A Crossover Acceptability Study Assessing a DPP Capsule for HIV and Pregnancy Prevention

• Status: Not yet recruiting
• Trial end date: 2023-01-15
• Target enrollment: 0
• Participant gender: Female

Summary

A randomized, crossover study to evaluate the acceptability of an over-encapsulated dual prevention pill (DPP capsule) containing pre-exposure prophylaxis (PrEP) and a combined oral contraceptive (COC) pill versus two separate tablets (PrEP and COC) among adolescent girls and young women (AGYW) at risk of HIV and unintended pregnancy in Harare, Zimbabwe

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Population Council
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined

Criteria

Inclusion Criteria:

• Age 16 through 24 years old (inclusive) at Screening, verified per site-specific SOPs

• 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 enroll 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

• 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 Enrollment per site-specific SOP

• Negative pregnancy test at Screening and Enrollment

• 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

Exclusion Criteria:

• Positive test for HIV at Screening or Enrollment

• Positive pregnancy test at Screening or Enrollment

• 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