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.: PACTR201502001011149 Date of Approval: 25/01/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of a multimodal approach to managing pain in rural amaXhosa women living with HIV/AIDS compared to a therapeutic relationship
Official scientific title Efficacy of a multimodal approach to managing pain in rural amaXhosa women living with HIV/AIDS compared to a therapeutic relationship
Brief summary describing the background and objectives of the trial Pain is frequently reported in people living with Human Immunodeficiency Virus/Acquired Immune Disease Syndrome (HIV/AIDS). The frequency and severity of these pains have a negative affect on various aspects of life including depression, function, health-related quality of life (HRQoL) and self-efficacy. With HIV/AIDS evolving into a long-standing debilitating disease, and pain currently being undermanaged in people living with HIV/AIDS, these symptoms need to be taken particularly seriously given their effect on HRQoL. Pain is currently being managed in HIV/AIDS by analgesics, cognitive-behavioural therapy, exercise and a recently developed multimodal approach of peer-led exercise and education. A multimodal six-week peer-led exercise and education intervention called ¿Positive Living¿ was effective and feasible in managing pain in South African urban amaXhosa women living with HIV/AIDS in a recent study. However this intervention has had no evaluation in a rural amaXhosa population. This study aims to determine the effect of a multimodal intervention, in comparison to an education intervention or a therapeutic relationship intervention on pain severity, pain interference, symptoms of depression, physical function, HRQoL and self-efficacy in rural amaXhosa women living with HIV/AIDS. The study¿s objectives are to determine the efficacy of these interventions on the above mentioned health-related symptom measures by using the Simmonds Battery of Functional Tests and the Xhosa versions of the Brief Pain Inventory, Beck Depression Inventory, EuroQol QoL Scale, Self-Efficacy for Managing Chronic Disease 6-Item Scale.
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 Treatment: Other
Anticipated trial start date 23/02/2015
Actual trial start date
Anticipated date of last follow up 23/02/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group multimodal group 2 hours, once a week; at week 0,4,8,12,3 months, 6 months, 12 months 6 weeks; over a year education and exercise group; and a therapeutic relationship 24
Experimental Group therapeutic relationship at week 0,4,8,12 and 3 months and 6 months and 12 months over a year therapeutic relationship instilled by the outcome measurer 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any women who is ambulant, HIV+, amaXhosa and aged 18-40 years. Any women who attends Pumalanga or Ngcwanguba clinic for ARV treatment or is being monitored at the clinic. Any women who answers ¿yes¿ to the first question on the Brief Pain Inventory: ¿Throughout our lives most of us have had pain from time to time (such as minor headaches, sprains, toothaches). Have you had pain other than these everyday kinds of pain during the last three months?¿ Any women who is on ARV treatment but has yet not been on his/her present treatment regime consistently for three months. Any women who has previously participated in an education and/or exercise intervention to instill skills for managing pain. Any women who is considered unfit for exercise according to the American College of Sports Medicine (ACSM) guidelines. Any women who has a cognitive impairment or moderate to severe intellectual disability as assessed by medical officer. 18 Year(s) 40 Year(s) Female
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 17/12/2014 University of Cape Town Faculty of Health Science Human Resource Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E52-24 Old Main Building, Groote Schuur, Observatory, 7925 Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain severity (measured by the Brief Pain Inventory 0 weeks 4 weeks 8 weeks 12 weeks 6 months 12 months
Primary Outcome Pain interference, measured by the Brief Pain Inventory 0 weeks 4 weeks 8 weeks 12 weeks 6 months 12 months
Secondary Outcome Symtoms of depression, measured by the Beck Depression Inventory 0 weeks 4 weeks 8 weeks 12 weeks 6 months 12 months
Secondary Outcome Physical function, measured by the Simmonds Battery of Functional Tests 0 weeks 4 weeks 8 weeks 12 weeks 6 months 12 months
Secondary Outcome Health related quality of life, as measured by the EuroQol 0 weeks 4 weeks 8 weeks 12 weeks 6 months 12 months
Secondary Outcome Self-efficacy, measured by the Self-Efficacy for Managing Chronic Diseases 0 weeks 4 weeks 8 weeks 12 weeks 6 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ngcwanguba Clinic N/A (Ncwanguba Village) Mqanduli 5080 South Africa
Pumalanga Clinic N/A (Pumalanga village) Mqanduli 5080 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation Thuthuka Grant Meiring Naude Road, Brummeria Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Foundation Thuthuka Grant Meiring Naude Road, Brummeria Pretoria 0001 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Romy Parker Division of Physiotherapy, Department of Health and Rehabilitation Sciences, F45 Old Main Building, Groote Schuur Hospital, Anzio Road, Observatory Cape Town 7725 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kirsty Jackson kirstynontsikelelojackson@gmail.com 027826849760 1 Budock Rd, Claremont
City Postal code Country Position/Affiliation
Cape Town 7708 South Africa Student and Physiotherapist
Role Name Email Phone Street address
Public Enquiries Kirsty Jackson kirstynontsikelelojackson@gmail.com 027826849760 1 Budock Rd, Claremont
City Postal code Country Position/Affiliation
Cape Town 7708 South Africa Student and Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Kirsty Jackson kirstynontsikelelojackson@gmail.com 027826849760 1 Budock Rd, Claremont
City Postal code Country Position/Affiliation
Cape Town 7708 South Africa Student and Physiotherapist
REPORTING
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