Stigma Management Interventions for HIV
(Yomelela Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve the health and care of people living with HIV by testing different counseling approaches to manage HIV-related stigma. Participants will receive either standard HIV counseling, counseling with self-regulation skills, or counseling with both self-regulation skills and stigma management. The goal is to determine which method best helps people remain in care and adhere to their medication. This trial suits individuals with unsuppressed HIV (not controlled, meaning the virus is still detectable in their blood) who have access to a phone but are not part of an adherence club. As an unphased trial, this study offers a unique opportunity to explore innovative counseling methods that could enhance care and support.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on managing HIV stigma to improve medication adherence, so it's likely you will continue your current HIV treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that behavioral counseling, such as Behavioral Self-Regulation Skills Counseling, is generally safe and well-received. Studies have found it helps people take their medication more regularly when delivered via mobile phone, with no reports of harmful effects. This counseling adapts easily to different cultures and is delivered by trained community members, making it accessible and safe for many communities.
For Behavioral Self-Regulation Skills Counseling combined with Stigma Management, research also supports its safety. Programs aimed at reducing HIV-related stigma have helped patients follow their treatment plans. These methods focus on reducing stigma and improving mental health, both crucial for people living with HIV.
Overall, both types of counseling are non-invasive and mainly involve talking and support. They are designed to help without causing harm, making them a safe option for those considering joining a clinical trial.12345Why are researchers excited about this trial?
Researchers are excited about these interventions because they focus on enhancing HIV care through innovative counseling approaches. The Behavioral Self-Regulation Skills Counseling uses mobile phone-delivered sessions to help patients stick to their HIV treatment by involving culturally tailored support, which is more accessible and personal than traditional methods. Additionally, the version with added Stigma Management directly targets the stigma-related issues that patients face, which is a crucial barrier to effective treatment that standard care doesn't address. These approaches aim to improve patient retention in care and help maintain viral suppression, offering a more holistic and supportive strategy for managing HIV.
What evidence suggests that this trial's treatments could be effective for managing HIV-related stigma?
Research shows that counseling to manage behavior can significantly improve adherence to HIV medication. In this trial, some participants will receive Behavioral Self-Regulation Skills Counseling, which studies have found more effective in helping patients maintain their medication schedules compared to the Uniform Standard of Care Counseling. This counseling also aids in keeping individuals in treatment, crucial for effective HIV management.
Another group in this trial will receive Behavioral Self-Regulation Skills Counseling combined with Stigma Management. Addressing stigma can enhance the counseling's effectiveness. A review found that programs focusing on reducing stigma not only diminish the stigma itself but also improve medication adherence. This approach is particularly beneficial in communities with high HIV stigma, leading to better health outcomes for those living with the virus.26789Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mobile phone-delivered counseling to improve HIV care retention and medication adherence, with some receiving additional stigma management components
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Behavioral Self-Regulation Skills Counseling
- Behavioral Self-Regulation Skills Counseling + Stigma Management
- Uniform Standard of Care Counseling
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Connecticut
Lead Sponsor
Medical Research Council, South Africa
Collaborator