Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IN-US-276-1340 | Other Identifier | Gilead Sciences Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.
Study Design:
This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.
Primary objectives:
Secondary objective:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP with Truvada | Experimental | All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenofovir disoproxil and emtricitabine | Drug | Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas | Attitudes towards PrEP will be assessed with questionnaires at weeks 12 and 24. | 24 Weeks |
| Assess feasibility of Truvada procurement through the established Gilead access program | Logistic regression comparing the proportion of participants with tenofovir plasma levels greater than 0.3 will be analyzed | 24 Weeks |
| Evaluate adherence to Truvada PrEP at week 12 and week 24 using dried blood spots | Adherence to Truvada PrEP will be assessed at week 12 and week 24 using dried blood spots and questionnaire responses concerning adherence to PrEP | 24 Weeks |
Not provided
Not provided
Inclusion Criteria:
18 - 64 years old
Able to give consent
"At risk" for HIV as defined by any of the following:
CrCl ≥ 60 ml/min
HIV- uninfected women desiring PrEP
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shobha Swaminathan, MD | New Jersey Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Rush University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 5, 2025 | |
| Reset | Sep 26, 2025 | |
| Release | Apr 13, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2016 | May 1, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Chicago |
| Illinois |
| 60612 |
| United States |
| New Jersey Medical School Clinical Research Center | Newark | New Jersey | 07103 | United States |
| West Virginia University | Morgantown | West Virginia | 26505 | United States |
| Reset | Apr 29, 2026 |
| Release | May 1, 2026 |
| Reset | May 26, 2026 |
| Release | Jun 9, 2026 |
| Reset | Jul 6, 2026 |
| ICF_000.pdf |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 5, 2025 | Sep 26, 2025 | |||
| Apr 13, 2026 | Apr 29, 2026 | |||
| May 1, 2026 | May 26, 2026 | |||
| Jun 9, 2026 | Jul 6, 2026 | |||
| Jul 8, 2026 |
| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided