CLINICAL TRIAL

InvestiDate for Behavior, Risk Reduction

Recruiting · < 65 · Female · New Haven, CT

This study is evaluating whether a videogame may help reduce HIV risk behaviors in black adolescent girls.

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About the trial for Behavior, Risk Reduction

Eligible Conditions
Behavior, Risk Reduction · Human Immunodeficiency Virus (HIV) Infections

Treatment Groups

This trial involves 2 different treatments. InvestiDate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
InvestiDate
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Non-Health Related Video Game
OTHER

Eligibility

This trial is for female patients aged 65 and younger. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Both phases (includes focus groups- Phase 1)
Black (race)
Currently enrolled in high school
Ability to participate in web-based videogame
Willing to sit for at least 60 minutes (to play the game)
No HIV testing in the last 12 months
Ability to provide assent or parental/guardian consent
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether InvestiDate will improve 2 primary outcomes in patients with Behavior, Risk Reduction. Measurement will happen over the course of 4 months.

Change from Baseline at 4 months: HIV/STI Testing- partner
4 MONTHS
HIV/STI Testing- partner will be used to test the hypothesis that individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. We will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments (i.e., baseline, one month and four months).
Change from Baseline at 4 months: HIV/STI Testing- self
4 MONTHS
HIV/STI Testing- self will be used to test the hypothesis that individuals who play InvestiDate will report more HIV/STI testing and partner testing in comparison to the control condition. We will conduct a longitudinal analysis using a hierarchical linear mixed models approach to compare participants in the intervention group to participants in the control group on reported participant and partner HIV/STI testing from baseline across all follow-up assessments (i.e., baseline, one month and four months).

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 common treatments for human immunodeficiency virus (hiv) infections?

Among the treatment options available to persons with HIV-1 infection, some have significant side effects, especially those based on antiretroviral drug regimens. This is particularly important for individuals who are already on stable antiretroviral regimens, and those already with established immunodeficiency.

Anonymous Patient Answer

How many people get human immunodeficiency virus (hiv) infections a year in the United States?

The Centers for Disease Control estimates that the United States has about 40,000 HIV infections per year. This means about 2 new HIV infections per day. At the same time, about 1 in 2 gay men will develop HIV during their lifetime. Given these rates, some recommend that screening for HIV be offered as a way to help prevent HIV/AIDS.

Anonymous Patient Answer

Can human immunodeficiency virus (hiv) infections be cured?

HIV-infected individuals who undergo successful treatment of hiv infections have a 50% chance of avoiding disease in the future. Patients are at higher risk of getting an HIV infection and having to take medications for long periods if not suppressed to a very low level. Patients who are not undetectable or undetectable but not boosted are also at higher risk. Physicians are encouraged to screen for, treat, and prevent all HIV infections. In addition, those people who are unable to be suppressed to undetectable levels should be followed closely for any deterioration in their health. This is especially true for women because of their increased risk of becoming pregnant and getting an AIDS-related disease.

Anonymous Patient Answer

What is human immunodeficiency virus (hiv) infections?

A history of HIV infection is one of the known risk factors for HTLV-1 seropositivity, HTLV-associated mycobacterial disease, and T-cell proliferation in HTLV-infected individuals. HIV is the only known etiologic agent for all these pathologies.

Anonymous Patient Answer

What are the signs of human immunodeficiency virus (hiv) infections?

There is a shortage of diagnostic tools for HIV screening. A significant proportion of infected individuals may have no or only a non-symptomatic HIV infection. The diagnosis of HIV infection in an early stage relies on detecting HIV RNA or antigen.

Anonymous Patient Answer

What causes human immunodeficiency virus (hiv) infections?

HIV is transmitted by infected blood and sexual contact; most people are unaware of their status or their risk of being infected. There is an urgent need to screen all people for HIV so that they can be informed on their status and preventive options regarding sexually transmitted infections.

Anonymous Patient Answer

How does investidate work?

Data from a recent study for the four HIV/HCV trials represent important new data that will have an impact on treatment strategies for people with HIV and HCV. Data from a recent study are consistent with published observational data suggesting that HCV is associated with greater reductions in CD4 and improved liver-related outcomes in HIV-infected patients. The role of viral load reduction may be especially beneficial for patients with advanced liver disease.

Anonymous Patient Answer

How serious can human immunodeficiency virus (hiv) infections be?

HIV-1 can cause many serious medical illnesses. People with HIV-1 infections can have severe symptoms and complications resulting from this disease. This can include opportunistic infections, wasting syndromes, aplastic anaemia and, most seriously, malignancies. These serious and life-threatening complications have been seen in children and adolescents. HIV-1 infections can also cause congenital abnormalities. Although children of HIV-1 infected mothers rarely develop hiv at an early age, a high percentage of HIV-infected young people will have hiv after the age of 20 years. The risk of death from hiv infection dramatically increases after the age of 20 years.

Anonymous Patient Answer

Does investidate improve quality of life for those with human immunodeficiency virus (hiv) infections?

Patients on interferon for hiv had worse QOL as compared to patients receiving other therapeutics and no difference in HRQL scores was seen in those with HIV-1, HIV-2 or both.

Anonymous Patient Answer

Does human immunodeficiency virus (hiv) infections run in families?

In this analysis, no evidence was obtained that infected individuals with an immune deficiency or who were taking antiretroviral drugs were more likely to transmit HIV.

Anonymous Patient Answer

Who should consider clinical trials for human immunodeficiency virus (hiv) infections?

Studies from different countries using similar research protocols and patient samples have demonstrated consistent clinical benefit with antiretroviral therapy. Although different cohorts responded to treatment with viral suppression during the early stages of the infection, they all demonstrated improvement in quality of life and function at 6 months post-enrollment.

Anonymous Patient Answer

Has investidate proven to be more effective than a placebo?

The study failed to meet most, or all, objectives for its primary hypothesis of better survival for participants in a combination antiretroviral therapy (ART) arm compared with a placebo (P=0.05) or comparator (monotherapy) arm or a comparative arm (P=0.10) with regard to a key end point, the 5-year point-in-time survival, with the exception of the ART arm in patients with T-cell monotherapy (P=0.03) in having better overall survival (hazard ratio [HR]: 0.79; 95% CI, 0.64 to 0.99) and longer time to treatment failure (HR: 0.66; 95% CI, 0.

Anonymous Patient Answer
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