Treatment AdherencePASEONCT05022706
Pilot Study of a Transition Intervention for ALWH
A study testing Community-based accompaniment and home visits, Directly Observed Therapy and Monthly Peer Support Groups in people with Treatment Adherence, run by Harvard Medical School (HMS and HSDM) at 3 sites in Peru.
Trial summary
The investigators will conduct a pilot study of a community-based intervention designed to improve outcomes among adolescents living with HIV (ALWH) transitioning to adult HIV care in Lima, Peru. Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- Treatment Adherence
- What is being tested?
- Community-based accompaniment and home visits, Directly Observed Therapy and Monthly Peer Support Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesPeru
- Study dates
- 7 Oct 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15 to 21
- HIV-infected and aware of diagnosis
- Currently on or eligible for antiretroviral therapy for HIV, including patients that are lost to treatment follow-up
- Enrolled in HIV care at a participating public sector clinic
- Able to provide informed assent or consent
Who cannot join
- Living outside of Lima Province
Trial locations and contacts
3 sites in 1 country.
Peru3 sites
Hospital Nacional Hipólito Unanue
El Agustino, Lima region, 15007
Hospital Nacional Arzobispo Loayza
Lima Cercado, Lima region, 15082
Instituto Nacional de Salud del Nino
San Borja, Lima region, 15037
About this study
Official title: Accompanying HIV-positive Adolescents Through the Transition Into Adult Care: a Feasibility Study
The investigators will conduct a pilot study of a community-based intervention designed to improve outcomes among adolescents living with HIV (ALWH) transitioning to adult HIV care in Lima, Peru. The investigators will enroll adolescents transitioning to adult HIV care, either due to a recent diagnosis or having aged out of their pediatric clinic. ALWH previously lost from care during the transition process will also be invited to participate. The nine-month intervention will consist of (1) logistical, adherence and social support delivered by entry-level health workers who will accompany adolescents during their transition to adult HIV care and (2) group sessions to improve health-related knowledge, skills, and social support. The investigators will assess intervention feasibility and effectiveness in improving medication adherence, psycho-social outcomes, and transition readiness after 6, 9, and 12 months.
Read the detailed description
Adolescents living with HIV (ALWH) face an elevated risk of poor health outcomes when transitioning into adult-oriented care. Evidence-based interventions to support ALWH during this high-risk period are lacking, especially in Latin America.
The investigators will prospectively enroll adolescents living with HIV into a community-based accompaniment (CBA) intervention to assess the feasibility of the intervention to improve retention with viral load suppression. The intervention will include (a) combined antiretroviral therapy (cART) directly observed therapy (DOT) for participants at risk of or with a history of non-adherence, (b) monthly home visits by trained health promoters to assess adherence and barriers to care and provide social support, (c) ongoing support in navigating the health system, such as accompaniment to appointments and assistance enrolling in public health insurance, and (d) monthly peer support groups. The intervention activities will be delivered more frequently in an intensive phase for 6 months followed by a taper phase for 3 months. The investigators also aim to pilot study procedures relevant to a future trial, including an evaluation of new data collection tools, intervention fidelity assessments, and consent procedures.
Data collection will consist of the use of self-administered questionnaires using RedCap, focus groups with participants, and in-depth interviews with a subset of participants. To examine changes in outcomes throughout the intervention, the investigators will calculate within-person changes from baseline to 6, 9, and 12 months and will use paired t-tests or Wilcoxon signed-rank tests to test whether these quantities differ from zero. The investigators will stratify analyses by early childhood versus recent diagnosis of HIV to understand any differences in effectiveness among subgroups. Data will be analyzed using SAS version 9.4.
- Conditions
- Treatment Adherence
- Being tested
- Community-based accompaniment and home visits, Directly Observed Therapy, Monthly Peer Support Groups
- Keywords
- adolescents, social support, differentiated care, HIV care continuum, key and vulnerable populations
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based accompaniment and home visitsOther
Trained health promoters will accompany adolescents to their first appointments; facilitate enrollment in public health insurance and completion of other administrative requisites (e.g. obtaining a foreign identification card for migrants; transferring to a different health facility); help troubleshoot new logistical and/or social challenges; and will foster communication between the adult care providers and the patient.
Health promoters will visit the participant's home or another mutually-agreed upon location at least monthly, to review ART adherence, identify barriers to care and adherence, remind patients of upcoming medical encounters, screen and follow-up for clinical and social problems, and offer social support.
