Optimizing Care Delivery to Support Reengagement in PLWH Returning to HIV Care After Treatment Lapses in Zambia

NCT06803316 | Enrolling By Invitation

• 2 other identifiers: REENGAGEMENT (R34)1R34MH129219-01A1
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

1.0 Introduction The scale-up of human immunodeficiency virus (HIV) treatment services has expanded rapidly in Zambia, facilitated by evolution of the HIV response from centralized services to decentralized care and now towards differentiated service delivery models. Nevertheless, optimal effectiveness remains elusive because timely engagement in care to allow uninterrupted access to antiretroviral therapy (ART) and sustained viral suppression remain incomplete1. Ensuring retention in care is especially relevant since greater numbers of HIV-infected patients are also entering a phase of long-term follow-up. After receiving access to HIV care, a high fraction become lost to follow up with some estimates as high as 25-40%2-5, which is defined as the outcome where the patient has missed their appointment by 30 days and has not died or seeking care at a different healthcare facility, or disengaged from care altogether. Research also suggests that LTFU outcomes are driven by a multitude of factors including structural and clinic-based barriers, individual and community-based barriers. A new generation of innovative interventions is needed to overcome these multifaceted barriers to optimization of the engagement of HIV infected patients with the public health systems that have emerged to serve them. Sustained retention is a critical determinant of viral suppression for PLWH, but treatment interruptions put them at high risk for viremia6-16 and mortality17. Emerging evidence clearly demonstrates that people living with HIV (PLWH) frequently transition in and out of care over time in sub-Saharan Africa6-13,16, and the time of re-engagement in HIV care presents a critical opportunity to break these ongoing cycles of disengagement. Since the presence of specific barriers leads to disengagement from care for some patients, designing strategies targeting these barriers can offer up a natural prospect for ensuring long-term care engagement. It is evident that the strategies required to initiate a patient into care would be markedly different than those to ensure reengagement in care. Even when PLWH return to care after loss to follow-up (LTFU), rates of repeat LTFU in the future are very high18-24. Our preliminary data from Zambia suggests that 30% become LTFU again within 6 months of return, and that 50% of those who are currently LTFU have previously cycled in and out of care5,25. Few interventions have successfully improved return rates among those LTFU9,26,27, but an estimated 50-70% return to care on their own by one year5,28-30. Strategies for intervening at the time of reengagement in care are urgently needed to break these cycles of disengagement in this high-risk population9. To address these knowledge gaps, we seek to engage key stakeholders in developing a reengagement program to address critical barriers to reengagement and strengthen long-term reengagement in care. This reengagement study will provide important direction for furture interventions and studies to formally test this health-system intervention for patients reengaging in HIV care after LTFU. 1.1 Rationale Evidence from our groups as well as throughout Africa highlight the critical needs to strengthen programs for reengagement into HIV care. It is well documented that PLWH frequently transition in and out of care over time in sub-Saharan Africa6-13,16 leading to treatment interruptions that can put them at high risk for viremia6-16 and mortality17. Among those who return to care after loss to follow-up (LTFU), rates of repeat LTFU in the future are also very high18-24 with up to 30% becoming LTFU again within 6 months of return. Additionally, among those who are currently LTFU, 50% have previously cycled in and out of care5,25, indicating missed opportunities to intervene. As an estimated 50-70% of those LTFU return to care on their own by one year5,28-30, strategies for intervening at the time of reengagement in care are very promising to help break these cycles of disengagement in this high-risk population9. 1.2 Research Question What are the most important needs and preferences of patients and providers for a multicomponent reengagement strategy? 2.0 Study Objectives 2.1 Study Specific Aim To develop a reengagement strategy that meets the needs and preferences of patients and providers in public health HIV settings. 2.2 Scientific Objectives The study has three main objectives. These include:

1. 1.Assess patient and provider needs and preferences for reengagement strategies using best-worse scaling experiments.
2. 2.Assess patient and provider needs and preferences for reengagement strategies using qualitative methods.
3. 3.Develop an intervention to optimize the experience of reengagement in HIV care using human-centered design.

Conditions

HIV Antiretroviral Therapy (ART) Adherence

Keywords

HIV; Antiretroviral Therapy (ART); Retention; Reengagement

Outcome Measures

Primary Outcomes (1)

• Retention

  Those who are less than 30 days late to their scheduled appointments and consistently taking their medication

  2022 to 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient Semi-Structured Interviews: We will recruit PLWH (age≥18 years) who reengaged in care within the past 6 months at four health care facilities supported by CIDRZ in Lusaka and subsequently did (n=15) and did not (n=15) remain in care. We will recruit individuals amongst our survey cohort who agreed to be contacted in the future for qualitative interviews. Reengaging in care will be defined as returning to care after being considered LTFU, which is defined as being greater than 30 days late to their last appointment per Zambian HIV guidelines105 and or not having ART drugs for greater than 30 days. Healthcare workers: The target population for this objective are all health care workers involved in delivery HIV care at our study facilities. This includes clinic leadership (i.e., in-charge), medical officers, clinical officers, nurses, lay health care workers, and pharmacists. We use convenience sampling to identify HCW for in-depth interviews (IDIs) (i.e., clinicians, nurses,

You may qualify if:

• Participant must be over 18 years of age.
• Should be LTFU for greater than 30 days or
• Should not have had ART drugs for greater than 30 days;
• Illiterate participants willing to provide informed consent in Nyanja or Bemba provided there is a witness.

You may not qualify if:

• Participant is too sick i.e., failing to talk, general discomfort and emergency cases).
• Participant is unable to provide written informed consent in English, Nyanja or Bemba.
• Participant who is drunk or mentally ill.

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• Washington University School of Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia (CIDRZ)

Lusaka, Lusaka Province, 10101, Zambia

Location

Study Officials

• Izukanji Sikazwe, Medical Officer

  Centre for Infectious Disease Research in Zambia (CIDRZ)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 700 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: August 10, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 2022 - 2025

Locations

ZA (1)