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.: PACTR202202748760768 Date of Approval: 28/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title "Fresh start" text messaging to improve return to HIV care for adult patients who are lost to follow-up in the Capricorn District, South Africa.
Official scientific title "Fresh start" text messaging to improve return to HIV care for adult patients who are lost to follow-up in the Capricorn District, South Africa.
Brief summary describing the background and objectives of the trial South Africa has the largest antiretroviral therapy (ART) programme in the world, with an estimated 5.6 million people on ART in 2020. Patient retention is a critical element in ensuring success of ART programmes. Modelling data shows that South Africa is lagging on attaining sufficient ART coverage, the second “95” in the UNAIDS 95-95-95 targets set for 2030. Treatment interruptions are a major contributor to not meeting this target. In Capricorn district, health facility staff begin tracking patients with missed visits via telephone first. If they are unable to get hold of the patient telephonically, ward based outreach teams (WBOTs) conduct home tracing. If a patient is not traced within 3 months, they are classified into the loss to follow-up (LTFU) list, and further tracing is stopped. SMS text messaging using behavioural economic principles is an innovative way to nudge people living with HIV (PLHIV) to return to care, in particular patients classified as LTFU, as there is limited communication with this category of individuals. In this study,we will test whether highlighting temporal landmarks in messaging will increase the number of patients returning to antiretroviral treatment after a treatment interruption of at least 28 days. The primary outcome will be to compare the proportion of adult ART patients re-initiating ART after having missed their last scheduled appointment by more than 28 days across three study groups: Standard of care (SOC) with no SMS message; Standard SMS messaging message at two time points; and Standard SMS message with “fresh start” date at two time points.
Type of trial RCT
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 Re-engagement in care after treatment interruptions
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 9630
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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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
Control Group Behavioural Insights Test Fresh start SMS messaging Telephonic tracing within 2 weeks of missed appointment, home visits following telephonic tracing if patient not successfully reached. Less than 3 months after missed visit The first step is to call the patient via cell phone. At least 3 telephone attempts should be made, and the outcome documented as successful or unsuccessful. If the patient is not reached telephonically, a home visit by the WBOT is conducted. ART patients who have not reported to the health facility for three months since their last visit and not known to be dead or transferred out after 3 months of intensive tracing are classified as LTFU. 3210 Dose Comparison
Experimental Group Behavioural Insights Test Fresh start SMS messaging 1-2 weeks before the temporal landmark; 2-3 days before the temporal landmark Between April and May 2022 In addition to the standard of care (Group 1) that the patient may receive, they will now also receive two SMS messages asking them to return to the clinic. The standard SMS messaging message supports framing adopted by the National Department of Health during their ”Welcome Back” campaign that addresses the barrier of individuals perceiving clinics as being unfriendly and unapproachable. Two messages will be sent approximately 1-2 weeks apart. The first message will be sent approximately 1-2 weeks before a temporal landmark (i.e., public holiday, start of new month). The second message will be sent approximately 2-3 days preceding the temporal landmark or the first day of the month. A basic planning prompt (i.e., Make a note of this) will be included as part of the text message to encourage the patient to follow through on the message. Importantly, the message will be sent around a temporal landmark, yet the message itself will not refer to the temporal landmark. 3210
Experimental Group Behavioural Insights Test Fresh start SMS messaging 1-2 weeks before the temporal landmark; 2-3 days preceding the temporal landmark April 2022- May 2022 In addition to the standard of care (Group 1) that the patient may receive, they will now also receive two SMS messages asking them to return to the clinic highlighting the relevant temporal landmark. This group will be sent the messages on the same dates as those in Group 2 to allow direct comparison and limit the impact of secular changes that may be occurring. That is, the first message will be sent approximately 1-2 weeks before a temporal landmark (i.e., public holiday, start of new month) and the second message will be sent approximately 2-3 days preceding the temporal landmark. These messages while very similar to those in Group 2 but will specifically reference a “fresh start” and highlight the temporal landmark in the message to increase the salience and likelihood that it will act as a turning point in behaviour. As with Group 2, a basic planning prompt (i.e., Make a note of this.) will be included as part of the text message to encourage the patient to follow through on the message. 3210
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All adult patients aged 18 years and above who have previously initiated ART (either first-line or second-line ART) and have missed their last scheduled clinic appointments by more than 28 days. • The study will include patients who are routinely seen at the clinic as well as stable patients who have been enrolled into differentiated care models (decanting). For decanted patients, we will identify the patient’s missed clinic visit. • All patients included into the study must have a documented cell phone number on Tier.Net. • All adult patients who have been documented as transferred out to another clinic. • All adult patients who are documented as deceased. Adult: 19 Year-44 Year 19 Year(s) 100 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
No 07/02/2022 Wits Human research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Wits Health Consortium, 31 Princess of Wales Terrace. Parktown 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of patients re-initiating ART within 45 days of the first SMS text message being sent. 45 days after the first SMS is sent.
Secondary Outcome Not applicable - no secondary outcome is stated in the protocol. We will conduct a multivariable logistic regression with ART re-initiation as the binary outcome (dependent) variable and the following variables as the exploratory (independent) variables: i) study arm; ii) demographic variables- age, sex; iii) treatment characteristics- duration of treatment interruption, ART duration prior to treatment interruption; iv) level of direct service provision- intense vs limited; v) geographical location- sub-district; and vi) clinical variables- last viral load prior to treatment interruption, baseline CD4 count at ART initiation, new ART patient versus treatment experienced patient. Not applicable - analysis will be conducted at the end of the data collection/ cleaning period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Anova Health Institute 12 Sherborne Rd Parktown 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Pennsylvania 3451 Walnut Street Philadelphia 19104 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Pennsylvania 3451 Walnut Street Philadelphia 19104 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Anova Health Institute 12 Sherborne Rd Parktown 2193 South Africa
HE2RO Indlela 39 Empire Road Parktown 2193 South Africa
University of Pennsylvania 3451 Walnut Street Philadelphia 19104 United States of America
Boston University 801 Massachusetts Avenue Boston MA 02118 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kate Rees rees@anovahealth.co.za +27823035855 12 Sherborne Rd
City Postal code Country Position/Affiliation
Parktown 2193 South Africa Public Health Specialist Anova Health Institute
Role Name Email Phone Street address
Public Enquiries Christine Njuguna njugunac@anovahealth.co.za +27722406866 12 Sherborne Road
City Postal code Country Position/Affiliation
Parktown 2193 South Africa Public Health Analyst Anova Health Institute
Role Name Email Phone Street address
Scientific Enquiries Candice Chetty Makkan cchetty@heroza.org +27832892181 39 Empire Road
City Postal code Country Position/Affiliation
Parktown 2193 South Africa Senior Researcher Health Economics and Epidemiology Research Office
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Confidentiality measures will apply to all aspects of the study processes. Privacy and confidentiality will be maintained by ensuring that the messages sent do not include any mention of the patient’s HIV diagnosis or use of ART. To minimize the likelihood of the SMS being read by the wrong recipient, mobile numbers are usually confirmed at each visit. Therefore, the mobile numbers that we will be utilizing will be the most recent ones. Study team members outside of Anova Health Institute will not have any access to information that will identify individual respondents. In addition to data being de-identified, we will also aggregate findings when reporting. Study Protocol All individual de-identified patient level data will be shared with the study team immediately after data collection and then for a period of 15 months. Thereafter the electronic de-identified data will be stored at Anova Health Institute for a period of 5 years before being destroyed. De-identified aggregate data.
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