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

NCT04778514 | Completed DMC

• 1 other identifier: Protocol #952
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study design is a single-site, two-arm, randomized, open-label crossover trial in 30 AGYW aged 16-24 in Chitungwiza (Harare), Zimbabwe. The aim of the study is to assess the acceptability of, preference for, and adherence to a single DPP capsule containing one PrEP tablet and one COC tablet compared to two separate tablets (FTC/TDF and EE/LNG), each taken for three consecutive menstrual cycles for a total of 24 weeks among current COC users.

Conditions

HIV Infections; Contraception

Outcome Measures

Primary Outcomes (2)

• To determine preference for taking a single DPP capsule versus 2 separate tablets (PrEP and COC) once daily among women after using each regimen for three 28-day cycles.

  Proportion of women who prefer the DPP (Regimen A) vs 2 separate tablets (Regimen B) after using each regimen for 3 28-day cycles, per self-report on computer-assisted self-interviewing (CASI).

  at study completion (approximately 24 weeks)

• To assess the acceptability of taking the DPP capsule versus two separate tablets once daily to prevent HIV and unintended pregnancy among women who use each regimen for three 28-day cycles.

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

  At the 3 and 6 month visits.

Secondary Outcomes (6)

• To assess and compare daily adherence to PrEP for six 28-day cycles among AGYW when taken in the DPP capsule (Regimen A) or as a separate tablet (Regimen B) via a biomarker.

  Monthly, through 24 weeks

• To assess and compare self-reported adherence to PrEP for six 28-day cycles among AGYW when taken in the DPP capsule (Regimen A) or as a separate tablet (Regimen B).

  Monthly, through 24 weeks

• To assess and compare adherence to the DPP (Regimen A) vs PrEP as a separate tablet (Regimen B) each used for 3 28-day cycles by pill count.

  Monthly, through 24 weeks

• To explore if socio-ecological factors, product characteristics and product use experiences are associated with adherence to PrEP whether taken as part of the DPP capsule or as a separate tablet.

  Baseline and monthly through 24 weeks

• To explore if socio-ecological factors, product characteristics and product use experiences are associated with acceptability of the DPP and of 2 separate tablets.

  at study completion (approximately 24 weeks)

Study Arms (2)

Sequence 1

OTHER

This arm is a single, over-encapsulated DPP containing PrEP (200 mg of emtricitabine \[FTC\], 300 mg of tenofovir disoproxil fumarate \[TDF\]) and a COC (30 mcg of ethinyl estradiol \[EE\], 150 mcg of levonorgestrel \[LNG\]) taken once daily for three 28-day cycles followed by PrEP (FTC/TDF) and a COC (EE/LNG) taken daily for three 28-day cycles.

Drug: Dual Prevention Pill; Drug: PrEP and combined oral contraceptive (COC) as two separate tablets

Sequence 2

OTHER

This arm is two separate tablets (PrEP \[FTC/TDF\] and COC \[EE/LNG\]) taken once daily for three 28-day cycles followed by single, over-encapsulated DPP containing PrEP (FTC/TDF) and a COC (EE/LNG) taken once daily for three 28-day cycles.

Drug: Dual Prevention Pill; Drug: PrEP and combined oral contraceptive (COC) as two separate tablets

Interventions

Dual Prevention Pill DRUG

a single over-encapsulated DPP containing a PrEP tablet and a COC

Also known as: DPP

Sequence 1; Sequence 2

PrEP and combined oral contraceptive (COC) as two separate tablets DRUG

PrEP tablet and a COC as two separate tablets

Also known as: Truvada, Zinnia F

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 \[18 years old\] 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 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, 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.
• 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.

You may not qualify if:

• Currently using emtricitabine (FTC) or tenofovir (TDF) at Screening (per self-report)
• 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).
• 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).
• History of cerebro-vascular or coronary artery disease reported at Screening.
• Ischemic heart disease (per self-report).
• Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies (per self-report).
• Migraines with aura
• History of undiagnosed abnormal genital bleeding reported at Screening.
• 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.

Sponsors & Collaborators

• Population Council: lead
• University of Zimbabwe: collaborator

Study Sites (1)

University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC)

Belgravia, Harare, Zimbabwe

Location

Related Publications (2)

• Mgodi NM, Burnett-Zieman JB, Murombedzi C, Dandadzi A, Gatsi V, Musara P, Matimbira S, Mavemwa G, Jambaya J, Chidemo T, Plagianos M, Haddad LB, Bruce IV, Mathur S, Friedland BA. A Dual Prevention Pill for HIV & Pregnancy Prevention: A Pilot Study Among Adolescent Girls and Young Women in Zimbabwe. AIDS Behav. 2025 Nov 18. doi: 10.1007/s10461-025-04909-2. Online ahead of print.

  PMID: 41251867 DERIVED

• Friedland BA, Mgodi NM, Palanee-Phillips T, Mathur S, Plagianos MG, Bruce IV, Lansiaux M, Murombedzi C, Musara P, Dandadzi A, Reddy K, Ndlovu N, Zulu SK, Shale LR, Zieman B, Haddad LB. Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlled, cross-over studies in South Africa and Zimbabwe. BMJ Open. 2024 Mar 12;14(3):e075381. doi: 10.1136/bmjopen-2023-075381.

  PMID: 38479746 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Contraceptives, Oral, Combined; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Barbara Friedland, MPH

  Population Council

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, parallel group, 2-way crossover study A total of 24 weeks (6 28-day menstrual cycles); 3 cycles of DPP capsule (12 weeks); 3 cycles of 2 separate tablets (PrEP and COC tablets; 12 weeks)

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 3, 2021
• Study Start: December 7, 2022
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1)