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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV I Infection
• Intervention / Treatment: Behavioral: Uniform Standard of Care Counseling; Behavioral: Behavioral Self-Regulation Skills Counseling; Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma Management

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 Type: Interventional
• Enrollment (Actual): 3771
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • University of Connecticut Field Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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: 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
Active Comparator: 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; 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: Medical Research Council, South Africa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: HIV
• Other Study ID Numbers: H19-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No