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

Study Overview
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Other: Survey
* Other: Focus group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Adult patients within 6 months of ART initiation or re-initiation | Other: Survey<br>* Interviewer-administered survey<br>Other: Focus group<br>* Focus group for selected participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, antiretroviral treatment, differentiated service delivery, retention in care