NCT05040841Completed
Supporting Sustained HIV Treatment Adherence After Initiation
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
The investigators will implement a 24-month fractional factorial design study (Aim 1). The investigators will recruit 510 patients initiating antiretroviral therapy (ART) at three City of Cape Town ART clinics. Each patient will have adherence monitored using the Wisepill® electronic adherence monitoring device (EAM). After eligibility has been confirmed, each participant will be randomized to one of 16 experimental conditions. Each condition includes a unique combination of five adherence intervention components. Three of these components focus on identifying individuals with poor adherence, with increasing degrees of sophistication, with immediate linkage to adherence support. Two components focus on supporting good adherence. They both supplement the existing adherence support program delivered at the study clinics operated by City of Cape Town (standard of care component). Based on Self-Determination Theory, the investigators postulate these intervention components will: 1) enhance feelings of autonomy support, social support, and knowledge; 2) improve motivation and self-competence; and 3) increase ART retention, adherence, and viral suppression. A subset of the participants, as well as clinic staff, will be invited to in-depth interviews to explore mediating factors (Aim 1) and the implementation process (Aim 2); and the data collected in Aims 1 and 2 will be used to explore cost effectiveness (Aim 3).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 534 (actual)
- First submitted
- 1 Sept 2021
- Start date
- 9 Mar 2022
- Primary completion date
- 28 May 2026
- Lead sponsor
- Boston University
- Diseases
- HIV
- NCT number
- NCT05040841
What you commit to
- Study type: Interventional
- Participants enrolled: 534
- From 9 Mar 2022 to the primary completion date, 28 May 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Age
- 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.
Other
- Planning to leave Cape Town permanently within the next 24 months.
- None.
- Aim 2: Questionnaires and IDIs with staff members at clinics. • None.
- Aim 2: FGD with City of Cape Town officials.
- None.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mzamomhle Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Weltevreden Valley Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Phumlani Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.