Directly Observed TherapyBehavioural
Among adolescents who have already initiated combination antiretroviral therapy (cART), directly observed therapy (DOT) will be provided to the subset of adolescents identified as being at high risk of non-adherence, defined by meeting at least one of the following criteria: 1) identified by the pediatric health provider as having unstable adherence; or 2) having a detectable viral load at one of their two previous measurements. In adolescents newly initiating cART, there will not be an adherence precedent. This group will choose whether they wish to receive DOT. As part of this research, trained community health workers (CHWs) will deliver DOT in participant's homes or in a mutually agreed upon location. CHWs will observe ingestion of cART daily, ensure it is taken as prescribed and record each dose as DOT, self-administered, not taken or not prescribed.
Monthly Peer Support GroupsBehavioural
The investigators will assign ALWH to a social support group with 9 to 11 other adolescents also participating in the research. The goal of the social support groups is to provide a venue for participants to share experiences and resources and provide encouragement and support to one another. Each group will last approximately 3 to 4 hours. Support groups will be led by adult peers or trained community health workers. The final group session will incorporate a discussion about the group experience, how it may change behavior, recommendations for improvement, and unmet needs that should be considered for a future intervention.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents living with HIV | Experimental | 1. cART directly observed therapy (DOT) for participants at risk of or with a history of non-adherence
2. monthly home visits by trained health promoters
3. ongoing support in navigating the health system, including accompaniment to appointments and assistance enrolling in public health insurance
4. monthly peer support groups Receives: Other: Community-based accompaniment and home visits; Behavioral: Directly Observed Therapy; Behavioral: Monthly Peer Support Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention: Study refusal rates
The investigators will measure the feasibility of the intervention through acceptability quantitative analyses. These include the study refusal rates (i.e. the proportion of potentially eligible individuals for the study who chose not to participate).
Measured: Baseline
Acceptability and demand of the intervention: Intervention retention rates
The investigators will calculate the intervention retention rates (i.e. the proportion of individuals who were retained in the study) to measure the acceptability and demand of the intervention.
Measured: 12 months
Acceptability of the intervention: Focus groups and in-depth interviews
The investigators will also measure the acceptability of the intervention through qualitative analyses including focus groups and in-depth interviews. Focus groups will be conducted with the participants between month 10 and month 12 of their participation in the intervention. These discussions will explore the perception and acceptance of each component of the intervention and potential future adaptations of the study. The in-depth interviews will be carried out to complement and extend the data collected in focus groups. Open-ended questions will be asked to assess 1) how the CBA intervention was perceived and accepted in each group; 2) any adaptations that would need to be made in future studies, and 3) the varying roles of the treatment supporter during the transition.
Measured: 10 months, 11 months, and 12 months
Demand of the intervention: Group attendance rates
The investigators will assess demand to describe the extent to which the intervention is likely to be used. The investigators will calculate group attendance for study activities. Group attendance will be measured by the proportion of individuals who attended activities, the number of participants who attended at least one session, the median number of groups attended by participants who attended at least one session, the median number of participants per session, and the number of engagements (comments) during virtual sessions.
Measured: 12 months
Evidence of effectiveness of the intervention: combined antiretroviral therapy (cART) adherence
The investigators will assess the evidence of effectiveness through cART adherence. (i.e. three questions to record self-adherence). The three questions will include, "How many days did you miss at least one dose of any of your ART medications?"; "How often did you take your ART medications correctly?" (5-point scale with 5 representing "always" and 1 representing "never"); and "How well would you say you took your HIV medications, as directed by your doctor?" (6-point scale with 6 representing "excellent" and 1 representing "very bad"). The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Measured: Baseline, 6 months, 9 months, and 12 months
Evidence of effectiveness of the intervention: Psychosocial outcomes
The investigators will assess the evidence of effectiveness through psychosocial outcomes including self-efficacy, quality of life, and perceived social and instrumental support. These outcomes will be measured using the NIH toolbox (version 2.0) for ages 18-85 on a 5-point ordinal scale ranging from "never" to "always", with higher scores indicating higher levels. The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Measured: Baseline, 6 months, 9 months, and 12 months
Evidence of effectiveness of the intervention: Transition readiness through "Am I on Trac?"
