Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

Not Applicable

Recruiting

• Conditions: HIV I Infection

• Registration Number: NCT05110963
• Lead Sponsor: University of Connecticut

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.

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Primary Completion: 2024-06-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. 18 years of age or older
2. current clinic visit to receive cART in differentiated care outside of an adherence club
3. unsuppressed HIV at the most recent clinical testing confirmed in run-in
4. access to a phone

Exclusion Criteria

Not meeting inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medical Records of Care Appointments	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	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 Outcome Measures

Name	Time	Method
Antiretroviral Medication Adherence	12-months	Monthly unannounced phone assessments are used to conduct pill counts of antiretroviral medications. The pill counts are used to calculate the proportion of pills taken relative to the number of pills prescribed over a 30 day period.

Trial Locations

Locations (2)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States

University of Connecticut Field Site; 🇺🇸 Atlanta, Georgia, United States