R34 DPP Clinical Study-A crossover acceptability study assessing a DPP capsule for HIV and pregnancy prevention

Primary Sponsor Details

Secondary Sponsor Details

South Africa and Zimbabwe

• Cisgender female aged 16 through 24 years old (inclusive) at Screening.
• Able and willing to provide informed consent per site SOPs. [If under the legal age of consent (18 years old) and/or an unemancipated minor, be able to provide informed assent and obtain parental or guardian permission/consent, to be screened for and to enrol in the study]
• Fluent (speaking) Shona and/or English
• Able and willing to provide adequate locator information, as defined in site SOPs.
• Able and willing to comply with all study procedures.
• Post-menarche, per participant report at Screening.
• Sexually active, defined as having had penile-vaginal sex with a male within the 3 months before Screening (per self-report)
• At moderate to high risk of HIV infection based on modified VOICE risk score [87, 88]
• Considers herself to be at moderate to high risk of HIV acquisition based on self-assessment.
• Currently using COCs for contraception, and has been using them for at least 3 months prior to Screening
• HIV-negative per rapid test at Screening and Enrolment per site-specific SOP
• Negative pregnancy test at Screening and Enrolment
• Negative for chlamydia, gonorrhea, trichomoniasis, and syphilis at Screening; women who test positive at Screening may be treated and enrolled
• Hepatitis B surface antigen and Hepatitis C negative per blood test at Screening
• Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening

• Positive test for HIV at Screening or Enrolment
• Positive pregnancy test at Screening or Enrolment
• Currently using emtricitabine (FTC) or tenofovir (TDF) at Screening (per self-report)
• Use of PEP within 3 months of Screening (per self-report).
• Intends to become pregnant within the next 12 months.
• Intolerance, SAE or laboratory abnormality associated with PrEP use in the past.
• Breast feeding < 6 months postpartum (per self-report).
• < 6 weeks (<=42 days) postpartum and not breastfeeding (per self-report).
• History of thrombophlebitis or thromboembolic disorders at Screening (per self-report or medical records)
• History of cerebro-vascular or coronary artery disease reported at Screening
• History of carcinoma of the breast or other estrogen-dependent neoplasia reported at Screening
• History of undiagnosed abnormal genital bleeding reported at Screening
• Benign or malignant liver tumor reported at Screening
• Prolonged immobilization
• Known thrombogenic mutation\Complicated valvular disease
• Ischemic heart disease
• Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
• Migraines with aura, if under 35 years old
• Migraines without aura, if 35 years and older
• History of smoking or current smoker, if 35 years and older
• Diabetes with nephropathy, retinopathy or neuropathy
• Diabetes for > 20 years
• Symptomatic gall bladder disease
• Severe Cirrhosis
• Liver tumor
• Estimated creatinine clearance (eCrCl) < 60 ml/min per Screening blood test
• Any other condition the clinician feels would jeopardize the health and wellbeing of the participant

Preference

Proportion of women who prefer the DPP capsule versus 2 separate tablets after using each regimen for three 28-day cycles.

Acceptability

Acceptability scores by regimen and overall, per a quantitative acceptability questionnaire.

9.0 DESIGN OF THE TRIAL

If controlled