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

NCT ID: NCT05454839

Last Updated: 2024-12-27

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1098 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-08

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Keywords

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HIV antiretroviral treatment differentiated service delivery retention in care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants

Adult patients within 6 months of ART initiation or re-initiation

Survey

Intervention Type OTHER

Interviewer-administered survey

Focus group

Intervention Type OTHER

Focus group for selected participants

Interventions

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Survey

Interviewer-administered survey

Intervention Type OTHER

Focus group

Focus group for selected participants

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Witwatersrand, South Africa

UNKNOWN

Sponsor Role collaborator

Clinton Health Access Initiative Inc.

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sydney Rosen

Role: STUDY_DIRECTOR

Boston University

Locations

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Mhairi Maskew

Johannesburg, Gauteng, South Africa

Site Status

Clinton Health Access Initiative

Lusaka, , Zambia

Site Status

Countries

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South Africa Zambia

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.

Reference Type BACKGROUND
PMID: 32875281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38343769 (View on PubMed)

Benade M, Maskew M, Ntjikelane V, Scott N, Ngcobo N, Nichols B, Malala L, Manganye M, Rosen S. Prior antiretroviral therapy exposure among clients presenting for HIV treatment initiation in South Africa: an exploratory mixed-methods study using multiple indicators of exposure. BMC Infect Dis. 2025 Jul 26;25(1):947. doi: 10.1186/s12879-025-11340-4.

Reference Type DERIVED
PMID: 40713520 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39891834 (View on PubMed)

Other Identifiers

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H-42726

Identifier Type: -

Identifier Source: org_study_id