Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments (Yomelela)

University of Connecticut

Status: Active, not recruiting

Conditions: HIV I Infection

Treatments: Behavioral: Uniform Standard of Care Counseling; Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma Management; Behavioral: Behavioral Self-Regulation Skills Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT05110963

H19-157

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,771 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,771 participants in 3 patient groups, including a placebo group

Uniform Standard of Care Counseling

Placebo Comparator group

Description:

Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence.

Treatment:

Behavioral: Uniform Standard of Care Counseling

Behavioral Self-Regulation Skills Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Behavioral Self-Regulation Skills Counseling

Behavioral Self-Regulation Skills Counseling + Stigma Management

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma Management