Transcendent Health for HIV Prevention

Overseen By Michele Ybarra, PhD

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Center for Innovative Public Health Research

Disqualifiers: None

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a text messaging program called Transcendent Health, designed to help prevent HIV among transgender girls and nonbinary youth assigned male at birth. One group will receive messages with information, motivation, and skills for preventing HIV and managing relationships, while another group will receive basic information about HIV prevention and healthy living. The researchers aim to determine if these messages can effectively encourage safer behaviors on a large scale. Ideal participants are non-cisgender youth, aged 14-18, who speak English and have a cell phone with unlimited texting. As an unphased trial, this study provides a unique opportunity to contribute to innovative prevention strategies tailored for transgender and nonbinary youth.

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 this intervention is safe for HIV prevention?

Research shows that PrEP (pre-exposure prophylaxis) effectively prevents HIV when taken as directed and has been found safe for most people. This suggests that similar methods, such as the Transcendent Health program, might also be safe.

While specific safety data for Transcendent Health is not available, the success of PrEP provides some confidence in this approach. Additionally, the Transcendent Health program uses text messaging, a safe and non-invasive method that does not cause physical harm. However, the exact safety details remain unknown, so please consider this when deciding to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transcendent Health program because it offers a fresh approach to HIV prevention through a text messaging-based intervention. Unlike standard treatments that focus on medication, this program emphasizes education and empowerment by providing information, motivation, and skills for preventing HIV. Additionally, it includes guidance on maintaining healthy relationships and addressing gender-related issues, which are not typically covered in traditional prevention methods. This holistic, personalized delivery method is designed to engage users over a 5-month period, potentially leading to more effective and lasting behavioral changes compared to conventional approaches.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that preventive measures can lower the risk of sexually transmitted infections (STIs), including HIV, by 41%. This conclusion arises from combining results from various studies. The Transcendent Health program is being tested in this trial with two different arms. The Information, Motivation, and Skills arm uses text messages to share information and skills for preventing HIV, focusing on motivation and behavior skills to encourage safer practices. The Information Only arm provides information about HIV prevention and aspects of a healthy adolescent lifestyle. Studies have found that programs like these can help reduce risky behaviors linked to HIV. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for transgender girls and nonbinary youth assigned male at birth who are interested in a program aimed at preventing HIV. Specific eligibility criteria details are not provided, so it's best to contact the study organizers for more information.

Inclusion Criteria

I was assigned male at birth and now identify as a different gender.

Youth will have access to the Internet to complete online surveys

Youth will intend to have the same cell number for the next 6 months

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a text messaging-based program focusing on HIV prevention, healthy relationships, and gender-related issues

5 months

Follow-up

Participants are monitored for HIV testing and PrEP usage after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Transcendent Health

Trial Overview

The intervention being tested is called 'Transcendent Health,' which may influence HIV preventive behavior among participants. The goal is to see if this program can be scaled up effectively on a larger scale if successful.

How Is the Trial Designed?

Group I: Information, Motivation and Skills arm Experimental Treatment 1 Intervention

Text messaging-based program that lasts 5 months. Content includes information, motivation and behavioral skills about how to prevent HIV, as well as information about healthy and unhealthy romantic relationships, and navigating issues related to one's gender.

Group II: Information Only arm Placebo Group 1 Intervention

Text messaging-based program that lasts 5 months. Content includes information about HIV prevention and aspects of a healthy adolescent lifestyle (e.g., self-esteem).

Who Is Running the Clinical Trial?

Center for Innovative Public Health Research

Lead Sponsor

Trials

11

Recruited

8,100+

Ann &amp; Robert H. Lurie Children&#39;s Hospital of Chicago

Collaborator

Trials

1

Recruited

200+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Ann and Robert H Lurie Childrens Hospital of Chicago

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

The study involved 12 individuals diagnosed with HIV or AIDS, focusing on their experiences of hope despite engaging in high-risk behaviors after their diagnosis.

Participants identified various sources of hope, which can inform treatment approaches for newly diagnosed individuals who may be at risk, emphasizing the importance of understanding personal experiences in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding hope in the face of an HIV diagnosis and high-risk behaviors. Harris, GE., Larsen, D.[2008]

Offering hope to clients, especially those in extreme poverty, is crucial as it can combat feelings of hopelessness and promote healthier behaviors.

Hope has been linked to positive health outcomes, such as better nutrition, regular exercise, safer sexual practices, quitting smoking, and adherence to medication, highlighting its importance in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health in hope: finding the soul of primary care. Long, T.[2018]

The study developed a method to extract comprehensive drug safety information from adverse event narratives using natural language processing (NLP), analyzing 3723 narratives from the Korea Adverse Event Reporting System (KAERS) between 2015 and 2019.

