MACS/WIHS Combined Cohort Study

  • STATUS
    Recruiting
  • sponsor
    NIH/NHLBI
Updated on 12 April 2021

Summary

A collaborative research study that aims to understand co-morbidities and chronic health conditions among men and women living with HIV.

Description

The purpose of this study is to look at the effects of human immunodeficiency virus (HIV) infection on men and women. Volunteers may be eligible if they are HIV positive or HIV negative. Researchers believe that this study may help us to understand and reduce the effect that health problems have on people living with HIV, such as heart disease. 

This study involves at least one in-person study visit every year. The study visit includes an interview, physical exam, blood draw, biospecimen collection, and a number of medical tests to study health conditions. A biospecimen is a sample of human tissue, blood, urine, or other material. 

Details
Condition HIV, *Healthy Patient Studies, HIV (Pediatric), *Healthy Volunteers
Clinical Study IdentifierTX271071
SponsorNIH/NHLBI
Last Modified on12 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must be between 30 and 70 years old
Participants must be able and willing to give informed consent. For new recruits, this must be done in writing, in person
Participants must be able to participate in a baseline visit
Participants must be willing and able to have blood drawn for laboratory testing
Participants must consent to have their specimens stored in the MWCCS national repository
Participants must agree to be re/tested for HIV if hardcopy documentation of a reactive result is unavailable; all HIV‐negative individuals must agree to regular HIV testing in accordance with the protocol stated timeline
Participants recruited at the Johns Hopkins University clinical research site must speak English
HIV-negative men must meet at least one of the following high-risk exposure criteria within the five years prior to screening for enrollment
1.) Diagnosis by a healthcare provider with >2 STIs
2.) Report having unprotected sex with six or more men or women
3.) Report having sex for drugs, money, or shelter
4.) Report having sex with known HIV-positive individual
5.) Report injection drug use, or use of crack, cocaine, heroin, or methamphetamine
6.) Have a partner who engaged in any of the following
a.) Partner reported injection drug use, or use of crack, cocaine, heroin, or methamphetamine
b.) Partner diagnosed by a healthcare provider with an STI
c.) Partner reported having unprotected sex with six or more individuals
d.) Partner reported having sex for drugs, money, or shelter
e.) Partner reported having sex with known HIV-positive individual
HIV-negative women must meet at least one of the following high-risk exposure criteria within the five years prior to screening for enrollment
1.) Diagnosis by a healthcare provider with >1 STI
2.) Report having unprotected sex with six or more men
3.) Report having sex for drugs, money, or shelter
4.) Report having sex with known HIV-positive individual
5.) Report injection drug use, or use of crack, cocaine, heroin, or methamphetamine
6.) Have a partner who engaged in any of the following
a.) Partner reported injection drug use, or use of crack, cocaine, heroin, or methamphetamine
b.) Partner diagnosed by a healthcare provider with an STI
c.) Partner reported having unprotected sex with six or more individuals
d.) Partner reported having sex for drugs, money, or shelter
e.) Partner reported having sex with known HIV-positive individual

Exclusion Criteria

HIV‐positive participants must not have ever used ddI (Videx, didanosine), ddC (Hivid,zalcitabine) d4T (Zerit, stavudine), or early Protease Inhibitors (saquinavir, indinavir, fulldose ritonavir, tipranavir, fosamprenavir, nelfinavir), unless use was only during pregnancy(women only) or for PEP/PrEP
HIV‐positive men and women who acquired HIV perinatally will not be eligible for enrollment
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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