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Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa (PREFER-SA)

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ClinicalTrials.gov Identifier: NCT05454839
Recruitment Status : Not yet recruiting
First Posted : July 12, 2022
Last Update Posted : August 31, 2022
University of the Witwatersrand, South Africa
Clinton Health Access Initiative-Zambia
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Boston University

Brief Summary:

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.

Condition or disease Intervention/treatment
HIV Other: Survey Other: Focus group

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Adult patients within 6 months of ART initiation or re-initiation
Other: Survey
Interviewer-administered survey

Other: Focus group
Focus group for selected participants

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults who have initiated or re-initiated antiretroviral therapy for HIV within 6 months of study enrollment, including the same day.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05454839

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Contact: Sydney Rosen +18572077909 sbrosen@bu.edu
Contact: Mariet Benade mbenade@bu.edu

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South Africa
Mhairi Maskew
Johannesburg, Gauteng, South Africa, 2193
Clinton Health Access Initiative
Lusaka, Zambia
Sponsors and Collaborators
Boston University
University of the Witwatersrand, South Africa
Clinton Health Access Initiative-Zambia
Bill and Melinda Gates Foundation
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Study Director: Sydney Rosen Boston University
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT05454839    
Other Study ID Numbers: H-42726
First Posted: July 12, 2022    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will share anonymized data that are generated by the study. Medical record data will not belong to the study team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
antiretroviral treatment
differentiated service delivery
retention in care