Status:
ACTIVE_NOT_RECRUITING
A Crossover Adherence and Acceptability Study Assessing a DPP Capsule for HIV and Pregnancy Prevention
Lead Sponsor:
Population Council
Conditions:
HIV Infections
Eligibility:
FEMALE
16-40 years
Phase:
NA
Brief 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 combin...
Detailed Description
SOUTH AFRICA We will conduct a randomized, open-label, parallel group, 2-way crossover study among approximately 96 women aged 16-40 years old to compare adherence, preference, acceptability and safet...
Eligibility Criteria
Inclusion
- 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, including being comfortable taking the study products as evident by nurse/clinician-observed swallowing at Screening of a large Vitamin capsule that is of similar size to the study products.
- 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 clinician assessment.
- 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 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 (HBsAG) negative per blood test at Screening.
- Normal estimated creatinine clearance (eCrCl) ≥ 60 ml/min per blood test at Screening.
Exclusion
- Intends to become pregnant within the next 12 months.
- Intolerance, adverse reaction, or laboratory abnormality associated with PrEP use in the past.
- Use of PEP within 3 months of Screening (per self-report).
- Breastfeeding \< 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 cigarettes (self-report).
- History of deep vein thrombosis / pulmonary embolism (self-report) or history of thrombophlebitis or thromboembolic disorders at Screening (per self-report or medical records).
- 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
- 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) or history of carcinoma of the breast or other estrogen-dependent neoplasia reported at Screening.
- 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).
- Any other condition the clinician feels would jeopardize the health and wellbeing of the participant.
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04778527
Start Date
September 13 2022
End Date
January 31 2024
Last Update
February 6 2024
Active Locations (1)
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1
Witwatersrand Reproductive Health & HIV Institute's (WITS RHI)
Johannesburg, Gauteng, South Africa, 2001