Stigma Counseling for HIV Prevention

Overseen By Moira Kalichman, MSW

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Connecticut

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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed research aims to assess the multiple forms and paths of stigma and substance use as they relate to pre-exposure prophylaxis (PrEP) use for HIV prevention. How stigma and an evolving public health landscape impact PrEP use among Black sexual minorit men who use substances is unknown. The current application focuses on addressing critical and novel questions to improving the essential building blocks of biomedical prevention approaches by providing crucial information for enhancing interventions to lower HIV prevalence among substance using Black sexual minority men.

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 data supports the effectiveness of stigma counseling for PrEP use in HIV prevention?

Research shows that stigma can negatively impact the use of PrEP, a medication that helps prevent HIV. Addressing stigma through counseling may improve how people use PrEP by increasing their confidence and willingness to take the medication regularly. ^{1 2 3 4 5}

Is stigma counseling for HIV prevention safe for humans?

The research articles reviewed do not provide specific safety data for stigma counseling for HIV prevention or related interventions like PrEP. They focus on stigma and barriers to access rather than safety concerns. ^{2 5 6 7 8}

How does stigma counseling for HIV prevention differ from other treatments?

Stigma counseling for HIV prevention is unique because it focuses on addressing the social and psychological barriers, like stigma, that prevent people from using effective HIV prevention methods such as PrEP (pre-exposure prophylaxis). Unlike traditional medical treatments, this approach aims to improve the uptake and continuation of preventive measures by tackling the stigma associated with them. ^{2 6 7 9 10}

Research Team

Lisa A Eaton, PhD

Principal Investigator

University of Connecticut

Eligibility Criteria

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 am 18 years old or older.

Exclusion Criteria

N/A

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Clinic-Level Strategies for Mitigating Structural and Interpersonal HIV Pre-Exposure Prophylaxis Stigma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Social, structural, behavioral and clinical factors influencing retention in Pre-Exposure Prophylaxis (PrEP) care in Mississippi. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Validation of the HIV Pre-exposure Prophylaxis Stigma Scale: Performance of Likert and Semantic Differential Scale Versions. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Considering Stigma in the Provision of HIV Pre-Exposure Prophylaxis: Reflections from Current Prescribers. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

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

8. New Zealand pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Assessment of Barriers and Facilitators to Prescribing HIV Preexposure Prophylaxis by Primary Care Providers. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

PrEP Stigma, HIV Stigma, and Intention to Use PrEP among Women in New York City and Philadelphia. [2022]