The KAERS-BERT model achieved high performance in extracting relevant data, improving data completeness by an average of 3.24% in structured fields, indicating that enhanced NLP techniques can significantly improve the quality of drug safety information in spontaneous reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques. Kim, S., Kang, T., Chung, TK., et al.[2023]

The Holistic Health Recovery Program for HIV+ (HHRP+) can potentially avert up to 29,000 HIV infections among people who inject drugs (PWID) over 10 years, with a cost-effectiveness of $7,777 per quality-adjusted life year (QALY) gained.

The abbreviated Holistic Health for HIV (3H+) program is slightly more cost-effective at $7,707/QALY and could avert 19,000 infections, highlighting that both programs effectively reduce HIV incidence not only in PWID but also in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of brief and expanded evidence-based risk reduction interventions for HIV-infected people who inject drugs in the United States. Song, DL., Altice, FL., Copenhaver, MM., et al.[2023]

The 3H+ intervention, a simplified version of the Holistic Health Recovery Program (HHRP+), is being tested in a non-inferiority randomized controlled trial to see if it can effectively reduce HIV risk behaviors and improve adherence to antiretroviral therapy (ART) among HIV-infected people who use drugs (PWUDs).

If the 3H+ intervention is found to be comparable and more cost-effective than the original HHRP+, it could be easily implemented in addiction treatment settings, addressing a significant gap in HIV prevention efforts for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-inferiority trial of an evidence-based secondary HIV prevention behavioral intervention compared to an adapted, abbreviated version: Rationale and intervention description. Shrestha, R., Krishnan, A., Altice, FL., et al.[2020]

Only 38% of the 345 transwomen surveyed in Rio de Janeiro were aware of PrEP, but a significant 76.4% of those who identified as HIV-negative expressed willingness to use it, highlighting a gap in awareness despite a strong interest in prevention.

Factors such as recent health access, education level, and perceived risk of HIV infection positively influenced PrEP awareness and willingness, indicating that targeted outreach and education could enhance PrEP uptake among transwomen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness, Willingness, and PrEP Eligibility Among Transgender Women in Rio de Janeiro, Brazil. Jalil, EM., Grinsztejn, B., Velasque, L., et al.[2020]

The transtheoretical model of behavior change was effectively applied in multisite HIV prevention programs aimed at increasing condom and contraceptive use among women at risk for or infected with HIV.

Both facility-based and community-level interventions demonstrated that complex behavioral theories can be successfully implemented by frontline providers with minimal prior training, highlighting the model's practical value in designing HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the transtheoretical model for HIV prevention in a facility-based and a community-level behavioral intervention research study. Cabral, RJ., Cotton, D., Semaan, S., et al.[2004]

A multidisciplinary HIV consult team implemented during hospitalization significantly improved engagement in care and virologic suppression among HIV-positive patients, with increases of 23.7% and 28.3% respectively for those receiving the consult.

Overall, hospitalization provided an opportunity to enhance HIV care outcomes, as all patients showed improved engagement and retention in care after hospitalization, highlighting the importance of targeted interventions in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV care cascade before and after hospitalization: impact of a multidisciplinary inpatient team in the US South. Nijhawan, AE., Bhattatiry, M., Chansard, M., et al.[2022]

A study of 94 healthcare providers revealed that they believe instilling hope in HIV-infected patients is crucial for improving treatment adherence, highlighting the importance of emotional support in healthcare.

Despite some uncertainty about patients' futures, most providers maintained a positive outlook and reported feeling more positive than negative emotions while working with HIV patients, indicating a supportive and hopeful healthcare environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hope, attitudes, emotions, and expectations in healthcare providers of services to patients infected with HIV. Westburg, NG., Guindon, MH.[2019]

In a review of three randomized trials and two cohort studies involving microbicide candidates in sub-Saharan Africa, the incidence of social harms related to trial participation was found to be low, ranging from 1.10 to 3.25 per 100 person-years.

Most reported social harms were linked to male partners rather than community stigma, highlighting the importance of monitoring these partner-related issues to ensure the safety and ethical conduct of HIV prevention research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social harms in female-initiated HIV prevention method research: state of the evidence. Montgomery, ET., Roberts, ST., Nel, A., et al.[2022]

In a study involving 557 pregnant and postpartum women living with HIV, no cases of AIDS-defining illnesses were reported, indicating that continuing antiretroviral therapy (ART) is effective in preventing severe health outcomes.

