Clinical trial NCT04781400: Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People
Official title: Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Covid19
Health Care Utilization
Gender-based Violence
Lead sponsor: Desmond Tutu HIV Foundation
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
name: Karolinska Institutet
name: University of North Carolina, Chapel Hill
name: University of KwaZulu
First posted: 2021-03-04
Enrollment: 536
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Young people living with HIV who meet all of the following criteria will be eligible for inclusion into this study:

1. Speak isiXhosa and or English, residing in the Khayelitsha /Mitchell's Plain area
2. 13-24 years (inclusive)
3. Willing and able to provide informed telephonic or in person consent
4. 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)
5. 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)

Young people living without HIV from the same communities who meet all of the following criteria will be eligible for inclusion into this study:

1. Speak isiXhosa and or English, residing in the Khayelitsha / Mitchell's Plain area
2. 13-24 years (inclusive)
3. Willing and able to provide informed telephonic or in person consent
4. Has not previously tested positive for HIV and self-reports being HIV negative (i.e., not known to be living with HIV).
5. 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)

Exclusion Criteria:

Young people living with HIV who meet any of the following criteria will be excluded from this study:

1. Not 13-24 years (inclusive)
2. Unwilling or unable to provide informed telephonic or in person consent
3. Not currently receiving ART care at a Desmond Tutu Health Foundation health facility
4. No regular access to a mobile phone with SMS or WhatsApp capacity
5. Planning to relocate in the next 6 months

Young people living without HIV from the same communities who meet any of the following criteria will be excluded this study:

1. Not 13-24 years (inclusive)
2. Unwilling or unable to provide informed telephonic or in person consent
3. Previously tested positive for HIV or is known to be living with HIV
4. No regular access to a mobile phone
5. Planning to relocate in the next 6 months

Primary outcomes:
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.
timeFrame: 6 months
measure: Engagement in HIV care assessed by serial measurements of HIV Viral load.
timeFrame: 6 months
measure: Changes in Gender Based Violence (GBV) incidence as a result of COVID lock-down measures as assessed by self reported surveys.
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of COVID-19 infection by assessing participant IgG antibody levels.
timeFrame: 6 months
measure: Qualitative themes assessed from in-depth individual interview data
timeFrame: 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Gugulethu Community Health Centre
state: Western Cape
Study officials:
affiliation: Desmond Tutu HIV Foundation
name: Linda-Gail Bekker
role: PRINCIPAL_INVESTIGATOR
References: