HIV InfectionsBUDDYNCT04781400
Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People
A study testing Mobile phone support and Remote service delivery model in people with HIV Infections and Covid19, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
Trial summary
Sub Saharan Africa is home to only 12% of the population, but accounts for approximately 70% of the global burden of HIV infection and 84% of infections among young people aged 10-24 years. South Africa, which currently has the largest SARS-CoV-2 pandemic in SSA, also has the largest HIV epidemic globally. Read more about this study
- Who is it for?
- Ages 13 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Covid19, Health Care Utilization
- What is being tested?
- Mobile phone support and Remote service delivery model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteSouth Africa
- Study dates
- 8 Feb 2021to 13 May 2022
- 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 13 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young people living with HIV who meet all of the following criteria will be eligible for inclusion into this study:
- Speak isiXhosa and or English, residing in the Khayelitsha /Mitchell's Plain area
- 13-24 years (inclusive)
- Willing and able to provide informed telephonic or in person consent
- Initiated ART at one of two health facilities and are currently in HIV care (i.e. received ART and had a viral load measurement in the past six months)
- Regular access to a mobile phone with SMS or WhatsApp capacity (can include the phone of a parent/caregiver if the participant is <18 years or does not have their own phone)
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- Young people living without HIV from the same communities who meet all of the following criteria will be eligible for inclusion into this study:
- Speak isiXhosa and or English, residing in the Khayelitsha / Mitchell's Plain area
- 13-24 years (inclusive)
- Willing and able to provide informed telephonic or in person consent
- Has not previously tested positive for HIV and self-reports being HIV negative (i.e., not known to be living with HIV).
- Regular access to a mobile phone (can include the phone of a parent/caregiver if the participant is <18 years or does not have their own phone)
Who cannot join
- Young people living with HIV who meet any of the following criteria will be excluded from this study:
- Not 13-24 years (inclusive)
- Unwilling or unable to provide informed telephonic or in person consent
- Not currently receiving ART care at a Desmond Tutu Health Foundation health facility
- No regular access to a mobile phone with SMS or WhatsApp capacity
- Planning to relocate in the next 6 months
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- Young people living without HIV from the same communities who meet any of the following criteria will be excluded this study:
- Not 13-24 years (inclusive)
- Unwilling or unable to provide informed telephonic or in person consent
- Previously tested positive for HIV or is known to be living with HIV
- No regular access to a mobile phone
- Planning to relocate in the next 6 months
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Gugulethu Community Health Centre
Cape Town, Western Cape, 7806
About this study
Sub Saharan Africa is home to only 12% of the population, but accounts for approximately 70% of the global burden of HIV infection and 84% of infections among young people aged 10-24 years. South Africa, which currently has the largest SARS-CoV-2 pandemic in SSA, also has the largest HIV epidemic globally. Access and service delivery barriers to engaging in HIV care have contributed to estimates that only 49% of adolescents (aged 10-19 years) entering care from 2005-2016 have initiated antiretroviral therapy (ART). In response to the SARS-CoV-2 pandemic the South African government has implemented national lock-down orders that we predict will further inhibit treatment engagement among young people. Research is needed to identify best practices for safely retaining young people living with HIV (YPLWH) in care during COVID-19.
Read the detailed description
The primary objectives of this study are to examine the feasibility, acceptability, and preliminary efficacy of a remote service delivery model for young people living with HIV aged 13-24 years that will include a monthly service needs assessment and optional delivery of HIV treatment services. YPLWH will also be randomized to receive (or not receive) mobile check-ins from study staff and access to two-way messaging capabilities to obtain continuous support for adherence to ART and COVID-19 prevention guidelines.
Investigators will also assess the impact of the COVID-19 lock-down orders on multi-level factors (individual, socio-behavioral, structural) over time among young people aged 13-24 years living with HIV (same cohort as above) and without HIV. Particular focus will be given to experience and perpetration of gender based violence. In addition, investigators will assess the impact of multi-level factors on compliance with COVID-19 prevention guidelines, health service utilization, and engagement in HIV care (YPLWH only). Findings will be examined overall and stratified by HIV status and gender.
Ultimately investigators hope to: (i) determine whether a remote service delivery model will help retain young people in HIV care and (ii) Inform the development of an intervention for young people in the study communities who may be experiencing GBV and associated outcomes in the wake of the pandemic.
- Being tested
- Mobile phone support, Remote service delivery model
- Medical subject headings
- HIV Infections, COVID-19, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone supportBehavioural
Mobile phone support (SMS)
Remote service delivery modelBehavioural
ART treatment delivery via a courier service
| Study group | Role | What they receive |
|---|---|---|
| Remote service delivery model PLUS mobile phone support | Experimental | Remote service delivery plus mobile intervention via SMS will include weekly check-ins from study staff, calls from a trained counsellor on request, and access to a two-way messaging feature. Receives: Behavioral: Mobile phone support; Behavioral: Remote service delivery model |
| Remote service delivery model | Active comparator | Remote service delivery model. Receives: Behavioral: Remote service delivery model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of a remote service delivery and mobile support intervention assessed by the number of participants opting in to receive courier delivery of ART.
Program evaluation of a remote service delivery including mobile support intervention and courier delivery of ART amongst young people living with HIV.
Measured: 6 months
Engagement in HIV care assessed by serial measurements of HIV Viral load.
Measurement of HIV viral load will be done at baseline, month three and month six to determine whether adherence to ART has been met (decrease or increase in HIV Viral load)
Measured: 6 months
Changes in Gender Based Violence (GBV) incidence as a result of COVID lock-down measures as assessed by self reported surveys.
Investigate changes in self-reported GBV experience or perpetration, and other individual, social-behavioral, and structural factors that have been impacted by COVID-19 lock down orders.
