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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02732730
• Date of registration: 02/03/2016
• Prospective Registration: Yes
• Primary sponsor: HIV Prevention Trials Network
• Public title: Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
• Scientific title: Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
• Date of first enrolment: October 12, 2016
• Target sample size: 451
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02732730
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

South Africa, Zimbabwe

Contacts

• Name: Connie Celum, MD, MPH
• Affiliation: University of Washington

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 25 Years
Gender: Female

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Drug: Truvada

Primary Outcome(s)

Adherence to Truvada of women randomized to enhanced counseling vs standard [Time Frame: Up to 24 months]

Proportion of women who accept vs decline Truvada at Enrollment [Time Frame: Up to 24 months]

Secondary Outcome(s)

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

Creatinine clearance adverse events in those who accept vs decline Truvada [Time Frame: Up to 24 months]

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

Adverse evens in those who accept vs decline Truvada [Time Frame: Up to 24 months]

Proportion of women who declined Truvada who elect to accept it during the study [Time Frame: Up o 24 months]

Secondary ID(s)

HPTN 082

12068

UM1AI068619

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)

Gilead Sciences

National Institute of Allergy and Infectious Diseases (NIAID)