Kickin it with the Gurlz for HIV Infections

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
HIV Infections+1 More
Kickin it with the Gurlz - Behavioral
Eligibility
18+
Male
Eligible conditions
HIV Infections

Study Summary

This study is evaluating whether a new intervention may help improve HIV care continuum outcomes for transgender women of color.

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Eligible Conditions

  • HIV Infections
  • Acceptability of Health Care

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Kickin it with the Gurlz will improve 1 primary outcome and 3 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Changes from baseline to 3-month follow up.

Changes from baseline to 3-month follow up
Generalized Anxiety Disorder (GAD-7)
PTSD Checklist for DSM-4 (PLC-5)
Patient Health Questionnaire (PHQ-9)
Self-report past 3 months viral load

Trial Safety

Trial Design

2 Treatment Groups

Control
Kicking it with the Gurlz

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Kickin It With The Gurlz is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Kicking it with the Gurlz
Behavioral
This multicomponent intervention includes a violence and gender affirmation screening tool, a peer delivered adaptation of the group-level Seeking Safety Program, and individual-level peer navigation sessions.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: changes from baseline to 3-month follow up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly changes from baseline to 3-month follow up for reporting.

Who is running the study

Principal Investigator
K. G.
Prof. Kristi Gamarel, Assistant Professor
University of Michigan

Closest Location

University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least 18 years old
Assigned male at birth; identifies as female, transgender woman, or another feminine gender identity
Self-identifies as a person of color (any racial/ethnic identity except non-Hispanic white)
Self-reports as HIV-positive
History of trauma (i.e., endorses at least 2 items on the adapted Trauma History Screener which includes IPV and experiencing or witnessing other forms of violence for transgender women
Living or willing to travel to Detroit
English-speaking
Willing and able to provide informed consent.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hiv infections?

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In South Africa, HIV infections are relatively rare. The majority reported they only had sex one time and that men who've sex with men (MSM) are at high risk of contracting HIV. It is important to educate men not to have unprotected anal or oral sex (because both can spread the virus to sexual partners) and to practise safe sex. The more frequently used condoms and the more they practise safe sex are factors that reduce the risk of contracting HIV. [Sex Roles And The Risk of AIDS In South Africa 2001(http://www.health-education.

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What is hiv infections?

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HIV is an infectious disease that primarily affects adults and is caused by HIV-1, HIV-2, and SIV. AIDS is an inflammation in the body that occurs when HIV progresses to AIDS. It has many causes, including infection with HIV. HIV infections that may result in AIDS are spread mainly by unprotected sex, sharing needles, receiving contaminated blood products, and being pregnant. The average age of diagnosis is 38 years, with females diagnosed two years earlier than males. It can cause abnormal or absent growth in babies, loss of one or more fingers, or toes, HIV-related or unrelated cancers, and diseases involving the brain such as AIDS dementia complex and cryptococcal meningitis.

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Can hiv infections be cured?

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HIV infection can be cured if untreated. In the United States, this results in an average life expectancy from diagnosis of more than 20 years, including the potential of cure. In South-east Asia, however, the outlook may be bleak, especially when HIV has spread widely and advanced to more advanced stages. It is vital to educate health professionals and the general public precisely in what situations a successful treatment might be possible.

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What are common treatments for hiv infections?

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Many HIV-infected individuals benefit with antiretroviral therapy (ART) and do suffer from side-effect. Treatment of HIV infections including ART often requires multiple medications over many years. Many HIV patients experience problems with managing their symptoms including depression, cognitive impairment, and decreased quality of life. These patients may also suffer from substance abuse, which is a substantial cause or comorbidity of HIV. These patients often find it difficult to live with HIV in a society where people often make judgments about their sexual health regardless of their HIV status.

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What causes hiv infections?

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HIV disease is not believed to be caused by a virus, although scientists believe that the Epstein-Barr virus and human T-lymphotropic virus are the causative agent of infectious mononucleosis and Kaposi's sarcoma respectively. Virus-specific immune complexes occur in the blood, and these may be used in the diagnosis of HIV-1 infection. HLA antigen incompatibility and HLA incompatibility with viral antigens are thought to play a causal role in transmission to a partner. HLA-A11- B52-DR15- haplotypes confer high levels of HIV-1 risk in South African, Japanese and North African communities.

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How many people get hiv infections a year in the United States?

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In 2003, there will be more than 1.38 million new infections of HIV. At this rate, an estimated 734,000 people in the United States will become infected with HIV by 2014. By 2015, an estimated 1.48 million people will be infected with HIV. Approximately 700,000 people will be diagnosed with HIV infection each year.

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Have there been other clinical trials involving kickin it with the gurlz?

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We found the potential for benefit of this intervention in those with an increased risk for HIV infection. Therefore, the impact of this study is that even if the results were negative, it would still be worth trying to learn more about the topic.

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What is the latest research for hiv infections?

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As HIV treatments are proving less effective with time, new/increasing/different types of treatment(s) are being investigated for HIV patients that may be better suited as they offer more options for patients and are also less costly than the treatments already in use(s). These treatments may provide an additional option to doctors and their patients who must decide what therapy to adopt for their respective HIV cases.

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What are the common side effects of kickin it with the gurlz?

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Results from a recent clinical trial show that a large majority of women reported an increased appetite, fatigue, weight gain, vomiting, diarrhea, and nausea. These symptoms have been reported previously in women who had been treated with various immunosuppressants. We propose that these data reflect a class effect of immunosuppressants. We feel that it is important for investigators to collect accurate information from as many patients as possible about the frequency of side effects in these patients, and we recommend that they collect this information.

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Is kickin it with the gurlz typically used in combination with any other treatments?

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In a recent study, findings is the first to evaluate the utilization of KIN in the setting of HIV clinical trials. Most recent trials use multiple strategies to facilitate patient compliance and are likely to be the most optimal for achieving clinical benefit.

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Is kickin it with the gurlz safe for people?

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Kickin it with the gurlz is not and should be avoided. The use of alcohol (including alcohol-based hand rubs) and/or cigarettes is also not safe for people. Contacting the gurlz is not recommended due to the risk of further exposure.

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Does kickin it with the gurlz improve quality of life for those with hiv infections?

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Our qualitative results indicate that using the internet can serve as a useful channel for disseminating knowledge about HIV and HIV treatment from experts to the less educated communities. The online information may potentially improve sexual, gender, and reproductive health, and may reduce misconceptions associated with HIV/AIDS.

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Get access to this novel treatment for HIV Infections by sharing your contact details with the study coordinator.