Measured: 6 months
Secondary outcomes (2)
Incidence of COVID-19 infection by assessing participant IgG antibody levels.
Retrospective COVID-19 antibody testing at baseline and month
Measured: 6 months
Qualitative themes assessed from in-depth individual interview data
Qualitative interviews will be used to inform intervention utility and the development of an intervention to reduce GBV
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start8 Feb 2021
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu HIV Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, Karolinska Institutet, University of North Carolina, Chapel Hill, University of KwaZulu
- Responsible party
- Sponsor
- Investigators
- Linda-Gail Bekker, Principal investigator, Desmond Tutu HIV Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781400
- Sponsor's protocol ID
- 448/2020
- Acronym
- BUDDY
- Status last verified
- Aug 2022
- First submitted
- 22 Feb 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People
- ClinicalTrials.gov ID
- NCT04781400
- Acronym / sponsor ID
- BUDDY / 448/2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Desmond Tutu HIV FoundationUniversity, hospital or other
- Collaborators
- ViiV Healthcare, Karolinska Institutet, University of North Carolina, Chapel Hill, University of KwaZulu
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 4 Mar 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.
Sub Saharan Africa is home to only 12% of the population, but accounts for approximately 70% of the global burden of HIV infection and 84% of infections among young people aged 10-24 years. South Africa, which currently has the largest SARS-CoV-2 pandemic in SSA, also has the largest HIV epidemic globally. Access and service delivery barriers to engaging in HIV care have contributed to estimates that only 49% of adolescents (aged 10-19 years) entering care from 2005-2016 have initiated antiretroviral therapy (ART). In response to the SARS-CoV-2 pandemic the South African government has implemented national lock-down orders that we predict will further inhibit treatment engagement among young people. Research is needed to identify best practices for safely retaining young people living with HIV (YPLWH) in care during COVID-19.
Detailed description
The primary objectives of this study are to examine the feasibility, acceptability, and preliminary efficacy of a remote service delivery model for young people living with HIV aged 13-24 years that will include a monthly service needs assessment and optional delivery of HIV treatment services. YPLWH will also be randomized to receive (or not receive) mobile check-ins from study staff and access to two-way messaging capabilities to obtain continuous support for adherence to ART and COVID-19 prevention guidelines.
Investigators will also assess the impact of the COVID-19 lock-down orders on multi-level factors (individual, socio-behavioral, structural) over time among young people aged 13-24 years living with HIV (same cohort as above) and without HIV. Particular focus will be given to experience and perpetration of gender based violence. In addition, investigators will assess the impact of multi-level factors on compliance with COVID-19 prevention guidelines, health service utilization, and engagement in HIV care (YPLWH only). Findings will be examined overall and stratified by HIV status and gender.
Ultimately investigators hope to: (i) determine whether a remote service delivery model will help retain young people in HIV care and (ii) Inform the development of an intervention for young people in the study communities who may be experiencing GBV and associated outcomes in the wake of the pandemic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote service delivery model PLUS mobile phone support | Experimental | Behavioral: Mobile phone support, Behavioral: Remote service delivery modelRemote service delivery plus mobile intervention via SMS will include weekly check-ins from study staff, calls from a trained counsellor on request, and access to a two-way messaging feature. |
| Remote service delivery model | Active comparator | Behavioral: Remote service delivery modelRemote service delivery model. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Young people living with HIV who meet all of the following criteria will be eligible for inclusion into this study:
- Speak isiXhosa and or English, residing in the Khayelitsha /Mitchell's Plain area
- 13-24 years (inclusive)
- Willing and able to provide informed telephonic or in person consent
- Initiated ART at one of two health facilities and are currently in HIV care (i.e. received ART and had a viral load measurement in the past six months)
Key exclusion criteria (12 listed)
- Young people living with HIV who meet any of the following criteria will be excluded from this study:
- Not 13-24 years (inclusive)
- Unwilling or unable to provide informed telephonic or in person consent
- Not currently receiving ART care at a Desmond Tutu Health Foundation health facility
- No regular access to a mobile phone with SMS or WhatsApp capacity
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 |
|---|---|---|
| Mobile phone supportMobile phone support (SMS) | Behavioural | Remote service delivery model PLUS mobile phone support |
| Remote service delivery modelART treatment delivery via a courier service | Behavioural | Remote service delivery model, Remote service delivery model PLUS mobile phone support |
Primary outcome
Acceptability of a remote service delivery and mobile support intervention assessed by the number of participants opting in to receive courier delivery of ART.
Time frame: 6 months
Program evaluation of a remote service delivery including mobile support intervention and courier delivery of ART amongst young people living with HIV.
Engagement in HIV care assessed by serial measurements of HIV Viral load.
Time frame: 6 months
Measurement of HIV viral load will be done at baseline, month three and month six to determine whether adherence to ART has been met (decrease or increase in HIV Viral load)
Changes in Gender Based Violence (GBV) incidence as a result of COVID lock-down measures as assessed by self reported surveys.
Time frame: 6 months
Investigate changes in self-reported GBV experience or perpetration, and other individual, social-behavioral, and structural factors that have been impacted by COVID-19 lock down orders.
2 secondary outcomes
Incidence of COVID-19 infection by assessing participant IgG antibody levels.
Time frame: 6 months
Qualitative themes assessed from in-depth individual interview data
Time frame: 6 months
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 17 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Linda-Gail Bekker principal investigator
Desmond Tutu HIV Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone support and Remote service delivery model in people with HIV Infections and Covid19, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
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 12 inclusion and 12 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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 a remote service delivery and mobile support intervention assessed by the number of participants opting in to receive courier delivery of ART. (time frame: 6 months). The study lists 3 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 17 Aug 2022.