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Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02732730
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Gilead Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
HIV Prevention Trials Network

Brief Summary:
To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.

Condition or disease Intervention/treatment Phase
HIV Drug: Truvada Phase 4

Detailed Description:
A Phase IV randomized multi-site prospective study to assess PrEP acceptance and adherence among HIV-uninfected young women. All women who accept open-label daily oral PrEP will be randomized 1:1 to receive enhanced adherence counselling based on feedback from observed drug levels or standard adherence support. A subset of up to ~25 women per site (maximum 75), will participate in qualitative assessments of facilitators and barriers for PrEP acceptance, adherence and continuation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
Actual Study Start Date : October 12, 2016
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
Experimental: PrEP Acceptor

For those women who choose to accept PrEP (Truvada), the following adherence support package will be provided:

  • Cognitive Behavioral Theory adherence support sessions
  • Two-way SMS communications
  • Optional monthly adherence support clubs Drug level counseling for those randomized to that extra intervention (1:1)
Drug: Truvada
400 women who accept to initiate PrEP
Other Name: PrEP Acceptor

No Intervention: PrEP Decliner
Standard of care



Primary Outcome Measures :
  1. Proportion of women who accept vs decline Truvada at Enrollment [ Time Frame: Up to 24 months ]
  2. Adherence to Truvada of women randomized to enhanced counseling vs standard [ Time Frame: Up to 24 months ]
    Plasma drug level monitoring


Secondary Outcome Measures :
  1. Proportion of women who declined Truvada who elect to accept it during the study [ Time Frame: Up o 24 months ]
    self report

  2. Proportion and timing of women who discontinue Truvada [ Time Frame: Up to 24 months ]
    self report

  3. Creatinine clearance adverse events in those who accept vs decline Truvada [ Time Frame: Up to 24 months ]
    DAIDS Toxicity Table and Schwartz equation

  4. HIV incidence during the study in those who accept vs decline Truvada [ Time Frame: Up to 24 months ]
    Viral load

  5. Adverse evens in those who accept vs decline Truvada [ Time Frame: Up to 24 months ]
    DAIDS Toxicity Table- numbers, types and severity of adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Young women who meet all of the following criteria are eligible for inclusion in this study:

  • Female at birth
  • Age 16-25 years
  • Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
  • Literate in one or more of the study languages
  • Willing and able to provide informed consent or assent (if parental consent is required per local regulations)
  • If parental consent is required per local regulations, parent/legal guardian willing and able to consent to all study procedures including HIV testing
  • Able and willing to provide adequate locator information, as defined in site Standard Operating Procedures (SOPs)
  • Have a score of 5 or greater on the Vaginal and Oral Intervention to Control the Epidemic (VOICE) risk score tool
  • Interest in PrEP (ascertained by selected questions from the HIV Prevention Readiness Measure (HPRM) and Prep Belief Measure (PBM) defined in the Study Specific Procedures [SSP] Manual)
  • Regular access to a mobile phone with SMS capacity
  • Agrees not to participate in other research studies involving drugs or medical devices for the next 12 months
  • Hepatitis B virus (HBV) seronegative and accepts HBV vaccination.

Exclusion Criteria:

Young women who meet any of the following criteria will be excluded from this study:

  • Planning to relocate in the next 12 months
  • Has a job or other obligations that would require long absences from the area (> 4 weeks at a time) for 12 months
  • Any health condition that may interfere with participation, including any debilitating or life-threatening conditions
  • Currently pregnant or planning to become pregnant in the next 12 months
  • Any reactive or positive HIV test at Screening or Enrollment, even if subsequent testing indicates that the person is HIV-uninfected
  • Renal dysfunction (Creatinine Clearance < 60 ml/min, Schwartz Equation)
  • Any reported PrEP use within the last 12 months
  • Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
  • Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
  • Signs or symptoms of acute HIV infection (as described in the SSP Manual)
  • Current active and serious infections which could interfere with study participation, including active tuberculosis infection, osteomyelitis, and all infections requiring parenteral antibiotic therapy (other than STIs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly-controlled cardiac disease (e.g., symptoms of ischemia, congestive heart failure), or previously diagnosed malignancy expected to require further treatment.
  • Current use of ARV drugs for post-exposure prophylaxis (PEP) or completion of a PEP regimen within 4 weeks prior to Screening
  • History of pathological bone fracture not related to trauma
  • Known allergy/sensitivity to the study drug or its components
  • Receiving ongoing therapy with any of the following: investigational ARV agents, interferon or interleukin therapy, agents with substantial nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents
  • Any other condition that, based on the opinion of the site Investigator of Record (IoR) or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732730


Locations
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South Africa
Wits Reproductive Health and HIV Institute
Johannesburg, Gauteng, South Africa, 2001
Emavundleni CRS
Cape Town, Western Cape, South Africa, 7750
Zimbabwe
Spilhaus CRS
Harare, Belgravia, Zimbabwe, 306
Sponsors and Collaborators
HIV Prevention Trials Network
National Institutes of Health (NIH)
Gilead Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Connie Celum, MD, MPH University of Washington
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Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT02732730    
Other Study ID Numbers: HPTN 082
UM1AI068619 ( U.S. NIH Grant/Contract )
12068 ( Other Identifier: DAIDS )
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be pooled by PID for central analysis by the Fred Hutch in Seattle, Washington
Keywords provided by HIV Prevention Trials Network:
ART (Antir-retroviral therapy)
PrEP (Pre-Exposure Prophylaxis)
DAIDS (Division of AIDS)
HPTN (HIV Prevention Trials Network)
Additional relevant MeSH terms:
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Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents