PrTNER Program for HIV Prevention

(PrTNER Trial)

Recruiting at 1 trial location

Overseen By Renata Sanders, MD

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Transgender, Outside age criteria, others

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

Compensation: Varies

Number of Visits: 4

275 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to prevent and manage HIV among young Black and Latino men who have sex with men. The study tests a program called CC PrTNER, which pairs participants with a peer coach, provides education, and sets health goals to determine if it can increase the use of preventative medication (PrEP) and control viral loads in those with HIV. Suitable candidates are young men aged 15-24 in the Philadelphia or Baltimore areas, who identify as Black or Latino, and are either at risk for HIV or already living with the condition. Participants will also have a history of substance use and engage in certain risk behaviors.

As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for HIV prevention and management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CC PrTNER intervention is safe for young Black and Latino men who have sex with men?

Research shows that the CC PrTNER treatment is safe for participants. In similar programs, such as those for HIV partner services, studies have found a low risk of negative effects. Additionally, relationship-based HIV prevention efforts have succeeded without major safety issues. Although specific safety data for CC PrTNER is not available, evidence from similar treatments suggests it is well-tolerated. This treatment does not involve new drugs or invasive procedures, further indicating a lower risk of harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PrTNER Program for HIV prevention because it integrates a personalized coaching approach along with psychoeducation and health goal setting, which is a new angle compared to traditional methods. Unlike standard care that relies mainly on electronic alerts and provider discretion for support and resources, this program assigns participants a peer coach to offer ongoing guidance and motivation. This personalized touch, coupled with structured behavioral surveys, aims to enhance participant engagement and potentially improve adherence to preventive measures, making it a promising strategy in the fight against HIV.

What evidence suggests that the CC PrTNER intervention is effective for increasing PrEP initiation and decreasing viral load among YBLMSM?

This trial will compare the CC PrTNER program with standard care. Studies have shown that programs like CC PrTNER can help individuals make safer sexual choices, such as using condoms. For instance, programs focusing on relationships have successfully reduced instances of unprotected sex. Research also shows that couple counseling can lower risky behaviors. These programs often include peer support and education, guiding individuals toward safer decisions. Overall, evidence suggests that these methods effectively manage HIV risk and improve health outcomes. ^{4 6 7 8 9}

Who Is on the Research Team?

Renata Sanders, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for young Black and Latino men aged 15-24 who have sex with men, are at risk for HIV or living with HIV/AIDS, and dealing with substance use disorders. Participants should be interested in starting PrEP to prevent HIV or aiming to reduce their viral load if they already have HIV.

Inclusion Criteria

I am a 15-24 year old Black or Latino male, had male-male sex, at HIV risk, not on PrEP, use substances, live near Philadelphia or Baltimore, and speak English.

Aim 2: 15-24 years old cisgender male self-identified Black/African American race or Latino/Hispanic ethnicity report prior oral/anal sex with another male living with a diagnosis of HIV a period of time in the last 6 months not taking oral/injectable ART exactly as prescribed CRAFFT score ≥2 living in Philadelphia, PA or Baltimore, MD, and surrounding areas able to read and write in English

Aim 3: All randomized study participants will be included in Aim 3.

Exclusion Criteria

Aim 2: assigned female sex at birth identify as transgender outside the age criteria (<15 or >24 years old) cognitively unable to complete study requirements living outside of the two geographic areas do not screen positive for SU no prior substance use history no prior oral or anal sex consistent oral/injectable PrEP use the last 6 months or consistent oral/injectable ART use the last 6 months unable to read or write in English plan to move in the next 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys and sample collection

1 visit

1 visit (in-person)

Intervention

Participants in the CC PrTNER arm receive psychoeducation, identify health goals, and are assigned a peer coach. Standard of Care participants receive provider alerts and potential referrals.

12 months

Visits at baseline, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for PrEP uptake, HIV virologic suppression, and substance use outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CC PrTNER

Trial Overview The study is testing a Collaborative Care approach called PrTNER aimed at helping participants start on preexposure prophylaxis (PrEP) if they're at risk of getting HIV, or manage their health better to decrease the viral load if they're already living with HIV.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants randomized to CC PrTNER will be assigned a peer coach, complete interviewer-administered behavioral surveys, receive psychoeducation, identify health goals.

Group II: Standard of Care Active Control 1 Intervention

The participant's provider will receive an electronic alert in real time of the participant's positive screen for SU and a list of area substance treatment resources. The provider at their discretion will provide counseling or initiate a referral to in-clinic or community-based resources for SU assessment and treatment. Each of our clinical sites has case management resources for counseling and support for linkage to co-located SU treatment or community-based resources for inpatient or outpatient SU treatment as indicated at the discretion of the HIV/PrEP provider. SOC arm participants will not be assigned a coach. Study visit surveys and sample collection at baseline, 3, 6, 9, and 12 months are identical for intervention and SOC arm participants. Research personnel will make no attempts to provide brief intervention, motivational interviewing (MI), or case management.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Baltimore City Health Department

Collaborator

Trials

9

Recruited

19,200+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1447878/

The Efficacy of a Relationship-Based HIV/STD Prevention ... These findings show that 6 sessions of a relationship-based HIV/STD prevention intervention were efficacious in reducing the number of unprotected sexual acts ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2729473

Effectiveness of a Couple-Based HIV and Sexually ... Conclusions and Relevance The PACT intervention appeared to reduce risky sexual behaviors, such as condomless intercourse; this finding suggests ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666606523000901

Effectiveness and safety of community-led assisted partner ... We provided evidence that aPS involving CBOs and HIV self-testing is an effective and safe public health intervention for newly or established HIV-diagnosed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3608180/

Effectiveness of Couple-Based HIV Counseling and Testing ... A randomized trial was conducted to test the effectiveness of couple-based HIV counseling and testing (CB-HIV-CT) and women-only relationship-focused HIV ...

5. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(23)00153-5/fulltext

Real-world impact of integrating HIV assisted partner ... We assessed effectiveness outcomes, which consisted of the proportion of male partners newly diagnosed with HIV and the proportion males partners testing for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3954957/

Safety and Acceptability of Couples HIV Testing ... Based on the preliminary data, CHTC is safe for male couples, and it is equally acceptable to iVCT for men who have main partners.

7. cdc.gov cdc.gov/hiv-data/nhss/national-hiv-prevention-and-care-outcomes.html

National HIV Prevention and Care Objectives | HIV Data In 2022, over 80% of people with diagnosed HIV were linked to care within one month of diagnosis. Only 76% had received some care, 54% were retained in care, ...

8. thelancet.com thelancet.com/journals/lanwpc/article/PIIS2666-6065(23)00090-1/fulltext

a multicentre, randomized controlled trial in China The primary outcome was the number of index patients whose any sexual partner tested for HIV during the 6-month study. Completion of HIV testing ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jia2.25314

The power of partners: positively engaging networks ... Low risk of adverse outcomes in an HIV assisted partner services program in Cameroon. J Int AIDS Soc. 2019; 22(S3): e25308. 10.1002/jia2 ...