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.: PACTR202311618532061 Date of Approval: 21/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating an economic empowerment intervention to improving caregiver wellbeing post-COVID-19
Official scientific title Caregiver wellbeing plus (CWeL+) study: Strengthening the impact of South Africa’s COVID-19 Social Relief of Distress grant: A pilot randomised control trial evaluating a cash transfer plus gender transformative economic empowerment intervention to improve psychological wellbeing and gender equality among unpaid caregivers of children and adolescents living with HIV in KwaZulu-Natal, South Africa
Brief summary describing the background and objectives of the trial Background: COVID-19 has exacerbated the already strained ability of caregivers to provide quality care to children and adolescents living with HIV (CALHIV). South Africa has rolled-out a COVID-19 Social Relief of Distress (SRD) Grant for households in need. Two SAMRC-led trials testing cash transfers (CWEL) and a group-based gender transformative economic empowerment intervention (Stepping Stones Creating Futures- SSCF) showed promise with respect to wellbeing, earnings, and gender attitudes. These interventions could be leveraged to strengthen governments COVID-19 recovery efforts. Research question: Can combining a cash transfer with a group-based economic empowerment intervention strengthen the health and economic outcomes for caregivers of CALHIV? Objective: To evaluate whether a gender transformative economic empowerment intervention when combined with cash improves psychological wellbeing and gender equality among woman caregivers of CALHIV from KwaZulu-Natal, South Africa. Objective: To co-develop and test the feasibility, assess the potential effect sizes, and cost-effectiveness, of a combined cash transfer and gender transformative economic empowerment intervention for improving psychological wellbeing and gender equality among women caregivers of CALHIV in KwaZulu-Natal, South Africa. Methodology: A pilot two-arm cluster randomised trial will be conducted with 20 HIV clinic clusters (10 intervention, 10 control) of 120 caregivers of CALHIV in each arm. The SSCF will be adapted and pre-tested with caregivers. Intervention clusters will receive a monthly cash transfer to the value of the SRD grant ($30 CAD) and the adapted SSCF over a 6-month period. Control clusters will only receive the monthly cash transfer ($30 CAD). Questionnaires will assess pre- and post-intervention psychological wellbeing, intimate partner violence (IPV), depressive symptoms, gender attitudes and earnings.
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 Cash transfer plus gender transformative economic empowerment intervention
Anticipated trial start date 07/06/2023
Actual trial start date 07/06/2023
Anticipated date of last follow up 24/06/2024
Actual Last follow-up date 30/08/2024
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 273
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cash transfer plus gender transformative economic empowerment sessions There are 10 clusters in the intervention, comprising of approximately 12 caregivers in each cluster. Each group receives R350 cash payments each month for 6 months and 10 gender transformative economic empowerment sessions. 6 months The ntervention comprises an unconditional cash incentive (R350 per month for 6 months), and a gender transformative economic empowerment programme . Whereas control arm participants will only receive the cash incentive (R350 per month for 6 months). Each intervention cluster will undergo approximately 10 face-to-face workshops over a 6-month period at our project office. These sessions will be delivered by experienced facilitators in the area of GBV and mental health, using the SSCF manual adapted for caregivers (see Phase 1 of project), which incorporates adult-based participatory learning approaches. Topics will focus on maintaining positive mental health and wellbeing, gender norms and prevention of GBV, managing one’s finances and caregiving of ALHIV, and will be reinforced through mobile short text messaging (SMS) as per the CWEL trial. At the end of each session, participants will receive their cash incentive (R350). This cash payment is unconditional whether or not intervention arm participants attend the programme. The cash transfers to workshop attendees after their session is mainly to assist them in real-time with any complications that might arise with the electronic banking transfer system. 12
Control Group Monthly cash transfers worth R350 for 6 months R350 6 months Participants in the control arm receive their monthly cash incentive (R350). In addition, control arm participants also receive one SMS text message at the beginning of the study encouraging them to access routine public sector healthcare services at their nearest government clinic, where they will have access to health and social services (including social worker, counselling, linkage to care). 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Cluster: • A public sector HIV clinic within the eThekwini municipality Participant: • A female carer (18-58 years of age) caring for a CALHIV aged 5 to 19 years • A female carer (18-58 years of age) receiving child support grant • A caregiver who is currently not receiving the Social Relief of Distress government grant and meets the eligibility criteria for this grant • A caregiver who has access to a mobile phone • Caregiver who is able to provide verbal informed consent. Cluster: • A public sector HIV-clinic currently participating in a mental health or GBV CRT Participant: • A caregiver who is not the primary caregiver of the CALHIV • A caregiver that will be aged 60 years by follow-up and will be receiving state pension or a caregiver receiving state pension at the time of enrolment • A caregiver who is currently receiving a Social Relief of Distress grant, is in full-time employment or whose household income is above average household poverty threshold • A caregiver who is unable to comprehend the nature of the study (during the information session) in either English or isiZulu • A caregiver currently experiencing suicidal ideation, intoxication, and requiring urgent medical attention Adult: 19 Year-44 Year 18 Year(s) 59 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 04/04/2023 SAMRC HUMAN RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive, Parowvallei, 7505, Cape Town Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Psychological wellbeing- percentage change in caregiver wellbeing scores between baseline and endline the intervention versus control arm. 2. Depressive symptoms- percentage change in depressive symptom scores between baseline and endline in the intervention versus control arm 3.Intimate Partner Violence Difference in mean scores at end-line between intervention and control Baseline and Follow up
