Healthcare Counseling for HIV Prevention

(SS4SH Trial)

Recruiting at 1 trial location

Overseen By Errol Fields, MD, PhD, MPH

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Not male-self identified

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to connect men who have sex with men (MSM) to HIV prevention and care in Baltimore City. It aims to determine if a peer health navigator (someone who guides and supports participants) is more effective than standard service referrals. Participants will be divided into two groups: one receiving peer navigator support and the other receiving standard referrals. Men who have had sex with another man in the past year and live in Baltimore may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in HIV care and prevention.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on connecting participants with HIV prevention services, so it's unlikely that you would need to stop other medications, but you should confirm with the study team.

What prior data suggests that this healthcare counseling service is safe?

Research has shown that peer support programs for people living with HIV are generally well-received. Studies have found that adding peer support to regular medical care often leads to better health outcomes for those with HIV. These programs help people stay engaged in their care and overcome challenges in accessing treatment.

No direct evidence indicates negative effects from peer support services. The main goal is to help individuals connect to the care they need, such as pre-exposure prophylaxis (PrEP) for preventing HIV. This approach is widely used and considered safe and effective in helping people manage their health.

In summary, peer health support services have proven safe and helpful in connecting people to important HIV care and prevention services. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve HIV prevention through healthcare counseling. Unlike the standard of care, which typically involves just referring individuals to local HIV care sites, this trial tests the impact of peer health navigation. Participants in the intervention group receive personalized support, including weekly follow-ups and assistance in selecting and scheduling appointments at preferred clinics. This approach aims to tackle the barriers to accessing care, particularly in underserved communities, by making the linkage to HIV prevention services more supportive and tailored to individual needs. The trial hopes to uncover whether this method can lead to better engagement and outcomes in HIV prevention.

What evidence suggests that this trial's healthcare counseling services could be effective for HIV prevention?

Research has shown that a peer health navigator can greatly enhance connections to HIV care. In this trial, participants in the intervention group will receive peer health navigation, which has been linked to higher use of PrEP and more consistent HIV care. This method guides individuals through the healthcare system, facilitating appointment attendance and treatment initiation. Early findings suggest it might be more effective than the standard referral process, which participants in the control group will receive. Studies have found that those supported by peers often feel more respected and engage more with care services. ^{3 6 7 8 9}

Who Is on the Research Team?

Errol L Fields, MD, PhD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for men who have sex with men (MSM), aged 18-49, living in Baltimore City. It's designed to help those at risk of HIV by connecting them with healthcare services. Participants must not be currently receiving PrEP or HIV care to qualify.

Inclusion Criteria

I have had sexual relations with a male in the last year.

Ability to read and speak English

Reside in Baltimore City

Exclusion Criteria

I do not identify as male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are assigned to either Arm A (peer health navigator) or Arm B (standard referral) for PrEP or HIV care linkage

6 weeks

Weekly visits (virtual or in-person)

Follow-up

Participants are monitored for retention and effectiveness of care linkage strategies

6 weeks

1 visit (virtual) for status assessment

Evaluation

Assessment of feasibility, effectiveness, and acceptability of the intervention

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthcare counseling service

Trial Overview The study tests if adding a peer health navigator to guide participants through getting pre-exposure prophylaxis (PrEP) or HIV care is more effective than just giving referrals. Participants will be randomly placed into two groups: one receives personal navigation assistance, the other gets referral information only.

How Is the Trial Designed?

Group I: Intervention group receiving peer health navigation follow-up Experimental Treatment 1 Intervention

Participants randomly assigned to Arm A will receive a navigation/care linkage needs assessment followed by peer navigation once weekly after discussing their test results with the navigator to support their linkage to PrEP or HIV care over a six-week period. Navigators will complete the following care linkage steps: 1) assess interest in linkage, 2) identify preferred clinic for care linkage, and 3) assist with scheduling initial PrEP/HIV provider appointment. Additionally, the investigators will use the qualitative data collected from in-depth interviews (IRB00375934) of Black MSM and key informant interviews of care linkage stakeholders on barriers and facilitators to HIV prevention and care linkage strategies to inform the peer navigation that Arm A receives.

Group II: Control group receiving standard of care referral Active Control 1 Intervention

Participants randomly assigned to Arm B will go through the standard of care referral process to a local community site providing PrEP or HIV care after discussing their test results with a navigator. During this discussion with a navigator, participants will receive information about the PrEP/HIV care sites where the participants can go for services. Six weeks following this initial follow-up, participants will meet virtually with the navigator to complete a PrEP/care linkage status assessment to determine if the participants attended the initial PrEP/HIV provider appointment.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8753897/

Exploring peer navigation and support in the quality of HIV ... Peer navigation was positively associated with experiencing more respectful treatment by clinic staff (AOR: 6.65, 95% CI: 2.32–19.02), and ...

2. joghr.org joghr.org/article/28347-results-from-a-peer-based-digital-systems-navigation-intervention-to-increase-hiv-prevention-and-care-behaviors-of-young-trans-women-in-rio-de-janeiro

Results from a peer-based digital systems navigation ... We measured HIV testing, PrEP use and HIV care outcomes. HIV care engagement included linkage to care, visit attendance, antiretroviral therapy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8451756/

Community engagement and linkage to care efforts by peer ... This paper evaluates the impact of outreach activities led by nurse supervised community healthcare workers (CHWs) on the PrEP care cascade.

4. publichealth.jmir.org publichealth.jmir.org/2024/1/e45647

Counseling Supporting HIV Self-Testing and Linkage to Care ... Counseling supporting HIV self-testing (HIVST) is helpful in facilitating linkage to care and promoting behavior changes among men who have sex with men (MSM).

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0252623

The effectiveness of peer-support for people living with HIV Overall, peer-support with routine medical care is superior to routine clinic follow-up in improving outcomes for people living with HIV.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9640407/

A Scoping Review of Peer Navigation Programs for People ... This scoping review maps recent research into peer navigation programs for people living with HIV. Four databases were systematically searched in June 2020.

7. hptn.org hptn.org/sites/default/files/inline-files/15_Lessons%20Learned.pdf

clinical supervision of peer navigators (5, 23) Interventions included screening for HIV, testing for other sexually transmitted infections and risk reduction counseling. Peer navigation served as the ...

8. state.gov state.gov/wp-content/uploads/2024/01/Overcoming-Barriers-to-HIV-Care.pdf

Overcoming Barriers to HIV Care: Findings from a Peer‐ ... Processes evaluated include uptake of CDC and WHO recommended linkage services, and the types and frequencies of barriers that peer counselors identified.

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08042-8

Peers plus mobile app for treatment in HIV (PATH): protocol ... Studies have shown that intervention approaches that involve peer navigation may play an important role in supporting patients to stay engaged ...