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Clinical Trials/NCT05110963
NCT05110963
Active, not recruiting
Not Applicable

Intervention to Improve HIV Care Retention and Antiretroviral Adherence in Stigmatized Environments

University of Connecticut2 sites in 1 country3,771 target enrollmentFebruary 1, 2021
ConditionsHIV I Infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV I Infection
Sponsor
University of Connecticut
Enrollment
3771
Locations
2
Primary Endpoint
Medical Records of Care Appointments
Status
Active, not recruiting
Last Updated
8 months ago

Overview

Brief Summary

Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. The proposed study will test theory-based interventions designed to manage HIV stigma in order to improve care retention and medication adherence in communities with high-levels of HIV-related stigma.

Detailed Description

This trial is conducting a randomized test of a behavioral self-management intervention designed to improve HIV treatment outcomes in people living with HIV in stigmatized contexts. The trial includes a control arm and a non-stigma enhanced treatment adherence intervention arm. Participants living in an economically under-resourced area of South Africa are recruited through clinical care settings. The goal of the research is to examine whether directly addressing HIV stigma and medication adherence management improves treatment outcomes beyond those observed from a standard behavioral intervention without added stigma-addressing components.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
November 1, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • current clinic visit to receive cART in differentiated care outside of an adherence club
  • unsuppressed HIV at the most recent clinical testing confirmed in run-in
  • access to a phone

Exclusion Criteria

  • Not meeting inclusion

Outcomes

Primary Outcomes

Medical Records of Care Appointments

Time Frame: 12-months

Medical records are retrospectively collected for all scheduled care visits and coded for whether the visits were attended.The records are exclusively from the clinic where patients are initially recruited and with patient permission. The data obtained are expressed as the ratio of the number of care appointments attended relative to the number scheduled.

Blood Plasma RNA

Time Frame: 12-months

Collection of dried blood spots are tested for HIV RNA (viral load) using PCR tests with results expressed as the number of RNA copies per mL of blood plasma.

Secondary Outcomes

  • Antiretroviral Medication Adherence(12-months)

Study Sites (2)

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