The investigators will assess transition readiness through "Am I On TRAC?" scales, which consist of knowledge and behavior indices adapted to the local context. The knowledge scale will assess the health condition and general medical self-care of the participant. The behavior scale will measure the frequency with which participants engage in individual health-related behaviors related to transition. The investigators will report the summed score of the subscales. The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Measured: Baseline, 6 months, 9 months, and 12 months
Evidence of effectiveness of the intervention: Transition readiness through Got transition checklist
The investigators will also assess transition readiness through the "Got Transition?" checklist (version 2.0). This checklist will analyze personal health knowledge and use of medical services. The questionnaire has a 3-point scale ranging from "not my responsibility" to "yes, I know this." The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Measured: Baseline, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start7 Oct 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, Partners HealthCare, Socios En Salud Sucursal, Peru, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Molly Franke, Harvard Medical School (HMS and HSDM)
- Investigators
- Molly F Franke, ScD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022706
- Sponsor's protocol ID
- IRB19-0086
- Other IDs
- 5R21AI143365-02
- Acronym
- PASEO
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not release personal information because the small number of patients consecutively enrolled at each facility, could potentially make them identifiable, even in the absence of direct identifiers
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accompanying HIV-positive Adolescents Through the Transition Into Adult Care: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05022706
- Acronym / sponsor ID
- PASEO / IRB19-0086
- Conditions
- Treatment Adherence
- Keywords
- adolescents, social support, differentiated care, HIV care continuum, key and vulnerable populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- University of South Florida, Partners HealthCare, Socios En Salud Sucursal, Peru, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a pilot study of a community-based intervention designed to improve outcomes among adolescents living with HIV (ALWH) transitioning to adult HIV care in Lima, Peru. The investigators will enroll adolescents transitioning to adult HIV care, either due to a recent diagnosis or having aged out of their pediatric clinic. ALWH previously lost from care during the transition process will also be invited to participate. The nine-month intervention will consist of (1) logistical, adherence and social support delivered by entry-level health workers who will accompany adolescents during their transition to adult HIV care and (2) group sessions to improve health-related knowledge, skills, and social support. The investigators will assess intervention feasibility and effectiveness in improving medication adherence, psycho-social outcomes, and transition readiness after 6, 9, and 12 months.
Detailed description
Adolescents living with HIV (ALWH) face an elevated risk of poor health outcomes when transitioning into adult-oriented care. Evidence-based interventions to support ALWH during this high-risk period are lacking, especially in Latin America.
The investigators will prospectively enroll adolescents living with HIV into a community-based accompaniment (CBA) intervention to assess the feasibility of the intervention to improve retention with viral load suppression. The intervention will include (a) combined antiretroviral therapy (cART) directly observed therapy (DOT) for participants at risk of or with a history of non-adherence, (b) monthly home visits by trained health promoters to assess adherence and barriers to care and provide social support, (c) ongoing support in navigating the health system, such as accompaniment to appointments and assistance enrolling in public health insurance, and (d) monthly peer support groups. The intervention activities will be delivered more frequently in an intensive phase for 6 months followed by a taper phase for 3 months. The investigators also aim to pilot study procedures relevant to a future trial, including an evaluation of new data collection tools, intervention fidelity assessments, and consent procedures.
Data collection will consist of the use of self-administered questionnaires using RedCap, focus groups with participants, and in-depth interviews with a subset of participants. To examine changes in outcomes throughout the intervention, the investigators will calculate within-person changes from baseline to 6, 9, and 12 months and will use paired t-tests or Wilcoxon signed-rank tests to test whether these quantities differ from zero. The investigators will stratify analyses by early childhood versus recent diagnosis of HIV to understand any differences in effectiveness among subgroups. Data will be analyzed using SAS version 9.4.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents living with HIV | Experimental | Other: Community-based accompaniment and home visits, Behavioral: Directly Observed Therapy, Behavioral: Monthly Peer Support Groups1. cART directly observed therapy (DOT) for participants at risk of or with a history of non-adherence 2. monthly home visits by trained health promoters 3. ongoing support in navigating the health system, including accompaniment to appointments and assistance enrolling in public health insurance 4. monthly peer support groups |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 15 to 21
- HIV-infected and aware of diagnosis
- Currently on or eligible for antiretroviral therapy for HIV, including patients that are lost to treatment follow-up
- Enrolled in HIV care at a participating public sector clinic
- Able to provide informed assent or consent
Key exclusion criteria (1 listed)
- Living outside of Lima Province
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based accompaniment and home visitsTrained health promoters will accompany adolescents to their first appointments; facilitate enrollment in public health insurance and completion of other administrative requisites (e.g. obtaining a foreign identification card for migrants; transferring to a different health facility); help troubleshoot new logistical and/or social challenges; and will foster communication between the adult care providers and the patient. Health promoters will visit the participant's home or another mutually-agreed upon location at least monthly, to review ART adherence, identify barriers to care and adherence, remind patients of upcoming medical encounters, screen and follow-up for clinical and social problems, and offer social support. | Other | Adolescents living with HIV |
| Directly Observed TherapyAmong adolescents who have already initiated combination antiretroviral therapy (cART), directly observed therapy (DOT) will be provided to the subset of adolescents identified as being at high risk of non-adherence, defined by meeting at least one of the following criteria: 1) identified by the pediatric health provider as having unstable adherence; or 2) having a detectable viral load at one of their two previous measurements. In adolescents newly initiating cART, there will not be an adherence precedent. This group will choose whether they wish to receive DOT. As part of this research, trained community health workers (CHWs) will deliver DOT in participant's homes or in a mutually agreed upon location. CHWs will observe ingestion of cART daily, ensure it is taken as prescribed and record each dose as DOT, self-administered, not taken or not prescribed. | Behavioural | Adolescents living with HIV |
| Monthly Peer Support GroupsThe investigators will assign ALWH to a social support group with 9 to 11 other adolescents also participating in the research. The goal of the social support groups is to provide a venue for participants to share experiences and resources and provide encouragement and support to one another. Each group will last approximately 3 to 4 hours. Support groups will be led by adult peers or trained community health workers. The final group session will incorporate a discussion about the group experience, how it may change behavior, recommendations for improvement, and unmet needs that should be considered for a future intervention. | Behavioural | Adolescents living with HIV |
Primary outcome
Acceptability of the intervention: Study refusal rates
Time frame: Baseline
The investigators will measure the feasibility of the intervention through acceptability quantitative analyses. These include the study refusal rates (i.e. the proportion of potentially eligible individuals for the study who chose not to participate).
