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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732730
• Other study ID #: HPTN 082
• Secondary ID: UM1AI06861912068
• Status: Completed
• Phase: Phase 4
• Start date: October 12, 2016
• Est. completion date: October 25, 2018

Study information

• Verified date: November 2018
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Truvada
400 women who accept to initiate PrEP

Locations

Country	Name	City	State
South Africa	Emavundleni CRS	Cape Town	Western Cape
South Africa	Wits Reproductive Health and HIV Institute	Johannesburg	Gauteng
Zimbabwe	Spilhaus CRS	Harare	Belgravia

Sponsors (4)

Lead Sponsor	Collaborator
HIV Prevention Trials Network	Gilead Sciences, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Countries where clinical trial is conducted

South Africa,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who accept vs decline Truvada at Enrollment		Up to 24 months
Primary	Adherence to Truvada of women randomized to enhanced counseling vs standard	Plasma drug level monitoring	Up to 24 months
Secondary	Proportion of women who declined Truvada who elect to accept it during the study	self report	Up o 24 months
Secondary	Proportion and timing of women who discontinue Truvada	self report	Up to 24 months
Secondary	Creatinine clearance adverse events in those who accept vs decline Truvada	DAIDS Toxicity Table and Schwartz equation	Up to 24 months
Secondary	HIV incidence during the study in those who accept vs decline Truvada	Viral load	Up to 24 months
Secondary	Adverse evens in those who accept vs decline Truvada	DAIDS Toxicity Table- numbers, types and severity of adverse events	Up to 24 months