Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments

Not Applicable

Recruiting

• Conditions: HIV I Infection
• Interventions: Behavioral: Uniform Standard of Care Counseling; Behavioral: Behavioral Self-Regulation Skills Counseling + Stigma Management; Behavioral: Behavioral Self-Regulation Skills Counseling

• Registration Number: NCT05110963
• Lead Sponsor: University of Connecticut

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.

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 Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Primary Completion: 2024-06-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uniform Standard of Care Counseling	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 + Stigma Management	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 Self-Regulation Skills Counseling	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.

Primary Outcome Measures

Name	Time	Method
Medical Records of Care Appointments	12-months	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.
Blood Plasma RNA	12-months	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.

Secondary Outcome Measures

Name	Time	Method
Antiretroviral Medication Adherence	12-months	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.

Trial Locations

Locations (2)

University of Connecticut Field Site; 🇺🇸 Atlanta, Georgia, United States

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States