Secondary Outcome • Gender attitudes- we will use the 10-item Gender Role’s Belief scale that measure individual perceptions about gender roles (Brown and Gladstone, 2012). • Gender equality index- examines self-perceived gender equality in the relationship (e.g. sharing of time and responsibilities for household and work with partner) (Sörlin et al., 2011) • Earnings in the past month- mean log of income generated from paid work at baseline versus end-line in the intervention versus control arm • Economic empowerment- scales addressing financial self-efficacy, savings, control over assets, economic coercion (Yount et al., 2021) • Acceptability: participant’s perceptions on the intervention package and delivery in the intervention versus control arm • Total provider cost related to intervention delivery • Total participant-side cost- total direct and indirect costs associated with caregiving • Average cost per participant with an increase in wellbeing score in each arm Baseline and Follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KwaZulu Natal South Africa Durban Metropolitan area Durban Metropolitan area 4000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
IDRC Canada Canada Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IDRC Women RISE 45 OConnor St, Ottawa, ON K1P 1A4 Canada 1A4 Canada Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Simon Fraser University 8888 University Dr, Burnaby BC V5A1S6 Canada V5A1S6 Canada
Project empower 20 Diakonia Ave Durban 4001 Durban 4001 South Africa
Stellenbosch University 12 Joubert Street Stellenbosch 7600 Cape Town 7600 South Africa
South African Medical Research Council 491 Peter Mokaba Ridge Overport 4001 South Africa
Exeter University Stocker Road, Exeter EX4 4PY England 4PY United Kingdom
University of California San Diego 9500 Gilman Dr, La Jolla, CA 92093 California CA 92093 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Darshini Govindasamy darshini.govindasamy@mrc.ac.za 0219380365 491 Peter Mokaba Ridge
City Postal code Country Position/Affiliation
Overport 4001 South Africa SAMRC
Role Name Email Phone Street address
Scientific Enquiries Stanley Carries stanley.carries@mrc.ac.za +27312034871 491 Peter Mokaba Ridge
City Postal code Country Position/Affiliation
Overport 4001 South Africa SAMRC
Role Name Email Phone Street address
Public Enquiries Nokwanda Sithole nokwanda.sithole@mrc.ac.za 0813042009 491 Peter Mokaba Ridge
City Postal code Country Position/Affiliation
Overport 4001 South Africa SAMRC
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 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). All identifying information such as names, contact details and addresses will be removed. Requests from researchers to access the dataset derived from this study will be 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. Informed Consent Form,Study Protocol As soon as study completes and the data is cleaned Researchers whose study topic is inline with the consent and assent agreement with participants
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 16/11/2023 A comprehensive summary of trial. To co-develop and test the feasibility, assess the potential effect sizes, and cost-effectiveness, of a combined cash transfer and gender transformative economic empowerment intervention for improving psychological wellbeing and gender equality among women caregivers of CALHIV in KwaZulu-Natal, South Africa. Background: COVID-19 has exacerbated the already strained ability of caregivers to provide quality care to children and adolescents living with HIV (CALHIV). South Africa has rolled-out a COVID-19 Social Relief of Distress (SRD) Grant for households in need. Two SAMRC-led trials testing cash transfers (CWEL) and a group-based gender transformative economic empowerment intervention (Stepping Stones Creating Futures- SSCF) showed promise with respect to wellbeing, earnings, and gender attitudes. These interventions could be leveraged to strengthen governments COVID-19 recovery efforts. Research question: Can combining a cash transfer with a group-based economic empowerment intervention strengthen the health and economic outcomes for caregivers of CALHIV? Objective: To evaluate whether a gender transformative economic empowerment intervention when combined with cash improves psychological wellbeing and gender equality among woman caregivers of CALHIV from KwaZulu-Natal, South Africa. Objective: To co-develop and test the feasibility, assess the potential effect sizes, and cost-effectiveness, of a combined cash transfer and gender transformative economic empowerment intervention for improving psychological wellbeing and gender equality among women caregivers of CALHIV in KwaZulu-Natal, South Africa. Methodology: A pilot two-arm cluster randomised trial will be conducted with 20 HIV clinic clusters (10 intervention, 10 control) of 120 caregivers of CALHIV in each arm. The SSCF will be adapted and pre-tested with caregivers. Intervention clusters will receive a monthly cash transfer to the value of the SRD grant ($30 CAD) and the adapted SSCF over a 6-month period. Control clusters will only receive the monthly cash transfer ($30 CAD). Questionnaires will assess pre- and post-intervention psychological wellbeing, intimate partner violence (IPV), depressive symptoms, gender attitudes and earnings.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 21/10/2024 We have now completed the trial, and we did follow up interviews up until 30 August 2024 24 Jun 2024 30 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 21/10/2024 Data collection is officially complete as of 30 September 2024 273
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 21/10/2024 Study is now complete Recruiting Completed