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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| HE2RO, University of the Witwatersrand | UNKNOWN |
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Despite much progress towards reaching UNAIDS goals for HIV treatment, disengagement from care remains one of the biggest obstacles to HIV elimination. In many African countries, including South Africa, the early treatment period (first six months after starting or re-starting antiretroviral therapy (ART)) is the interval with the highest risk of treatment interruption and disengagement, but until recently, this period had received relatively little attention from researchers and policy makers. The Retain6 project was launched in 2021 to generate data about the early treatment period, propose potential improvements to guidelines and models of care, and conduct preliminary tests of some potential interventions. Since then, Retain6 has collected detailed data about, among other topics:
Under the proposed BRIDGE (Behavioral Risk Identification and Decision Guidance for Engagement) protocol, the investigators aim to synthesize the data listed above to create and test a client retention toolkit comprising a package of targeted, light-touch interventions that aim to improve outcomes during the early treatment period. The retention toolkit is expected to include:
This package is currently being co-designed with key stakeholders, including the National Department of Health, and is intended to be implemented within the existing systems and require minimal additional resources. On completion of the co-design process, the investigators will conduct a pilot assessment of the retention toolkit to describe acceptability, feasibility, uptake, and preliminary impact on near-term outcomes (attendance at next scheduled visit) at a selected set of primary healthcare clinics in South Africa. The study procedures will combine secondary analysis of de-identified medical record data and qualitative data collection among patients and providers. Data collection will take place during the first half of 2026, with a waiver of consent requested for medical record data and written informed consent for qualitative data collection. The maximum total sample size for the medical record data will be 30,000 patients and for the qualitative data collection will be 180 patients and 90 providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART clients seeking care at study sites | Adult clients initiating ART (newly or re-engaging after a period of interruption) or currently receiving ART at one of the participating study sites |
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| ART clients exposed to intervention | Adult ART clients who were exposed to the intervention during a routine clinic visit |
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| Providers exposed to the intervention | Healthcare service providers at implementation facilities who participated in implementing the intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retention toolkit to improve HIV treatment outcomes during the early treatment period | Behavioral | The proposed retention toolkit to be tested in this study has six components, all of which are intended to be low-cost, light-touch changes to standard of care that are designed to help patients overcome barriers to retention in the early treatment period; can be implemented by existing public sector clinic staff with existing resources; and can be evaluated using a combination of routinely collected medical record data and qualitative surveys. The toolkit will be implemented at facility level, such that all clients seeking relevant services will be exposed to it during the pilot period. The toolkit's components are:
The toolkit will be implemented by facility staff as part of routine care during a pilot program; the study will evaluate its implementation and outcomes. |
| Measure | Description | Time Frame |
|---|---|---|
| Visit attendance | Attendance at the next visit scheduled to occur after the visit at which participant was exposed to the retention toolkit | 1-6 months following exposure to retention toolkit |
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Inclusion Criteria:
Group 1:
Group 2:
Group 3:
Exclusion Criteria:
No exclusion criteria for any group.
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Groups 1 and 2 will comprise ART clients initiating or re-initiating ART or on ART at one of the study sites during the pilot evaluation period. Group 3 will comprise healthcare providers at the study sites who were exposed to the intervention (implemented the retention toolkit).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Sande | Contact | 27 63 115 1952 | lsande@heroza.org | |
| Mhairi Maskew | Contact | 27 82 330 9216 | mmaskew@heroza.org |
| Name | Affiliation | Role |
|---|---|---|
| Sydney Rosen | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Economics and Epidemiology Research Office | Recruiting | Johannesburg | Gauteng | South Africa |
We will post completely anonymized, coded data sets generated by the study to a public repository after all analysis and publication has been completed. Individual transcripts are too identifiable to be posted alone, even if they are deidentified. Data from medical records will not belong to the study team and will not be posted.
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