Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

NCT05110963 | Active Not Recruiting

• 1 other identifier: H19-157
• Study Type: interventional
• Target: 3,771
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

HIV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Antiretroviral Medication Adherence

  12-months

Study Arms (3)

Uniform Standard of Care Counseling

PLACEBO COMPARATOR

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

Behavioral Self-Regulation Skills Counseling

ACTIVE COMPARATOR

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

Behavioral Self-Regulation Skills Counseling + Stigma Management

EXPERIMENTAL

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

Interventions

Uniform Standard of Care Counseling BEHAVIORAL

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

Uniform Standard of Care Counseling

Behavioral Self-Regulation Skills Counseling BEHAVIORAL

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

Behavioral Self-Regulation Skills Counseling + Stigma Management BEHAVIORAL

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 Self-Regulation Skills Counseling + Stigma Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• current clinic visit to receive cART in differentiated care outside of an adherence club
• unsuppressed HIV at the most recent clinical testing confirmed in run-in
• access to a phone

Sponsors & Collaborators

• University of Connecticut: lead
• Medical Research Council, South Africa: collaborator

Study Sites (2)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

University of Connecticut Field Site

Atlanta, Georgia, 30308, United States

Location

Related 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.

  PMID: 30500309 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study condition masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Behavioral skills training to improve medication adherence

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 8, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)