Stigma Counseling for HIV Prevention

Overseen By Moira Kalichman, MSW

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: HIV positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how stigma and substance use affect the use of PrEP, a medication that helps prevent HIV, among Black sexual minority men. Researchers seek to understand how these factors impact PrEP usage to improve interventions and reduce HIV rates in this community. Participants will receive stigma counseling for PrEP use to address stigma related to PrEP access. Men who identify as Black or from the African diaspora, have engaged in condomless anal sex with another man in the past six months, tested HIV negative, and recently used substances may be a good fit for this study. As an unphased study, this trial offers participants the opportunity to contribute to important research that could lead to better health outcomes in their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that stigma counseling for PrEP use is safe?

Research shows that stigma counseling can increase confidence and willingness to take PrEP (pre-exposure prophylaxis) regularly. As this counseling focuses on behavior rather than medicine, no side effects have been reported, making it generally easy to manage.

The counseling seeks to reduce negative feelings or embarrassment about using PrEP. Currently, no solid evidence indicates risks or side effects from the counseling. It primarily focuses on changing attitudes and providing support for effective PrEP use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stigma counseling for PrEP use because it addresses a critical barrier to HIV prevention that current medical treatments don't tackle directly. While existing options like antiretroviral drugs focus on the biological aspect of preventing HIV, stigma counseling targets the social and psychological hurdles that prevent people from accessing these life-saving medications. This approach could significantly increase the uptake and consistent use of PrEP by empowering individuals to overcome societal stigma, making it a promising complementary strategy in the fight against HIV.

What evidence suggests that stigma counseling is effective for improving PrEP use among Black sexual minority men?

Research has shown that counseling to address stigma can help people use PrEP (a medication to prevent HIV) more effectively. In this trial, participants will receive stigma counseling to improve PrEP access and adherence. Studies have found that stigma around taking PrEP can reduce willingness to use it properly. Stigma counseling addresses these issues, helping people feel more confident about taking PrEP regularly. When taken as directed, PrEP can reduce the risk of HIV infection by up to 99%. Therefore, stigma counseling could play a crucial role in enhancing PrEP's effectiveness by encouraging adherence to the treatment plan. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa A Eaton, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

This trial is for Black men and transwomen over the age of 18, who use substances, have had condomless sex with a man in the past six months, and are HIV negative. Participants must identify as part of the African diaspora and will be tested for recent substance use.

Inclusion Criteria

You have used drugs or alcohol within the past three months.

Positive drug toxicology for substance use

I was assigned male at birth.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PrEP Engagement Counseling

Participants receive evidence-based PrEP engagement counseling to facilitate access to PrEP care

18 months

Every 2 months (psychosocial and health care access assessments), every 3 months (HIV/STI testing and dried blood spot testing)

Follow-up

Participants are monitored for PrEP use, adherence, and persistence through TFV-DP biological testing

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Stigma counseling for PrEP use

Trial Overview The study is examining stigma counseling as an intervention to encourage pre-exposure prophylaxis (PrEP) usage among participants. It aims to understand how stigma and substance use affect PrEP adherence for HIV prevention in this demographic.

How Is the Trial Designed?

Group I: Stigma Counseling for PrEP Access Experimental Treatment 1 Intervention

Behavioral counseling

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Published Research Related to This Trial

A study involving 32 US-based PrEP providers highlighted that barriers such as insurance coverage, provider bias, and stigma significantly limit the uptake and persistence of pre-exposure prophylaxis (PrEP) for HIV prevention.

Providers emphasized the need for clinic-level interventions that normalize PrEP education and services, focusing on patient-centered care and community engagement to effectively address these barriers and improve access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic-Level Strategies for Mitigating Structural and Interpersonal HIV Pre-Exposure Prophylaxis Stigma. Price, DM., Unger, Z., Wu, Y., et al.[2023]

PrEP (pre-exposure prophylaxis) is a safe and effective method for preventing HIV, but stigma surrounding its use significantly hinders interest and uptake, particularly among certain social groups.

Current implementation strategies that focus solely on high-risk groups may reinforce negative stereotypes and stigma, suggesting that more inclusive messaging and integration into healthcare could improve PrEP adoption and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding, Contextualizing, and Addressing PrEP Stigma to Enhance PrEP Implementation. Calabrese, SK.[2021]

A study involving 30 young men who have sex with men (YMSM) in Jackson, Mississippi, identified key factors affecting PrEP uptake and retention, including structural issues like cost, social stigma, and clinical perceptions of side effects.

Despite challenges, many participants reported positive health impacts from PrEP, and outreach efforts were effective, as four out of seven men who initially dropped out of care re-enrolled after interviews, highlighting the importance of ongoing support in maintaining PrEP adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social, structural, behavioral and clinical factors influencing retention in Pre-Exposure Prophylaxis (PrEP) care in Mississippi. Arnold, T., Brinkley-Rubinstein, L., Chan, PA., et al.[2023]

The newly developed PrEP Stigma Scale, tested on a sample of 273 diverse men who have sex with men (MSM), demonstrated high reliability (alpha=0.96), indicating it can effectively measure stigma related to PrEP use.

Identifying two reliable subscales within the PrEP Stigma Scale suggests that understanding specific stigma factors may help address barriers to PrEP adoption among MSM, who are at high risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pre-Exposure Prophylaxis (PrEP) Stigma Scale: Preliminary findings from a pilot study. Klein, H., Washington, TA.[2022]

A study involving 18 early-adopting PrEP prescribers revealed that stigma, both structural and interpersonal, significantly hinders access to HIV pre-exposure prophylaxis (PrEP), particularly for populations with medical mistrust or low health literacy.

Participants suggested that standardizing PrEP service delivery and enhancing cultural competence training for healthcare providers could help address these stigma-related barriers and improve access for marginalized groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considering Stigma in the Provision of HIV Pre-Exposure Prophylaxis: Reflections from Current Prescribers. Calabrese, SK., Tekeste, M., Mayer, KH., et al.[2020]

In a study of 160 PrEP-eligible women aged 18-55 in Philadelphia and New York City, higher levels of PrEP stigma were linked to lower intentions to start PrEP, highlighting a significant barrier to HIV prevention.

Interestingly, HIV stigma did not show a relationship with PrEP initiation intention, suggesting that targeted interventions should focus specifically on reducing PrEP stigma to improve uptake among women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEP Stigma, HIV Stigma, and Intention to Use PrEP among Women in New York City and Philadelphia. Chittamuru, D., Frye, V., Koblin, BA., et al.[2022]

Preexposure prophylaxis (PrEP) is highly effective in preventing HIV infection, but its implementation is hindered by challenges in adherence, access, and social stigma associated with its use.

Stigma surrounding PrEP, linked to perceptions of high-risk behavior and alternative prevention methods, significantly impacts its uptake; addressing these stigmas through targeted health promotion campaigns is essential for improving PrEP acceptance and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis-related stigma: strategies to improve uptake and adherence - a narrative review. Haire, BG.[2020]

A study involving 100 current PrEP users in Birmingham, Alabama found that internalized stigma negatively impacts self-reported adherence to PrEP, suggesting that feelings of shame or embarrassment may hinder effective use of this HIV prevention method.

The research indicates that the relationship between stigma and adherence is mediated by self-efficacy, meaning that individuals who feel more confident in their ability to adhere to PrEP are less affected by stigma, highlighting the need for interventions that boost self-efficacy among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between HIV Pre-exposure Prophylaxis Stigma and Treatment Adherence Among Current HIV Pre-exposure Prophylaxis Users in the Southeastern U.S. Van Gerwen, OT., Yigit, I., Crockett, KB., et al.[2023]

HIV preexposure prophylaxis (PrEP) is highly effective in preventing HIV-1 transmission, but its uptake remains low despite its proven efficacy.

The study aimed to identify barriers and facilitators to prescribing PrEP in a community health clinic, highlighting the need for improved access and awareness to enhance its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Barriers and Facilitators to Prescribing HIV Preexposure Prophylaxis by Primary Care Providers. Kilboy, M., Shihabuddin, C., Morgan, E., et al.[2023]

A new HIV PrEP Stigma Scale (HPSS) was developed and validated among 279 men who have sex with men, showing high internal consistency and better construct validity with the Likert version, which is crucial for understanding stigma's impact on PrEP uptake.

The scale revealed that PrEP stigma accounts for 25% of the variance in willingness to use PrEP, highlighting its significant influence on individuals' decisions to initiate this effective HIV prevention method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the HIV Pre-exposure Prophylaxis Stigma Scale: Performance of Likert and Semantic Differential Scale Versions. Siegler, AJ., Wiatrek, S., Mouhanna, F., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4610795/

Preexposure prophylaxis-related stigma: strategies to ... Despite high levels of efficacy, the implementation of preexposure prophylaxis (PrEP) as a strategy to prevent new HIV infection has been slow.

2. withpower.com withpower.com/trial/stigma-counseling-for-hiv-prevention-c5773

Stigma Counseling for HIV Prevention · Info for Participants Addressing stigma through counseling may improve how people use PrEP by increasing their confidence and willingness to take the medication regularly.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9147022/

Understanding the Association between PrEP Stigma and ... Internalized PrEP stigma has significantly reduced the likelihood of PrEP willingness and PrEP uptake among this group. The trend analysis showed significant ...

4. ajpmonline.org ajpmonline.org/article/S0749-3797(21)00358-5/fulltext

Pre-exposure Prophylaxis Uptake, Adherence, and ... In MSM, ≥4 doses per week has been shown to reduce the risk of HIV infection by 90%. Data are less robust in women, although modeling analyses suggest that as ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0749379721003640

Academic Detailing to Increase Prescribing of HIV Pre ... Pre-exposure prophylaxis (PrEP) decreases HIV incidence by up to 99% when medication adherence is high,1, 2, 3, 4, 5, 6, 7 and HIV incidence is decreasing in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4566537/

How Stigma Surrounding the Use of HIV Preexposure ... Withholding PrEP from an individual on the basis of collective behavior would unfairly penalize individuals for whom PrEP could be an important health resource.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547221000970

The key role of non-medical staff in enhancing HIV ... The limited extant literature on PrEP and HIV stigma among methadone patients shows that PrEP stigma may be a barrier to PrEP uptake and adherence and HIV- ...

8. cdc.gov cdc.gov/hivnexus/hcp/prep/index.html

Clinical Guidance for PrEP | HIV Nexus It may also help patients overcome embarrassment or stigma that could prevent them from disclosing their HIV risk factors.