PrEP N' Shine: Strength Based Case Management (Stage 1) for Prevention

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCLA, Los Angeles, CA
Prevention
PrEP N' Shine: Strength Based Case Management (Stage 1) - Behavioral
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

Adaptive Intervention for PrEP Uptake and Adherence Among At-Risk TGW

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether PrEP N' Shine: Strength Based Case Management (Stage 1) will improve 3 primary outcomes and 1 secondary outcome in patients with Prevention. Measurement will happen over the course of Stage 1: one month post-baseline.

Stage 1: one month post-baseline
Verified medical visit and PrEP prescription
Month 3
Concentrations of TFV-DP in Dried Blood Spots at 3 months
Month 6
Concentrations of TFV-DP in Dried Blood Spots at 6 months
Month 6
Change in sexual risk behavior based on self report

Trial Safety

Trial Design

4 Treatment Groups

Standard of Care:Stage 1
1 of 4
Standard of Care: Stage 2
1 of 4
Strength Based Case Management (SBCM)
1 of 4
PrEP adherence training and counseling
1 of 4
Active Control
Experimental Treatment

This trial requires 106 total participants across 4 different treatment groups

This trial involves 4 different treatments. PrEP N' Shine: Strength Based Case Management (Stage 1) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Strength Based Case Management (SBCM)
Behavioral
Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
PrEP adherence training and counseling
Behavioral
Stage 2: Stepped Intervention: Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.
Standard of Care:Stage 1Stage 1: Referral to local PrEP clinic
Standard of Care: Stage 2Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: stage 2: 6 months post-baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly stage 2: 6 months post-baseline for reporting.

Who is running the study

Principal Investigator
M. M. S. M.
Matthew Mimiaga ScD,, MA, Principal Investigator
University of California, Los Angeles

Closest Location

UCLA - Los Angeles, CA

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age: 18 years or older
Male sex at birth
Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
PrEP naïve
PrEP indicated per CDC guidelines (incl. HIV negative)
Owns a cell phone or willing to use one in the study
Able to understand and speak English or Spanish

Patient Q&A Section

What causes prevention?

"Prevention of some serious diseases is possible, with concerted action by governments, international trade organizations, and international agencies. Prevention also helps to alleviate poverty and to alleviate the burden of disease in developing countries. But many countries around the world have inadequate or insufficient healthcare systems and access to medicines. Even in developed countries, health systems can be overwhelmed by the need for new drugs. New drugs must be discovered within five years of their approval or they will not be available to patients for years. Moreover, if new drugs are developed, their price will be higher than drugs that have already been developed and made available." - Anonymous Online Contributor

Unverified Answer

What is prevention?

"Every year thousands will seek treatment for non-serious problems. Many of these problems are caused by unhealthy lifestyles and over time are a result of poor decisions and inadequate thinking. Some problem are treatable with some lifestyle changes, but can be prevented with others. Good lifestyle choices are not always easy to make, but if we do make them, and make them often enough, then we can keep the chances of getting ill or having a disability in check and keep us healthy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prevention?

"Immunization is the most common treatment against infectious diseases among high-risk individuals, including high-risk patients with HIV or hepatitis C, but only a small number of low-risk individuals receive routine immunizations. Hepatitis B and influenza vaccines are recommended for all high-risk individuals and for certain low-risk individuals, including those at high risk for HIV and those with other contraindications to immunization." - Anonymous Online Contributor

Unverified Answer

What are the signs of prevention?

"There are a number of barriers to the uptake of oral health services, including a failure of effective systems at delivery level. The use of signs is being evaluated by dental practitioners as an adjunct to other methods. This is a promising innovation which should be considered further by the oral health workforce." - Anonymous Online Contributor

Unverified Answer

Can prevention be cured?

"Most preventive interventions have an uncertain efficacy, and their use has not significantly improved over the past three decades, despite advances in knowledge and the growing recognition of their public health importance and limited public funding." - Anonymous Online Contributor

Unverified Answer

How many people get prevention a year in the United States?

"Approximately one-half of American adults do not get regular preventive care. There is a significant need for population-based educational and preventive measures to improve individual and public health." - Anonymous Online Contributor

Unverified Answer

How serious can prevention be?

"These data clearly demonstrate that even though this topic is not as shocking as many things in the news, we all want to do our best to keep our children from contracting any of the many serious diseases that we, in our youth, have seen grow as we have age. Vaccination is something we can embrace in order to stop some of the many deadly diseases that we encounter in life. We can no longer rely solely on doctors to diagnose and treat us as they always do. We have to take the initiative. We are the leaders in this matter." - Anonymous Online Contributor

Unverified Answer

Does prep n' shine: strength based case management (stage 1) improve quality of life for those with prevention?

"This is the first large scale randomized trial (and the first controlled trial of any treatment) demonstrating that a strength-based intervention can have a substantial effect on a range of health and social outcomes for people with prevention. Future work will help clarify the processes by which the intervention achieves a positive impact." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of prep n' shine: strength based case management (stage 1)?

"The prep-n-shine is one of the most important and effective tools in helping women with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) live and feel stronger, more engaged & mobile, and in their own hands. It is also a first-line approach in the management of the menstrual issues of the menopause transition. This book is a reflection that many women can feel and use the prep-n-shine to ease the side effects of the mastectomy & chemotherapy that women receive from the cancer treatment. By using the prep-n-shine to help your menopause transition, you will reap the greatest rewards." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prevention?

"Older people may be at higher risk of trial participation if they have high educational level, adequate reading of information leaflets, good health status and good literacy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prevention?

"It is reasonable to suspect that the primary cause of anosmia is multifactorial. The most likely factor associated with anosmia, sinusitis, seems to be related to impaired mucociliary clearance of mucus, which might be a primary result of chronic disease, rather than a secondary manifestation as a result of sinus disease. Smoking is also likely to play a role." - Anonymous Online Contributor

Unverified Answer

Is prep n' shine: strength based case management (stage 1) typically used in combination with any other treatments?

"Among those receiving case management alone, case management has been shown to be as effective as treatment by a therapist when a combination of case management and psychotherapy is used in the treatment of depression." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Prevention by sharing your contact details with the study coordinator.