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A kinder, more personal touch may help people with HIV stay in care — a large trial in zambia puts it to the test

NCT ID NCT07021092

Disease control 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests whether person-centered counseling and community outreach can help people with HIV who have fallen out of care get back on track. Researchers will work with 3,000 patients in Zambia who are late for appointments or missing viral load tests. The goal is to see if building trust and rapport can reduce viremia and improve 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
person-centered counseling and outreach interventions
What this could lead to
If successful, this approach could offer a scalable way to improve HIV care engagement and reduce viremia in hard-to-reach populations.
What could go wrong
This is an early-stage behavioral study without a control group, so it is unclear if the approach will work better than standard care. Results may also vary across different communities.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Patients that are lost to follow up (\[LTFU\] from HIV care i.e. confirmed \>30 days late for a scheduled appointment) at the time of sampling. (i.e. not people who were previously LTFU but then returned and have a documented VL.) 2. Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia) 3. Patients that are 6 months late for a scheduled Viral Load (VL) according to Ministry of Health guidelines at the time of sampling (regardless of care status) 4. Patients that have a last documented VL that is elevated, \> 1000 copies/ml at time of sampling in current clinic population (CCP) (regardless of care status) 5. Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba. Exclusion Criteria: 1. Patients that are unable to provide consent or unwilling to participate in the study 2. Participant who is NOT living with HIV/AIDS; 3. Participant is too sick i.e., failing to talk, general discomfort and emergency cases);

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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 viremia HIV-1-infection

Contacts and locations

Locations

  • Ministry of Health

    Lusaka, Lusaka Province, 10101, Zambia

  • Railway GRZ Urban Health Centre, Kafue District Health Hospital, Nangongwe OPD Urban Health Centre, Chawama 1st level hospital, Chipate 1st level hospital, Matero Reference Health Centre, Mtendere Health Centre, Lwiimba Rural Health Centre

    Lusaka, Lusaka Province, 10101, Zambia

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