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

NCT04778527 | Active Not Recruiting DMC

• 1 other identifier: Protocol #953
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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 combined oral contraceptive (COC) versus two separate tablets (PrEP and COC) among women at risk of HIV and unintended pregnancy in Johannesburg, South Africa

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (6)

• To compare adherence to the DPP capsule (Regimen A) versus 2 separate tablets (Regimen B) among women using each regimen daily for 3 28-day menstrual cycles during the Crossover period.

  TFV-DP levels in dried blood spots (DBS) by regimen, and overall, at follow up visits every 4 weeks during Crossover period.

  At the end of Cycle 3 (each cycle is 28 days)

• To compare adherence among women who choose the DPP capsule (Regimen A) versus adherence among women who choose 2 separate tablets (Regimen B), each taken daily during the Choice period.

  TFV-DP levels in DBS by regimen, and overall, at follow up visits every 4 weeks during Choice period.

  At the end of Cycle 3 (each cycle is 28 days)

• To assess and compare self-reported adherence to Regimen A vs Regimen B during the Crossover period, and to the chosen method during the Choice period.

  Self-assessment of ability to adhere to instructions for product use (DPP capsule, FTC/TDF and COCs as applicable) in CASI interviews at follow up visits every 4 weeks during the Crossover and Choice periods.

  Monthly for up to 48 weeks

• To assess and compare adherence to Regimen A vs Regimen B during the Crossover period, and to the chosen method during the Choice period based on pill count.

  Proportion of doses taken vs expected by pill count (DPP capsule, FTC/TDF and COCs as applicable) at follow up visits every 4 weeks during the Crossover and Choice periods.

  Monthly for up to 48 weeks

• 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 the end of Cycle 3 (each cycle is 28 days)

• To determine if more women choose Regimen A versus Regimen B for the Choice period.

  Proportion of women who choose Regimen A vs B for the Choice period.

  At the end of the Crossover period (6 months)

Secondary Outcomes (6)

• To compare the safety of Regimen A versus Regimen B among women using each regimen for 3 28-day cycles during the Crossover period, and the safety of Regimen A versus Regimen B among women choosing each regimen during the Choice period.

  Monthly for up to 48 weeks

• To explore facilitators and barriers to use, as well as socio-ecological factors that may be associated with adherence.

  Monthly for up to 48 weeks

• To assess the acceptability of the DPP vs 2 separate tablets taken daily to prevent HIV and unintended pregnancy among women using each regimen for 3 28-day cycles during the Crossover period, and for up to 6 28-day cycles during the Choice period.

  3 months, 6 months, 12 months

• To assess if pre-use opinions are associated with actual experiences and preferences after using each regimen.

  Baseline and end of Crossover (6 months)

• To qualitatively understand barriers and facilitators to product use and adherence.

  through study completion, an average of 48 weeks

Study Arms (2)

Over-encapsulated DPP

EXPERIMENTAL

A single, over-encapsulated DPP taken once daily for three 28-day cycles (Regimen A) followed by two separate tablets (oral PrEP and COC) taken once daily for three 28-day cycles (Regimen B)

Drug: Dual Prevention Pill

Two Separate Tablets

EXPERIMENTAL

Two separate tablets (oral PrEP and COC) taken once daily for three 28-day cycles followed by a single, over-encapsulated DPP taken once daily for three 28-day cycles

Drug: PrEP tablet and a 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

Over-encapsulated DPP

PrEP tablet and a COC as two separate tablets DRUG

PrEP tablet and a COC as two separate tablets

Also known as: Truvada, Zinnia F

Two Separate Tablets

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Population Council: lead

Study Sites (1)

Witwatersrand Reproductive Health & HIV Institute's (WITS RHI)

Johannesburg, Gauteng, 2001, South Africa

Location

Related Publications (2)

• Ndlovu N, Plagianos M, Palanee-Phillips T, Reddy K, Zulu SK, Kgoa RFO, Irene B, Shale LR, Burnett-Zieman BJ, Sigcu NS, Mathur S, Haddad LB, Friedland BA. Adherence, Preference, and Acceptability of an Overencapsulated Dual Prevention Pill for HIV and Pregnancy Prevention Among Women in Johannesburg, South Africa. J Acquir Immune Defic Syndr. 2026 Feb 1;101(2):141-152. doi: 10.1097/QAI.0000000000003780.

  PMID: 41526807 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

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)

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; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Barbara Friedland, MPH

  Population Council

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 3, 2021
• Study Start: September 13, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)