Gugulethu Community Health Centre
Cape Town, Western Cape, 7806, South Africa
NCT Number: NCT04781400
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.
Looking for future studies?
Notify Me13 year–24 year
All sexes
Interventional
Not applicable
Cape Town, Western Cape, 7806, South Africa
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Young people living with HIV who meet all of the following criteria will be eligible for inclusion into this study:
Young people living without HIV from the same communities who meet all of the following criteria will be eligible for inclusion into this study:
Exclusion criteria
Young people living with HIV who meet any of the following criteria will be excluded from this study:
Young people living without HIV from the same communities who meet any of the following criteria will be excluded this study:
Mobile phone support (SMS)
ART treatment delivery via a courier service
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.
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)
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.
Time frame: 6 months
Retrospective COVID-19 antibody testing at baseline and month
Time frame: 6 months
Qualitative interviews will be used to inform intervention utility and the development of an intervention to reduce GBV
Desmond Tutu HIV Foundation
Other
Acronym: BUDDY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02447159
Behavior, Blood-Borne Infections
Eket, Akwa Ibom State, Nigeria
View Trial DetailsNCT05168813
Blood-Borne Infections, COVID-19
Gaborone, Botswana
View Trial DetailsNCT04813484
Acceptability of Health Care, Behavior
Ann Arbor, Michigan, United States
View Trial DetailsNCT05028881
Blood-Borne Infections, COVID-19
Hong Kong, China
View Trial Details