Prevention Ambassadors for HIV Service Engagement

Overseen By Heather Pines

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Formative study participants

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve HIV testing and service use among people who use drugs (PWUD) in Riverside County, California. It collaborates with a local syringe service program to create "Prevention Ambassadors" who will distribute HIV self-testing kits and share information about local HIV services. The trial will evaluate the effectiveness, acceptability, and practicality of this approach. Individuals who have recently used drugs and are open to discussing HIV testing within their social circles may be well-suited for this trial. As an unphased study, this trial provides participants the chance to contribute to innovative strategies that could enhance community health services.

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 the Prevention Ambassadors intervention is safe for promoting HIV testing among people who use drugs?

Research has shown that programs like the Prevention Ambassadors can increase HIV testing among people who use drugs. In this program, trained individuals, called ambassadors, share HIV self-testing kits and information with their friends. Although specific safety data for this program is unavailable, similar programs have been safely used in communities.

The Prevention Ambassadors program focuses on education and peer support, which typically pose very low risks for participants. Since this trial does not involve taking any drugs or undergoing medical procedures, it is considered low-risk. Participants mainly engage in social activities and receive information, which are generally easy to handle. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Prevention Ambassadors" approach because it offers a fresh strategy for engaging individuals in HIV prevention services. Unlike traditional methods that might rely heavily on clinical settings or medical interventions, this approach leverages community-based ambassadors who can connect with individuals on a more personal and relatable level. This method aims to increase awareness and uptake of prevention services by building trust and fostering open communication within communities. By focusing on peer-led engagement, it has the potential to reach populations that are often underserved or hesitant to access conventional healthcare services.

What evidence suggests that the Prevention Ambassadors intervention is effective for promoting HIV testing and service uptake among people who use drugs?

Research has shown that social networks, such as the Prevention Ambassadors program tested in this trial, can increase HIV testing among people who use drugs. In similar programs, peer leadership has made testing more accessible and relatable. Early efforts with these strategies have shown promise in increasing testing and connecting individuals to services. This approach involves peers distributing HIV self-testing kits and sharing information about local services, which has successfully led to more frequent testing and service use in other areas. People are more likely to take action when encouraged by a trusted community member. ^{1 6 7 8 9}

Who Is on the Research Team?

Heather A Pines

Principal Investigator

San Diego State University

Angela R Bazzi

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for people who use drugs (PWUD) in Riverside County, California, and are clients of a syringe service program (SSP). It's designed to help them get tested for HIV and connect with HIV services. The specific eligibility criteria aren't provided here, but typically participants would need to meet certain health conditions and agree to the study procedures.

Inclusion Criteria

Index Participant: Reporting drug use (past month)

Index Participant: Having other people who use drugs (PWUD) in one's social network

Peer-Recruit Participant: Reporting drug use (past 3 months)

Exclusion Criteria

Persons who participated in formative study activities related to the development of the PA intervention will not be eligible to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The Prevention Ambassadors intervention is piloted to promote HIV testing and service uptake among PWUD via peer delivery of HIV self-testing kits

3 months

Follow-up

Participants are monitored for PrEP/ART uptake, HIV testing, and linkage to PrEP/HIV care

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Prevention Ambassadors

Trial Overview The 'Prevention Ambassadors' intervention is being tested. This involves PWUD distributing HIV self-testing kits within their networks alongside information about local HIV services and referrals. The goal is to see if this peer-led approach increases engagement with HIV testing and services.

How Is the Trial Designed?

Group I: SSP Standard of Care Experimental Treatment 1 Intervention

Group II: Prevention Ambassadors Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Dap Health

Collaborator

Trials

1

Recruited

150+

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A pilot training program for 70 healthcare providers in South Africa aimed at improving HIV prevention messaging unexpectedly resulted in a decrease in the delivery of prevention messages to HIV positive patients, with the overall message delivery rate dropping from 56% to 50%.

The training did not significantly affect the delivery of prevention messages to HIV negative patients, who maintained a stable message delivery rate of 32%, suggesting that the training's effectiveness may vary based on patient status and that a more focused approach to messaging could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre/post evaluation of a pilot prevention with positives training program for healthcare providers in North West Province, Republic of South Africa. Kemp, CG., de Kadt, J., Pillay, E., et al.[2020]

The study found that primary peer-referral engagement (PRE) strategies, particularly social network strategies (SNS), were significantly more effective in identifying people with HIV (PWH) who are undiagnosed or out-of-care, recruiting 256.5 individuals compared to only 15 with sexual partner contact tracing (SPCT).

SNS was able to identify a higher number of undiagnosed (32) and out-of-care (159) PWH compared to SPCT, which only identified 2 undiagnosed and 9 out-of-care individuals, highlighting the importance of social networks in engaging at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging social networks for identification of people living with HIV who are virally unsuppressed. Cummins, B., Johnson, K., Schneider, JA., et al.[2023]

Altruism and personal connections to HIV were the primary motivations for healthy volunteers participating in early phase prophylactic HIV vaccine trials, highlighting the importance of emotional and social factors in recruitment.

Effective recruitment strategies included targeting organizations related to HIV and health issues, while resource-efficient methods like word of mouth and direct emails proved more successful than group discussions or broader outreach efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in two phase II prophylactic HIV vaccine trials in the UK. Gray, K., Legg, K., Sharp, A., et al.[2016]

Involving people living with HIV in the redesign of an outpatient clinic in Southern Norway led to significant improvements in service delivery, emphasizing user-defined targets like optimal health and holistic care.

The establishment of a user board was crucial in this process, providing a structured way for service users to influence the clinic's operations and ensuring that their needs were met through actionable points like the introduction of HIV nurse coordinators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

True User Involvement by People Living With HIV is Possible: Description of a User-driven HIV Clinic in Norway. Berg, RC., Gamst, A., Said, M., et al.[2019]

Facilitators of HIV prevention interventions emphasized the importance of specific training related to HIV, including opportunities for observation and mock workshops, which can enhance their effectiveness in delivering interventions.

They identified key characteristics for successful facilitators, such as being open, flexible, and culturally competent, while also noting that addressing the psychosocial challenges faced by low-income participants can complicate the facilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voices from the trenches: facilitators' perspectives on HIV risk reduction interventions. Senn, TE., Carey, MP.[2012]

Eight patient advocates received 18 hours of training in basic counselling skills over 3 months to support users of antiretroviral therapy (ART), showing promising results in several counselling activities.

While the advocates demonstrated acceptable skills in areas like summarizing and encouraging, they needed further training in more complex counselling techniques such as exploring feelings and challenging clients, highlighting areas for improvement in their support roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training lay counsellors to provide psychosocial support to ART users: successes and failures. Kagee, A.[2013]

The MAPPS training program successfully trained HIV-positive peer mentors to effectively deliver a comprehensive behavioral change intervention aimed at increasing engagement in HIV care, demonstrating both feasibility and effectiveness.

Mentors rated the training program highly, and objective assessments showed they could meet the necessary standards for intervention fidelity, indicating that peer-led approaches can be a valuable strategy in promoting patient self-care in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot testing of a standardized training program for a patient-mentoring intervention to increase adherence to outpatient HIV care. Cully, JA., Mignogna, J., Stanley, MA., et al.[2021]

Improving engagement in HIV care is essential for treatment success, as it affects both individual health outcomes and public health efforts.

Key factors influencing engagement include the need for distinct strategies for initial linkage and retention in care, the identification of patients at risk through missed appointments, and the importance of ancillary services in supporting patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving engagement in HIV care: what can we do? Mugavero, MJ.[2008]

The Risk Avoidance Partnership (RAP) project trains active drug users as Peer/Public Health Advocates (PHAs) to implement harm reduction strategies within their social networks, effectively addressing the social context of drug use.

Initial findings indicate that PHAs experience a positive change in their roles and are able to successfully deliver health advocacy interventions in high-risk areas, even without direct support from project staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Risk Avoidance Partnership: Training Active Drug Users as Peer Health Advocates. Weeks, MR., Dickson-Gomez, J., Mosack, KE., et al.[2021]

The enhanced patient care (EPC) intervention significantly improved viral suppression rates among unsuppressed HIV patients in Kenya, achieving 84.4% suppression compared to 64.4% in the standard of care group after 6 months.

Patients receiving EPC, which included provider-patient communication training, had much higher odds of achieving viral suppression (odds ratio = 0.36) compared to those receiving standard care, highlighting the importance of effective communication in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Enhanced Patient Care Intervention on Viral Suppression Among Patients Living With HIV in Kenya. Wachira, J., Genberg, B., Mwangi, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06848686

Prevention Ambassadors: Intervention to Promote HIV ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. reporter.nih.gov reporter.nih.gov/project-details/10453054

Developing and Pilot Testing Peer Ambassador Stories ... This supplement seeks to bolster the parent K23, by developing and pilot testing a “peer ambassador stories” implementation strategy to enhance the reach of ...

3. prepwatch.org prepwatch.org/resources/ambassador-training-package-toolkit/

HIV Prevention Ambassador Training Package and Toolkit The HIV Prevention Ambassador Training Package and Toolkit was created to prepare potential and current PrEP users to be leaders – or “Ambassadors” – in the ...

4. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06848686

Intervention to Promote HIV Service Engagement in the ... This project will develop the SSP-based "Prevention Ambassadors" (PA) intervention to promote HIV testing and service uptake among PWUD.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40882210/

Protocol for Type I Hybrid Implementation Study (Carolinas ... Social network approaches have led to increased HIV testing uptake. Social network interventions that are responsive to individuals' needs among ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8087129/

ID/HIV Physician Ambassadors: Advancing Policy to Improve ... This article discusses the advocacy of ID/HIV physicians and other healthcare professionals in federal health policy.

7. prepwatch.org prepwatch.org/wp-content/uploads/2020/12/HIV_PreventionAmbassadorTraining_Nov2020.pdf

HIV Prevention Ambassador Training Package • Helping Ambassadors to develop their own support networks. • Facilitating community engagement activities with community leaders, health care providers ...

8. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/hiv-aids

UCSD HIV/AIDS Clinical Trials for 2025 — San Diego Prevention Ambassadors: Intervention to Promote HIV Service Engagement in the Networks of SSP Clients. open to eligible people ages 18 years ...

9. publichealth.jmir.org publichealth.jmir.org/2025/1/e69495

An Enhanced Social Network Strategy to Increase the Uptake ... Social network approaches have led to increased HIV testing uptake. Social network interventions that are responsive to individuals' needs among ...