NCT04781400

Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: Desmond Tutu HIV Foundation · Academic / Other
• Sex: All
• Age: 13 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections
• Covid19
• Health Care Utilization
• Gender-based Violence

Interventions

Type	Name	Description
BEHAVIORAL	Mobile phone support	Mobile phone support (SMS)
BEHAVIORAL	Remote service delivery model	ART treatment delivery via a courier service

Timeline

• Start date: 2021-02-08
• Primary completion: 2022-05-13
• Completion: 2022-05-13
• First posted: 2021-03-04
• Last updated: 2022-08-17

Locations

1 site across 1 country: South Africa