Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201410000902600 Date of Approval: 06/10/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparison of non-pharmacological interventions for reducing pain in individuals with HIV
Official scientific title A comparison of non-pharmacological interventions for reducing pain in individuals with HIV
Brief summary describing the background and objectives of the trial Pain is among the commonest symptoms in people living with HIV/AIDS (PLWHA). It occurs at multiple sites and is typically of moderate to severe intensity. Pain is poorly managed in all PLWHA populations including in South Africa. Reasons why pain management in HIV is challenging include failure of some common HIV-associated pains to respond to available analgesics and a paucity of high quality research into optimal non-pharmacological interventions. Exercise has repeatedly been shown to benefit PLWHA. A peer-led exercise and education intervention was piloted in South African amaXhosa women in Cape Town living with HIV/AIDS and pain. Substantial reductions in pain occurred with the intervention, but some reduction also occurred in controls, who received the same education and assessments without the exercise intervention. This raises the question of whether repeated follow-up (a supportive relationship, alone or with education) is a more cost effective, non-pharmacological intervention for pain in PLWHA in South Africa. Indeed there is also evidence that pain in HIV may be attenuated if the patient believes someone cares. It is important to understand the precise additional benefit of any intervention over and above a supportive relationship alone, as this has real resource implications in our setting. Aims To measure the relative effects on pain and health-related quality of life in people with pain and HIV, from: - A supportive relationship group who will return to the same research assistant for all follow up appointments; - A supportive relationship and education group, who will additionally receive educational material - A supportive relationship, education and exercise group, who will additionally receive the relatively resource-intensive peer-led group exercise and goal setting intervention. 2. To explore sociodemographic effects (e.g. literacy) on responses to the interventions by assessing urban versus rural people living with HIV.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Supportive care
Anticipated trial start date 06/10/2014
Actual trial start date 06/10/2014
Anticipated date of last follow up 24/02/2016
Actual Last follow-up date 08/04/2017
Anticipated target sample size (number of participants) 183
Actual target sample size (number of participants) 160
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
M140877 Human Research Ethics Committee (Medical), University of the Witwatersrand
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised simple randomisation using computer generated random number allocation Allocation determined by the holder of the sequence who is off site Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Supportive relationship 6 occasions: baseline and follow up at 4, 8, 12, 24, 48 weeks 1 hour Patients will return to the same caring, empathetic research assistant for all follow up appointments 92
Experimental Group Supportive relationship and education Education book given at beginning. Supportive relationship on 6 occasions: baseline and follow up at 4, 8, 12, 24, 48 weeks Supportive relationship 1 hour on each occasion Patients will return to the same caring, empathetic research assistant for all follow up appointments and additionally be given an educational book on living with HIV 20
Experimental Group Supportive relationship and peer-led exercise and goal setting intervention Peer-led group: once a week for six weeks. Supportive relationship on 6 occasions: baseline and follow up at 4, 8, 12, 24, 48 weeks Peer-led group: two hours, once a week for six weeks. Supportive relationship sessions: 1 hour Patients will attend a peer-led exercise, education and goal setting group for six weeks. They will be given the educational book for living with HIV and also be followed up by the same caring, empathetic research assistant. 92
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Confirmed HIV infection On a stable HAART regimen ¿ 6 months ¿3 month history of pain PLWHA who have any mental incapacity(defined as an inability to comprehend basic questions or information given about the study during recruitment) Non-ambulatory patients or those who do not fulfill American College of Sports Medicine Health/Fitness Facility Pre-participation Screening Questionnaire criteria 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/09/2014 Human Research Ethics Committee (Medical), University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Senate House, 10th Floor, Office no 10004 Johannesburg 2001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No Human Research Ethics Committee, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Old Main Building, Groote Schuur Hospital Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/09/2014 Human Research Ethics Committee (Medical), University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Senate House, 10th Floor, Office no 10004 Johannesburg 2001 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/10/2014 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Observatory Cape Town South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/10/2014 Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Observatory Cape Town South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/11/2014 Human Research Ethics Committee, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Observatory Cape Town South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/12/2014 Human Research Ethics Committee, University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences, Observatory Cape Town South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain severity Baseline 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Secondary Outcome Pain interference Baseline 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Secondary Outcome Health-related quality of life Baseline 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Secondary Outcome Depression Baseline 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Secondary Outcome Self-efficacy Baseline 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
Secondary Outcome Physical function Baseline 4 weeks 8 weeks 12 weeks 24 weeks 48 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Retreat Clinic 138 11th Ave, Retreat Cape Town 8001 South Africa
Charlotte Maxeke Academic Hospital 5 Jubilee Street Johannesburg 2193 South Africa
Manguzi Hospital Hospital Road KwaNgwanase 3973 South Africa
Zithulele Hospital Zithulele Village Mqanduli 5080 South Africa
Riversdale Hospital Hospital Street Riversdale 6670 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF Thuthuka Meiring Naude Road Pretoria South Africa
Faculty of Health Sciences, University of the Witwatersrand 7 York Road Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Romy Parker Department of Health and Rehab Sciences, F45 OMB, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa University
Secondary Sponsor Antonia Wadley School of Physiology, Faculty of Health Sciences, 7 York Road, Parktown Johannesburg 2193 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Sarah Cameron Department of Health and Rehab Sciences, F45 OMB, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Antonia Wadley School of Physiology, Faculty of Health Sciences, 7 York Road, Parktown Johannesburg 2196 South Africa
Cameron Reardon Department of Health and Rehab Sciences, F45 OMB, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Romy Parker Department of Health and Rehab Sciences, F45 OMB, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Dershnee Devan School of Physiology, Faculty of Health Sciences, 7 York Road, Parktown Johannesburg 2193 South Africa
Victoria Madden Department of Health and Rehab Sciences, F45 OMB, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Peter Kamerman School of Physiology, Faculty of Health Sciences, 7 York Road, Parktown Johannesburg 2196 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Romy Parker romy.parker@uct.ac.za 27214066431 Department of Health and Rehab Sciences, F45 OMB, Groote Schuur Hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer, School of Physiotherapy, University of Cape Town
Role Name Email Phone Street address
Public Enquiries Antonia Wadley antonia.wadley@wits.ac.za 27117172152 School of Physiology, Faculty of Health Sciences, 7 York Road, Parktown,
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Postdoctoral Fellow
Role Name Email Phone Street address
Scientific Enquiries Romy Parker romy.parker@uct.ac.za 27214066431 Department of Health and Rehab Sciences, F45 OMB, Groote Schuur Hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer, School of Physiotherapy, University of Cape Town
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