Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in Zambia
NCT ID: NCT05454852
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
771 participants
OBSERVATIONAL
2022-09-15
2026-12-31
Brief Summary
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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-Zambia study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-Zambia 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 12 healthcare facilities in Zambia. Results are expected to inform the design of better models of service delivery for the early treatment period.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants
Adult patients within 6 months of ART initiation or re-initiation
Survey
Interviewer-administered survey
Focus group
Focus group for selected participants
Interventions
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Survey
Interviewer-administered survey
Focus group
Focus group for selected participants
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years old (18 and older considered adult for research purposes in Zambia)
* Presented at the study site for routine HIV-related care
* Provide written informed consent to participate.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of the Witwatersrand, South Africa
UNKNOWN
Clinton Health Access Initiative Inc.
OTHER
Bill and Melinda Gates Foundation
OTHER
Boston University
OTHER
Responsible Party
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Principal Investigators
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Sydney Rosen
Role: STUDY_DIRECTOR
Boston University
Locations
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Mhairi Maskew
Johannesburg, Gauteng, South Africa
Clinton Health Access Initiative
Lusaka, , Zambia
Countries
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References
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Rosen S, Grimsrud A, Ehrenkranz P, Katz I. Models of service delivery for optimizing a patient's first six months on antiretroviral therapy for HIV: an applied research agenda. Gates Open Res. 2020 Jul 29;4:116. doi: 10.12688/gatesopenres.13159.1. eCollection 2020.
Maskew M, Ntjikelane V, Juntunen A, Scott N, Benade M, Sande L, Hasweeka P, Haimbe P, Lumano-Mulenga P, Shakewelele H, Mukumbwa-Mwenechanya M, Rosen S. Preferences for services in a patient's first six months on antiretroviral therapy for HIV in South Africa and Zambia (PREFER): research protocol for a prospective observational cohort study. Gates Open Res. 2024 Jan 9;7:119. doi: 10.12688/gatesopenres.14682.2. eCollection 2023.
Mutanda N, Morgan A, Kamanga A, Sande L, Ntjikelane V, Maskew M, Haimbe P, Lumano-Mulenga P, Rosen S, Scott N. Experiences and Preferences in Zambia and South Africa for Delivery of HIV Treatment During a Client's First Six Months: Results of the PREFER Study's Cross-Sectional Baseline Survey. AIDS Behav. 2025 Jun;29(6):1713-1728. doi: 10.1007/s10461-025-04640-y. Epub 2025 Feb 1.
Other Identifiers
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H-42903
Identifier Type: -
Identifier Source: org_study_id