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

Active, not recruiting

• Conditions: HIV
• Interventions: Other: Survey; Other: Focus group

• Registration Number: NCT05454852
• Lead Sponsor: 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-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

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-09-15
• Primary Completion: 2024-05-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 771

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 Zambia)
• Presented at the study site for routine HIV-related care
• Provide written informed consent to participate.

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Survey	Adult patients within 6 months of ART initiation or re-initiation
Participants	Focus group	Adult patients within 6 months of ART initiation or re-initiation

Primary Outcome Measures

Name	Time	Method
Retention	6 months	Not missing a scheduled clinical or medication pickup visit during the first 6 months after treatment initiation by more than 28 days.

Trial Locations

Locations (2)

Mhairi Maskew; 🇿🇦 Johannesburg, Gauteng, South Africa

Clinton Health Access Initiative; 🇿🇲 Lusaka, Zambia