Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

HIV I Infection Clinical Trial

— Yomelela  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05110963
• Other study ID #: H19-157
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2021
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV I Infection

Intervention

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 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 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.

Locations

Country	Name	City	State
United States	University of Connecticut Field Site	Atlanta	Georgia
United States	University of Connecticut	Storrs	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut	Medical Research Council, South Africa

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kalichman SC, Mathews C, Banas E, Kalichman MO. Stigma management intervention to improve antiretroviral therapy adherence: Phase-I test of concept trial, Cape Town South Africa. Glob Public Health. 2019 Aug;14(8):1059-1074. doi: 10.1080/17441692.2018.1552307. Epub 2018 Nov 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Records of Care Appointments	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.	12-months
Primary	Blood Plasma RNA	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.	12-months
Secondary	Antiretroviral Medication Adherence	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.	12-months