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

NCT04778514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-06

No results posted yet for this study

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

Interventions

DRUG

Dual Prevention Pill

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

DRUG

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

PrEP tablet and a COC as two separate tablets

Sponsors & Collaborators

  • University of Zimbabwe

    collaborator OTHER

  • Population Council

    lead OTHER

Principal Investigators

  • Barbara Friedland, MPH · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2023-09-11
Completion
2023-09-11

Countries

  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778514 on ClinicalTrials.gov