New study tests simple strategies to keep HIV patients on track
NCT ID NCT05040841
First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study tests different ways to help people with HIV take their medication regularly. Researchers will enroll 534 people starting HIV treatment in Cape Town. They will use a device to track pill-taking and try different outreach methods, like calls or texts, to support adherence. The goal is to see which strategies help more people achieve undetectable virus levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioural intervention (outreach calls, texts, and adherence support)
- What this could lead to
- If successful, this could show which simple, low-cost strategies best help people stay on HIV treatment and keep the virus under control.
- What could go wrong
- This is a behavioral study, not a drug trial, so it won't cure HIV. Results may vary by clinic and may not apply to all settings.
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
-
534 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
-
Jun 2026
- 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
-
16 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 Hide 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 - Main study: * Adults (≥18 years) and adolescents 16-17 years. * HIV-positive and attending a local City of Cape Town (COCT) clinic to commence ART. * Able to provide full informed consent, with a written signature. For those who are illiterate, a witness will be present throughout the process and will sign the form, while the participant will add their right thumb print. For those who are aged 16-17 years, informed written assent will be obtained, and the adolescent must have a parent or guardian who can provide full informed consent (see \*\*below for how parent/guardian is defined for this purpose). * Access to a working cellphone and willingness to receive study-related messaging on that phone. * Willingness to comply with study procedures, including providing regular updates of contact details /locator information, and use a EAM device for the duration of participation. Other Inclusion Criteria: Aim 1: In-depth interviews (IDIs) with subset of trial subjects at baseline and months 12 and 24. * Participation in the main trial. * Self-reported prior experience with substance use, depression, gender inequity, stigma, or transport/clinic issues. Aim 2: Questionnaires and IDIs with staff members at study clinics (three total clinics). * Adults (≥18 years) * Staff at study clinics, providing HIV care and/or treatment. Aim 2: Focus group discussion (FGD) with City of Cape Town officials. * Adults (≥18 years) * Staff at City of Cape Town. Exclusion Criteria - Main study: * Clinical conditions as assessed by the COCT clinic clinicians at first visit e.g. renal disease, which preclude the use of a single tablet regimen (with the exception of those on tuberculosis (TB) treatment who are required to take an extra dose of dolutegravir daily). * Planning to leave Cape Town permanently within the next 24 months. * Being perinatally infected with HIV. Being infected from birth typically means a set of experiences and complications at a young age that require unique and special attention. * If an adolescent, taking their ART medication as a syrup, as they are required to use the electronic adherence monitor (Wisepill device), which is only suitable for tablets. Other Inclusion Criteria: Aim 1: IDIs with trial subjects. • None. Aim 2: Questionnaires and IDIs with staff members at clinics. • None. Aim 2: FGD with City of Cape Town officials. • None.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adherence, medication are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mzamomhle
Cape Town, Western Cape, South Africa
-
Phumlani
Cape Town, Western Cape, South Africa
-
Weltevreden Valley
Cape Town, Western Cape, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Three-Session couples program cut drug use and HIV risk?
- Decades of HIV data could reveal which treatments last
- Can testing together again keep male couples HIV-Free?
- Can a rapid HIV test get people treated sooner?
- Can Same-Day HIV prevention reach people before infection takes hold?
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?