Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05110963

Intervention to Improve HIV Care Retention by Addressing Stigma 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV I Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut, Storrs, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

Not meeting inclusion

Treatment and study plan

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

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 + 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.

Primary outcomes

  1. Medical Records of Care Appointments

    Time frame: 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.

  2. Blood Plasma RNA

    Time frame: 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 outcomes

  1. Antiretroviral Medication Adherence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Medical Research Council, South Africa

Registry information

Official study title

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

Acronym: Yomelela

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2021
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.