NCT05110963

Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,771 (actual)
• Sponsor: University of Connecticut · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV I Infection

Interventions

Type	Name	Description
BEHAVIORAL	Uniform Standard of Care Counseling	Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence
BEHAVIORAL	Behavioral Self-Regulation Skills Counseling	Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context. This is a culturally tailored adaptation of CDC disseminated Phone-Delivered Support Counseling for HIV treatment Adherence.
BEHAVIORAL	Behavioral Self-Regulation Skills Counseling + Stigma Management	Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory with stigma management to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context with added components directly targeting stigma-related experiences and concerns.

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-06-01
• Completion: 2026-11-01
• First posted: 2021-11-08
• Last updated: 2025-08-29

Locations

2 sites across 1 country: United States