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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
| Karolinska Institutet | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| University of KwaZulu |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Remote service delivery model | Active Comparator | Remote service delivery model. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile phone support | Behavioral | Mobile phone support (SMS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of COVID-19 infection by assessing participant IgG antibody levels. | Retrospective COVID-19 antibody testing at baseline and month | 6 months |
| Qualitative themes assessed from in-depth individual interview data |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Linda-Gail Bekker | Desmond Tutu HIV Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gugulethu Community Health Centre | Cape Town | Western Cape | 7806 | South Africa |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086382 | COVID-19 |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| OTHER |
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| Remote service delivery model | Behavioral | ART treatment delivery via a courier service |
|
Qualitative interviews will be used to inform intervention utility and the development of an intervention to reduce GBV
| 6 months |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |