The Retain6 Project

With the advent of universal treatment eligibility (“treat all”) and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient’s first six months after ART initiation, with about quarter of all patients not retained by the end of Month 6.

One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity “differentiated service delivery” models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time. Reconsideration of how best to deliver ART during the first six months is overdue.

The Retain6 project focuses on optimizing the delivery of ART in the first six months after treatment initiation for both naïve and re-initiating patients. Retain 6’s focus countries are South Africa and Zambia. The project is a collaboration among Boston University’s Department of Global Health, the Health Economics and Epidemiology Research Office (HE2RO) in South Africa, and the Clinton Health Access Initiative (CHAI) in Zambia.

During its first phase (Phase 1, 2021-2023), Retain6 attempted to answer research questions such as:

  • What is the pattern of treatment engagement in the first six months? What proportion of patients experience interruptions in care (and when and for how long) and what proportion disengage entirely during this period?
  • How many clinic visits and other healthcare system interactions to patients make during the first six months, and does it align with guidelines?
  • What are the characteristics, needs, and preferences of HIV treatment patients during the early treatment period?
  • What proportion of patients who present for HIV treatment initiation have prior experience on treatment and are in fact re-initiators? Do their characteristics, needs, and/or preferences differ from those of naive initiators?
  • Can we predict which patients are at high risk of treatment interruption?

In Phase 2 (2024-2026), Retain6 is addressing specific topics relevant to the early treatment period and of high priority to each focus country’s Ministry or Department of Health. These include:

South Africa

  • Evaluation of the implementation of South Africa’s revised 2023 guidelines for the early HIV treatment period. The evaluation will focus on assessing the fidelity of guideline implementation at the healthcare facility level, including capturing facility level adaptation and identification of barriers and facilitators to adoption of the revised guidelines. To the extent that data access allows, a secondary goal of the evaluation will be to estimate health outcomes before and after adoption of the new guidelines, including retention in care and viral suppression.
  • Improved risk scoring tools. In Phase 1, Retain6 invested in developing and testing a risk scoring algorithm and scorecard that uses routinely collected clinic data to predict whether any individual client is likely to miss their next scheduled clinic visit and thus target services to them. In Phase 2, we propose to develop this approach (called PREDICT) further using other types of data (e.g. client socioeconomic and behavioral data) and linking the risk profiles identified to a “menu” of risk-appropriate interventions and packages of services. We will also create a “Client Roadmap” that can be given to initiating and re-initiating ART patients to outline the HIV care and service delivery journey and options for the first 6 months on ART.
  • Optimized tracing procedures. A large proportion of clients who interrupt ART have been found to return to care voluntarily within one month of a missed interaction (and most within two weeks). Investing clinic resources in trying to find and bring these patients back into care is not efficient. At the same time, there is no evidence available about what types (characteristics) of patients are more likely to respond positively to a tracing intervention, and those who are not. This activity will will comprise a detailed analysis of tracing of clients during the early treatment period, in order to identify characteristics of clients who should or should not be traced, the optimal timing of tracing interventions for different subgroups, and the characteristics of those most likely to return after tracing.

Zambia

  • Assessment of care for advanced HIV disease (AHD). Throughout the region, 20-30% of individuals continue to present for HIV treatment initiation with advanced HIV disease. There is a dearth of knowledge about the characteristics of patients starting or re-starting treatment AHD, the specific services they receive, and their outcomes on treatment. Phase 2 in Zambia will be mixed methods, cohort study to describe AHD clients’ demographic, social, and economic characteristics and HIV care histories, document services provided and utilized, and estimate 6-month outcomes for these individuals.