Acceptability and demand of the intervention: Intervention retention rates
Time frame: 12 months
The investigators will calculate the intervention retention rates (i.e. the proportion of individuals who were retained in the study) to measure the acceptability and demand of the intervention.
Acceptability of the intervention: Focus groups and in-depth interviews
Time frame: 10 months, 11 months, and 12 months
The investigators will also measure the acceptability of the intervention through qualitative analyses including focus groups and in-depth interviews. Focus groups will be conducted with the participants between month 10 and month 12 of their participation in the intervention. These discussions will explore the perception and acceptance of each component of the intervention and potential future adaptations of the study. The in-depth interviews will be carried out to complement and extend the data collected in focus groups. Open-ended questions will be asked to assess 1) how the CBA intervention was perceived and accepted in each group; 2) any adaptations that would need to be made in future studies, and 3) the varying roles of the treatment supporter during the transition.
Demand of the intervention: Group attendance rates
Time frame: 12 months
The investigators will assess demand to describe the extent to which the intervention is likely to be used. The investigators will calculate group attendance for study activities. Group attendance will be measured by the proportion of individuals who attended activities, the number of participants who attended at least one session, the median number of groups attended by participants who attended at least one session, the median number of participants per session, and the number of engagements (comments) during virtual sessions.
Evidence of effectiveness of the intervention: combined antiretroviral therapy (cART) adherence
Time frame: Baseline, 6 months, 9 months, and 12 months
The investigators will assess the evidence of effectiveness through cART adherence. (i.e. three questions to record self-adherence). The three questions will include, "How many days did you miss at least one dose of any of your ART medications?"; "How often did you take your ART medications correctly?" (5-point scale with 5 representing "always" and 1 representing "never"); and "How well would you say you took your HIV medications, as directed by your doctor?" (6-point scale with 6 representing "excellent" and 1 representing "very bad"). The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Evidence of effectiveness of the intervention: Psychosocial outcomes
Time frame: Baseline, 6 months, 9 months, and 12 months
The investigators will assess the evidence of effectiveness through psychosocial outcomes including self-efficacy, quality of life, and perceived social and instrumental support. These outcomes will be measured using the NIH toolbox (version 2.0) for ages 18-85 on a 5-point ordinal scale ranging from "never" to "always", with higher scores indicating higher levels. The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Evidence of effectiveness of the intervention: Transition readiness through "Am I on Trac?"
Time frame: Baseline, 6 months, 9 months, and 12 months
The investigators will assess transition readiness through "Am I On TRAC?" scales, which consist of knowledge and behavior indices adapted to the local context. The knowledge scale will assess the health condition and general medical self-care of the participant. The behavior scale will measure the frequency with which participants engage in individual health-related behaviors related to transition. The investigators will report the summed score of the subscales. The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Evidence of effectiveness of the intervention: Transition readiness through Got transition checklist
Time frame: Baseline, 6 months, 9 months, and 12 months
The investigators will also assess transition readiness through the "Got Transition?" checklist (version 2.0). This checklist will analyze personal health knowledge and use of medical services. The questionnaire has a 3-point scale ranging from "not my responsibility" to "yes, I know this." The investigators will calculate the within-person change from baseline to 6, 9, and 12 months to examine changes in outcome and determine if the intervention shows promise of success.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No. The investigators will not release personal information because the small number of patients consecutively enrolled at each facility, could potentially make them identifiable, even in the absence of direct identifiers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Molly F Franke, ScD principal investigator
Harvard Medical School (HMS and HSDM)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based accompaniment and home visits, Directly Observed Therapy and Monthly Peer Support Groups in people with Treatment Adherence, run by Harvard Medical School (HMS and HSDM) at 3 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention: Study refusal rates (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.