MACS/WIHS Combined Cohort Study

Last updated: April 12, 2021
Sponsor: NIH/NHLBI
Overall Status: Active - Recruiting

Phase

1

Condition

Hiv

Hiv (Pediatric)

Treatment

N/A

Clinical Study ID

TX271071
  • Ages 30-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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.

Study Design

Study Start date:
January 01, 2020
Estimated Completion Date:

Study 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.