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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG1MD019435-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.
This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months.
In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18-24 months in two 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV.
The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation.
The study duration is two years (about 5-7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 12 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer navigation effectiveness | Other | To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer navigation effectiveness | Behavioral | To determine the effectiveness of peer navigation on viral suppression and retention in care among adolescents living with HIV in South Africa. |
| Measure | Description | Time Frame |
|---|---|---|
| Peer navigation - viral suppression (effectiveness) | To determine the effectiveness of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL <50 copies/ml) over 18 months. | 18 months |
| Peer navigation - retention in care (effectiveness) | To determine the effectiveness of peer navigation on retention among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) over 18 months. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peer navigation - viral suppression (sustainability) | To assess the sustainability of the impact of peer navigation on viral suppression among adolescents living with HIV in South Africa using the endpoint of viral load suppression (VL <50 copies/ml) at 18 and/or 24 months. | 36 months |
| Peer navigation - retention (sustainability) |
| Measure | Description | Time Frame |
|---|---|---|
| Providing long-acting injectable ART and peer navigators | Using the RE-AIM framework, determine the implementation factors involved in providing peer navigation and long-acting injectable ART during adolescent-friendly clinics across multiple settings in South Africa. Based on the implementation science framework RE-AIM, the Reach (enrolment in each region), Effectiveness (viral suppression and retention in care), Adoption (uptake at each regional clinic, acceptability, and feasibility), Implementation (fidelity to protocol) and Maintenance (sustainability and costing) of the interventions will be measured using the implementation strategies of peer navigation and audit and feedback. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Moherndran Archary, MBChB, PhD | Contact | +27834461973 | mo.archary@ahri.org | |
| Leora Sewnarain, HDE | Contact | +27739634573 | leora.sewnarain@ahri.org |
| Name | Affiliation | Role |
|---|---|---|
| Prof Moherndran Archary, MBChB, PhD | Africa Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlotte Maxeke Hospital | Recruiting | Johannesburg | Gauteng | 2001 | South Africa |
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In Stage 1, we will evaluate the peer navigation intervention in a stepped-wedge, cluster-randomised trial.
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To assess the sustainability of the impact of peer navigation on retention in care among adolescents living with HIV in South Africa using the endpoint of retention (at least 1 health care visit in the last 90 days) at 24 months and 36 months. |
| 36 months |
| long-acting injectable ART - acceptability | To identify the preferred user characteristics influencing the acceptability of long-acting injectable ART for adolescents with HIV with a qualitative evaluation of preferred user characteristics. Nine focus group discussions (FGDs) will be conducted with key stakeholders (caregivers of ALHIV, ALHIV ages 12 to less than 19, and adolescent HCWs/policy makers) to identify preferred user characteristics. | 36 months |
| Economic evaluation analysis of providing LAI | The cost analysis and economic impact of long-acting injectable antiretroviral therapy on viral suppression and care retention in adolescents living with HIV and receiving care in South Africa. Average per patient treated per year; average cost per patient retained; average cost per patient virally suppressed; incremental cost per additional person virally suppressed; incremental cost per additional person retained; incremental cost per life year saved (ART) | 36 months |
| Economic evaluation analysis of providing peer navigation | The cost analysis and economic impact of peer navigation on viral suppression and care retention in adolescents living with HIV and receiving care in South Africa. Average per patient treated per year; average cost per patient retained; average cost per patient virally suppressed; incremental cost per additional person virally suppressed; incremental cost per additional person retained; incremental cost per life year saved (ART). | 36 months |
| Cost-effectiveness analyses of providing LAI | A time and motion evaluation will be conducted. The estimated average staff time-spend with patients triangulated with the cost of clinical staff salaries from public sector salaries, the type and number of laboratory tests per patient (patient medical records), and cost per test (National Health Laboratory Service, NHLS). Medication costs will also be monitored (patient medical records, published national drug unit costs), and consumable resources will be used during study procedures (staff interviews, government tenders from the National Department of Health, National Treasury). The total floor space required for the study will be calculated, and a market-related average rental cost per square meter will be applied to estimate the cost of the building. Utility costs will be obtained for the facility and applied by square meter. | 36 months |
| Cost-effectiveness analyses of providing peer navigation | A time and motion evaluation will be conducted. The estimated average staff time-spend with patients triangulated with the cost of clinical staff salaries from public sector salaries, the type and number of laboratory tests per patient (patient medical records), and cost per test (National Health Laboratory Service, NHLS). Medication costs will also be monitored (patient medical records, published national drug unit costs), and consumable resources will be used during study procedures (staff interviews, government tenders from the National Department of Health, National Treasury). The total floor space required for the study will be calculated, and a market-related average rental cost per square meter will be applied to estimate the cost of the building. Utility costs will be obtained for the facility and applied by square meter. | 36 months |
| 36 months |
| Rahima Moosa Mother and Child Hospital | Recruiting | Johannesburg | Gauteng | 2001 | South Africa |
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| Kgabo CHC | Not yet recruiting | Pretoria | Gauteng | 0001 | South Africa |
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| KT Motubatse CHC | Not yet recruiting | Pretoria | Gauteng | 0001 | South Africa |
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| Soshanguve Block JJ | Not yet recruiting | Pretoria | Gauteng | 0001 | South Africa |
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| Soshanguve Block TT | Not yet recruiting | Pretoria | Gauteng | 0001 | South Africa |
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| Cato Manor CHC | Recruiting | Durban | KwaZulu-Natal | 4001 | South Africa |
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| KwaMashu CHC | Recruiting | Durban | KwaZulu-Natal | 4001 | South Africa |
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| Mtubatuba CHC | Recruiting | Mtubatuba | KwaZulu-Natal | 3935 | South Africa |
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| Somkhele CHC | Recruiting | Mtubatuba | KwaZulu-Natal | 3935 | South Africa |
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| Eerste River Hospital | Not yet recruiting | Cape Town | Western Cape | 8001 | South Africa |
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| Michael Mapongwana CHC | Not yet recruiting | Cape Town | Western Cape | 8001 | South Africa |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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