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

Trial Summary

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 the treatment Transcendent Health for HIV prevention?

The research suggests that spirituality and optimism, which are components of the Transcendent Health treatment, can positively influence health and slow HIV progression. Additionally, fostering hope, as discussed in the studies, can lead to healthier behaviors and improved treatment adherence, which are beneficial for HIV prevention. ^{1 2 3 4 5}

What safety data exists for Transcendent Health for HIV Prevention?

There is no specific safety data available for Transcendent Health for HIV Prevention in the provided research articles. ^{6 7 8 9 10}

How does the Transcendent Health treatment for HIV prevention differ from other treatments?

Transcendent Health is unique because it incorporates a mind-body approach through Transcendental Meditation, which focuses on reducing stress to improve health outcomes for people with HIV. This is different from traditional treatments that primarily focus on medication or behavioral interventions. ^{11 12 13 14 15}

What is the purpose of this trial?

If, over time, data suggest the intervention impacts HIV preventive behavior at the population level, it will be unique in that it can be quickly and cost effectively scaled up to impact thousands of trans girls and nonbinary youth assigned male at birth.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

HIV care cascade before and after hospitalization: impact of a multidisciplinary inpatient team in the US South. [2022]

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

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

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

Spirituality and optimism: a holistic approach to component-based, self-management treatment for HIV. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Understanding hope in the face of an HIV diagnosis and high-risk behaviors. [2008]

6. England pubmed.ncbi.nlm.nih.gov

Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Social harms in female-initiated HIV prevention method research: state of the evidence. [2022]

8. New Zealand 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. [2022]

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

Brief Report: Impact of ART on Maternal Health After Cessation of Breastfeeding. [2023]

11. United States 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Effects of behavioral stress reduction Transcendental Meditation intervention in persons with HIV. [2021]

13. United States 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. [2020]

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

Awareness, Willingness, and PrEP Eligibility Among Transgender Women in Rio de Janeiro, Brazil. [2020]

15. United States 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. [2004]