NCT05454839Active, not recruiting
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient's first six months after ART initiation, with about quarter of all patients not retained by the end of month 6. One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity, patient-centered "differentiated service delivery" models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time. This protocol is for the PREFER-South Africa study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-South Africa will collect data on patients' characteristics, clinical and non-clinical needs, and preferences for different types of services during their first six months after initiating ART. The investigators will conduct an observational, prospective cohort survey of newly-initiated or re-initiated adult ART patients at a selected set of 18 healthcare facilities in South Africa. Results are expected to inform the design of better models of service delivery for the early treatment period.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1098 (actual)
- First submitted
- 6 Jul 2022
- Start date
- 8 Sept 2022
- Primary completion date
- 31 May 2024
- Lead sponsor
- Boston University
- Diseases
- HIV
- NCT number
- NCT05454839
What you commit to
- Study type: Observational
- Participants enrolled: 1098
- From 8 Sept 2022 to the primary completion date, 31 May 2024
- 2 sites in 2 countries
- 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.
Other
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff
- Unwilling to take the time required to complete the questionnaire on the day of consent
Who the study is looking for
- Living with HIV and on ART for 0-6 six months at the study site
- ≥ 18 years old (18 and older considered adult for research purposes in South Africa)
- Presented at the study site for routine HIV-related care
- Provide written informed consent to participate.
- For patients providing a dried blood spot specimen, initiating or re-initiating ART at the study enrollment visit.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mhairi Maskew Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Clinton Health Access Initiative Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.