However, women who continued ART experienced more grade 3 or higher adverse events, particularly moderate weight loss, suggesting that while ART is effective, it may also lead to significant side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding. Brummel, SS., Taha, TE., Angelidou, KN., et al.[2023]

Transcendental Meditation (TM) was found to be a feasible intervention for individuals with HIV, showing significant improvements in vitality and health-related quality of life after six months in a small study of 22 participants.

The study demonstrated a 100% retention rate in the TM group, suggesting high acceptability of the intervention, although the small sample size indicates that further research with larger groups is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of behavioral stress reduction Transcendental Meditation intervention in persons with HIV. Chhatre, S., Metzger, DS., Frank, I., et al.[2021]

Out of 249,066 individuals using Dolutegravir (DTG) in Brazil, only 1.39% reported adverse drug reactions (ADRs), indicating that DTG has good tolerability and safety among people living with HIV.

The majority of reported ADRs were mild and included gastrointestinal, neurological, and psychiatric issues, with serious ADRs being rare, suggesting that DTG is a safe treatment option overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil. Mendes, JC., Ceccato, MDGB., Reis, AMM., et al.[2023]

Participation in the SystemCHANGE™-HIV intervention led to significant increases in overall spiritual well-being (11.5 points) and religious well-being (6.3 points) among people living with HIV, indicating a positive impact on their health and quality of life.

While there was a slight increase in total optimism (0.8 points), it was not statistically significant, suggesting that the intervention primarily enhanced spiritual aspects rather than optimism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spirituality and optimism: a holistic approach to component-based, self-management treatment for HIV. Brown, J., Hanson, JE., Schmotzer, B., et al.[2021]

In a study of 2650 patients on antiretroviral therapy in Nigeria, the incidence of adverse drug reactions (ADRs) was found to be 4.6 per 100 person-years, with the majority of ADRs occurring in the first six months of treatment, highlighting the need for close monitoring during this period.

Most ADRs were mild (grade 1), with pain and skin rash being the most common types reported, and patients on tenofovir (TDF) experienced fewer ADRs compared to those on zidovudine (AZT) or stavudine (d4T), suggesting that TDF may be a safer option in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. Eluwa, GI., Badru, T., Agu, KA., et al.[2022]

Citations

1.

cdc.gov

cdc.gov/hivpartners/php/riskandprevention/index.html

HIV Risk and Prevention Estimates | HIV Partners

There is evidence for the effectiveness of PrEP when used recentlyb (based on detecting TFV in plasma), which is estimated to be 88 – 90% as ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5678381/

The Effectiveness of HIV Prevention Interventions in ...

The combined obtained effect (RR = 0.59; 95% CI = 0.46, 0.75) indicated that preventive interventions significantly reduced the risk of STIs by 41%. No ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S037687161930095X

Outcome evaluation of a “common factors” approach to ...

This paper examines whether provider-developed interventions based on common factors of effective, evidence-based behavioral interventions led ...

4.

gilead.com

gilead.com/news/news-details/2024/gilead-presents-additional-efficacy-safety-and-demographic-data-from-purpose-2-trial-at-5th-hiv-research-for-prevention-conference

October 7, 2024

Efficacy and Safety Data Demonstrated 96% Reduction in HIV Infections with Lenacapavir Compared to Background HIV Incidence Among a ...

5.

californiaaidsresearch.org

californiaaidsresearch.org/funded-research/implementation-science.html

Implementation Science - CHRP

We are proposing a 3-year project to implement and pilot test TransPrEP, a comprehensive implementation strategy that addresses structural barriers.

6.

gilead.com

gilead.com/news/news-details/2025/gilead-presents-new-hiv-research-data-at-eacs-2025--driving-scientific-innovation-in-treatment-and-prevention

Gilead Presents New HIV Research Data at EACS 2025

The use of lenacapavir in virologically suppressed people with HIV is investigational and the safety and efficacy of this use have not been established. There ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10687690/

Efficacy and Safety of Pre-Exposure Prophylaxis to Control ...

The findings indicated that PrEP is a highly effective and feasible strategy against HIV infection in terms of prophylactic response, retention, and compliance.

8.

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, ...

9.

viivhealthcare.com

viivhealthcare.com/en-us/about-hiv/hiv-prevention/

What you should know about HIV Prevention

We believe in a comprehensive approach to HIV prevention that considers both medical and non-medical alternatives that are accessible to all.

10.

chembio.com

chembio.com/wp-content/uploads/2021/12/MSDS-005-Chembio-HIV-Rapid-Test-Control-Pack-PN-60-9549-0-Rev-2.pdf

SAFETY DATA SHEET

A heat inactivation procedure was carried out on each member of the Chembio HIV Rapid Test Control Pack. This method is validated to be.