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.: PACTR202203585402090 Date of Approval: 24/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Caregiver wellbeing (CWeL) study
Official scientific title Caregiver wellbeing (CWeL) study: Feasibility, acceptability and preliminary effectiveness of an economic incentive to improve the wellbeing among caregivers of adolescents living with HIV in KwaZulu-Natal, South Africa: a mixed method pilot randomised controlled trial
Brief summary describing the background and objectives of the trial Background: Despite the remarkable progress in the scale-up of anti-retroviral therapy, treatment and mental health outcomes among adolescents living with HIV (ALHIV) in sub-Saharan Africa remain sub-optimal. Positive caregiving is a key predictor of successful health outcomes among ALHIV. However, the ability of caregivers to provide quality care to ALHIV is undermined by their ability to maintain their own wellbeing due to multiple factors (i.e. poverty, stigma, lack of access to social support services). Promotion of caregiver wellbeing could have substantial gains for the health and wellbeing of ALHIV. Economic incentives such as cash incentives combined with SMS reminders have been shown to improve HIV treatment outcomes and wellbeing. However, there is lack of preliminary evidence on the potential of economic incentives to promote caregiver wellbeing in this setting. Aim: To investigate the feasibility, acceptability and preliminary effectiveness of an economic incentive (cash+SMS) for improving wellbeing among caregivers of ALHIV
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CWEL
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Psychosocial
Anticipated trial start date 01/11/2021
Actual trial start date 10/11/2021
Anticipated date of last follow up 25/03/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Closed to recruitment,follow-up continuing
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 Randomised Permuted block randomization Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Economic incentive One a month 3 months Participants in the intervention group will receive an economic incentive package comprising a monthly motivational SMS and cash to the value of ZAR 350 (23 USD) for three months. The SMS will promote key behavioural economic principles (aspiration framing, loss aversion, altruism), aligned to wellbeing dimensions that matter to people in this context. The R350 incentive amount was chosen because it is within the margin of social support grants in South Africa (South African Government, 2021). It will be delivered via electronic local banking services. Participants will have 30 days to claim the receipt of their cash. 50
Control Group Control arm Once 1 month The control group will receive a once-off SMS encouraging access to public health clinic services as per the standard message sent by the Department Health for patients accessing clinic services. Participants in this group will not receive cash. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Caregivers (≥ 18 years of age) of ALHIV aged 10-19 years • Caregiver who has their own personal cellphone • Caregiver who is unable to comprehend the nature of the study (during the information session) in either English or isiZulu • Current suicidal ideation, intoxication, and requiring urgent medical attention* Adult: 19 Year-44 Year 18 Year(s) 80 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 28/09/2021 SAMRC Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive, Parowvallei Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome percentage change in caregiver wellbeing scores between M1 and M5 in the intervention versus control arm month 1 and 3
Secondary Outcome Consent rate: proportion of potentially eligible caregivers approached who consent to participate in the trial. A successful consent rate will be defined at ≥ 80%. M0
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
RICE Clinic RK Khan Hospital 101 Chatsworth Crescent Durban 4030 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Francie van Zilj Drive, Parrowvallei Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council Francie van Zijl Drive, Parrowvallei Cape Town 7505 South Africa Parastatal
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Darshini Govindasamy darshini.govindasamy@mrc.ac.za +2721930365 491 Peter Mokaba Ridge Road, Overport
City Postal code Country Position/Affiliation
Durban 4091 South Africa Specialist Scientist
Role Name Email Phone Street address
Scientific Enquiries Stanley Carries stanley.carries@mrc.ac.za +27312034871 491 Peter Mokaba Ridge Road, Overport
City Postal code Country Position/Affiliation
Durban 4051 South Africa Senior Scientist
Role Name Email Phone Street address
Public Enquiries Zibuyisile Mkhwanazi zibuyisile.mkhwanazi@mrc.ac.za +2131204858 491 Peter Mokaba Ridge Road, Overport
City Postal code Country Position/Affiliation
Durban 4051 South Africa Research Assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will make trial study instruments, datasets and analytical open-access via the SAMRC open access data sharing portal. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol July 2022- for 2 years The final electronic quantitative and qualitative datasets, together with codebooks, STATA do files and questionnaires will be curated and stored in the SAMRC online microdata repository (http://medat.samrc.ac.za/index.php/catalog/HSRU). Requests from researchers to access the dataset derived from this study will be potentially managed by this data repository. Access to the dataset will be limited to researchers whose research topic or analysis plans are compatible with consent and assent agreements from participants.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://medat.samrc.ac.za/index.php/catalog/HSRU No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information