Clinical trial NCT05454839: Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Official title: Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV
Keywords: HIV
antiretroviral treatment
differentiated service delivery
retention in care
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: University of the Witwatersrand, South Africa
name: Clinton Health Access Initiative Inc.
name: Bill and Melinda Gates Foundation
First posted: 2022-07-12
Enrollment: 1098
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Retention
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Mhairi Maskew
state: Gauteng
city: Lusaka
country: Zambia
facility: Clinton Health Access Initiative
Study officials:
affiliation: Boston University
name: Sydney Rosen
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.