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Can a new strategy break the cycle of HIV care dropout?

NCT ID NCT06803316

Knowledge-focused Sponsor: Centre for Infectious Disease Research in Zambia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study aims to develop a program to help people living with HIV in Zambia re-engage with care after they have missed appointments or stopped taking their medication. Many people cycle in and out of HIV care, and returning is a critical moment to prevent future lapses. Researchers will ask patients and healthcare providers about their needs and preferences to design a supportive strategy. The goal is to create a practical intervention that improves long-term retention and health outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A multicomponent reengagement strategy developed through patient and provider input, using human-centered design.
What this could lead to
If successful, this could lead to a practical program that helps people with HIV stay in care after returning, reducing treatment interruptions and improving long-term health.
What could go wrong
This is an early-stage study focused on developing the strategy, not testing its effectiveness. The intervention may not work in real-world settings or may not be feasible across all clinics.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

658 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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 guidelines 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,

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * Pregnant women who meet inclusion criteria * Illiterate participants willing to provide informed consent in Nyanja or Bemba provided there is a witness. Exclusion Criteria: * 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. Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV antiretroviral therapy (ART) adherence

Contacts and locations

Locations

  • Centre for Infectious Disease Research in Zambia (CIDRZ)

    Lusaka, Lusaka Province, 10101, Zambia

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