Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B

NCT ID: NCT03120494

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-11-30

Brief Summary

75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.

Detailed Description

75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.

All subjects will have a total of at least 8 study visits during which routine assessment are performed for patients on Truvada for PrEP. Apart from offering routine medical care, a baseline questionnaire that includes socio-demographic variables, PrEP knowledge and acceptability and sexual conducts will be offered. At the 6 months visit, an abbreviated sexual conducts questionnaire will be offered.

Conditions

HIV/AIDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Subjects at risk of HIV

25 high risk MSM and 50 negative partners in a sero-discordant couple will be recruited and emtricitabine and tenofovir (Truvada) for PrEP will be provided, per guidelines, for one year

Group Type: EXPERIMENTAL

Emtricitabine and Tenofovir

Intervention Type: DRUG

All subjects will be provided study drug for use daily for one year.

Interventions

Emtricitabine and Tenofovir

All subjects will be provided study drug for use daily for one year.

Intervention Type: DRUG

Other Intervention Names

Truvada

Eligibility Criteria

Inclusion Criteria

1. Subject is a male, female or transgender female age 21 or older

2. Subject provides written informed consent.

3. Subject provides written authorization for use and disclosure of protected health information (PHI).

4. Subject has one of the following risk factors:

• male, female or transgender female or female sexual partner of an HIV-infected individual, ideally who is not virologically suppressed
• high risk MSM as defined by: having unprotected sexual intercourse with at least two male partner in the last 6 months, or
• diagnosed with an STI in the past 6 months

5. Baseline eCrCl of ≥60 ml/min (calculated using the CKD-EPI formula)

6. Negative Hepatitis B serology

7. No medical contraindications to the use of PrEP

8. Confirmed HIV negative by 5th generation (AB/antigen) HIV test

Exclusion Criteria

1. younger than 21 years of age

2. unable to provide consent

3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).

4. Positive pregnancy test: Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry. Pregnancy testing will also be performed in enrolled female participants prior to any study procedures being performed

5. Baseline eCrCl <60 ml/min

6. Positive Hepatitis B serology to avoid potential flares upon product discontinuation

7. Any medical contraindication to the use of PrEP or any other conditions deemed by the study investigator to exclude the subject's participation in the study

8. HIV infected

9. Signs and symptoms of acute HIV infection

10. For sero-discordant couples: upon review of HIV positive partner's chart, evidence of resistance to any of the components of the study drug.

11. Illness or other condition that, in the opinion of the PI, may interfere with study participation at the time of enrollment.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Puerto Rico Community Network for Clinical Research on AIDS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivian M Tamayo-Agrait, MD

Role: PRINCIPAL_INVESTIGATOR

PR-CoNCRA

Locations

Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)

San Juan, PR, Puerto Rico

Countries

Puerto Rico

Other Identifiers

Puerto Rico PrEP study- Part B

Identifier Type: -

Identifier Source: org_study_id