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Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

NCT05110963 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3771

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

  • HIV I Infection

Interventions

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.

Sponsors & Collaborators

  • Medical Research Council, South Africa

    collaborator OTHER

  • University of Connecticut

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2026-06-01
Completion
2026-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110963 on ClinicalTrials.gov