Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
International AIDS Vaccine Initiative
Age
18–49
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Willing to comply with the protocol and available for follow-up for the study duration
Has understood the information provided and has provided written informed consent before any study-related procedures are performed
Willing to undergo couple HIV testing, sexually transmitted infection (STI) screening, HIV counseling and receive test results, and share results with partner
At risk for HIV infection as defined by: has an HIV-infected partner not using ART in the past 3 months and had episodes of unprotected sex with partner in the past 3 months
If a female of childbearing potential:
* using an effective method of non-barrier contraception (hormonal contraceptive
* intrauterine device (IUD)
* surgical sterility) from 7 days prior to randomization until the end of the study
* all female volunteers must be willing to undergo urine pregnancy tests
HIV-infected partner is willing and eligible to enroll in the study
HIV-1 infected partner of an HIV-uninfected volunteer who meets study eligibility
Plan to remain in the relationship for the duration of the study period
Willing and able to provide written informed consent \& locator information
You may not be if
Confirmed HIV-1 or HIV-2 infection
Any clinically significant acute or chronic medical condition that is considered progressive, including severe infections requiring treatment such as tuberculosis, and alcohol or drug abuse
Any of the following abnormal lab parameters:
* Haemoglobin \< 9.0 g/dL
* Creatinine clearance \<80mL/min, as calculated by Cockcroft-Gault equation
* AST: \> 2.5 x ULN
* ALT: \> 2.5 x ULN
* Total bilirubin \> 1.5 x ULN
* Serum amylase \> 1.5 x ULN
* Serum phosphorus \< 2.4 mg/dL
* Urinalysis: Two abnormal dipsticks showing any of the following:
* blood = 2+ or more (not due to menses);
* protein = 1+ or more
* leucocytes = 2+ or more
* glucose= 1+ or more
Confirmed diagnosis of chronic hepatitis B infection (HBsAg positive)
If female, pregnant or planning a pregnancy within 4 months after enrolment or lactating
Participation in another clinical study of a product currently, or within the 3 mo. prior to enrolment
Current use of antiretroviral therapy
Concurrent enrollment in another HIV treatment trial
Clareo Health | A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
