A Crossover Adherence and 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 compare adherence, preference and acceptability of an over-encapsulated dual prevention pill (DPP capsule) containing oral pre-exposure prophylaxis (PrEP) and a combined oral contraceptive (COC) versus two separate tablets (PrEP and COC) among women at risk of HIV and unintended pregnancy in Johannesburg, South Africa

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Population Council

Criteria

Inclusion Criteria:

• Age 16 through 40 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] be able to provide informed assent and obtain parental or guardian consent, to be screened for and to enroll in the study.)

• Fluent in spoken Zulu 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 validated risk measure, such as the modified VOICE risk score.

• Considers herself to be at moderate to high risk of HIV acquisition based on self-assessment.

• Has been using COCs for contraception for at least 3 months prior to Screening as confirmed by contraceptive card and intends to continue using COCs for at least 12 months.

• HIV-negative per rapid test at Screening and Enrollment per site-specific SOP (see Appendix 3 for HIV testing algorithm).

• 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 (HBsAG) negative per blood test at Screening.

• Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening.

Exclusion Criteria:

• Positive HIV test at Screening or Enrollment (see Appendix 3 for algorithm).

• Positive pregnancy test at Screening or Enrollment.

• Intends to become pregnant within the next 12 months.

• Intolerance, SAE or laboratory abnormality associated with PrEP use in the past.

• Use of PEP within 3 months of Screening (per self-report).

• Breast feeding < 6 months postpartum (per self-report).

• Less than 6 weeks (<=42 days) postpartum and not breastfeeding (per self-report).

• For women 35 and older, currently smokes (self-report).

• History of deep vein thrombosis / pulmonary embolism (self-report).

• Prolonged immobilization (self-report).

• Known thrombogenic mutation/complicated valvular disease (per self-report).

• Ischemic heart disease (per self-report).

• Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies (per self-report).

• Migraines with aura (per self-report).

• For women over 35 years old, migraines without aura (per self-report).

• Current breast cancer or within 5 years of past breast cancer (per self-report).

• Diabetes with nephropathy, retinopathy or neuropathy (per self-report).

• Diabetes for > 20 years (per self-report).

• Symptomatic gall bladder disease (per self-report).

• Severe Cirrhosis (per self-report).

• Liver tumor (per self-report).

• 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.