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Stigma Management Interventions for HIV (Yomelela Trial)

N/A
Recruiting
Research Sponsored by University of Connecticut
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Current clinic visit to receive cART in differentiated care outside of an adherence club
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months

Summary

This trial will test interventions to manage HIV stigma in order to improve care retention and medication adherence in communities with high levels of HIV-related stigma.

Who is the study for?
This trial is for adults over 18 with HIV who are not currently in an adherence club but visit a clinic for antiretroviral therapy, have unsuppressed HIV at their latest test, and own a phone. It's not open to those who don't meet these conditions.
What is being tested?
The study tests interventions to manage HIV-related stigma: one group receives Behavioral Self-Regulation Skills Counseling; another gets this plus Stigma Management; and a third gets standard care counseling. The goal is better care retention and medication adherence.
What are the potential side effects?
Since the interventions involve counseling rather than medications, typical drug side effects aren't expected. Participants may experience emotional or psychological discomfort when discussing sensitive topics like stigma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am visiting the clinic for my HIV treatment outside of an adherence club.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Plasma RNA
Medical Records of Care Appointments
Secondary study objectives
Antiretroviral Medication Adherence

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Behavioral Self-Regulation Skills Counseling + Stigma ManagementExperimental Treatment1 Intervention
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.
Group II: Behavioral Self-Regulation Skills CounselingActive Control1 Intervention
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.
Group III: Uniform Standard of Care CounselingPlacebo Group1 Intervention
Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence.

Find a Location

Who is running the clinical trial?

University of ConnecticutLead Sponsor
189 Previous Clinical Trials
159,718 Total Patients Enrolled
Medical Research Council, South AfricaOTHER
72 Previous Clinical Trials
204,026 Total Patients Enrolled

Media Library

Behavioral Self-Regulation Skills Counseling Clinical Trial Eligibility Overview. Trial Name: NCT05110963 — N/A
HIV Research Study Groups: Uniform Standard of Care Counseling, Behavioral Self-Regulation Skills Counseling, Behavioral Self-Regulation Skills Counseling + Stigma Management
HIV Clinical Trial 2023: Behavioral Self-Regulation Skills Counseling Highlights & Side Effects. Trial Name: NCT05110963 — N/A
Behavioral Self-Regulation Skills Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT05110963 — N/A
~253 spots leftby Nov 2025
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