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NCT Number: NCT05454839

Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mhairi Maskew, Johannesburg, Gauteng, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Survey

Other

Interviewer-administered survey

Focus Group

Other

Focus group for selected participants

Primary outcomes

  1. Retention

    Time frame: 6 months

    Not missing a scheduled clinical or medication pickup visit during the first 6 months after treatment initiation by more than 28 days.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Clinton Health Access Initiative Inc.
  • University of Witwatersrand, South Africa

Registry information

Acronym: PREFER-SA

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jul 12, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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