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

HIV Clinical Trial

— PREFER-SA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05454839
• Other study ID #: H-42726
• Status: Active, not recruiting
• Start date: September 8, 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1098
• Est. completion date: December 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Survey
Interviewer-administered survey
• Focus group
Focus group for selected participants

Locations

Country	Name	City	State
South Africa	Mhairi Maskew	Johannesburg	Gauteng
Zambia	Clinton Health Access Initiative	Lusaka

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	Bill and Melinda Gates Foundation, Clinton Health Access Initiative-Zambia, University of the Witwatersrand, South Africa

Countries where clinical trial is conducted

South Africa,  Zambia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Not missing a scheduled clinical or medication pickup visit during the first 6 months after treatment initiation by more than 28 days.	6 months