eligible clinics for at least 6 months PLWHA: 1. Adults PLWHA from age 18 years 2. A positive diagnosis of HIV/AIDS and in care for at least 6 months, to ensure that PLWHA has the experience of care to reflect on; and 3. PLWHA who have the cognitive ability to consent to participate in the study (the researchers will assume PLWHA have the capacity to consent, unless proven otherwise) 4. PLWHA attending the clinic for ART refill, adherence counselling, psychosocial and spiritual support, including other services targeted at PLWHA who are in care
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/02/2025: HIV clinics: 1. Clinics that are less than 3 km distance apart with potential for treatment contamination 2. Clinics not willing to participate in the study and or not willing to comply with ethics requirements; and 3. Clinics with less than two HCP who meet the inclusion criteria at the time of clinic inclusion. HCP: 1. HCP not providing regular hands-on care to PLWHA; and 2. HCP providing care for PLWHA in eligible clinics for less than six months. PLWHA: 1. PLWHA under age 18 years 2. Diagnosed with HIV and in care for less than 6 months 3. PLWHA not having cognitive ability to consent. 4. PLWHA having <200 cells/mm3 CD4 count or having severe complications/ co-morbidities including cardiovascular diseases, malignancies, pneumonia and requiring specialised treatment at secondary/tertiary health facility). 5. Persons attending clinic for pre-counselling & testing services including prevention of mother-to-child-transmission. _____ Previous exclusion criteria: HIV clinics: 1. Clinics not willing to participate in the study 2. Clinics not willing to commit to comply with ethics requirements 3. Clinics with less than two HCP who meet the inclusion criteria at the time of clinic inclusion HCP: HCP who have been working with PLWHA for less than 6 months PLWHA: 1. PLWHA under age 18 years 2. PLWHA diagnosed less than 6 months 3. PLWHA who do not have the cognitive ability to consent 4. PLWHA who are too ill to participate (having <200 cells/mm3 CD4 count or PLWHA having severe complications/comorbidities including cardiovascular diseases, malignancies, pneumonia and requiring specialised treatment at secondary/tertiary health centres) 5. Patients coming to the clinic for pre-counselling and testing services including prevention of mother-to-child-transmission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 05/02/2025: Quality of life (QoL) measured at the individual level using Medical Outcomes Study–HIV (MOS-HIV) at baseline, 1st appointment after randomisation, then 3, 6, 9 and 12 months. _____ Previous primary outcome measure: Quality of life (QoL) measured at the individual level using Medical Outcomes Study–HIV (MOS-HIV) at baseline, 3, 6, 9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/02/2025: 1. Person-centredness and wellbeing of PLWHA measured using the Positive Outcomes HIV PROM at baseline, 1st appointment after randomisation, then 3, 6, 9 and 12 months. 2. Patient-clinician communication, patient involvement in care decisions and patient experience of ExtraCECI/care delivery process, measured using the Picker Patient Experience Questionnaire (PPE-15) at baseline, 1st appointment after randomisation, then 3, 6, 9 and 12 months. 3. The amount of empathy that a patient feels they have received during consultation, measured using the Consultation and Relational Empathy (CARE) Measure at baseline, 1st appointment after randomisation, then 3, 6, 9 and 12 months. _____ Previous secondary outcome measures: 1. Person-centredness and wellbeing of PLWHA measured using the Positive Outcomes HIV PROM at baseline, 3, 6, 9 and 12 months 2. Patient-clinician communication, patient involvement in care decisions and patient experience of ExtraCECI/care delivery process, measured using the Picker Patient Experience Questionnaire (PPE-15) at baseline, 3, 6, 9 and 12 months 3. The amount of empathy that a patient feels they have received during consultation, measured using the Consultation and Relational Empathy (CARE) Measure at baseline, 3, 6, 9 and 12 months | — |
Countries
Ghana
Contacts
Public ContactMary Abboah-Offei
Outcome results
None listed