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NCT Number: NCT07439003

Behavioral Risk Identification and Decision Guidance for HIV Engagement

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:

* Patient-level preferences, barriers, and facilitators of care during the first six months to help predict interruption risks and develop relevant interventions (PREFER survey, protocol M220440 (Wits HREC), H-42726 (BU IRB) * Predictors of risks of treatment interruption during the early treatment period and characteristics of patients most likely to experience interruptions, with an improved risk assessment approach for use at primary clinic level (PREDICT model, protocol M210472) * Interventions currently available at primary healthcare clinics to improve engagement in care, to match interventions to risks * Current facility compliance with South Africa's 2023 HIV treatment guidelines (FIRST-HIV, protocol 250409) * Provider views of retention in care and potential ways to improve it, to understand facility barriers to implementing guidelines (FIRST-HIV, protocol 250409) * Effectiveness of tracing interventions following an interruption, to optimize tracing procedures once disengagement occurs (GREAT-South Africa, protocol M2409113).

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:

* An updated adherence risk/vulnerability assessment tool for use by clients and providers during consultations to identify clients vulnerable to disengagement from care * A "menu" of available interventions that can be matched to identified vulnerability factors for disengagement and allow patients to choose what they believe will be most effective for them * A "treatment roadmap" to help new and re-starting ART patients understand and adhere to treatment schedules * A WhatsApp based tool, AI Coach, developed by external colleagues to provide confidential and empathetic support and information after treatment initiation. * An improved process for identifying patients eligible for tracing and monitoring tracing results. * A co-designed, user-friendly checklist/job aid to support providers in adhering to the 2023 ART guidelines during early treatment.

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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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Economics and Epidemiology Research Office

Johannesburg, Gauteng, South Africa

Location status: Recruiting

Location contact

Jacqui Miot

CONTACT

[email protected]

27 83 616 0008

Nyasha Mutanda

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1:

  • ≥18 years old at treatment initiation or re-initiation
  • Initiating ART (newly or re-engaging after a period of interruption) or currently receiving ART at one of the participating study sites.

Group 2:

  • Seeking care at an intervention site during their early treatment period
  • Reachable at telephone (mobile) number provided
  • Consented to participate in qualitative data collection

Group 3:

  • Employed by DOH or an implementing partner at a study site
  • Trained and participated in delivering the intervention
  • Consented to participate in qualitative data collection

Exclusion criteria

No exclusion criteria for any group.

Treatment and study plan

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:

  • Risk/vulnerability self-assessment tool
  • Intervention menu
  • Patient roadmap
  • WhatsApp coach
  • Guideline desk reference
  • Tracing job aid

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.

Primary outcomes

  1. Visit attendance

    Time frame: 1-6 months following exposure to retention toolkit

    Attendance at the next visit scheduled to occur after the visit at which participant was exposed to the retention toolkit

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Sande

CONTACT

[email protected]

27 63 115 1952

Mhairi Maskew

CONTACT

[email protected]

27 82 330 9216

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • HE2RO, University of the Witwatersrand

Registry information

Official study title

Behavioral Risk Identification and Decision Guidance for Engagement

Acronym: BRIDGE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Apr 2, 2026

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.

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