Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
220 participants
INTERVENTIONAL
2017-05-25
2018-06-30
Brief Summary
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Detailed Description
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Baseline blood samples will be obtained from participants at month 0. A monthly diary card will be provided for self documenting sexual exposure, alcohol use and pill taking. Participants will receive provisions of PrEP (tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) sufficient for one month, will be instructed on the daily prophylaxis and on how to record adherence on the diary card. Participants will be asked to return each month for treatment re-provisioning and a new card. The content of the diary card will be discussed in a short interview each month.
At month 6 and 12 blood samples will be collected for evaluating immune responses to HIV-1. Additional tests will be done for monitoring HIV-1 status, pregnancy and sexually transmitted infections (STIs). After month 12 PrEP will be discontinued (unless participants opt to continue PrEP until the end of the follow up) and all participants will provide blood samples at month 18.
Baseline and follow-up peripheral blood mononuclear cells (PBMC) samples will be compared for T cell responses to HIV by interferon-γ (IFN-γ) enzyme-linked immunospot (ELISPOT). In case of a positive immune response, plasma collected at the same time point will be nucleic acid test (NAT) tested to verify absence of HIV infection.
HIV infected participants will be evaluated for cluster of differentiation 4 (CD4) T cells and viral load and referred to a Care Program (PEPFAR).
At month 6, 12 and 18 in-depth interviews will be conducted with a randomly selected sample of 44 women (20 percent) to discuss facilitators and barriers to adherence. The diary answers will be tabulated to look for patterns and trends. A framework approach to analysis will be used for the analysis of the qualitative data from interviews.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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TDF/FTC
All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months.
TDF/FTC
All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months.
Interventions
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TDF/FTC
All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* not intending to move away from the clinic's catchment area for the next 2 years
* HIV-1 antibody negative
* reports commercial sex work
* contact information is provided
* written informed consent
Exclusion Criteria
* participation in previous or concurrent HIV vaccine trials
* lactating, pregnant or planning pregnancy
* renal function impairment (serum creatinine \>1.5 mg/dl), Fanconi syndrome
* abnormal liver function tests (AST/ALT \> 43 U/L), liver disease, viral hepatitis, hepatitis B virus (HBV) infection
* serum phosphorus \<2.2mg/dl, osteoporosis
* known sensitivity to components of the Truvada® formulation
* any immunosuppressive treatment, such as systemic corticosteroids
* assumption of medication that interacts with Truvada®
* high likelihood of poor adherence to PREP and clinic attendance
* any condition that in the opinion of the attending physician could endanger the health of the participant or render her unsuitable to participate in the trial
18 Years
FEMALE
Yes
Sponsors
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MRC/UVRI and LSHTM Uganda Research Unit
OTHER
Responsible Party
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Principal Investigators
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Pietro Pala, MD
Role: PRINCIPAL_INVESTIGATOR
MRC/UVRI and LSHTM Uganda Research Unit
Locations
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MRC/UVRI Uganda Research Unit on Aids - Good Health for Women Project
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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References
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Cranage M, Sharpe S, Herrera C, Cope A, Dennis M, Berry N, Ham C, Heeney J, Rezk N, Kashuba A, Anton P, McGowan I, Shattock R. Prevention of SIV rectal transmission and priming of T cell responses in macaques after local pre-exposure application of tenofovir gel. PLoS Med. 2008 Aug 5;5(8):e157; discussion e157. doi: 10.1371/journal.pmed.0050157.
Other Identifiers
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PREPPIE001
Identifier Type: -
Identifier Source: org_study_id